linjc16/ctgov huggingface dataset:
S90652 in Paediatric Hypertension

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the long-term safety and effects on blood pressure of a paediatric formulation of perindopril in hypertensive children

Official Title
-----------------
Safety and Effects on Blood Pressure of Daily Dose 0.025 to 0.135 Milligram Per Kilogram of S90625 a Paediatric Formulation of Perindopril, in Hypertensive Children - 24 Months

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Perindopril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertensive children, who have been treated for four months at least with S90652, with safety and efficacy Exclusion Criteria: Poorly controlled hypertension Girls with signs of pubescence

Ages Eligible for Study
-----------------
Minimum Age: 30 Months
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical safety assessed from the patient's (parents) complaints and clinical follow-up |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  |  |
Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process in healthy Japanese subjects.

Official Title
-----------------
A Single-centre, Randomised, Double Blind, Cross-over Trial Demonstrating the Bioequivalence Between NN2000-Mix30 and NN-X14Mix30 (NovoRapid® 30 Mix) in Healthy Japanese Subjects

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: biphasic human insulin 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese Considered generally healthy based on medical history and physical examination Body Mass Index (BMI) between 18 and 27 kg/m^2 (both inclusive) Fasting plasma glucose between 3.8 mmol/L (68.4 mg/dL) and 6.0 mmol/L (108.0 mg/dL) Exclusion Criteria: Clinically significant abnormal values in clinical laboratory tests of haematology, biochemistry, fasting plasma glucose and urinalysis Any serious systemic infectious disease that occurred during the last 4 weeks before trial Any inter-current illness that may affect blood glucose Subject with a first degree relative with diabetes mellitus Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NN2000<br> | Drug: biphasic human insulin 30<br>* Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits<br>|
| Active Comparator: NN-X14<br> | Drug: biphasic human insulin 30<br>* Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h) |  | From 0 to 16 hours after injection | 
| Maximum insulin aspart concentration (Cmax IAsp) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve of insulin aspart concentration (AUC IAsp) |  |  | 
| Time to maximum insulin aspart concentration (tmax IAsp) |  |  | 
| Terminal elimination half life (t½) |  |  | 
| Body weight |  |  | 
| Adverse events |  |  |
Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the cortical regulation of the paraspinal muscles in chronic low back pain. These (possible) changes in regulatory mechanisms are being compared to other motor control tests in order to determine whether correlations are found. Furthermore the patients are being treated with repetitive transcranial magnetic stimulation (rTMS) and tested afterwards. The purpose is to find out if rTMS-therapy is capable of normalizing motor control deficits.

Official Title
-----------------
Regulatory Central Mechanisms in Chronic Nonspecific Low Back Pain With Lumbar Dysfunction

Conditions
-----------------
Chronic Nonspecific Low Back Pain

Intervention / Treatment
-----------------
* Device: transcranial magnetic stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic nonspecific low back pain for at least six months male gender age 25-50 yrs average pain during last week 4-8/10 by VAS Oswestry disability index 20-80 % Exclusion Criteria: former spinal operations rheumatic disease, marked spondylolysis and -olisthesis, other diseases that markedly reduce physical or psychological performance, history of epilepsy, history of taking epileptic or strong opioid drugs

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cortical function<br>Activity/inhibition of the cortex | Device: transcranial magnetic stimulation<br>* rTMS therapy daily for two weeks, five times per week each lasting for half an hour<br>|
| Active Comparator: Cortical regulation<br> | Device: transcranial magnetic stimulation<br>* rTMS therapy daily for two weeks, five times per week each lasting for half an hour<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between cortical activity and other motor control tests |  | day 1 and day 19 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of rTMS-therapy for clinical outcome and motor control tests |  | day 19, 1 month, 2 months, 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain, motor control, cortical regulation, transcranial magnetic stimulation
Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn more about a condition called 'unclassified hyperoxaluria'. People with this condition have large amounts of oxalate in their urine, which can cause kidney stones and kidney failure. We do not know what causes the high level of oxalate in the urine. In this study, we will evaluate absorption of a test dose of oxalate taken orally by measuring the amount of the test dose that is eliminated in the urine. We will compare the results of affected patients to healthy volunteers.

Detailed Description
-----------------
Participants' oxalate intake and output will be monitored and assessed over a 24 hour period. Participants will ingest a prescribed oxalate dose and urine oxalate will be monitored for the 24 hour study period.

Official Title
-----------------
Investigations Into the Genotype and Phenotype of Unclassified Hyperoxaluria: Enteric Oxalate Absorption Study

Conditions
-----------------
Enteric Hyperoxaluria, Hyperoxaluria

Intervention / Treatment
-----------------
* Drug: C-13 labeled oxalate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age equal to or greater than 4 years (patient must be able to void on request). Have good health. Exclusion Criteria: Any prior history of renal disease, or hypertension ALL subjects (controls and affected patients) will be asked to discontinue any diuretics, calcium supplements, H2 blockers, proton pump inhibitors or gastrointestinal motility agents for approximately one week prior to initiation of the study. Subjects with GFR < 50 cc/min will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 4 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: C-13 labeled oxalate<br>Hyperoxaluric patients | Drug: C-13 labeled oxalate<br>* A single prescribed dose of C-13 labeled oxalate will be given orally in capsule form or in jello. Urine will be collected for 24 hours after the dose. Take one capsule by mouth for one day.<br>* Other names: oxalate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine oxalate measured following absorption of oral oxalate dose | Subjects with hyperoxaluria will be given an oral test dose of oxalate, with measurement of urine oxalate excretion over the next 24 hours. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
C13, Hyperoxaluria, Unknown Hyperoxaluria, Enteric Hyperoxaluria, Oxaluric, High Oxalate, Oxalate, Oxalate Diet
Correlation of Hepatitis C, Alcoholic Liver Disease, and Renal Failure With Hyperfibrinolysis in Liver Failure

Study Overview
=================
Brief Summary
-----------------
Further characterize the incidence of hyperfibrinolysis in cirrhotics Correlate hyperfibrinolysis with hepatitis C alcoholic liver disease the subset of a&b with renal failure with and without dialysis Better describe the hyperfibrinolytic ROTEM profile in cirrhotics

Conditions
-----------------
Cirrhosis

Intervention / Treatment
-----------------
* Other: Rotem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be on the the liver transplant waiting list Exclusion Criteria: liver failure without eligibility for transplant

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 |
| --- | --- |
| Waiting list<br>Patients on the liver transplant waiting list | Other: Rotem<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients who exhibit fibrinolysis | The percentage of patients who exhibit fibrinolysis, defined as a decrease in maximum clot firmness <15% within 60 minutes of sample run time. | Within 60 minutes of sample run time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fibrinolysis, liver transplant, thromboelastometry
Myomectomies:Tumor Characteristics and Clinical Implications

Study Overview
=================
Brief Summary
-----------------
This project focuses on myomectomy patients in reproductive age. The aim is to study both the molecular characteristics of uterine fibroids and to characterize the clinical effects of surgical treatment. Patient series is mainly retrospective and consists of individuals who have undergone myomectomy at Helsinki University Central Hospital (HUCH) during 2009-2015. In addition, the investigators have started a prospective sample collection starting in October 2015, collecting samples from myomectomies. Clinical data sources include medical records, specific questionnaires and a quality of life -questionnaire filled by patients.

Official Title
-----------------
Myomectomies:Tumor Characteristics and Clinical Implications

Conditions
-----------------
Uterine Myomectomy, Genetics, Quality of Life, Gynecologic Surgical Procedures

Intervention / Treatment
-----------------
* Procedure: Myomectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uterine leiomyoma Seeking for surgery Exclusion Criteria: Language proficiency in Finnish, Swedish or English

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Myomectomy|The patient series consists of consecutive patients scheduled for elective laparotomic, traditional laparoscopic or robotic assisted laparoscopic myomectomy. The surgical method is selected based on clinician´s preference.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measured by a validated questionnaire (UFS-QOL) | UFS-QOL: Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate after myomectomy, data collected with questionnaire |  | Five years |
Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51

Study Overview
=================
Brief Summary
-----------------
The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.

Official Title
-----------------
Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51. An Uncontrolled Phase 3 Follow-up Study

Conditions
-----------------
Japanese Encephalitis

Intervention / Treatment
-----------------
* Biological: Japanese Encephalitis purified inactivated vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects at least 18 years of age Written informed consent obtained prior to study entry Subjects correctly included and having completed clinical studies IC51-301 (NCT00604708) and IC51-302 (NCT00605085) with at least one vaccination Exclusion Criteria: Inability or unwillingness to provide informed consent and to abide the requirements of the study

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Japanese Encephalitis purified inactivated vaccine|Japanese Encephalitis purified inactivated vaccine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) | first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302 | 24 months after the first vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) |  | 6, 12, 36, 48 and 60 months after 1st vaccination | 
| Geometric Mean Titers |  | 6, 12, 36, 48 and 60 months | 
| Adverse Events |  | 6, 12, 24, 36, 48 and 60 months after 1st vaccination |
Sacroiliitis in Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
One of the major problems of systemic sclerosis (SSc) patients is suggested to be articular involvement. Mostly involved joints in SSc were reported as wrist, carpometacarpal-interphalangeal, foot, knee, hip and shoulder however there have been little knowledge on sacroiliac joint. Here the investigators plan a study on the involvement of this joint in SSc.

Conditions
-----------------
Systemic Sclerosis, Sacroiliitis, Inflammatory Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed as systemic sclerosis and rheumatoid arthritis and healthy volunteers Exclusion Criteria: Not giving informed consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SSc<br>Sacroiliitis | |
| Rheumatoid arthritis<br>Sacroiliitis | |
| Healthy controls<br>Sacroiliitis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of sacroiliitis in systemic sclerosis |  | One year |
Prospective Multicenter Study in Patients With a Tumor Benign Ovarian Presumed on the Use of Algorithms Such as Roma and RMI and Tumor Markers Such as CA125 and HE4

Study Overview
=================
Brief Summary
-----------------
Ovarian cancer is the fifth leading cause of cancer death in women worldwide. Most of these cancers are manifested in the form of an ovarian cyst. Practitioners are faced with two main difficulties. The first is to establish an early diagnosis. The second is to differentiate a benign tumor, a malignant tumor. To date, there is only one biological tumor marker routinely performed before an ovarian cyst, the CA-125 (cancer antigen 125). Unfortunately, many studies have been performed and show a sensitivity and specificity unsatisfactory in view of the severity of the disease. The principal investigator therefore propose to evaluate a new tumor marker, as well as its use in algorithms to help differentiate benign from malignant tumors, and allow earlier diagnosis in cases of ovarian cancer.

Official Title
-----------------
Prospective Multicenter Study in Patients With a Tumor Benign Ovarian Presumed on the Use of Algorithms Such as Roma and RMI (Risk of Malignancy Index) and Tumor Markers Such as CA125 (Cancer Antigen 125) and HE4 (Human Epididymal Protein 4)

Conditions
-----------------
Ovarian Tumor, Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients to undergo surgery for an ovarian cyst presumed benign ovarian tumor (according to the rules of the IOTA(International Ovarian Tumor Analysis Group) group) agreement to participate in the study Exclusion Criteria: pregnant patient minor patient Patient under guardianship, trusteeship, or deprived of liberty Patient with ascites or metastases or malignant ovarian mass presumed under the rules of IOTA group. Patient with an adnexal torsion is suspected Patient unable to understand the proposed study

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

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

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 |
| --- | --- | --- |
| tumor marker CA125 and HE4 |  | Baseline |
Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone.

Official Title
-----------------
Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blood glucose criteria must be met On a stable dose of metformin as defined by the protocol Body mass index (BMI) in the range 22-45 Exclusion Criteria: Type 1 diabetes Pregnancy or lactation Evidence of serious diabetic complications Evidence of serious cardiovascular complications Laboratory value abnormalities as defined by the protocol Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c after 24 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose at 24 weeks |  |  | 
| Patients with endpoint HbA1c <7% after 24 weeks |  |  | 
| Patients with reduction in HbA1c >/=to 0.7% after 24 weeks |  |  | 
| Change from baseline in body weight at 24 weeks |  |  | 
| Change from baseline in fasting lipids at 24 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, vildagliptin