linjc16/ctgov huggingface dataset:
Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the prevalence of dental caries in preterm birth children aged 2-5 years in primary dentition.

Detailed Description
-----------------
The purpose of the study is to determine the prevalence of dental caries in preterm birth children aged 2-5 years in primary dentition. PICO format:- Population (P) = preterm children aged 2-5 years attending Cairo University Children's Hospital Abo El-Rish at El-Monira, Cairo, Egypt. Outcome (O) =prevalence of dental caries

Official Title
-----------------
Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition: Across Sectional Study

Conditions
-----------------
PreTerm Birth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 2-5 years old. Presence of primary teeth only. Children born preterm at gestational age of 6,7 and 8 month. Exclusion Criteria: Children with disability or mental disorders. Children with immune compromising conditions. Hospitalized and chronically ill children.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of dental caries. | measured by counting the number of participants affected by dental caries/total number of study sample X100 , measurement unit is a percentage (%) | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of oral hygiene . | using a Questionnaire (binary' yes or no questions'):- record child brushing habits(once or twice) consumption of fluoridated water (yes/no). visits to dentists (yes/no) Also using a dental mirror and a probe to detect presence of plaque (plaque index) and presence of caries (dmf score). | 12 month | 
| Assessment of dietary habits | questionnaire (binary yes/no questions)about the past and current feeding habits:- initial feeding of the child (breast or bottle answered yes/no) length of the breast feeding ( normal '0-2 years or prolonged >2years) usage of bottle after weaning (yes/no). number of meals per day (one,two or three, answered in yes/no manner) number of snacks per day (one,two or three in yes/no answers). Also using a dental mirror and a probe to detect caries presence (dmf score), higher scores indicates faulty dietary habits. | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pre-term children
Effects of Bilateral GPI DBS on Freezing of Gait in PD

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the effect of deep brain stimulation in the the globus pallidus (Gpi) on freezing of gait in patients with Parkinson's disease.

Official Title
-----------------
Effects of Bilateral Pallidal Deep Brain Stimulation on Freezing of Gait in Parkinson's Diseases

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years of age,male or female patients Idiopathic Parkinson's disease with freezing of gait Had GPI deep brain stimulation implant Exclusion Criteria: Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials Epilepsy Pregnant female History of severe neuropsychiatric disease Patients are taking part in other clinical trials in recent several months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| GPI DBS<br>patients who had freezing of gait and underwent deep brain stimulation (DBS) of the globus pallidus interna (GPi) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changs in the score of Stand-Walk-Sit Test |  | baseline, 3month, 6month, 9month, 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the scores in UPDRS |  | baseline, 3month, 6month, 9month, 12 month | 
| Change of the score in PDQ-39 |  | baseline, 3month, 6month, 9month, 12 month | 
| Change of the score in the Freezing of Gait Questionnaire (FOG-Q) |  | baseline, 3month, 6month, 9month, 12 month | 
| Change of the score in the Gait and Falls Questionnaire (GFQ) |  | baseline, 3month, 6month, 9month, 12 month | 
| Change of the score in the Mini-Mental State Examination (MMSE) |  | baseline, 3month, 6month, 9month, 12 month | 
| Change of the score in the Montreal Cognitive Assessment (MoCA) Beijing Version |  | baseline, 3month, 6month, 9month, 12 month | 
| Change of the score in the Frontal Assessment Battery (FAB) |  | baseline, 3month, 6month, 9month, 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GPi, freezing of gait, Parkinson disease
Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy

Study Overview
=================
Brief Summary
-----------------
The objective of this clinical trial is to assess the safety and efficacy of sublingual application of allergen extracts for specific immunotherapy in patients suffering from perennial allergic rhinitis due to house dust mites.

Official Title
-----------------
Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Biological: Allergen extract
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive history of perennial allergic rhinitis Positive screening skin prick test (wheal diameter > 3 mm) Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication Signed and dated patient´s Informed Consent, Exclusion Criteria: Previous immunotherapy with allergen extracts within the last 3 years, Simultaneous participation in other clinical trials, Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance), Auto-immune disorders, Severe chronic inflammatory diseases, Malignancy, Alcohol abuse, Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection, Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allergen extract<br> | Biological: Allergen extract<br>* sublingual application<br>|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* sublingual application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom and medication score |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of sublingual application |  | 1 year | 
| Protocol of adverse events |  | 1 year | 
| Quality of Life Questionnaire |  | 1 year | 
| Evaluation of patients' related clinical global improvement |  | 1 year |
Enhancing Cognitive Training Using tDCS

Study Overview
=================
Brief Summary
-----------------
Cognitive rehabilitation involves enhancing an individual's capacity to process information to improve their everyday functioning. One common form of intervention is computerised cognitive training (CT); however, efficacy results have been mixed. This research aims to investigate a novel method for enhancing outcomes from CT through combining CT with transcranial direct current stimulation (tDCS), a non-invasive and painless form of brain stimulation. In this study we aim to determine the efficacy of this approach through comparing in a randomized controlled study tDCS combined with CT versus CT and tDCS alone in healthy participants. We hypothesise that tDCS combined with CT will have greater generalisability effects than the other conditions.

Conditions
-----------------
Cognition

Intervention / Treatment
-----------------
* Procedure: Transcranial direct current stimulation (tDCS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants will be healthy right-handed subjects aged 18 to 40 Exclusion Criteria: Concurrent medication likely to affect mental performance History of drug or alcohol abuse or dependence current or in the last 3 months Any psychiatric or neurological disorder, recent head injury, or history of seizure or stroke

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

Design Details

Primary Purpose: Basic Science


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS and cognitive training<br> | Procedure: Transcranial direct current stimulation (tDCS)<br> <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
-----------------
tDCS, cognitive training
U-Act-After: An Observational Study on Long-Term Efficacy of Tight Control RoActemra/Actemra (Tocilizumab) and/or Methotrexate in Patients With Early Rheumatoid Arthritis Who Have Participated in the U-Act-Early Study (ML22497)

Study Overview
=================
Brief Summary
-----------------
This non-interventional, observational, open-label multi-center follow-up study of patients from the U-Act-Early trial (ML22497) will evaluate the long-term efficacy and safety of starting tight control treatment with RoActemra/Actemra (tocilizumab) and/or methotrexate in patients early in the disease followed by treatment according to standard of care in routine clinical practice in a three year follow-up, independently of what treatment the patient will be receiving.

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have participated in the U-Act-Early trial (ML22497); these are adult patients (> 20 years of age) with rheumatoid arthritis. Patients must be willing to give written informed consent Exclusion Criteria: Patients who did not participate in the U-Act-Early trial Patients who are drop-outs in the U-Act-Early trial due to withdrawal of consent, are lost to follow-up or are serious protocol violators

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Disease Activity Score (DAS28) |  | from baseline to Month 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in disability, assessed by the Dutch consensus Health Assessment Questionnaire (HAQ) |  | from baseline to Month 36 | 
| Measure of progressive joint destruction (vdHSS) |  | from baseline of U-Act-Early to Month 24 of U-Act-After | 
| Changes in concomitant medication (especially tapering of corticosteroids) |  | from baseline to Months 36 | 
| Sustained remission rates/drug-free remission rates |  | 36 months | 
| Dose modifications/interruptions of RA treatment |  | 36 months | 
| Safety: Incidence of adverse events, adverse events of special interest and serious adverse events |  | 36 months |
Assessment of the Burden Within the Dyad Patient/Caregiver

Study Overview
=================
Brief Summary
-----------------
This study is about the patients life ending and their caregiver, when a return to home is planned. This is a behavioral sciences study (= interventional study for french law)

Official Title
-----------------
Crossed Assessment of the Burden Within the Dyad Patient/Caregiver: Analysis of Explanatory Factors and Consequences for Return at Home of the Life-ending Patient

Conditions
-----------------
Palliative Care

Intervention / Treatment
-----------------
* Behavioral: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient > 18 years old Cancer for which no curative treatment is envisaged Palliative treatment only For the caregiver: designated by the patient like the referring individual

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: dyad<br>life-ending patient and its caregiver | Behavioral: Questionnaires<br>* During a consultation: 3 questionnaires (HADS, FRI, CRA) and a form for the sociodemographic data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver Reaction Assessment (CRA scale) completed by patient (hetero-perception) and its caregiver (auto-perception) |  | At baseline, to the announcement of the exclusive palliative care | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of the burden by the patient and its caregiver: search for potential predictive factors of the burden by statistic analysis HADS (The Hospital Anxiety and Depression Scale FRI (The Family Relationship Index) |  | At baseline, to the announcement of the exclusive palliative care | 
| Search for factors influencing the return at home of the life-ending patients by statistic analysis |  | Death | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Life-ending patient, caregiver
Cardiovascular Prevention During COVID-19 Pandemic Lockdown in Young Adults (COLA Trial)

Study Overview
=================
Brief Summary
-----------------
The study aims to determine the impact of COVID-19 pandemic lockdown on cardiovascular prevention behaviour.

Detailed Description
-----------------
The COVID-19 pandemic resulted in a lockdown and social distancing in most countries all over the world. The impact of this national intervention on cardiovascular prevention behaviour (physical exercise, nutrition, smoking) is unknown. The COLA Trial aims to help clarifying these questions. An online survey was distributed among bavarian students with standardized questions about physical activity, nutritional behavior, smoking and alcohol intake before and during lockdown.

Official Title
-----------------
Cardiovascular Prevention During COVID-19 Pandemic Lockdown in Young Adults (COLA Trial)

Conditions
-----------------
Cardiovascular Prevention Behaviour

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adults over 18 years Exclusion Criteria: any condition that does not allow physical activity

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of physical activity | Questionnaire, 3 level scale ranging from less activity (Level 1), unchanged activity (Level 2), to increased activity (Level 3) | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of nutrition behaviour | Questionnaire, 3 level scale ranging from less food intake (Level 1), unchanged food intake (Level 2), to increased food intake (Level 3) | 14 days | 
| semiquantitative change of alcohol intake | Questionnaire, 3 level scale ranging from less alcohol intake (Level 1), unchanged alcohol intake (Level 2), to increased alcohol intake (Level 3) | 14 days | 
| change of smoking behaviour | Questionnaire, 3 level scale ranging from less smoking(Level 1), unchanged smoking (Level 2), to increased smoking (Level 3) | 14 days | 
| change of stress level | Questionnaire, 3 level scale ranging from lower stress level (Level 1), unchanged stress level (Level 2), to increased stress level (Level 3) | 14 days | 
| step count | wearables | 6 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, cardiovascular prevention, physical exercise, risk factor, nutrition
A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to assess how effective PF-00592379 is in restoring penile erections in patients with erectile dysfunction. Patients will attend for 4 treatment visits where they will receive the following in random order; 2 separate doses of PF-00592379, sildenafil 100mg used as a positive control, or placebo (dummy medication). The effect on penile erections will be assessed in the clinic using penile plethysmography (RigiScan PlusTM technique).

Official Title
-----------------
A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses Of PF-00592379 On Erectile Function, Using 100mg Sildenafil As A Positive Control

Conditions
-----------------
Impotence

Intervention / Treatment
-----------------
* Drug: PF-00592379
* Drug: Sildenafil 100mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Erectile dysfunction, previous good response to an oral treatment for erectile dysfunction. Exclusion Criteria: Patients with high blood pressure or certain heart conditions (e.g. angina, heart failure), regardless of whether treated or not. Patients on nitrates or alpha-blocker medications.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PF-00592379|nan|
|Drug: Sildenafil 100mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration and quality of penile erections recorded in a self-assessment diary. |  |  |
Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.

Official Title
-----------------
Open-Label Extension Study to Evaluate the Safety of USL255 as Adjunctive Therapy in Patients With Refractory Partial-Onset Seizures Who Had Participated in P09-004, a Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: USL255


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have completed the maintenance period of the P09-004 study. Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant AEDs.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-label USL255<br>Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day | Drug: USL255<br> <br> * Other names: Topiramate extended-release;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations |  | Open label treatment of up to 62 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy, partial onset seizure, adjunctive therapy