linjc16/ctgov huggingface dataset:
Improve MRI Diagnosis

Study Overview
=================
Brief Summary
-----------------
The main objective of the research is to compare by two blind evaluators new MRI techniques with routinely used sequences.

Detailed Description
-----------------
The main evaluation criterion will be the choice of the two (or three) evaluators as to the best sequence between the new sequence and the standard sequence. The decision criterion for considering a new sequence as superior to the standard sequence will be based on two measures: The proportion of patients for whom the new sequence was preferred, which must be greater than or equal to 75%; Inter-observer agreement (Cohen's Kappa coefficient), which must be greater than or equal to 0.8; When these two criteria are met, the new sequence will be considered superior to the standard sequence

Official Title
-----------------
Evaluation of Advanced and New MRI Techniques to Improve Patient Diagnosis

Conditions
-----------------
New MRI Techniques

Intervention / Treatment
-----------------
* Diagnostic Test: MRI Image


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient Patient who signed a consent to participate in the study Affiliated patient or beneficiary of a social security scheme Patient having an MRI scheduled as part of their care pathway Absence of prohibition of participation in another research Exclusion Criteria: Patients under guardianship or curators Pregnant or breastfeeding patients Patients responding to a contraindication to performing an MRI Patient under state medical aid (AME) Adult patients protected by law

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Other: Adult patients having MRI planned at Paul Brousse Hospital<br>Evaluate new MRI sequences on a population of patients undergoing MRI as part of their usual care | Diagnostic Test: MRI Image<br>* MRI sequences<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality | The main evaluation criterion will be the choice of the two (or three) evaluators as to the best sequence between the new sequence and the standard sequence. | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acquisition period | Average acquisition time | 7 years | 
| Apnea | Proportion of patients for whom apnea was requested. | 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced MRI
Self-management Pessary Project

Study Overview
=================
Brief Summary
-----------------
The goal of this multicenter observational study is to study self-management of pessary therapy in patients with pelvic organ prolapse. The primary question it aims to answer is: • how many patients succeed learning self-management if offered a standardized training? Secondary outcomes are: how many patients are willing to learn self-management? what patient factors contribute to successfully learning self-management and willingness to self-manage? how satisfied are patients with pessary therapy and self-management? the occurrence of side-effects continuation and quitting of pessary therapy and self-management cross-over to surgery number of visits to doctor because of pessary therapy healthcare costs Participants will be asked to fill in questionnaires three times during the study (upon inclusion, 6 weeks and 12 months after starting self-management or after starting pessary therapy with a correctly fitting pessary). Researchers will compare the self-managing patient to the non-self-managing patients.

Official Title
-----------------
Dutch Title: Zelfmanagement Pessarium Project

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Other: self-management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fitted a ring, sieve of knob pessary above 18 years old able to understand patient information Exclusion Criteria: fitted a new pessary to replace an old one (continuing former pessary therapy) fitted a new pessary after they experienced adverse effects of a former pessary

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: self-management|self-managing a pessary: removing, cleaning and inserting|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients that succeed in learning self-management of the pessary | Patients were offered self-management training, after explanation they were asked to remove and insert their pessary twice. Succes was defined as removing and inserting the pessary completely independent the second time. | immediately after self-management training, it is determined whether patients can remove and insert their pessary | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pelvic organ prolapse, pessary, self-management
Swallowing Evaluation by HRIM in Patients With Cervical Spondylosis

Study Overview
=================
Brief Summary
-----------------
patients with cervical spondylolysis may have swallowing or eating difficulty. In this study, we will use high resolution impedance manometry to evaluate these patients' detailed swallowing mechanisms.

Detailed Description
-----------------
This study will aim to evaluate swallowing function in patients with cervical spondylolysis by using high resolution impedance manometry (HRIM) along with oral frailty and dysphagia questionnaires. Researchers will plan to enroll 50 patients to investigate this issue. The inclusion criteria will be as following:1) age higher or equal to 20 years old; 2) patients with cervical spondylolysis or associated symptoms. The exclusion criteria will be as following: major organ dysfunction, including chronic kidney disease, bleeding tendency. The primary outcome will be the upper esophageal sphincter relaxing pressure. The researchers will hope to find the swallowing dysfunction mechanisms in these patients.

Official Title
-----------------
Using High Resolution Impedance Manometry and Videofluoroscopic Measurements of Swallowing Function in Patients Undergoing Cervical Spine Patients

Conditions
-----------------
Upper Esophageal Sphincter Relaxing Pressure

Intervention / Treatment
-----------------
* Other: patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM
* Other: patients with EAT-10 lower than 3 or frailty questionnaire lower than 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with cervical spondylosis associated symptoms or expected to undergo cervical spine surgery patients with associated swallowing difficulty symptoms Exclusion Criteria: major organ dysfunction, such as renal insufficiency or bleeding tendency

Ages Eligible for Study
-----------------
Minimum Age: 20 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 EAT-10 higher than 3 or frailty questionnaire higher than 2<br>patients may have high risk of aspiration | Other: patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM<br>* patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM<br>|
| patients with EAT-10 lower than 3 or frailty questionnaire lower than 2<br>patients may have low risk of aspiration | Other: patients with EAT-10 lower than 3 or frailty questionnaire lower than 2<br>* patients with EAT-10 lower than 3 or frailty questionnaire lower than 2 examined by HRIM<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| upper esophageal sphincter pressure | upper esophageal sphincter opening ability questionnaire | 30 minutes |
Study on Gynecological Rare Cancers

Study Overview
=================
Brief Summary
-----------------
This is a prospective, observational, multicenter study on gynecological rare tumors.

Detailed Description
-----------------
This is a prospective registry aimed to better understand prognosis, clinical and pathological features, management of this rare cancer conditions for improving standard of care.

Official Title
-----------------
Prospective, Multicenter, Observational Study on Rare Gynecological Cancers

Conditions
-----------------
Gynecologic Cancer

Intervention / Treatment
-----------------
* Other: chemotherapy, surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rare gynecological malignancies written informed consent patient fit for follow-up Exclusion criteria -written informed consent not provided
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gynecologic rare tumors<br>The study will include patients with rare gynecologic malignancies | Other: chemotherapy, surgery<br>* this is an observational prospective study, therefore no intervention is planned. Patients perform medical and surgical treatment as per standard of case.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of gynecologic rare malignancies | To describe the prevalence of gynecologic rare tumors | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rare cancers, gynecologic malignancies
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1568 in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the pharmacokinetics and safety following administration of DWJ1568 and DWC202215 in healthy volunteers

Detailed Description
-----------------
The study design is a Randomized, Open-label, Oral, Single-dose, Four-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUCt of DWJ1568 and DWC202215. Secondary endpoints were AUCinf, Tmax, t1/2 of DWJ1568 and DWC202215.

Official Title
-----------------
An Open-label, Randomized, 2x4 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1568 and DWC202215 in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: DWJ1568
* Drug: DWC202215


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 19 year old Exclusion Criteria: Galactose intolerance Lapp lactase deficiency

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWJ1568<br>DWJ1568 | Drug: DWJ1568<br>* One tablet of DWJ1568<br>|
| Active Comparator: DWC202215<br>DWC202215 | Drug: DWC202215<br>* One tablet of DWC202215<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss of DWJ1568 and DWC202215 |  | At pre-dose (0 hour), and post-dose 0 to 72 hour. | 
| AUCt of DWJ1568 and DWC202215 |  | At pre-dose (0 hour), and post-dose 0 to 72 hour. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of DWJ1568 and DWC202215 |  | At pre-dose (0 hour), and post-dose 0 to 72 hour. | 
| Tmax of DWJ1568 and DWC202215 |  | At pre-dose (0 hour), and post-dose 0 to 72 hour. | 
| AUCt/AUCinf of DWJ1568 and DWC202215 |  | At pre-dose (0 hour), and post-dose 0 to 72 hour. | 
| t1/2 of DWJ1568 and DWC202215 |  | At pre-dose (0 hour), and post-dose 0 to 72 hour. |
The Effect of Eye Movement Desensitization and Reprocessing Intervention in Hypertension Patient.

Study Overview
=================
Brief Summary
-----------------
Eye Movement Desensitization and Reprocessing intervention may improve anxiety, depression, systolic blood pressure and heart rate variability in patients with hypertension.

Official Title
-----------------
The Effect of Eye Movement Desensitization and Reprocessing Reducing Anxiety, Depressive Symptoms, Blood Pressure, and Heart Rate Variability in Primary Hypertension： A Randomized Controlled Clinical Trial

Conditions
-----------------
Eye Movement Desensitization and Reprocessing Intervention, Blood Pressure, Heart Rate Variability, Anxiety

Intervention / Treatment
-----------------
* Behavioral: Eye Movement Desensitization and Reprocessing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age of 20-80 years, diagnosed with primary hypertension as in SBP ≥130 mmHg or DBP ≥80 mmHg, and able to read and understand Chinese or Taiwanese and willing to participate in this study, Exclusion Criteria: . Secondary hypertension . Hypertension Crisis.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eye Movement Desensitization and Reprocessing intervention<br>The goal of EMDR is to help manage physical and mental unpleasant experiences due to hypertension. The intervention group received EMDR therapy included eight phases, each lasting 60-90 minutes, and the intervention consisted of four weekly. In this study, a Nurse practitioner trained in EMDR performs an intervention in an outpatient clinic's quiet, empty room. | Behavioral: Eye Movement Desensitization and Reprocessing<br>* Effects of Eye Movement Desensitization and Reprocessing on Anxiety, Depression, Quality of Life, Blood Pressure and Heart Rate Variability in Patients with Hypertension.<br>|
| No Intervention: Eye Movement Desensitization and Reprocessing control<br>The control group received routine care and treatment as usual. They did not receive EMDR intervention or counseling. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | HADS-A score | Six month | 
| depression symptoms | CESD Scale | Six month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Blood pressure | Six month |
New Method for the Collection of the Output From the Ileostoma Using a Intestinal Tampon

Study Overview
=================
Brief Summary
-----------------
1 study: A pilot study of 8 adults with ileostomy was included in this trial of first in human with InterPoc™, an absorbent intestinal tampon safety and feasibility in humans with ileostomies. Study 2: A study in total with 24 participants, evaluating both the safety but also the functionality of InterPoc in humans with ileostomies.

Detailed Description
-----------------
Approximately 1 million individuals with ileostomies face limitations in design and complications with traditional stoma bags dating back to the 1950s. Colostomy care alternatives are unavailable for ileostomy patients, prompting the development of InterPoc™, an absorbent intestinal tampon. The first study aims to assess its safety and feasibility in humans, while the second study focuses of the overall safety and functionality of the tampon in all 24 participants.

Official Title
-----------------
First Study: InterPoc's Safety and Tolerability in Adults With Second Study: Safety and Functionality of InterPoc

Conditions
-----------------
Ileostomy - Stoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of at least 18 Ileostoma at least created 6 months prior Ileostoma opening of at least 15 mm Exclusion Criteria: Inflamatory condition in the stoma or other intestine diagnosed within 2 months of the study Parastomal hernia daily output above 2 litters

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients requiring pharmacological or surgical intervention due to the use of InterPOC for 6 hours | Safety of Interpoc during use | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during interpoc use | Using the NRS from 0-10 | 6 hours | 
| Early warning score during interpoc use (vital signs Pulse, blood pressure, oxygen saturation, respiratory rate, temperature), | A low score is better than a high score | 6 hours | 
| Scale (0-10) score of Discomfort, acid reflux, nausea | A low score is better than a high score | 6 hours | 
| InterPoc™ weight before and after insertion | For comparable | 6 hours | 
| Leakage around the stoma pouch | Scale: 1-3) | 6 hours | 
| Fecal output in stoma bag (ml) before and after the trail | scale 1-3 | 6 hours | 
| InterPoc™ Skin Irritation | (Scale: 1-3) | 6 hour | 
| Insertion and removal resistance | scale 1-3) | 6 hour | 
| Food consumption | descriptive | 6 hour |
Study to Evaluate the Safety and Pharmacokinetics of CKD-379

Study Overview
=================
Brief Summary
-----------------
A study to compare the pharmacokinetics and safety between CKD-379 and D759, D745, D029, D150 combination

Detailed Description
-----------------
A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-379 in healthy volunteers under fed conditions

Official Title
-----------------
A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-379 in Healthy Volunteers Under Fed Conditions

Conditions
-----------------
Type II Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: CKD-379
* Drug: D759+D745+D029+D150


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 19 aged and 50 aged in healthy adult 18.0kg/m2≤body mass index(BMI)≤27.0kg/m2 and 50.0kg≤Body weight≤90.0kg Exclusion Criteria: Have clinical significant medical history or disease that blood, kidney(moderate nephropathy and etc.), endocrine system(type I or type II diabetes mellitus, diabetic ketoacidosis, diabetic coma and etc.), respiratory system, gastrointestinal system, urinary system, cardiovascular system(heart failure, Torsades de pointes and etc.), liver(moderate liver disorder and etc.), mental system, nervous system, immune system Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery Those who are pregnant or breastfeeding Those who are deemed inappropriate to participate in clinical trial by investigators

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Period 1: Reference drug(D759+D745+D029+D150) Period 2: Test drug(CKD-379) | Drug: CKD-379<br>* 2 tablet administration under fed condition<br>Drug: D759+D745+D029+D150<br>* 4 tablet co-administration under fed condition<br>|
| Experimental: Sequence 2<br>Period 1: Test drug(CKD-379) Period 2: Reference drug(D759+D745+D029+D150) | Drug: CKD-379<br>* 2 tablet administration under fed condition<br>Drug: D759+D745+D029+D150<br>* 4 tablet co-administration under fed condition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt | Maximum plasma concentration of the drug | 0 48hours | 
| Cmax | Area under the concentration-time curve from the time of dosing to the last measurable concentration | 0 48hours |