linjc16/ctgov huggingface dataset:
SNP-based Prediction of Recurrence Risk in Kidney Stone Patients

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to gain new knowledge about genetic risk factors that may affect the kidney stone recurrence. The study seeks to understand if different forms of genes result in an increased risk of kidney stone recurrence.

Detailed Description
-----------------
In this study, investigators are prospectively testing whether SNP are associated with kidney stone recurrence. Investigators will test the hypothesis that SNP predispose kidney stone patients to recurrence. Investigators hope to identify predictors for the kidney stone recurrence. This would allow the identification of a subpopulation of kidney stone patients that would benefit most from prevention measures.

Official Title
-----------------
SNP-based Prediction of Recurrence Risk in Kidney Stone Patients: a Prospective Multicenter Observational Study

Conditions
-----------------
Kidney Stone

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older Kidney stone former who the stone was removed completely. Ability to give informed consent Exclusion Criteria: Patient refuses or is unable to give consent

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 |
| --- | --- |
| Kidney stone former<br> | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone-free survival | Time to first stone recurrence from stone-free | From date of stone-free until the date of first stone recurrence (up to 7 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SNP, Kidney stone, Recurrence
Evaluation of the Efficacy, Safety and Toleration of CT327 Ointment in Patients With Psoriasis Vulgaris

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of 3 dose strengths of CT327 ointment (0.05%, 0.1% and 0.05% w/w) compared to a placebo, when applied twice daily for up to 8 weeks, to the psoriatic plaques of patients with psoriasis vulgaris.

Official Title
-----------------
A Randomized, Placebo-controlled, Phase IIb Study to Evaluate the Efficacy, Safety and Tolerability of 0.05%, 0.1% and 0.5% w/w Topical CT327 When Applied Twice Daily in Subjects With Psoriasis Vulgaris

Conditions
-----------------
Psoriasis Vulgaris

Intervention / Treatment
-----------------
* Drug: CT327 0.05%
* Drug: CT327 0.1%
* Drug: CT327 0.5%
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects aged at least 18 years. Stable psoriasis vulgaris Exclusion Criteria: Subjects with guttate, erythrodermic, exfoliative or pustular psoriasis.

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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.05% (w/w) CT327 ointment<br>0.05% (w/w) CT327 ointment applied BID for up to 8 weeks. | Drug: CT327 0.05%<br>* 0.05% CT327 (w/w) ointment<br>|
| Experimental: 0.1% (w/w) CT327 ointment<br>0.1% (w/w) CT327 ointment applied BID for up to 8 weeks. | Drug: CT327 0.1%<br>* 0.1% CT327 (w/w) ointment<br>|
| Experimental: 0.5% (w/w) CT327 ointment<br>0.5% (w/w) CT327 ointment applied BID for up to 8 weeks. | Drug: CT327 0.5%<br>* 0.5% CT327 (w/w) ointment<br>|
| Placebo Comparator: Placebo ointment<br>Placebo ointment | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of CT327 ointment (0.05%, 0.1% and 0.5% w/w) compared with placebo ointment. |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local and systemic toleration |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psoriasis vulgaris, topical ointment
Anal Fistula Repair With Platelet-rich Plasma

Study Overview
=================
Brief Summary
-----------------
Anal fistula is a very common disease with a high impact on life quality. The only commonly accepted treatment option is surgery. A wide range of operations and techniques have been developed all suffering from a relatively high recurrence rate. The investigators propose the combination of the mucosal advancement flap with application of platelet-rich plasma (PRP) in the fistulectomy site. This study aims to test the hypothesis that by applying PRP the healing rate of complicated anal fistulas can be improved in comparison to a control group where the operation is performed without addition of PRP.

Official Title
-----------------
Anal fistUla Repair With Platelet-Rich plasmA (AURoRA)

Conditions
-----------------
Rectal Fistula

Intervention / Treatment
-----------------
* Biological: PRP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: complicated anal fistula with patient fit for surgical treatment minimum 6 weeks after written informed consent Exclusion Criteria: age <18 pregnancy drug abuse, drug substitution program homeless (follow-up difficult) restricted in legal capacity simple fistulas requiring fistulotomy complicated fistulas requiring an anus praeter naturalis

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP<br>The operation will be performed with application of platelet rich plasma | Biological: PRP<br>* Application of platelet-rich plasma during surgery<br>|
| No Intervention: non-PRP<br>The operation will be performed without addition of platelet-rich plasma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing rate |  | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of risk factor smoking on healing rate |  | 2 years | 
| Influence of risk factor high BMI on healing rate |  | 2 years | 
| Influence of risk factor chronic renal failure on healing rate |  | 2 years | 
| Influence of sex on healing rate |  | 2 years |
Prediction of the Response to Neoadjuvant Radiation Chemotherapy Through Texture Analysis Derived From Medical Imaging

Study Overview
=================
Brief Summary
-----------------
In patient with complete pathological response, surgery could be omitted without compromising progression-free or overall survival. A powerful prediction model is needed to guide management of this population. Radiomics features provide complementary information about tumor heterogenity. The aim of the investigators is to develop a model combining clinical and radiomic criteria able to predict complete pathological response.

Official Title
-----------------
Prediction of the Response to Neoadjuvant Radiation Chemotherapy Through Texture Analysis Derived From Magnetic Resonance Imaging, Contrast Injection Computed Tomography and Positron Emission Tomography at 18-FDG in Locally Advanced Rectal Cancer

Conditions
-----------------
Rectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: locally advanced rectal cancer patients who received concomitant radio-chemotherapy followed by surgery pre-therapeutic MRI and CT-scan dicom available Exclusion Criteria: age under 18 yo lack of MRI or CT-scan

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 |
| --- | --- |
| training population<br>patients from which we will develop the prediction model | |
| testing population<br>patients on whom we will test the prediction model | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of the complete response (pCR) to neoadjuvant chemoradiotherapy | defined as the absence of tumor residue on the surgical specimen, ypT0N0 | TO = Immediately after biopsy and extension evaluation. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
locally advanced rectal cancer, radiomic
An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum

Conditions
-----------------
Pyoderma Gangrenosum

Intervention / Treatment
-----------------
* Drug: gevokizumab
* Drug: Placebo
* Drug: gevokizumab open-label


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A clinical diagnosis of classic pyoderma gangrenosum An active pyoderma gangrenosum ulcer Contraceptive measures adequate to prevent pregnancy during the study Exclusion Criteria: Clinical evidence of acutely infected pyoderma gangrenosum History of allergic or anaphylactic reactions to monoclonal antibodies History of recurrent or chronic systemic infections Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding Other protocol-defined inclusion/exclusion criteria may apply

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gevokizumab<br>Solution for subcutaneous injection (Part 1, Group B) | Drug: gevokizumab<br> <br> |
| Placebo Comparator: Placebo<br>Solution for subcutaneous injection (Part 1, Group A) | Drug: Placebo<br> <br> |
| Experimental: gevokizumab open-label<br>Solution for subcutaneous injection (Part 2, Open-label) | Drug: gevokizumab open-label<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects at Day 126 with complete closure of the PG target ulcer confirmed 2 weeks later (at Day 140) and without the need for rescue treatment |  | Day 126 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportions of subjects at Day 126 with a reduction in the target ulcer area of ≥ 75% or ≥ 90% from baseline. |  | Day 126 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pyoderma Gangrenosum, Classic Pyoderma Gangrenosum
A Study of CM310 in Children Patients With Moderate-to-severe Atopic Dermatis

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, single arm, open-label study to evaluate safety and primary efficacy in children patients with moderate-to severe atopic dermatis.

Official Title
-----------------
A Multicenter, Single-arm, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetics of CM310 in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Biological: CM310


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12 years ≤ age ≤ 18 years With atopic dermatis Voluntarily sign the informed consent form Exclusion Criteria: Weight < 30 kg Major surgery planed during the study

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM310<br>600 mg + 300 mg, subcutaneous injection, once every two weeks | Biological: CM310<br>* CM310 600 mg + 300 mg, subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Incidence of adverse events. | at week 14 |
Role of Self-focused Attention in Depression

Study Overview
=================
Brief Summary
-----------------
Using a task measuring the tracking of eye movements, the aim of this study is to demonstrate that individuals suffering from depression focus their attention more on their reflection in the screen after recalling a failure (and this all the more so as their depressive symptomatology is strong) .

Official Title
-----------------
Role of Self-focused Attention in Depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: Eye tracker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with depressive disorders according to the Diagnostic and statistical Manual of Mental Disorders (DSM-V) criteria Men or women, aged 18 to 60 patients without mental impairment patients without neurological impairment (epilepsy, encephalopathy, head trauma) patients with a sufficient command of French free patients, without guardianship or curators or subordination patients benefiting from coverage by a social security scheme or benefiting from it through a third party in accordance with the French law on biomedical research obtaining oral non-objection by the patient after clear and honest information about the study Patient with normal or corrected vision without rigid contact lenses Exclusion Criteria: patients with an intelligence quotient < 70 patients aged < 18 years or > 60 years patients with mental impairment patients with neurological impairment (epilepsy, encephalopathy, head trauma) patients who do not speak French well enough patients hospitalized under duress patients without social security Patient wearing rigid contact lenses

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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: Eye tracking<br>Utilisation of a eye tracker on a screen. | Behavioral: Eye tracker<br>* Eye movements on a screen are captured with an eye tracker during a repeated measures before/after a directed autobiographical recall.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time | Average percentage of time spent on the area of a reflective black computer screen after and before remembering a failure. The area of interest encompasses the reflection of the patient's face, without his attention being explicitly drawn to this area. | through study completion, an average of 10 months. |
Muscle Strength Assessment in Patients With Chronic Ankle Instability

Study Overview
=================
Brief Summary
-----------------
Patients with chronic ankle instability (CAI) show biomechanical and neuromuscular alterations during the performance of functional movements not only at the ankle joint level, but also in more proximal joints and segments. Few studies have been conducted to investigate the effects of chronic ankle instability on neuromuscular control at the knee joint level. The aim of this study is to investigate whenther abnormalities exists in maximal and sub-maximal isometric muscle strength expression in patients with CAI.

Official Title
-----------------
Valutazione Della Funzione Neuromuscolare Dei Muscoli Flessori ed Estensori Del Ginocchio in Pazienti Con instabilità Cronica di Caviglia (CAI)

Conditions
-----------------
Chronic Ankle Instability

Intervention / Treatment
-----------------
* Other: Chronic ankle instability


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 40 years chronic ankle instability physically active individuals Exclusion Criteria: sedentary behaviour previous injuries or surgeries to the lower limbs neurological disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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 |
| --- | --- |
| CAI group<br> | Other: Chronic ankle instability<br>* Persistent condition of ankle instability after a first ankle sprain episode.<br>|
| Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forces exerted by knee extensor and flexor muscles | The forces (N) exerted by knee extensor and flexor muscles will be assessed by means of a dynamometer during maximal and submaximal isometric muscle contractions. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee extensor and flexor muscles activations | Knee extensor and flexor muscles activations (mV) during the maximal and submaximal isometric contractions will be recorded by means of surface electrodes for electromyography. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ankle instability, muscle strength, quadriceps, hamstrings, maximal voluntary isometric contraction
Portuguese Inguinal Hernia Cohort (PINE) Study

Study Overview
=================
Brief Summary
-----------------
Prospective national cohort study of patients submitted to elective inguinal hernia repair. The primary outcome is the prevalence of chronic postoperative inguinal pain, according to the EuraHS QoL questionnaire at 3 months postoperatively. The study will be delivered in all Portuguese regions through a collaborative research network. Four 2-week inclusion periods will be open for recruitment. A site-specific questionnaire will capture procedure volume and logistical facilities for hernia surgery.

Official Title
-----------------
Portuguese Inguinal Hernia Cohort Study

Conditions
-----------------
Inguinal Hernia, Chronic Pain

Intervention / Treatment
-----------------
* Procedure: Inguinal hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective inguinal hernia repair in a portuguese hospital Willing and able to consent and comply with the follow up protocol Exclusion Criteria: Urgent/emergent inguinal hernia repair

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 |
| --- | --- |
| Chronic postoperative pain<br>Patients scoring 3 or more on the EuraHS Quality of Life assessment after elective inguinal hernia repair | Procedure: Inguinal hernia repair<br>* Inguinal hernia repair (open, laparo-endoscopic, robotic)<br>* Other names: surgery;|
| Non chronic postoperative pain<br>Patients scoring less than 3 on the EuraHS Quality of Life assessment after elective inguinal hernia repair | Procedure: Inguinal hernia repair<br>* Inguinal hernia repair (open, laparo-endoscopic, robotic)<br>* Other names: surgery;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic postoperative pain | Score of 3 or above on the pain domains of the European Registry for Abdominal Wall Hernias Quality of Life (EuraHS QoL) assessment, with higher scores indicating higher pain | 3 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients receiving antibiotic prophylaxis before inguinal hernia repair |  | Intraoperatively | 
| Proportion of patients operated as day case surgery |  | 30 days after surgery | 
| Postoperative morbidity |  | 30 days after surgery |