linjc16/ctgov huggingface dataset:
Evaluation of Pain During Hysterosalpingography With The Use Of Balloon Catheter Versus Metal Cannula

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the metal cannula routinely used in our clinical practice with intrauterine hysterosalpingography catheter as a probable alternative device in a prospective, single-blinded, randomized study.

Conditions
-----------------
Pain During Hysterosalpingography

Intervention / Treatment
-----------------
* Device: Balloon catheter
* Device: metal cannula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged between 18-47 years, applying for basic infertility evaluation to the Reproductive Endocrinology unit Exclusion Criteria: The patients with a known hypersensitivity to iodine or radio-opaque contrast dye, vaginal bleeding, genital malignancy and any sign of pelvic inflammatory disease (PID) were excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 47 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: balloon catheter<br> | Device: Balloon catheter<br> <br> |
| Other: metal cannula<br> | Device: metal cannula<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the degree of pain experienced during the procedure | The primary outcome was the degree of pain experienced during the procedure, pain was evaluated with the Wong Baker Faces Pain Rating Scale (WBS), which ranked the pain from 0 to 5. | 1 hour after the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hysterosalpingography, balloon catheter, metal cannula, pain assessment
A 52-Week Study to Assess the Effects of MK0822 on Knee Osteoarthritis (MK-0822-011)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test MK0822 on disease activity in patients with osteoarthritis in the knee. Disease modifying activity of MK0822 will be assessed by measurements of knee cartilage using Magnetic Resonance Imaging (MRI) of the knee. This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Official Title
-----------------
Proprietary Information - Exploratory (Non-Confirmatory) Trial

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: MK0822


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic knee osteoarthritis for at least 6 months based on clinical and radiographic criteria Patients should be in general good health and must have a certain level of knee pain or be taking pain medicines on most days Specific radiographic (X-ray) and MRI features must also be satisfied Exclusion Criteria: Non-osteoarthritic causes of knee pain Ineligibility to undergo MRI of the knee due to patient tolerability or safety reasons Previous septic arthritis, tibial osteotomy or knee replacement in both knees Acute injury of knee ligaments or meniscus in past 2 years Knee arthroscopy in past 12 months Anticipated arthroscopy or surgery in next 18 months Use of intra-articular injections of hyaluronan (e.g. Hyalgan (TM), Synvisc (TM), Orthovisc (TM)) in past 6 months, or injections of glucocorticoids (e.g. Kenalog (TM), Aristospan (TM), Depo-Medrol (TM)) in past 3 months or anticipated knee injections during the study Glucosamine or chondroitin sulfate are allowable if they are at a stable dose for past 3 months and will continue at that dose during the study Other exclusion criteria apply-Please ask the study doctor for details

Ages Eligible for Study
-----------------
Minimum Age: 40 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: MK0822|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proprietary Information - Exploratory (Non-Confirmatory) Trial |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proprietary Information - Exploratory (Non-Confirmatory) Trial |  |  |
Clinical Performance of the Globe® Mapping and Ablation System for the Treatment of Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
This is an observational, multicentre, prospective, post-market product registry for participants with AF for whom ablation by the commercially available Globe Mapping and Ablation System was indicated before enrolment into the registry. The aim of the registry is to confirm the clinical performance and safety of the Globe Mapping and Ablation System in a real-life setting.

Official Title
-----------------
Prospective, Multi-centre, Observational Registry to Evaluate the Clinical Performance of the Globe® Mapping and Ablation System for the Treatment of Atrial Fibrillation

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Participants with a documented history of atrial fibrillation indicated for ablation using the Globe Mapping and Ablation System before enrolment into registry Signed informed consent Exclusion Criteria: Contraindication for catheter ablation with the Globe System Participant is currently participating in an investigational study that would interfere with registry endpoints according to the participating physician's discretion. Physical or mental condition because of which, in the opinion of the physician, the participant is not able to give informed consent or comply with physician instructions.

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 |
| --- | --- | --- |
| Freedom from AF at 12 months following ablation with the Globe System |  | Up to 1 year | 
| Freedom from AF/AFL/AT at 12 months following ablation with the Globe System |  | Up to 1 year | 
| Device- and procedure-related adverse events within 12 months following ablation with the Globe System |  | Up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, Radiofrequency RF Ablation, Globe Mapping and Ablation System
Efficacy and Safety of Paliperidone ER in First Episode Psychosis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the efficacy and safety of Paliperidone ER in patients with first episode psychosis.

Official Title
-----------------
Efficacy and Safety of Paliperidone ER in Patients With First Episode Psychosis: an Open-label, Prospective Multi-center Study

Conditions
-----------------
First Episode Psychosis

Intervention / Treatment
-----------------
* Drug: paliperidone ER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-59 years and meet DSM-IV diagnostic criteria for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version. Exclusion Criteria: Meeting DSM-IV criteria for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness. Pregnant or lactating women or women without adequate contraception will be also excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: drug<br> | Drug: paliperidone ER<br>* 8 week prospective study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms assessment by objective rating scales | PANSS total score, SANS, CGI | week 1 | 
| Symptoms assessment by objective rating scales | PANSS total score, SANS, CGI | week 2 | 
| Symptoms assessment by objective rating scales | PANSS total score, SANS, CGI | week 3 | 
| Symptoms assessment by objective rating scales | PANSS total score, SANS, CGI | week 4 | 
| Symptoms assessment by objective rating scales | PANSS total score, SANS, CGI, CAI(Cognitive Assessment Interview) | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adverse events by objective rating scales and self report scales profile | NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS | week 1 | 
| Assessment of adverse events by objective rating scales and self report scales | NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS | week 2 | 
| Assessment of adverse events by objective rating scales and self report scales | NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS | week 4 | 
| Assessment of adverse events by objective rating scales and self report scales | NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS, Lipid profile | week 8 |
Development of a Software Correlating Simultaneously fMRI, EEG and Peripheral Physiological Activity

Study Overview
=================
Brief Summary
-----------------
The study aim to improve the quality of EEG recordings during simultaneous fMRI acquisitions. The second aim is to validate the correspondence between cerebral areas activated in fMRI and cortical areas identified with high density EEG during the listening of emotional musical pieces.

Official Title
-----------------
Development of a Software Correlating Simultaneously fMRI, EEG and Peripheral Physiological Activity

Conditions
-----------------
Music Listening

Intervention / Treatment
-----------------
* Device: simultaneous fMRI and EEG + peripheral measures
* Device: EEG and peripheral measures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Right handed healthy people Sensitive to music chill (Barcelona Reward music Questionnaire>50) Having given their participation agreement Individual with health insurance coverage. Exclusion Criteria: Pregnant women Individuals in exclusion period of another study No inclusion criteria of fMRI acquisition Subjects with auditory deficits.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music listening<br>The participants listens to their favorite emotional musical extracts. While listening, their Hemodynamic activity (with fMRI), their cerebral electric activity (with EEG) and their peripheral physiological parameters are recorded simultaneously | Device: simultaneous fMRI and EEG + peripheral measures<br>* Hemodynamic activity recorded with fMRI, cerebral electric activity recorded with EEG as well as peripheral physiological parameters will be recorded during music listening.<br>Device: EEG and peripheral measures<br>* cerebral electric( with EEG) as well as peripheral physiological parameters will be recorded during music listening.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between synchronous cerebral hemodynamics and electric patterns recorded with both EEG and fMRI simultaneously during the production of musical emotions. | The cerebral activity will be measured continuously during musical extracts listening and comparison of the participant self report emotional level will allow to compare fMRI and EEG data to ensure a good correspondence. | Day 0 |
Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in short children born SGA. Safety of the drug is a main objective as well. The growth promoting effect of two different dosages is compared. The effect of long-term treatment on final height is evaluated (according to several amendments)

Official Title
-----------------
Growth Hormone Treatment in Short Children Born Small for Date (Genotonorm)

Conditions
-----------------
Growth Disorders

Intervention / Treatment
-----------------
* Drug: Genotropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Birth length below -2 SD Height at start below - 2 Sd Exclusion Criteria: Any endocrine or chronic disease Any known syndrome with short stature

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 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: Genotropin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height, height velocity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  |  |
ACTION - Anticoagulation Treatment Influence on Post-operative Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare two different regimens of therapy, AVK and ASA (aspirin), in the early postoperative period after aortic valve replacement with SJM Epic™ or SJM Epic™ Supra Porcine Bioprosthetic Heart Valve by establishing the adverse event free survival rate at 3 month post intervention follow-up of the 2 groups(with special focus on thromboembolic events and bleedings).

Official Title
-----------------
Anticoagulation Treatment Influence on Post-operative Patients -Action SJM EPIC Trial

Conditions
-----------------
Heart Valve Disease

Intervention / Treatment
-----------------
* Device: Aortic valve replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient requires, for the first time, isolated aortic valve replacement (pacemaker insertion is allowed) Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements. Patient is of legal age in the host country The patient is in sinus rhythm before implantation Exclusion Criteria: Patient already has a prosthetic valve, other than the valve being replaced at this time. Patient requires double valve implantation Patient requires concomitant CABG Patients requires intra aortic balloon pump at intervention Patient has a medical condition which contraindicates implantation of the SJM Epic and/or SJM Epic Supra Porcine Bioprosthetic Heart Valve (e.g. patient on dialysis) Patient requires ASA or AVK therapy, i.e. not suitable for randomization Patient is pregnant or nursing. Patient is affected by active endocarditis. Patient is affected by aortic dissection. Patient has history of cerebral ischemia Patient is affected by coagulopathy, history of GI bleeding or increased bleeding risk Patient is affected by peripheral vascular disease requiring treatment Patient has previous chronic anticoagulation therapy Patient is allergic to ASA and/or AVK

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 |
| --- |
|Device: Aortic valve replacement|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
DIABASE; Diabetes Mellitus Registry in Second Care

Study Overview
=================
Brief Summary
-----------------
This study aims to examine real world data from medical devices and clinical outcome from diabetes mellitus patients to gain the necessary insights to be able to improve individual patient care by building a registry.

Official Title
-----------------
DIABASE; Diabetes Mellitus Registry in Second Care

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 1 or type 2 diabetes Patients aged 18 years or older Patients visiting the outpatient clinic internal medicine in the ZGT Hospital Written informed consent Exclusion Criteria: Severe general diseases or mental disorders making the participation in the study impossible

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 |
| --- | --- | --- |
| Real world data from medical devices and clinical outcome in a registry | Examine real world data from medical devices and clinical outcome in a registry to gain the necessary insights to be able to improve individual patient care | 0-30 years |
Clinical Evaluation of the STANDARD™ Q Malaria/CRP Duo Test

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the clinical performance (sensitivity, specificity, positive and negative predictive values) of the STANDARD™ Q Malaria/CRP Duo Test when used by health care workers (HW) in a point of care (POC) setting in malaria endemic areas in India. Performance will be assessed in comparison with expert microscopy as the reference test for malaria, and with a high quality, commercially available C-Reactive Protein (CRP) test kit run on a laboratory machine as a reference test for CRP.

Official Title
-----------------
Evaluation of the Clinical Performance of the STANDARD™ Q Malaria/CRP Duo Test (SD Biosensor, South Korea) for the Diagnosis of Malaria and the Detection of C-reactive Protein (CRP) in Fingerprick Blood of Febrile Patients

Conditions
-----------------
Fever Malaria

Intervention / Treatment
-----------------
* Diagnostic Test: Malaria/CRP combination test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically suspected malaria on the basis of fever or history of fever in the previous 72 h age ≥ 5 years, (iii) having been informed of the study and signed a written consent form Exclusion Criteria: signs of severe malaria or other severe disease patients not fulfilling the inclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Malaria/CRP combination test|Testing with a malaria/CRP combination test, in parallel with a standard malaria RDT (to guide case management), preparation of thin/thick films for expert malaria microscopy, and collection of venous blood for subsequent CRP quantification.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance of the Malaria/CRP combination test for malaria diagnosis at day 0 | Point estimates (with 95% confidence intervals) of the sensitivity, specificity, positive and negative predictive values of the STANDARD™ Q Malaria/CRP Duo Test for the diagnosis of malaria, in comparison with expert microscopy as the reference test at day 0 (first day of presentation). | Day 0 | 
| Clinical performance of the Malaria/CRP combination test for detection of high levels of C-reactive protein at day 0 | Point estimates (with 95% confidence intervals) of the sensitivity, specificity, positive and negative predictive values of the STANDARD™ Q Malaria/CRP Duo Test for the detection of CRP at day 0, in comparison with the CRP-LX reagent kit used with the Roche Diagnostics Cobas™ c111 chemistry analyser, or equivalent, as the reference test. | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malaria, fever, C-reactive protein, point-of-care testing