linjc16/ctgov huggingface dataset:
Canine-assisted ANxiety Reduction IN Emergency

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if dogs can reduce the anxiety level of patients in the emergency department.

Detailed Description
-----------------
Patients will score their pain, anxiety, and depression. A dog will then come into the patient's room for approximately 15 minutes after which the patient will score his/her pain, anxiety, and depression again.

Official Title
-----------------
Canine-assisted ANxiety Reduction IN Emergency

Conditions
-----------------
Anxiety

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Research staff will screen for inclusion criterion by asking the care providers if they agree with this statement, I believe this patient is experiencing moderate or greater anxiety. Exclusion Criteria: Extreme intoxication, agitation that precludes conversation with the patient, fear of dogs, dog bite, allergy to dogs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Dog<br>Patient sees therapy dog for 15 minutes, which is standard of care at this hospital. | |
| No Dog<br>Patient receives standard of care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety reduction from Scale | reduction in anxiety score (0-10). 0=balanced mood (least anxiety) 2= slight fear and worry 4=mild fear and worry 6= moderate worry, physical agitation 8=Feeling really bad, at the edge 10=out of control behavior, self-harm (worst anxiety) | 30 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction from Wong Baker faces scale | reduction in pain score (0-10). 0=no hurt (least pain) 2= Hurts little bit 4= Hurts little more 6= Hurts even more 8= Hurts whole lot 10=out of control behavior, self-harm (hurts worst) | 30 mins | 
| Depression reduction from scale | reduction in depression score (0-10). 0= Balanced mood (least depressed) 2= Slightly depressed 4= Mildly depressed 6= Definite malaise 8= Feeling reall bad, at the edge 10=Despair, suicidal feelings (worst depressed) | 30 mins | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety, Dog, Canine, Therapy, Depression, Pain
Safety and Tolerability of Single and Multiple Doses of VAK694 in Healthy and Atopic Subjects

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and tolerability of single and multiple doses of VAK694 in healthy volunteers and otherwise healthy volunteers with a history of allergies.

Official Title
-----------------
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic Profile and Pharmacodynamic Effect of Single and Multiple Doses of VAK694 in Healthy and Atopic Subjects

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

Intervention / Treatment
-----------------
* Drug: NVP-VAK694
* Drug: NVP-VAK694


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of allergic rhinitis (Part 2 only) Exclusion Criteria: Very low or high body weight Heavy or recent smoker Exposure to human monoclonal antibodies Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: NVP-VAK694<br> <br> |
| Placebo Comparator: 2<br> | Drug: NVP-VAK694<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Routine safety observations and pharmacokinetic measurements |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Routine safety observations and pharmacokinetic measurements |  | throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic rhinitis, anti-interleukin 4
Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.

Study Overview
=================
Brief Summary
-----------------
Fever is one of the most common symptoms in pediatrics and one of the most common reasons for visits in pediatricians' office and pediatric emergency departments. Many parents consider fever to be the most terrifying symptom. Ibuprofen is an effective and safe treatment for febrile children. Until recently ibuprofen was available only in tablets suspension and as a liquid gel. All these dosage form are administered orally. Rectal suppositories are often essential for treating febrile children who cannot take medications by mouth (e.g vomiting). In the current study we aim to compare the effect on fever of ibuprofen given as suspension with ibuprofen suppositories.

Official Title
-----------------
Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.

Conditions
-----------------
Fever

Intervention / Treatment
-----------------
* Drug: Ibuprofen suppository
* Drug: Ibuprofen Suspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 3 mo- 4 years Weight 6 - 18 kg Rectal temperature > 38.50 Exclusion Criteria: Treatment with acetaminophen in the last 4 hours Treatment with Ibuprofen in the last 6 hours Unable to take oral or rectal medications Hypersensitivity to ibuprofen Renal failure Liver disease Rectal temperature can't be measured (due to anatomical or medical problem) Informed consent could not be granted

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 5 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>Ibuprofen Suppository | Drug: Ibuprofen suppository<br>* 5-10mg/Kg of ibuprofen<br>|
| Active Comparator: 2<br>Ibuprofen suspension | Drug: Ibuprofen Suspension<br>* 5-10mg/Kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal change in temperature during the 4-hour period after enrollment. |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with a drop of at least 1°C and 2°C in mean temperature at 4h. Decrement in fever at each time point, and the area under the temperature (versus time) curve. Proportion of patients with temperature < 38 at 4 hours. |  | 4 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ibuprofen, Suppository, febrile children
Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.

Study Overview
=================
Brief Summary
-----------------
Phase 3 study to evaluate the effiacay and safety of YYC506

Detailed Description
-----------------
Phase 3 study to evaluate the effiacay and safety of YYC506 in patients with complex dyslipidemia where LDL-C is properly controlled but TG and HDL-C levels are not regulated by Atorvastatin alone.

Official Title
-----------------
Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.

Conditions
-----------------
Dyslipidemias

Intervention / Treatment
-----------------
* Drug: YYC506
* Drug: Control
* Drug: YYC506 Placebo
* Drug: Control Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A man or woman over 19 years old. LDL-C properly controlled, TG, HDL-C is not properly controlled Sign on ICF prior to study participation Exclusion Criteria: History of Fibromyalgia, Myopathy etc (CK ≥ 2XULN) Uncontrolled hypo-thyroidism (TSH≥1.5XULN) Severe renal impairemnet (Creainine clearance < 30mL/min) etc.

Ages Eligible for Study
-----------------
Minimum Age: 17 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
Interventional Model Description: A multicenter, Double-blind, Randomized, Active-controlled, Double dummy, Parelle-group comparative.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test Group<br>Take both YYC506 and Placebo(Control) | Drug: YYC506<br>* YYC506<br>Drug: Control Placebo<br>* Placebo<br>|
| Active Comparator: Control Group<br>Take both Contral and Placebo(YYC506) | Drug: Control<br>* Active control<br>Drug: YYC506 Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change (%) of non-HDL-C from baseline | non HDL-C = TC - HDL-C | from baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change (%) of non-HDL-C | non HDL-C = TC - HDL-C | from baseline at 4, 8, 14 weeks. | 
| Percent change (%) of lipid parameters | TC, HDL-C, LDL-C, TG | from baseline at 4, 8, 12, 24 weeks | 
| Percent change (%) of diabetes parameters | FBS, HbA1c, Insulin | from baseline at 4, 8, 12, 24 weeks |
Responsiveness and Validation Study of MFM-20 in SMA Patients Treated With Nusinersen

Study Overview
=================
Brief Summary
-----------------
The Motor Function Measure (MFM), a reliable tool assessing motor function and its progression in most neuromuscular diseases, is widely used in France in many teams. It can be used regardless of the severity of the motor impairment or the ambulatory status of the patient, allowing its use throughout the whole follow-up period of the patient, even in case of the loss of walking. Two versions of the MFM exist, one composed of 32 items validated for patients from 6 years old (MFM-32) and a shorter version composed of 20 items validated for patients between 2 and 6 years old (MFM-20). In order to show the possible use of MFM-20 as early as the age of 2 years to validly and reliably monitor the evolution of the motor function of children treated with Nusinersen, we propose in this project to study the sensitivity to treatment-induced change of MFM-20 and the validity of the scale in this population.

Official Title
-----------------
Responsiveness and Validation Study of MFM-20 in SMA Patients Treated With Nusinersen: Retro NusiMFM

Conditions
-----------------
Spinal Muscular Atrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Boys and girls with Type 1 or 2 Spinal Muscular Atrophy, genetically confirmed Aged 2 to 6 years old Treated by Nusinersen for at least two months With at least 3 MFM-20 repeated measures, and with adelay minimum between the first and the last MFM-20 of 6 months With parental assent Exclusion Criteria: - Patients with associated cognitive impairment making impossible evaluation of motor function Patients participating to a clinical study with a potential effect on their motor function.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

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 |
| --- | --- | --- |
| MFM-20 responsiveness | The MFM-20 sensitivity to change indexes considered will be the effect amplitude and the Standardized Response Mean (SRM). | At least 6 Months after the first MFM-20 assessment, and at maximum 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Muscular Atrophy, Motor Function Measure, Outcome Assessment, Nusinersen
Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)

Study Overview
=================
Brief Summary
-----------------
West syndrome (WS) is a specific type of epilepsy (or seizure disorder) that has three features: infantile spasms (type of seizure), loss of milestones, and a specific pattern on electroencephalogram (EEG or brain wave test) called hypsarhythmia. The purpose of this study is to detect pre-hypsarhythmia in infants at high-risk for WS and determine whether treatment with ACTH will prevent WS.

Detailed Description
-----------------
Hypothesis: Preemptive ACTH will halt the evolution of hypsarhythmia and improve the EEG patterns in infants with pre-hypsarhythmic EEG. Aim. To determine whether a low dose ACTH improves EEG, we will repeat EEG one month after a 2 week course of daily ACTH.

Official Title
-----------------
Early Treatment of Infants at High Risk of Developing West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)

Conditions
-----------------
West Syndrome

Intervention / Treatment
-----------------
* Drug: adrenocorticotropin hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Infants with pre-hypsarhythmia (Type 3 EEG) between 2 months to 12 months of age. Exclusion criteria: Infants with any of the following diagnoses: A previous history of infantile spasms; Known inborn error of metabolism; Other symptomatic epileptic encephalopathy (e.g. Ohtahara syndrome).

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 12 Months

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: ACTH treatment<br>Infants with a Type 3 EEG (pre-hypsarhythmia) will be treated with ACTH for 2 weeks. | Drug: adrenocorticotropin hormone<br>* ACTH 16 units intramuscular injection once daily for 2 weeks<br>* Other names: H.P. Acthar® Gel (repository corticotropin injection);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence for improvement in the EEG one month following initiation of the 2 week course of low-dose ACTH. | If pre-hypsarhythmia (Type 3) is detected, ACTH treatment is given for 2 weeks and an EEG is performed one month later. Primary outcome is improvement in EEG (as defined by assigned type). | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypsarrhythmia, Spasms, Infantile, West Syndrome
Effect of Urinary Indwelling Time on Early Continence After Robot-assisted Radical Cystectomy With Orthotopic Ileal Neobladder.

Study Overview
=================
Brief Summary
-----------------
The clinical trial assesses the effect of urinary indwelling time on early continence after robot- assisted radical cystectomy with orthotopic ileal neobladder.

Detailed Description
-----------------
Radical cystectomy is the gold standard for muscle-invasive bladder. Orthotopic ileal neobladder, as one of the urinary diversion methods, is preferred whenever possible to achieve a better postoperative quality of life. After surgery, the patient usually indwells a catheter until the anastomotic site heals. And the urinary indwelling time may have an effect on early continence. This is a prospective study including patients undergoing RARC with orthotopic ileal neobladder. Urinary continence recovery and perioperative complication will be analyzed.

Official Title
-----------------
Effect of Urinary Indwelling Time on Early Continence After Robot-assisted Radical Cystectomy With Orthotopic Ileal Neobladder.

Conditions
-----------------
Muscle-Invasive Bladder Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pathologically confirmed bladder cancer Undergoing robot-assisted radical cystectomy with orthotopic ileal neobladder Complete perioperative clinical data Exclusion Criteria: Patients diagnosed with distant metastasis Patients who had urinary incontinence before surgery Patients with unavailable follow-up data

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Day-time continence rate |  | 1 year | 
| Night-time continence rate |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
robot-assisted radical cystectomy, urinary indwelling time, continence, muscle-invasive bladder cancer
Prevalence of a Localized or Diffuse Pruritus in a Population With One or Several, Primitive or Secondary, Brain Tumor(s)

Study Overview
=================
Brief Summary
-----------------
The association between the presence of pruritus, especially centrofacial, and the presence of a brain tumor is a widespread notion in the medical community but based on a single publication by Andreev et al. in the British Journal of Dermatology published in 1975. No other study has studied this association with a rigorous methodology. The aim of this study is to evaluate the prevalence of pruritus in patients with one or more primary or secondary brain tumor(s), benign(s) or malignant(s).

Detailed Description
-----------------
Monocentric prospective observational study On the inclusion period Patients who are seen in radiotherapy consultation and / or department of neurosurgery Complying with the inclusion criteria, not falling within the exclusion criteria Re-reading of cerebral MRI (cMRI) with precision on the location(s) of the brain tumor(s) according to a predefined anatomic descriptive diagram Complete the questionnaire by a dermatologist (characteristics of pruritus, brain lesion(s), characteristics of the population)

Official Title
-----------------
Study on the Prevalence of a Localized or Diffuse Pruritus in a Population With One or Several, Primitive or Secondary, Brain Tumor(s)

Conditions
-----------------
Pruritus, Brain Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age > 18 years Diagnosis of benign or malignant brain tumor, primary or secondary. Accepted non-opposition Realization of a cerebral MRI (cMRI) Exclusion criteria: Age < 18 years Absence of cerebral imaging of the cMRI type Absence of non opposition Realization of a treatment modifying the brain structure (radiotherapy / surgery)

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

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 |
| --- | --- | --- |
| Presence of itching for more than 1 week in a patient with one or more brain tumor(s), primary or secondary, benign(s) or malignant(s). | Presence of itching for more than 1 week in a patient with one or more brain tumor(s), primary or secondary, benign(s) or malignant(s). | 1 year |
PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
The goal of PRESS-ALS is to study the earliest manifestations of disease in people with early ALS in whom some areas of the body are not yet affected.

Official Title
-----------------
PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria ALS group: Subject is a male or female, aged at least 18 years. Subject is affected with ALS (familial or sporadic). Subject has at least one limb in which there is no symptomatic upper and lower motor neuron dysfunction. Subject is willing and able to comply with all study procedures. Subject agrees to provide signed and dated informed consent form. Control group: Subject is a male or female, aged at least 18 years. Subject is not affected with ALS or an ALS-related disorder. Subject does not have a family history (i.e., at least 2 biological relatives) of ALS or an ALS-related disorder. Subject is willing and able to comply with all study procedures. Subject agrees to provide signed and dated informed consent form. Exclusion Criterion • Any condition or situation which, in the PI's opinion, could confound the biomarker data or may interfere significantly with the individual's participation and compliance with the study protocol, including but not limited to neurological, psychological and/or medical conditions (e.g., multiple sclerosis, neuropathy, myelopathy).

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy individuals (controls)<br> | |
| Individuals affected with ALS (sporadic or familial)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenoconversion |  | Every three months over the course of one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Disease onset, Disease progression