linjc16/ctgov huggingface dataset:
Product Evaluation of a Newly Developed Intermittent Catheter.

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the navigation of a newly developed catheter.

Conditions
-----------------
Incontinence, Urinary

Intervention / Treatment
-----------------
* Device: Coloplast test catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and at least 18 years Has used Intermittent self-catheterization at least 3 months Has normal to slightly reduced hand mobility Use catheter size CH12 or CH14 (must use same size during product evaluation) Exclusion Criteria: Currently receiving treatment for urinary tract infection Currently receiving chemotherapy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testing the new Coloplast Test catheter<br>The subjects used the new Coloplast Test catheter for 1 week | Device: Coloplast test catheter<br>* This is a newly developed catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Successfully Able to Insert Catheter | The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: How did you find the catheter navigates through the urethra during insertion ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'. | 1 week |
Human Papillomavirus (HPV) Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the performance of HPV self-sampling (self-HPV) in detecting residual/recurrent disease in women treated by loop electro-surgical excision (LEEP) for CIN1+.

Detailed Description
-----------------
The HPV test is an efficient method to assess the long-term risk of residual/recurrent disease in women treated for cervical intraepithelial neoplasia grade 1 or worse (CIN1+). Women treated by LEEP for CIN1+ will be invited to participate. Follow-up visits will be performed at 6 months and 12 months after treatment and will include cytology, colposcopy when indicated and HPV testing. Two weeks before each follow-up visit at the colposcopy clinic, a home-based Self-HPV will be organized. A sample of 168 women will be included. Agreement between the two methods (Dr-HPV vs. S-HPV) will be measured using the kappa statistic (κ). the investigators expect to find that Self-HPV may be an accurate method to predict residual and recurrent disease in women previously treated by LEEP.

Official Title
-----------------
HPV Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia

Conditions
-----------------
Cervical Intra-epithelial Neoplasia Grade 1 or Worse

Intervention / Treatment
-----------------
* Device: HPV self-testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: attending colposcopy clinic biopsy-proven CIN1+ lesion understands study procedures and accepts voluntarily to participate by signing the informed consent form Exclusion Criteria: pregnancy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPV self-testing<br>Patients will perform HPV self-testing at home, prior to their follow-up visit. At the colposcopy visit, the doctor or nurse will also perform HPV testing. This procedure will be repeated at 6 and 12 months following LEEP. | Device: HPV self-testing<br>* Patients will perform HPV testing themselves at home.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with CIN | Number of patients with CIN after LEEP. | 12 months |
Clinical Characteristics in Congenital Cataract Eyes

Study Overview
=================
Brief Summary
-----------------
This study involved children with congenial cataract eyes, who underwent cataract surgeries at the Eye Hospital of Wenzhou Medical University (Hangzhou, China). All medical records were reviewed for primary diagnosis. All surgeries were performed by one experienced surgeon (Z.Y.E) and videos were collected for reviews in details. the clinical data after the surgery were also recorded for further analysis.

Official Title
-----------------
Clinical Characteristics of Three Pathological Types of Posterior Capsule Abnormality in Congenital Cataract Eyes

Conditions
-----------------
Congenital Cataract

Intervention / Treatment
-----------------
* Other: eyes with congenital cataracts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with congenital cataracts who underwent cataract surgeries at the Eye Hospital of Wenzhou Medical University (Hangzhou, China) Exclusion Criteria: ocular trauma

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum 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 |
| --- | --- |
| CC<br>eyes with congenital cataracts | Other: eyes with congenital cataracts<br>* observation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rate | the complication occurrent rate | 3 months |
VR for Symptom Control and Wellbeing

Study Overview
=================
Brief Summary
-----------------
To investigate the effect that a Virtual Reality experience can have on patient symptoms and wellbeing for palliative care and oncology inpatients

Official Title
-----------------
The Use of Virtual Reality for Symptom Control and Wellbeing in Palliative Care and Oncology Patients

Conditions
-----------------
Oncology, End Stage Cancer, Palliative Care, Hematologic Malignancy

Intervention / Treatment
-----------------
* Device: Virtual Reality Headset to provide a Virtual Reality Experience


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria > 18 years of age Inpatient at RCHT know to the palliative care team Able to consent Able to speak and understand the English language Able to use the virtual reality system Able to complete ESAS-r Questionnaire Exclusion criteria <18 years of age Patient unable to consent Patient unable to speak English Unable to use the virtual reality system (e.g. visually impaired) Known Epilepsy or seizures or suspected predisposition to seizures (e.g. Brain metastasis)

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: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Cohort interrupted time series study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Headset<br>VR headset, programmed with a selection of 7 wellbeing programs to identify if use will improve participants wellbeing | Device: Virtual Reality Headset to provide a Virtual Reality Experience<br>* Participants will utilise a Virtual Reality experience for distraction therapy via a Virtual reality headset. Participants will wear the Virtual reality headset to be immersed in a multimedia experience.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ESAS-r Quality of Life Scores | Change in ESAS-r QoL score between start and finish of Virtual Reality experience. 0 = No symptoms to 10 = Worst Symptom | Time 0 & Time 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative clinician experience of VR intervention | Clinician score of patient experience using Virtual Reality intervention for symptoms and wellbeing between 0 (negative) and 10 (positive) | Time 60 minutes | 
| Quantitative clinician experience of VR intervention | Patient score of experience using Virtual Reality intervention for symptoms and wellbeing between 0 (negative) and 10 (positive) | Time 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Virtual Reality
Combining Active Living Programme (ALP) With Home-Use Wearable Technical Aids (WTA)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effectiveness of adopting a home-use Wearable Technical Aids (WTA) with the structured Active Living Program (ALP) to promote community participation in young stroke patients.

Detailed Description
-----------------
Two groups of patients would receive Wearable Technical Aids Training or Wearable Technical Aids Training and structured Active Living Program (ALP) for 8 sessions.

Official Title
-----------------
The Effectiveness of Combining Active Living Programme (ALP) With Home-Use Wearable Technical Aids (WTA) to Promote Community Participation in Young Stroke With Foot Drop Problem- The Pilot Study

Conditions
-----------------
Stroke, Foot Drop (Acquired)

Intervention / Treatment
-----------------
* Device: Active Living programme and wearable technical aids
* Device: Wearable technical aids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -diagnosed with foot drop with tibialis anterior muscle strength between 1 to 3- out of 5 in manual muscle testing for more than six months due to cerebrovascular accident (CVA) Exclusion Criteria: pre-existing orthopedic conditions affecting ambulation subjects who are incompetent in giving written consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Living programme and wearable technical aids<br>Active Living programme and wearable technical aids | Device: Active Living programme and wearable technical aids<br>* attend 6 weeks active living programme and apply wearable technical aids for 8 weeks.<br>|
| Active Comparator: Wearable technical aids<br>Wearable technical aids | Device: Wearable technical aids<br>* apply wearable technical aids for 8 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change score in Stroke Adapted 30 item version of the Sickness Impact Profile (SA-SIP 30) | The quality of life scale for the people with stroke | before intervention, 8 weeks (after intervention ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change score in 10 meters walk Test | 10 meters walk time | before intervention,8 weeks (after intervention) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wearable
Tap Block and Cesarean Delivery: Efficacy and Consumption of Postoperative Drugs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of Tap block after cesarean delivery as a component of multimodal analgesia and evaluation of postoperative drugs consumption.

Conditions
-----------------
Cesarean Delivery

Intervention / Treatment
-----------------
* Procedure: Tap block
* Other: intravenous analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years written consent anesthesiologist's assent on preoperative evaluation Exclusion Criteria: age< 18 years uncooperative patients written consent not obtained local anesthetic allergy BMI > 35

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tap block<br>Tap block with ropivacaine 2 mg/kg at the end of cesarean delivery. Postoperative analgesia with acetaminophen and tramadol plus NSAIDs (nonsteroidal anti-inflammatory drugs) as rescue dose. | Procedure: Tap block<br> <br> Other: intravenous analgesia<br> <br> |
| Active Comparator: control group<br>Postoperative analgesia after cesarean delivery with acetaminophen and tramadol plus NSAIDs (nonsteroidal anti-inflammatory drugs) as rescue dose. | Other: intravenous analgesia<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain evaluation with Numerical Rating Scale (NRS) | We don't want to measure the change between each assessment within a single group, instead we want considering the difference in the measurements between two separate groups (TAP block group and control group) for each time point. | Pain evaluation with NRS at 2,6,12,24 hours after cesarean delivery in TAP block group and in the control group. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of NSAIDs (nonsteroidal anti-inflammatory drugs) consumption as rescue dose during the first 24 hours after cesarean delivery |  | Doses of NSAIDs (nonsteroidal anti-inflammatory drugs) administered at 2, 6, 12 ,24 hours after cesarean delivery TAP block group and in the control group. |
Devitalized Non-valved Pulmonary Artery Allograft Implant for the Repair of Congenital Cardiac Abnormalities

Study Overview
=================
Brief Summary
-----------------
Study no longer required

Conditions
-----------------
NA-Study Withdrawn

Intervention / Treatment
-----------------
* Device: Investigational Device
* Device: Experimental
* Other: Cryopreserved


Participation Criteria
=================

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Device<br> | Device: Investigational Device<br> <br> Device: Experimental<br> <br> |
| Active Comparator: Cryopreserved<br> | Other: Cryopreserved<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Diet Orange Soda on Urinary Lithogenicity

Study Overview
=================
Brief Summary
-----------------
Beverages containing citrate may be useful in increasing urine citrate content and urine pH. Such changes in urine chemistry could help prevent kidney stones. Diet orange soda has more citrate than other similar beverages. The investigators are interested in whether diet soda will improve urine chemistry in the appropriate manner.

Detailed Description
-----------------
The effect of orange soda compared with water in changing 24 hour urine citrate excretion in mg/day will be determined.

Official Title
-----------------
Effect of Diet Orange Soda on Urinary Lithogenicity

Conditions
-----------------
Kidney Stones, Nephrolithiasis, Urolithiasis

Intervention / Treatment
-----------------
* Dietary Supplement: Orange soda


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years old able to sign consent ability to reliably urinate into a vessel and measure urine volume Exclusion Criteria: prior history of nephrolithiasis a known history of metabolic bone disease hyperthyroidism hyperparathyroidism or chronic kidney disease current use of diuretics current use of potassium citrate or other oral alkali supplementation and use of calcium supplementation that could not be stopped

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Water drinking<br>32 ounces of water/24 hours | Dietary Supplement: Orange soda<br>* 32 ounces per day<br>|
| Active Comparator: orange soda drinking<br>32 ounces orange soda | Dietary Supplement: Orange soda<br>* 32 ounces per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urine citrate content | Citrate is measured in 24h urine sample and expressed as mg/day | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urine pH | urine pH is measured in a 24h urine sample and has no units | One week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney stones, Calcium, citrate
Deep Friction Massage for Intercostal Pain in Patients With Heart Disease

Study Overview
=================
Brief Summary
-----------------
Studies show that chest pain is a common complaint presented in both general practice and in emergency units. Musculoskeletal causes are common, but frequently overlooked. No studies about treatment of chest pain from the intercostal muscles were found by search in medical literature databases. The purpose of this study is to evaluate the effect of two different physical therapy interventions on intercostal pain in patients with stable heart disease. The hypothesis was that deep friction massage combined with heat-pack is more effective than heat-pack only.

Official Title
-----------------
Standard Heat-pack With or Without Deep Friction Massage for Intercostal Pain in Patients With Heart Disease

Conditions
-----------------
Heart Diseases, Pain

Intervention / Treatment
-----------------
* Other: heat-pack with massage
* Other: heat-pack only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: increasing chest pain during a cardiac rehabilitation class stable coronary disease new re-vascularisation is not planned Exclusion Criteria: unstable coronary disease not able to perform the study abuse of drugs or alcohol participating in other ongoing study

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: heat-pack with massage<br>deep friction massage and standard heat-pack given a maximum of 8 treatments | Other: heat-pack with massage<br> <br> |
| Active Comparator: heatpack only<br>standard heat-pack given a maximum of 8 treatments | Other: heat-pack only<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | Analogue Scale (VAS) 0 to 100, where 0 is no pain and 100 intolerable pains | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | Health-related Quality of life ( HRQL) was evaluated by the disease-specific instrument MacNew and the generic instrument SF-36 | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thorax, Intercostal Muscles, massage, heat-pack, hot temperature