linjc16/ctgov huggingface dataset:
18F-FDG PET/CT and Molecular Tumor Characterisation for Staging and Follow-up of Colon Cancer

Study Overview
=================
Brief Summary
-----------------
The investigators are investigating the usefulness of 18F-Fluordeoxyglucose Positron Emission Tomography/ Computed Tomography (18F-FDG PET/CT) for staging and follow-up of colon cancer. Furthermore, the investigators combine 18F-FDG PET findings with clinical and histopathological features, circulating tumor cell (CTC) analyses, tumor gene expression and measurements of circulating cancer biomarkers sUPAR, TIMP-1 and CEA in order to predict tumor recurrence. The investigators hypothesis: The combination of functional imaging by 18F-FDG PET/CT and pre-existing and evolving molecular biomarkers will optimize tumor characterization, staging of disease and early detection of recurrence.

Official Title
-----------------
Value of 18F-Fluordeoxyglucose Positron Emission Tomography/ Computed Tomography and Molecular Tumor Characterisation in Preoperative Staging og Postoperative Control of Colon Cancer

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Other: 18F-fluordeoxyglucose positron emission tomography/ computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical or histological diagnosis of malignant clonic neoplasm (distance of more than 15 cm from anal ring) 18 years of age or older written informed consent Exclusion Criteria: diabetes known malignant disease other than colon cancer known metastatic disease impairment of renal function allergy to CT contrast agents body weight of more than 150 kg claustrophobia

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 |
| --- |
|Other: 18F-fluordeoxyglucose positron emission tomography/ computed tomography|18F-fluordeoxyglucose positron emission tomography/ computed tomography for preoperative staging and post-operative follow-up|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to recurrence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
positron emission tomography, computed tomography, fluordeoxyglucose, colon cancer, cancer, staging, imaging
Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion

Study Overview
=================
Brief Summary
-----------------
the aim of the present study is to Compare Safety and Efficacy of Vaginal dinoprostone Versus Lidocaine-prilocaine Cream in copper IUD Insertion in nulliparous women: a randomized controlled trial

Official Title
-----------------
Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion in Nulliparous Women: a Randomized Controlled Trial

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: vaginal dinoprostone
* Drug: Lidocaine-prilocaine Cream
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nulliparous women requesting copper IUD insertion Exclusion Criteria: multiparous women, active vaginal or cervical infections and contraindications to IUD Insertion.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vaginal dinoprostone<br>vaginal dinoprostone 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion. | Drug: vaginal dinoprostone<br>* vaginal dinoprostone 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion<br>|
| Active Comparator: lidocaine prilocaine cream<br>Lidocaine-prilocaine Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before IUD insertion | Drug: Lidocaine-prilocaine Cream<br>* Lidocaine-prilocaine Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion<br>|
| Placebo Comparator: placebo<br>inert placebo Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before IUD insertion | Drug: placebo<br>* inert placebo Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain during IUD insertion: visual analog scale | pain during copper IUD insertion evaluated by 10 cm visual analog scale where 0 denotes no pain and 10 cm denotes the worst pain imaginable | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of insertion | duration of insertion from speculum in to speculum out | 5 minutes |
Postmarketing Surveillance Study for IMOJEV® in Republic of Korea

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to perform the re-examination of IMOJEV® in routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation. Primary objective: To describe the safety profile of the first dose of IMOJEV® administered under routine health care visit as primary vaccination or as booster.

Detailed Description
-----------------
Subjects aged 12 months of age and older and who are given study vaccine during routine health-care visits will be enrolled in the study. No study vaccine will be supplied or administered as part of this study, subjects will be monitored following routine vaccine administration in clinical settings.

Official Title
-----------------
Postmarketing Surveillance Study for a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Republic of Korea

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent form signed by the subject (for subjects 19 years old and above) or the parent(s) or other legal representative (for subjects under 19 years of age) Receipt of the first dose of IMOJEV® (on the day of inclusion) according to approved local insert paper. Exclusion Criteria: Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure. Subjects who already participated in this study.

Ages Eligible for Study
-----------------
Minimum Age: 12 Months

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 |
| --- | --- |
| IMOJEV® Vaccine Group<br>Participants who are 12 months and older and who are given a first dose of IMOJEV® during a routine health care visit | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants reporting solicited injection-site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during the trial | Solicited injection-site reactions: Tenderness/Pain, Erythema, and Swelling. Solicited systemic reactions: infants and toddlers (12 to 23 months) Fever (temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite and Irritability; Subjects aged 2 years and above, Fever (Temperature), Headache, Malaise, and Myalgia | Day 0 up to Day 42 post-vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Japanese encephalitis, IMOJEV®, Japanese encephalitis chimeric virus vaccine
Biomarker in Tissue Samples From Patients With Ewing Sarcoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies biomarkers in tissue samples from patients with Ewing sarcoma.

Detailed Description
-----------------
OBJECTIVES: To determine the frequency of INI-1 protein loss in Ewing Sarcoma. OUTLINE: Previously collected tissue samples are analyzed for INI-1 protein loss by IHC and tissue microarray.

Official Title
-----------------
INI-1 Deletions in Ewing Sarcoma

Conditions
-----------------
Sarcoma

Intervention / Treatment
-----------------
* Genetic: microarray analysis
* Genetic: protein analysis
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of Ewing sarcoma Prepared tissue microarray with Ewing sarcoma samples available PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: microarray analysis|nan|
|Genetic: protein analysis|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of INI1 protein loss in Ewing Sarcoma |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET)
Quantitative Evaluation of Skin Shrinkage Caused by a Non-invasive Tightening Device

Study Overview
=================
Brief Summary
-----------------
This study is being done to measure the amount of skin shrinkage caused by a non-invasive skin tightening device.

Official Title
-----------------
Quantitative Evaluation of Skin Shrinkage Caused by a Non-invasive Tightening Device

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

Intervention / Treatment
-----------------
* Device: Radiofrequency device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 30-60 y/o Mild to moderate laxity of arm skin Skin of Fitzpatrick levels I-III Exclusion Criteria: Any active local arm infections Scarring or abnormalities in upper arm area Major systemic illnesses Any condition with delayed wound healing History of psychiatrist illnesses

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment using a non-invasive skin tightening radiofrequency device to observe skin shrinkage in the arms | Device: Radiofrequency device<br>* One treatment pass on one arm. 2-5 treatment passes on the other<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in Skin Tightening in the Upper Inner or Outer Arm (as Measured by Millimeters) | The documented variable was shrinkage length in millimeters as measured by the same straight ruler used throughout the experimentation. Measurements were taken immediately following treatment and thirty days following the last treatment | immediately following treatment and 30 days after last treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
None- Normal healthy upper arm skin will be used.
PMCF Study for Partial Vision Restoration Using the Subretinal Implant RETINA IMPLANT Alpha AMS

Study Overview
=================
Brief Summary
-----------------
This study is a post-market clinical follow-up (PMCF) study to monitor the safety, lifetime and efficacy of patients using the CE-certified RETINA IMPLANT Alpha AMS.

Detailed Description
-----------------
This study is a post-market clinical follow-up (PMCF) study to monitor the safety, lifetime and efficacy of patients using the CE-certified RETINA IMPLANT Alpha AMS. For Germany, it is under the exceptions mentioned in §23b MPG (Medizinproduktegesetz, German Medical Device Law). Its purpose is to collect data that is created during the regular therapy with the implant. No additional examinations are performed, except a patient questionnaire.

Official Title
-----------------
Post-Market Clinical Follow-up Study for Partial Vision Restoration Using the Subretinal Implant RETINA IMPLANT Alpha AMS

Conditions
-----------------
Retinitis Pigmentosa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received a RETINA IMPLANT Alpha AMS. Patients willing and able to give written informed consent. Exclusion Criteria: none

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 |
| --- | --- | --- |
| Time to device failure | Recording of device failures | 6 Years | 
| Number, nature and severity of challenges or complications during surgical procedures | Recording of adverse events | 6 Years | 
| Number, nature and severity of device-related adverse events and incidents until device failure or explantation | Recording of adverse events | 6 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Functional Vision Test | Eye-hand coordination: a cup should be placed in the middle of a plate | 6 Years | 
| 2. Functional Vision Test | Activity of daily living - Table test: 4 white items of big plate, small plate, bowl, cup and cutlery are placed on a black table cloth and should be identified and touched | 6 Years | 
| 3. Functional Vision Test | Activity of daily living - Clothes sorting: socks in white, grey and black should be sorted | 6 Years | 
| 4. Functional Vision Tests | Assessment of grating acuity: cards with grid patterns of different widths are presented and should be described | 6 Years | 
| Visual related quality of life (Patient reported outcome) | Impact of Vision Impairment - Very Low Vision Questionnaire (IVI-VLV) (Finger et al., 2014) is asking for vision-related quality of life by rating impact of eyesight on various tasks, referring to the last month | 6 Years |
Rapid Diagnostic Test for Septic Arthritis

Study Overview
=================
Brief Summary
-----------------
Diagnostic Validation Study of a Test Based on the Analysis of the Proteome by Mass Spectrometry for the Diagnosis of Septic Arthritis in Children Under 16 Years of Age

Detailed Description
-----------------
Arthritis is an inflammation of the joints that can have many causes. In children, septic arthritis (SA) is the most common cause of acute arthritis (around 45% of cases). Juvenile Idiopathic Arthritis (JIA) is a disease characterized the presence of arthritis in one or more of unknown origin in children under 16 years of age, lasting more than 6 weeks. It is the most common pediatric rheumatological disease with a prevalence of 16 to 150 cases per 100,000 children. Finally, in approximately 40% of children the origin of acute arthritis remains undetermined (ND arthritis). In this group, all the examinations performed are not in favor of a bacterial origin and the evolution of arthritis do not allow the diagnosis of JIA to be retained and no other disease is found. During the first few days of arthritis, differentiation between AS and non-septic arthritis is difficult. The available clinical and biological parameters do not allow for easy and rapid differentiation between AS and non-septic arthritis. This project aims to develop a new diagnostic technique based on molecular analysis of the proteome in the joint puncture fluid.

Official Title
-----------------
Diagnostic Validation Study of a Test Based on the Analysis of the Proteome by Mass Spectrometry for the Diagnosis of Septic Arthritis in Children Under 16 Years of Age.

Conditions
-----------------
Juvenile Idiopathic Arthritis, Arthritis, Septic, Arthritis, Unspecified

Intervention / Treatment
-----------------
* Diagnostic Test: Mass spectrometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >3 months of age <16 years of age Hospitalized for arthritis that started less than 6 weeks ago or patients with diagnosed inflammatory arthritis whose clinical course suggests bacterial superinfection Indication of a joint puncture for diagnostic purposes, confirmed by a senior physician after study of all available clinical and biological elements. Holders of parental authority who have accepted the participation of their children Patients benefiting from a social security scheme (excluding AME) Exclusion Criteria: Contraindications to joint puncture

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Mass spectrometry|Proteomic analysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass spectrometry profile | Proteomics | 15 months |
The Western Galilee Hospital in Nahariya Home Monitoring Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study workload assessment of home monitoring based follow up for ICD or CRTD implanted patient.

Detailed Description
-----------------
EP unit device clinic is a very busy clinic. Every 6 month the patients arrive for device follow up where the device parameters, patient condition and arrhythmic events are being reviewed, and reprogramming of the device (if needed) is done. Average net time of patient's stay in the clinic is between 30-45 minutes. Patients implanted with the Lumax device family allows for a better automated follow up procedure via remote management (Home Monitoring). The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.

Official Title
-----------------
Workload Assessment of a Home Monitoring Based Follow up for Biotronik ICD and CRTD Patients.

Conditions
-----------------
Tachycardia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Approved indication for ICD or CRTD. Implanted with or replaced with a Biotronik Lumax device. Patient is willing and able to sign consent form. Willing and able to attend clinic visits and follow up schedule. Transmission of more than 80% at 3-month FU. Patient older than 18 years. Exclusion Criteria: No indication for ICD or CRTD implant. Life expectancy shorter than 12 months. Pregnancy. Participation in other clinical studies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Home monitoring, cardiomessenger, ICD
Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy

Study Overview
=================
Brief Summary
-----------------
To enable an investigation of fetal movements, the researchers have developed a multichannel ultrasound pulsed Doppler called ACTIFOETUS. This new fetal monitor includes three transducers of four sensors which are placed on three different zones of the mother's abdomen. One of the transducers is aimed at the fetal heart, another at the lower limbs and one transducer at the thorax and the fetal upper limbs to detect heart and body movements. The signals are analysed and processed by software which computes a number of parameters describing the movements. Ninety pregnant women from 28 weeks gestation will be monitored over a 40 minute period every month or every 2 weeks in case of pathological pregnancy. The final purpose will be to develop a system of home monitoring as an indicator of fetal well-being.

Detailed Description
-----------------
The main objective of the study is to detect quantitative and qualitative disorders of fetal movements from 28 weeks of amenorrhea on a fetus presenting in fetal distress. The fetal rhythm will be recorded during 24 hours and a correlation between maternal and fetal movements will be studied. Specific measures: The fetal heart rate The number and extent of fetal movements

Official Title
-----------------
Qualitative and Quantitative Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy

Conditions
-----------------
Pregnancy, Fetal Distress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Pregnancy with singleton Woman from 28 weeks of amenorrhea Exclusion Criteria: Fetal malformation

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Maternal's movements recorded by a specific sensor, Parameters of fetal distress (umbilical and cerebral Doppler) and new-born parameters.