linjc16/ctgov huggingface dataset:
Amodiaquine+Artesunate vs. Artemether-Lumefantrine for Uncomplicated Malaria in Ghanaian Children

Study Overview
=================
Brief Summary
-----------------
Artemisinin combination therapies (ACT) are currently recommended for malaria treatment. Artemether-lumefantrine(A-L) and Artesunate+amodiaquine (A+A) have been the most commonly adopted of the recommended ACT regimens. In Ghana, A+A is the current first-line antimalarial treatment in Ghana, but there has been 1 efficacy report of this regimen in Ghana till date. Moreover, the safety of repeated treatments with ACT has been little studied. This study aims to evaluate the efficacy of A+A vs. A-L, as well as the safety of repeated treatments of these regimens in a longitudinal trial in which recruited children will be followed up for 1 year.

Conditions
-----------------
Uncomplicated Malaria

Intervention / Treatment
-----------------
* Drug: amodiaquine+artesunate/artemether-lumefantrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: microscopically confirmed acute uncomplicated falciparum malaria; temperature at screening 37.50C or more or history of fever 24 preceding enrollment; willingness to comply with follow up schedule; written informed consent by accompanying parent or guardian Exclusion Criteria: features of severe malaria or danger signs of malaria known intolerance or allergy to any of the study medications known treatment with any of the study medications in the month preceding enrollment serious underlying disease that may mask outcome assessment

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 14 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: amodiaquine+artesunate/artemether-lumefantrine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
EEG in Children With Unilateral Cerebral Injury During Action and Action Observation(AOE)

Study Overview
=================
Brief Summary
-----------------
To study the reactivity of the mu rhythm during action and action-observation by EEG in children with unilateral cerebral injury.

Official Title
-----------------
Exploration du système Des Neurones-miroirs Par Enregistrement EEG du Rythme mu Chez l'Enfant Atteint de lésion cérébrale unilatérale Lors d'Action, d'Observation et d'Imagination d'Action du Membre supérieur.  Action-Observation-EEG 

Conditions
-----------------
Child, Cerebral Palsy

Intervention / Treatment
-----------------
* Device: EEG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral cerebral injury hemiplegia Exclusion Criteria: visual or mental or cognitive impairment no health insurance

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>A 45 mn EEG for all the participants. | Device: EEG<br>* A 45 mn EEG will be performed in each participants during action and action observation of each hand.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change measures of mu rhythm desynchronization (i.e. alpha band power) before the action execution or action observation and after the action execution or action observation | The mu rhythm is a spontaneous sensorimotor rhythm made of neurophysiological oscillations with a frequency between 8 herz and 13 herz (alpha band), beside the sensorimotor cortex. The alpha band is recorded on surface electroencephalography (EEG). The power is the square of the amplitude of the spontaneous oscillations. | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Child, Electroencephalography, mu rhythm, Sensorimotor Cortex, Unilateral Cerebral Palsy
Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of The Safety, Tolerability And Efficacy Of Celecoxib 200 Mg Twice A Day (With A 400 Mg Attack Dose) Versus Sodium Diclofenac 75 Mg Twice A Day In Subjects With Acute Low Back Pain

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Drug: Diclofenac
* Drug: Celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Aged between 18 and 65 years Acute low back pain that falls into 1st or 2nd class of 'Quebec Task Force' classification of moderate to severe intensity (>50 mm in the VAS) Acute low back pain onset <72 hours prior to study inclusion and >6 weeks after the last acute low back pain episode Exclusion criteria: Scoliosis or known history of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or any other disease that cause pain Low back pain from major trauma or visceral disorder Esophageal ulcers, gastric or duodenal ulcers or bleeding within 30 days prior to being administered study drug

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Diclofenac<br>* 75 mg oral capsule twice daily for 7 days<br>|
| Experimental: B<br> | Drug: Celecoxib<br>* 400 mg oral capsule followed by 200 mg oral capsule with the evening meal (>=4 hours from first dose) on Day 1 then 200 mg oral capsule twice daily for 6 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment |  | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's quality of life, as measured by the SF-36 Health Survey |  | Day 7 | 
| Physical examination |  | Days 3 and 7 | 
| Pain relief score |  | Days 3 and 7 | 
| Vital signs |  | Days 3 and 7 | 
| Adverse events |  | Days 3 and 7 | 
| Change from baseline in VAS pain intensity assessment |  | Day 7 | 
| Categorical pain intensity score |  | Days 3 and 7 | 
| Subject's global assessment score |  | Days 3 and 7 | 
| Subject's functional ability, as measured by the Roland Morris Questionnaire about low back pain and disability |  | Day 7 |
Assessment of Third Trimester Post-void Residual and Validation of Bladder Scanner in Pregnancy and Post-partum

Study Overview
=================
Brief Summary
-----------------
This will be a descriptive study measuring the post-void residual of patients in the third trimester and postpartum. Also, bladder scan values will be compared to the amount of urine obtained from a Foley catheter to determine the accuracy of the bladder scanner in the third trimester and postpartum.

Official Title
-----------------
Assessment of Third Trimester Post-void Residual Along With Determining Validity of the Bladder Scanner in the Third Trimester of Pregnancy and Postpartum

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 years. Having a non-emergent Cesarean Delivery or labor epidural placed. Exclusion Criteria: Age less than 18 years. Emergent Cesarean delivery. No epidural labor analgesia.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bladder Scan Group<br>Patients who agree to enroll in the trial and allow their known bladder volumes and residual bladder volumes to be measured by actual volumes retrograde instilled, and also by bladder scanner ultrasound. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Define normal post-void residual volume in third trimester pregnancy and post-partum. |  | 12-24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculate the validity of measurements form the bladder scanner ultrasound for bladder volumes during the third trimester of pregnancy and post-partum. |  | 12-24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bladder volume measurement, pregnancy, bladder function, Postvoid residual volume assessment, Bladder volumes
Heath-related Quality of Life of Diabetic Transmetatarsal Amputees and Below-knee Prosthetic Users

Study Overview
=================
Brief Summary
-----------------
The present study assesses the health-related quality of life of diabetic transmetatarstal and below-knee prosthetic user. The study design is cross-sectional with a retrospective review of patient hospital records and an assessment with patient-reported outcome measure.

Detailed Description
-----------------
The present study aims to recruit 100 diabetic transmetatarsal and below-knee prosthetic user to assess the health-related quality of life (HRQoL) between these two patient groups. The 15D HRQoL instrument is applied. An additional comparison with the age-standardized Finnish general population will be performed.

Official Title
-----------------
Heath-related Quality of Life of Diabetic Transmetatarsal Amputees and Below-knee Prosthetic Users

Conditions
-----------------
Amputees, Diabetes Complications

Intervention / Treatment
-----------------
* Procedure: Amputation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diabetes Transmetatarsal amputation Below-knee prosthetic user 2-5 years from surgery Exclusion Criteria: No diabetes Other than transmetatarsal or below-knee amputation Below-knee amputation but not a below-knee prosthetic user Less than 2 years from the amputation Over 5 years from amputation

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 |
| --- | --- |
| Below-knee amputees<br>The present group consists of diabetic below-knee prosthetic user | Procedure: Amputation<br>* Transmetatarsal or below-knee amputation<br>|
| Transmetatarsal amputees<br>The present group consists of diabetic transmetatarsal amputees | Procedure: Amputation<br>* Transmetatarsal or below-knee amputation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life measured by the HRQoL score |  | 2-5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 15D health-related quality of life instrument |  | 2-5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, amputation, below-knee, transmetatarsal, [M01.150.100], [C19.246.099]
Macrolane Prospective Survey

Study Overview
=================
Brief Summary
-----------------
The study objective is to evaluate the long term safety when Macrolane Volume Restoration Factor is used in female breasts in clinical practice.

Official Title
-----------------
A Multi-center, Non-interventional, Prospective Study to Monitor Long Term Safety in Female Subjects After Treatment With Macrolane Volume Restoration Factor 20 and/or Macrolane Volume Restoration Factor 30 in the Breasts.

Conditions
-----------------
Females Recently Treated With Macrolane VRF in the Breasts

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females recently treated with Macrolane Volume Restoration Factor in the breasts. Signed informed consent Exclusion Criteria: There are no exclusion criteria
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women treated with Macrolane in the breasts<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macrolane
Impact of an Automated Telephone Intervention on Glycosylated Hemoglobin (HbA1c) in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Aim 1. Determine the impact of a daily, automated telephone intervention on HbA1c levels compared to standard care in older patients with type 2 diabetes. Aim 2. Determine the impact of the automated telephone intervention compared to standard care on adherence to prescribed SMBG frequency in older patients with type 2 diabetes. Aim 3. Determine the impact of the automated telephone intervention compared to standard care on self-reported diabetic control problems in older patients with type 2 diabetes. Aim 4. Determine the impact of the automated telephone intervention compared to standard care on self-reported attitudes and health beliefs concerning diabetes in older patients with type 2 diabetes

Official Title
-----------------
The Impact of an Automated Telephone Intervention on HbA1c in Type 2 Diabetes: A Randomized Controlled Trial

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: automated telephone intervention vs. usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater or equal to 55 Type 2 diabetes English speaking Ability to use glucose meter Exclusion Criteria: Unable to give informed consent Unwilling to allow SMBG levels to be shard with primary care physician

Ages Eligible for Study
-----------------
Minimum Age: 55 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: 1<br>Automated telephone intervention | Behavioral: automated telephone intervention vs. usual care<br> <br> |
| Active Comparator: 2<br>Usual care | Behavioral: automated telephone intervention vs. usual care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in adherence to SMBG frequency |  | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, telephone intervention, automated
Prediction of Pain During Old People Care Measured by Skin Conductance

Study Overview
=================
Brief Summary
-----------------
The purpose of the project is to validate the use of Pain Monitor™ device, not invasive and simple of employment, for old people able to answer to a digital scale of pain intensity. The main objective is to develop and to validate a model of prediction of the pain in old subject at the time of the care, using the measure of variation of the skin conductance.

Official Title
-----------------
Prediction of Pain During Old People Care Measured by Skin Conductance

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Device: Pain Monitor™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospitalized patient; patient over 65 years of age; communicating, without cognitive impairment; having to undergo an act presumed to be painful during which the patient's mobility is limited: nursing care (removal of a drain, dressing of a chronic wound, urinary catheterization, etc.), medical examination, etc.; benefiting from a social security scheme or having rights; having given their prior informed written consent; person able to read. Exclusion Criteria: cutaneous anomaly on the site of measure; pacemaker or internal defibrillator; extremities twitching; Treated by neostigmine.

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

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

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: Aged, 65 and over<br> | Device: Pain Monitor™<br>* Pain measured by Pain Monitor™<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between Number of pics of skin conductance per second measured by Pain Monitor™ device with Numerical visual scale score for pain |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression (HAD) score |  | 14 days | 
| Percentage of efficient poses of Pain Monitor |  | 14 days | 
| Percentage of patient refusal to use of the Pain monitor |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
65 years old
Validating the Digital Virginia Tech Carilion Cognitive Examination

Study Overview
=================
Brief Summary
-----------------
Currently, cognitive screening is performed in-person after the individual expresses symptoms or it is noticed by someone close to them and are largely done in clinical settings. The digital Virginia Tech Carilion Cognitive Examination (VTC-Cog) utilizes smart devices and allows for the early establishment of an individual's cognitive baseline. VTC-Cog has been designed to test all major aspects of cognition, as currently assessed using the Montreal Cognitive Assessment (MoCA) and Mini-Mental Status Examination (MMSE) but on a digital platform. The VTC-Cog allows for standardized scoring with no clinician bias and provides a clinician report that breaks down distinct changes in different areas of cognition (executive, visuospatial, memory, etc.) in order to refine clinician analysis.

Official Title
-----------------
Validating the Digital Virginia Tech Carilion Cognitive Examination - A Unique Tool for Cognitive Assessment

Conditions
-----------------
Cognitive Change

Intervention / Treatment
-----------------
* Device: The Digital Virginia Tech Carilion Cognitive Examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 50-80 years No current diagnosis of dementia Current stable mental health English speaker Carilion Clinic Medical Provider Exclusion Criteria: <50 years old or >80 years old Current diagnosis of dementia Unstable mental health Non-English speaker Medical provider outside the Carilion Clinic system

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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 |
| --- | --- |
| Test Group<br>Reported mild cognitive deficits | Device: The Digital Virginia Tech Carilion Cognitive Examination<br>* Completion of a newly developed digital cognitive screen<br>|
| Control Group<br>No cognitive deficits | Device: The Digital Virginia Tech Carilion Cognitive Examination<br>* Completion of a newly developed digital cognitive screen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of the Digital Virginia Tech Carilion Cognitive Examination against the Montreal Cognitive Assessment |  | 18-24 months |