linjc16/ctgov huggingface dataset:
Remodelling After Trampoline Fracture in Children

Study Overview
=================
Brief Summary
-----------------
The anterior tilting of the proximal tibia epiphyseal plate is a radiological tool for the diagnosis of suspected trampoline fracture. The tibial fracture leads to a ventral tilting of the tibial Plateau. This study is to document the long-term follow-up of the anterior tilt angle and to verify, if there is an uplift of the tibia plateau with correction of the anterior tilt angle to normal values (= remodelling) in order to guarantee optimal treatment of this rare fracture.

Official Title
-----------------
Remodelling After Trampoline Fracture in Children

Conditions
-----------------
Trampoline Fracture, Tibial Fracture

Intervention / Treatment
-----------------
* Diagnostic Test: radiographs in two views of the tibia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: trampoline fracture of the proximal lower leg Exclusion Criteria: proximal tibial fractures with unclear etiology

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: radiographs in two views of the tibia|The anterior tilt angle of the tibia will be measured by two specialized radiologists according to a specific radiological angle measurement tool (PACS Sectra IDS7TM, Linköping, Sweden).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anterior tilt angle of the tibia | radiological measurement of the anterior tilt angle of the tibia (degree) | one year after fracture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference of anterior tilt angle of the fractured tibia compared with the angle of the healthy tibia | difference of anterior tilt angle of the fractured tibia compared with the angle of the healthy tibia (degree) | one year after fracture | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ventral tilting of the tibial plateau, anterior tilt angle, proximal tibia epiphyseal plate
Hidradenitis Suppurativa Written Action Plan

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to evaluate if a written action plan for hidradenitis suppurativa (HS) will help patients with hidradenitis suppurativa gain a better understanding of the condition and how to manage the condition on a daily basis compared to a routine verbal consultation.

Official Title
-----------------
Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa

Conditions
-----------------
Hidradenitis Suppurativa

Intervention / Treatment
-----------------
* Behavioral: Verbal consultation
* Behavioral: Written Action Plan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has a diagnosis of HS Exclusion Criteria: Has been exposed to a written action plan for HS before

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Verbal Consultation, then Written Action Plan<br>CONTROL GROUP Survey A Routine clinic visit Verbal consultation only Survey B Verbal consultation AND Written Action Plan Survey C | Behavioral: Verbal consultation<br>* Verbal consultation only without written information before receiving written action plan<br>Behavioral: Written Action Plan<br>* Written handout of treatment plan and disease management strategies<br>|
| Experimental: Written Action Plan<br>INTERVENTION GROUP Survey A Routine clinic visit Verbal consultation AND Written Action Plan Survey C | Behavioral: Written Action Plan<br>* Written handout of treatment plan and disease management strategies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visits to high-cost care settings | Number of visits to ER, urgent care, or hospitalizations because of HS | 12 months |
Retrospective, Non-significant Risk, Deep Brain Stimulation (DBS) Care Management Software Feasibility Study

Study Overview
=================
Brief Summary
-----------------
To evaluate DBS device settings and match with the features of the DBS care management software.

Detailed Description
-----------------
This is a study done on Parkinson disease subjects who have received the DBS system implanted in their subthalamic nucleus.

Official Title
-----------------
OPTIVISE Map Concordance Study in DBS for Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Device: Medtronic DBS system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with Medtronic Deep Brain Stimulation therapy for idiopathic levodopa responsive Parkinson's Disease Patient who has had lead placement in the Subthalamic nucleus Patient with pre-op MRI available Patient with post-op CT scan available showing placement of the lead Patient who has documented improvement of at least 35% on UPDRS III scores from baseline preoperative off medication state compared to post DBS implant stimulation on/medications off Exclusion Criteria: Patient who has had clinically significant persistent stimulation related adverse effects Patient who has evidence of lead migration without lead revision Patient with other brain malformations that would make it difficult to process images (ablative surgery in the basal ganglia, resective surgery, brain tumor)

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 |
| --- | --- |
| Parkinson's disease Subjects<br>Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system in the subthalamic nucleus (STN). | Device: Medtronic DBS system<br>* Advanced Parkinson's disease patients implanted with the Medtronic Deep Brain Stimulation (DBS) system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap | The one-sided 95% exact binomial lower confidence bound of the proportion was calculated from subjects with readable images enrolled in the study. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores | The summary of UPDRS III medication off score at baseline and the UPDRS III stimulation on/medication off score at follow-up and the change from baseline to 18 months. The UPRS III has a range of 0 - 108. | Change from baseline to 18 months |
The Use of Ultrasound in Assessing Post-prostatectomy Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to determine whether there is additional utility to using vibroelastography, a noninvasive ultrasound technique to evaluate for the presence of tissue fibrosis, in conjunction with standard penile duplex Doppler ultrasound to assess erectile function (recovery) after prostate cancer surgery.

Official Title
-----------------
Ultrasound Vibroelastography in Post-Prostatectomy Erectile Dysfunction

Conditions
-----------------
Prostate Adenocarcinoma

Intervention / Treatment
-----------------
* Diagnostic Test: Ulrasound Vibroelastography (UVE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria include: Age > 40 years Clinically localized prostate cancer (American Urological Association Grade Groups 1-2; cT1c or cT2a-b; PSA < 10) without clinic or imaging evidence of localized extra-prostatic or metastatic disease (i.e. AUA low and favorable intermediate risk prostate cancer) International Index of Erectile Function (IIEF) of ≥ 21 points at baseline (no or mild erectile dysfunction) Patient-expressed interest in consultation for sexual function (erectile function) preservation/ optimization Planned bilateral nerves-paring prostatectomy Exclusion criteria include: Moderate or severe ED based in IIEF criteria (score < 21) History of prior pelvic or penile surgery Current or prior androgen deprivation therapy Planned non-nerve sparing prostatectomy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound viscoelastography (UVE) in radical proctectomy recovery<br>Subjects undergoing radical prostatectomy for prostate cancer disease as standard of care will have a ultrasound vibroelastography performed before surgery, 3 months, 6 months and 9 months post-prostatectomy. | Diagnostic Test: Ulrasound Vibroelastography (UVE)<br>* Ultrasound technique to quantitatively assess tissue stiffness (elasticity and viscosity) by applying vibration through a specialized probe (indenter).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Viscoelasticity | As measured by Ultrasound Vibroelastography (UVE) | Baseline, 3 months, 6 months and 9 months post-prostatectomy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radical Prostatectomy
Metastatic Colorectal Cancer. Real-World Data Analysis.

Study Overview
=================
Brief Summary
-----------------
The Treatment Choices, Duration and Outcomes in Patients with Ras Wild Type (RAS WT) Metastatic Colorectal Cancer (mCRC). Retrospective, Multi-Center, Real-World Data Analysis

Detailed Description
-----------------
In this study, with the given rationale is to reveal treatment approaches, survival data, side effect profile and their management in our country in RAS WT mCRC patients by means of the real-world data collection.

Official Title
-----------------
The Treatment Choices, Duration and Outcomes in Patients With Ras Wild Type (RAS WT) Metastatic Colorectal Cancer (mCRC). Retrospective, Multi-Center, Real-World Data Analysis

Conditions
-----------------
Metastatic Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been histologically diagnosed with mCRC Patients over the age of 18 Patients receiving at least a cycle systemic treatment for metastatic disease RAS wild type patients Patients who has demographic, histopathological and clinical information Exclusion Criteria: Patients diagnosed as mCRC but only referred to BSC Patients with RAS mutation Patients who were included in any clinical trial except standard treatments during their treatment

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metastatic Colorectal Cancer Patients<br>All RAS wild type metastatic colorectal cancer patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of use anti-EGFR agents | The anti-EGFR agent selection | throughout of treatment, 3 years | 
| Progression Free Survival (PFS) | PFS three years after initiation of treatment with anti-EGFR agents | 3 years treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Advers events | Advers event of anti EGFR is defined as any untoward or unfavourable medical occurrence, including any abnormal sign, symptom, or disease, temporally associated with the patient's participation. The CTCAE v.4.0 will use in this research. | throughout of treatment, 3 years |
Vitamin D Supplementation on Outcome and Disease Activity.

Study Overview
=================
Brief Summary
-----------------
To study efficacy of Vitamin D on outcome and disease activity ; DAS28-ESR in Rheumatoid arthritis patients at Rajavithi hospital .

Official Title
-----------------
Vitamin D Supplementation on Outcome and Disease Activity in Rheumatoid Arthritis Patients at Rajavithi Hospital : A Randomized Clinical Trial

Conditions
-----------------
Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR

Intervention / Treatment
-----------------
* Drug: Vitamin D 2
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 yrs old RA diagnosed by ACR/EULAR 2010 low to moderate disease activity on stable NSAIDs and DMARDs for at least 1 month Received Prednisolone less than or equal to 7.5 mg/day serum calcium, phosphorus and ALP are within normal limit. Exclusion Criteria: Chronic kidney disease stage 3 or higher History of TB History of Chronic liver disease Pregnancy or breast-feeding adjustment of immuno-suppressive drugs, steroid other connective tissue disease Vitamin D allergy received other drugs which have vitamin D component serum Vitamin D less than 10 ng/mL

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D supplementation group<br>First arm ; add on vitamin D 40,000 IU/week for 12 weeks | Drug: Vitamin D 2<br>* Randomized allocation first arm : add on vitamin D supplementation 40,000 iu/week for 12 weeks<br>|
| Experimental: second arm<br>add on placebo | Drug: Placebo<br>* Second arm : add on placebo for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study efficacy of vitamin D on disease activity RA patients at Rajavithi hospital | Determine disease activity by DAS28-ESR in relation with vitamin D supplementation. | 12 weeks | 
| To study efficacy of vitamin D on IL-6 in RA patients at Rajavithi hospital |  | 12 weeks |
Evaluation of Perineural Catheterization Practices in Postoperative Orthopedic Surgery

Study Overview
=================
Brief Summary
-----------------
Continuous peripheral nerve blocks are considered as the gold standard for postoperative analgesia in orthopaedic surgery (shoulder, knee, foot). These techniques are also used in chronic pain. The main disadvantage of these techniques is that they can drive a more or less deep motor block that slows down the rehabilitation process. This disadvantage could be prevented (or minimized) by adapting the protocol for administering local anesthetics or by changing molecules (levobupivacaine 0.625 mg/ml instead of ropivacaine 2 mg/ml). There is no literature comparing the effectiveness of the sensory block and its impact on the motor block according to the administration protocol and/or the type of local anesthetics. The main judgement criterion of such a study could be a composite criterion crossing the quality of the sensory block and the depth of the motor blockades, the ideal being to have a perfect sensory block without any motor block.

Official Title
-----------------
Evaluation of Perineural Catheterization Practices in Postoperative Orthopedic Surgery

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Drug: Levobupivacaïne


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years old ASA score 1 to 4 Scheduled orthopaedic surgery consent to participate Exclusion Criteria: Pregnant, parturient, or breastfeeding woman Emergency situation Contraindications to local anaesthesia Patient refusal

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

| Intervention/Treatment |
| --- |
|Drug: Levobupivacaïne|Use of Levobupivacaïne instead ropivacaïne|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between sensory Block Quality and motor Block deep | Composite score between 0 to 2 for Sensory Block and 0 to 2 for motor Block | Day1 to Day 3 |
Effect of a Nursing Program for Patients With Cystic Fibrosis on Disease Management

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of a nursing program in patients with cystic fibrosis.

Detailed Description
-----------------
All patients living with cystic fibrosis will be asked by questionnaire before (November 2014) and after (September 2016) the implementation of the program about their satisfaction with treatment, trust in the CF-Team, adherence, self-efficacy, treatment burden and quality of life.

Official Title
-----------------
Auswirkung Eines CF Nursing-Programms Auf Das Krankheitsmanagement Und Die Erfahrungen Der Behandlung Von Patientinnen Und Patienten

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Other: CF Nursing Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cystic Fibrosis 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CF Nursing Intervention<br> | Other: CF Nursing Program<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between baseline patient satisfaction and month 22 | Self-reported patient satisfaction will be measured with a newly developped questionnaire. | month 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between baseline adherence and month 22 | Self-reported adherence to therapy will be measured with the Medication Adherence Report Scale (MARS) and a newly developped questionnaire. | month 22 | 
| Difference between baseline self-efficacy and month 22 | Self-reported self-efficacy to master the the therapeutic regimen will be measured with a newly developped questionnaire. | month 22 | 
| Difference between baseline treatment burden and month 22 | Self-reported treatment burden will be measured wiht a subscale of the CFQ-R. | month 22 | 
| Difference between baseline trust and month 22 | Self-reported trust will be measured with the short version of the Wake Forest Trust Scale. | month 22 | 
| Difference between baseline information need and month 22 | Information needs will be assessed with a subscale of the PICKER-questionnaire for patients with CF. | month 22 |
Dose-dense Chemotherapy Versus Intraperitoneal Chemotherapy as First-line Chemotherapy in Advanced Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
To compare dose-dense chemotherapy with intraperitoneal chemotherapy in patients with advanced stage ovarian cancer.

Detailed Description
-----------------
Women aged 20 and above, diagnosed with advanced stage ovarian cancer (FIGO stage II IV), who had received debulking surgery, followed by adjuvant chemotherapy (either dose-dense or intraperitoneal) at our institution between 01 January 2006 and 31 December 2018 were included in the study. Patient characteristics, any treatment related side-effects (peri-operative and post-operative complications, chemotherapy related adverse events), treatment response (complete or partial response, stable disease or progressive disease), post-treatment surveillance (disease status: disease-free, recurrence or cancer-related death) will be recorded. Univariate and multivariate logistic regression analysis will be employed to evaluate the survival benefit of the two different chemotherapy methods.

Official Title
-----------------
Far Eastern Memorial Hospital

Conditions
-----------------
Advanced Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: Intraperitoneal chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with FIGO stage II IV ovarian cancer At least one cycle of intravenous dose-dense or intraperitoneal chemotherapy had been administered as the front-line chemotherapy. Exclusion Criteria: none

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intraperitoneal chemotherapy|Intraperitoneal or intravenous dose-dense platinum/taxane chemotherapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survivals between this intraveous and intraperitoneal chemotherapy groups | months | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survivals between this two groups | months | 10 years |