linjc16/ctgov huggingface dataset:
Translation of the Self Completed-Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale

Study Overview
=================
Brief Summary
-----------------
Neuropathic pain, described as 'pain arising as a direct consequence of a lesion or disease on the somatosensory system', affects up to 3-9.8% of the investigators' population, but is often underdiagnosed and undertreated. As treatment is different for patients with neuropathic pain and nociceptive pain, it is important to screen for neuropathic pain. Commonly employed questionnaire-based diagnostic tools in English speaking countries include the Leeds Assessment of Neuropathic Symptoms and Signs pain scale (LANSS) and Neuropathic pain questionnaire (NPQ). Self-completed LANSS is particularly useful as it is not restricted to clinician's examination and can be applied in large-scale research. S-LANSS has been successfully translated, validated and used successfully in Arabic and Turkish, but it has not been utilised in the Chinese population. As verbal translations of the English questionnaires used at the bedside may be prone to errors in interpretation and requires medical practitioners to interpret the questions. Therefore a translation and validation study is essential.

Official Title
-----------------
Translation and Validation of the Traditional Chinese-Cantonese Version of the Self Completed-Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale

Conditions
-----------------
Neuropathic Pain, Chronic Pain, Nociceptive Pain

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Native Chinese-Cantonese speaker Aged 18 to 80 Presence of pain for more than 3 months Able to understand, read and write Traditional Chinese Able to give informed written consent Ability to complete the questionnaire Exclusion Criteria: Patients who require active pain treatment and / or intervention within 1 week after the initial consultation Voluntary withdrawal from study at any stage

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neuropathic pain subjects<br>The diagnosis of neuropathic pain will be made by pain specialists based on a detailed history, physical examination, investigation results and medical records. | Other: Questionnaire<br> <br> |
| Nociceptive pain subjects<br>The diagnosis of nociceptive pain will be made by pain specialists based on a detailed history, physical examination, investigation results and medical records. | Other: Questionnaire<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire can successfully identify subjects with neuropathic pain, or nociceptive pain |  | One year from commencement of study |
Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to evaluate the change in disease activity following 12 weekly s.c. (under the skin) doses of NNC109-0012 compared to placebo in subjects with active Rheumatoid Arthritis (RA).

Official Title
-----------------
A Randomised, Double Blind, Placebo-controlled, Multiple Dose Trial of Anti-IL-20 (109-0012) in Subjects With Rheumatoid Arthritis

Conditions
-----------------
Inflammation, Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: NNC109-0012
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Czech Republic: Age between 18 - 65 years (both inclusive) A diagnosis of RA made at least 3 months prior to trial start Active RA Methotrexate treatment (between 7.5 mg and 25 mg/week, both inclusive) for at least 12 weeks with a stable dose for at least 4 weeks prior to trial start Female subjects must be willing to avoid pregnancy and breast feeding throughout this trial at least until 15 weeks following the last dose of trial medication Male subjects with partners of childbearing potential must be willing to use a highly effective contraception throughout trial incl. a 15 week follow up periode Exclusion Criteria: Known or suspected allergy to trial product or related products Body Mass Index (BMI) lower than 18.5 or higher than 35.0 kg/m^2 Subjects with chronic inflammatory autoimmune disease other than RA (except secondary Sjögren's syndrome or stable hypothyroidism)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: NNC109-0012<br>* The subjects will receive 12 weekly doses of 3 mg/kg of NNC109-0012 administered subcutaneously (under the skin)<br>|
| Placebo Comparator: B<br> | Drug: placebo<br>* The subjects will receive 12 weekly doses of 3 mg/kg of Placebo administered subcutaneously (under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value) |  | week 0, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Terminal serum half-life (t½) |  | end of treatment period | 
| Serum levels of NNC109-0012 |  | end of treatment period |
Food Habit Programming: Influence of Genetics and Early Nutrition in a Population of Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Influence of neonatal nutrition and growth on psychomotor development of 2 years preterm infants.-Joint influence of environmental factor (early nutrition) and genetics factors on feeding behaviour setting- up in a particular population of infants of whom nutrition and life conditions during first weeks of life were purely controlled.

Official Title
-----------------
Food Habit Programming: Influence of Genetics and Early Nutrition in a Population of Preterm Infants

Conditions
-----------------
Preterm Infants

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants < 33 SA who stayed at least 2 weeks after birth in Nantes hospital, included in the  Grandir ensemble  network, 2 years old in 2008 and 2009

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 25 Months

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 |
| --- | --- | --- |
| Neurodevelopmental evaluation by ASQ (Age and stages Questionnaire) at 2 years of age |  | 2 years of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Newborn, nutrition, genetic, feeding behaviour, psychomotor development, long-term effects, nutritional imprinting.
Ketamine Compared to Propofol for Pediatric GI Endoscopy

Study Overview
=================
Brief Summary
-----------------
Elective outpatient endoscopy for children can be safely performed under general anesthesia with either propofol (1) or ketamine (2) infusions. Both infusions have an advantage over general anesthesia with volatile agents because they do not require intubation. The goal of both infusions is to have the patient breath spontaneously without reacting to the endoscopy which is a noxious stimulus. Patient movement, stridor and vomiting are can interrupt the procedure and increase overall OR time. Propofol also carries the added risk of causing apnea. This side effect is not commonly seen with Ketamine. Our hypothesis is that Ketamine's profile makes it a superior drug to Propofol for elective outpatient endoscopy because of reduced profound intra-operative interruptions and faster recovery time. We plan a study of pediatric patients ages 1 to 10 years old undergoing elective outpatient endoscopy. The patients will be randomized to receiving either a Ketamine or Propofol infusion, and the intra-operative interruptions will be documented by the anesthesiologist. The Post Anesthetic Care Unit (PACU) time to recovery will be monitored and recorded by a third party.

Conditions
-----------------
Endoscopy

Intervention / Treatment
-----------------
* Drug: Ketamine
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 1-10 Endoscopy with sedation scheduled Exclusion Criteria: A history of chronic respiratory disease Upper respiratory infection Developmental delays Dysrhythmias Increased intercranial pressure Any sedatives or narcotics up to 6 weeks prior to procedure.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 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 |
| --- | --- |
| GI Endoscopy<br> | Drug: Ketamine<br>* Weight based dosage for Peds subjects, used for duration of the endoscopy.<br>Drug: Propofol<br>* Weight based dosage for Peds subjects, used for duration of the endoscopy.<br>|

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
-----------------
Child age 1-10 years having a GI Endoscopy with sedation
Platelet PAR-1 Activation in Health and Diabetes

Study Overview
=================
Brief Summary
-----------------
Platelet activation has been associated with bad events like heart attack and stroke. There are a variety of platelet activators that regulate how active a platelet is. We are interested in Protease-activated receptors (PAR)-1. We are currently studying PAR-1 activation in persons with severe peripheral artery disease. We seek, through this project, to understand PAR-1 activation in persons without peripheral artery disease. As many patients with peripheral artery disease have diabetes, we will also evaluate PAR-1 activation in persons with type 2 diabetes. In addition we will assess the impact of the glucagon-like peptide (GLP)-1 signaling pathway on platelet activation. Levels of platelet activation will be determined using platelet aggregation experiments and assessment of platelet-monocyte aggregates in peripheral blood.

Official Title
-----------------
Platelet PAR-1 Activation in Health and Diabetes

Conditions
-----------------
Type 2 Diabetes, Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women ≥60 years of age OR Type 2 diabetic men and women ≥60 years of age Exclusion Criteria: Active cancer Prior myocardial infarction, prior stroke, diagnosed peripheral artery disease Severe liver (cirrhosis, cancer, or end-stage liver disease), kidney disease (eGFR <30 cc/min). Pregnancy or lactation Active vasculitis Anticipated lifespan < 2 years Current use of a DOAC

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Healthy Subjects<br>Subjects will have a single visit where a short medical history/list of current medications and single blood draw will be performed. | |
| Type 2 Diabetic Subjects<br>Subjects will have a single visit where a short medical history/list of current medications and single blood draw will be performed. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet Activation | Number of dilysyl-MDA cross-links formed in human platelets | One day | 
| Protease Activated Receptor-1 Activation | Number of cleaved PAR-1 receptors in proportion to number of uncleared PAR-1 receptors | One day |
24-Hour Ambulatory Blood Pressure Monitoring in Community Pharmacies

Study Overview
=================
Brief Summary
-----------------
This study is designed to explore the feasibility of providing 24-hour ambulatory blood pressure monitoring in community pharmacies. The investigators hypothesize it will be feasible for community pharmacies to provide the service to assist medical providers in the diagnosing and management of high blood pressure. The investigators will also survey participants regarding their experience with the service as well as conduct interviews with participating pharmacists and medical providers to understand their views and opinions on the feasibility of the service.

Official Title
-----------------
Implementation & Evaluation of a 24-Hour Ambulatory Blood Pressure Monitoring Service in Community Pharmacies

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Other: ABPM service by Pharmacists


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults greater than or equal to 18 years of age suspected by their physician of having white coat or masked hypertension (HTN), hypotension symptoms due to antihypertensive therapy, uncontrolled sustained HTN, requiring additional confirmation of an initial diagnosis if HTN, or resistant HTN. Exclusion Criteria: Documented past medical history of persistent atrial fibrillation, on hemodialysis, pregnancy, or dementia.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: 24-hour ABPM by Pharmacists<br>Patients will meet with the pharmacist to be equipped with a 24-hour ambulatory blood pressure monitor (ABPM). Patients will return the monitor for the pharmacists to download the results to send to their medical provider. | Other: ABPM service by Pharmacists<br>* Patients will receive ABPM services provided by a pharmacist and complete a patient satisfaction survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with the pharmacy service and experience wearing the ABPM | Patient satisfaction will be assessed using a 9 item survey. Participants will rate items on a 5-point scale from strongly agree to strongly disagree. | up to 72 hours |
Trial Comparing Different Medical Devices for Infragenual Dilatation

Study Overview
=================
Brief Summary
-----------------
This study is a comparison of different medical devices for infragenual dilatation.

Detailed Description
-----------------
Dilatation and recanalisation of the distal veins (infragenual popliteal artery, tibiofibular trunc, posterior tibial artery, anterior tibial artery) by classical balloon dilatation or cutting balloon with or without stenting or by endovascular laser. This intervention happens only once; the duration of the intervention depends on the procedure and the original injuries(30 - 120 minutes).

Official Title
-----------------
Prospective Randomised Comparing Trial Between an Infragenual Dilatation (ID), an ID With Stenting, an ID With Cutting Balloon and Laser Therapy

Conditions
-----------------
Diabetic Angiopathies, Intermittent Claudication

Intervention / Treatment
-----------------
* Procedure: Infragenual dilatation
* Procedure: Infragenual dilatation with stenting
* Procedure: Infragenual dilatation with cutting balloon
* Procedure: Laser therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes type I or II with diabetic angiopathy stage IIb to IV (Fontaine) Atherosclerotic patients with distal angiopathy stage IIb to IV (Fontaine) Exclusion Criteria: Acute ischemia Multisegmentaric damage above the knee Sepsis: acute respiratory distress syndrome (ARDS), C-reactive protein (CRP) > 30, white blood cell (WBC) > 25,000 Acute myocardial infarction (AMI) during the last 14 days Operative contraindication Life expectancy < 2 years Blue toe syndrome (micro-embolisation)
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Infragenual dilatation with stenting<br> | Procedure: Infragenual dilatation with stenting<br>* Infragenual dilatation with stenting<br>|
| Active Comparator: Infragenual dilatation with cutting balloon<br> | Procedure: Infragenual dilatation with cutting balloon<br>* Infragenual dilatation with cutting balloon<br>|
| Active Comparator: Laser therapy<br> | Procedure: Laser therapy<br>* Laser therapy<br>|
| Placebo Comparator: Infragenual dilatation<br> | Procedure: Infragenual dilatation<br>* Infragenual dilatation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency after 6 months |  | After 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proving the superiority or non-superiority of one treatment procedure to another treatment procedure |  | After 6 months. |
Postoperative Pain Management in Cerebral Palsy - Comparative Observational Study

Study Overview
=================
Brief Summary
-----------------
In this study, our aim is to examine orthopedic interventions, anesthesia method, postoperative pain level and management applied to patients with CP in biruni university hospital.

Official Title
-----------------
Postoperative Pain Management in Pediatric Patients With Cerebral Palsy - Comparative Observational Study

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Behavioral: pain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with cerebral palsy between the ages of 3-15, Category 2 according to the Classification of the American Society of Anesthesiology (ASA 2), patients undergoing soft tissue release for knee or ankle flexion contracture of the lower extremity with palliative or reconstructive hip interventions Exclusion Criteria: Any child with CP younger than 3 years old and older than 15 years has undergone procedures without a specific diagnosis of CP, the need for bone surgery, requiring both hip, knee and ankle surgery in the same session, with autonomic neuropathy, Patients with a history of anticholinergic and vasoactive drug use or allergy to amide type local anesthetics

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 15 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 |
| --- | --- |
| regional block<br>epidural / peripheral nerve block | Behavioral: pain<br>* postoperative pain<br>|
| intravenous<br>intravenous analgesia | Behavioral: pain<br>* postoperative pain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | pain score with r-FLACC | 6 month |
Jejunoileal vs Gastric GIST in the Era of Imatinib.

Study Overview
=================
Brief Summary
-----------------
Introduction: Gastrointestinal Stromal Tumors (GISTs) located in the jejunum or ileum (JI-GIST) are considered of worse prognosis compared to other locations. It has been suggested that this dogma should be revised. The aim of this study is to describe the characteristics of jejunoileal GISTs and its prognosis; and to compare them with gastric GISTs in the era of imatinib. Patients and methods: We retrospectively reviewed the clinical histories of all the patients diagnosed with GISTs between January 2000 and November 2016. Clinical and pathological data, as well recurrence, metastatic, disease-free survival (DFS) as overall (OS) rates of patients with JI-GIST or gastric GIST (G-GIST) were collected and compared.

Official Title
-----------------
Characteristics and Prognosis of Jejunoileal Gastrointestinal Stromal Tumors (GISTs) in the Era of Imatinib. A Comparative Retrospective Study With Gastric GISTs.

Conditions
-----------------
Disease-free Survival, Overall Survival, Recurrence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any kind of primary mesenchymal tumor of the gastrointestinal tract with a histomorphological and immunohistochemical (CD117 (+) and/or DOG1 (+)) profile consistent with GIST. Exclusion Criteria: -

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 |
| --- | --- |
| JI-GIST<br>The series comprises 77 patients, of which 29 (37.7%) were located in the jejunum or ileum (JI-GIST). | |
| G-GIST<br>The series comprises 77 patients, of which 48 (62.3%) were located in the stomach (G-GIST). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KIT Gene mutation | Number of patients with a molecular analysis positive for KIT mutation | 15 years | 
| PDGFRA Gene mutation | Number of patients with a molecular analysis positive for PDGFRA mutation | 15 years | 
| Expression of CD117 | Number of patients with immunohistochemical expression of CD117 | 15 years | 
| Expression of DOG1 | Number of patients with immunohistochemical expression of DOG1 | 15 years | 
| Recurrence | Number of patients with recurrence after treatment with tyrosinkin inhibitors. | 15 years | 
| Deceased | Number of patients deceased during follow-up. | 15 years | 
| Location | Location of the tumor (gastric o jejunoileal) | 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GIST, small bowel, jejunum, ileum