linjc16/ctgov huggingface dataset:
Comparison of 2 NovoFine® Needles on the Reflux of Insulin

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. This trial aims to ensure that there is no substantial clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and NovoFine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis.

Official Title
-----------------
Insulin Leakage and Pain Perception in IDDM Children or Adolescents, Where the Injections Are Performed With NovoFine™ 6 x 0.30 mm Needles and NovoFine® 8 x 0.30 mm Needles: An Open, Randomized, Two-period Cross-over, Multi-centre, Phase IIIb Trial at 4 Centres

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Delivery Systems

Intervention / Treatment
-----------------
* Device: NovoFine® needle 6 mm
* Device: NovoFine® needle 8 mm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children/adolescents with type 1 diabetes mellitus Usage of NovoPen® 1.5 for at least 3 months Duration of insulin treatment more than 1 year Normal weight according to Tanner scales The means of the last 2 HbA1c measurements taken within the last 6 months must be less than 10.5% Exclusion Criteria: Pregnancy or desire to become pregnant Clinical relevant peripheral neuropathy as judged by the investigators Pronounced lipodystrophy in accordance with investigator's evaluation Use of drugs that can influence the trial Coagulation disorders (use of anti-coagulants) Serious, chronic diseases, making it highly unlikely that the subject can complete the trial

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NovoFine® needle 6 mm|nan|
|Device: NovoFine® needle 8 mm|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weighing of reflux of insulin |  | 6 seconds after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perception |  | after 6 weeks of treatment | 
| Number and severity of bleedings |  | after 6 weeks of treatment | 
| Reactions at injection sites |  | after 6 weeks of treatment |
MR Fingerprinting for Vestibular Schwannomas

Study Overview
=================
Brief Summary
-----------------
MR Fingerprinting (MRF) will be performed in patients who will be treated with Gamma Knife radio surgery for a vestibular schwannoma before the intervention. Fifty patients will be included with a vestibular schwannoma of minimum 1cm in size. During follow-up, response of the tumor to radiosurgery will be evaluated for each patient with MRI. The aim of the study is to find patterns of vestibular schwannomas in MRF data which correlate with the type of response to radio surgery, i.e. tumor control after radiosurgery, further tumor growth despite radiosurgery, cystic transformation after radiosurgery.

Official Title
-----------------
MR-Fingerprinting for the Prediction of the Response of Vestibular Schwannomas to Gamma Knife Radiosurgery

Conditions
-----------------
Vestibular Schwannoma

Intervention / Treatment
-----------------
* Other: MR Fingerprinting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned Gamma Knife radiosurgery for vestibular schwannoma of minimum 1cm in size - Exclusion Criteria: Vestibular Schwannoma of less than 1cm in size. Other a priori treatment than Gamma Knife radiosurgery -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: MR Fingerprinting|Specific Magnetic Resonance Imaging protocol|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor control | Number of patients without further growth of the tumor on follow-up MRI after radiosurgery | 3 years | 
| Tumor growth | Number of patients with growth of the tumor on follow-up MRI after radiosurgery | 3 years | 
| Cystic transformation | Number of patients with cystic transformation of the tumor on follow-up MRI after radiosurgery | 3 years |
Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Montelukast Tablet under fasted conditions

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 10 mg Tablets Under Fasted Conditions

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Montelukast
* Drug: Singulair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to montelukast or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Montelukast<br>10 mg Tablet | Drug: Montelukast<br>* 10 mg Tablet<br>* Other names: Singulair;|
| Active Comparator: Singulair<br>10 mg Tablet | Drug: Singulair<br>* 10 mg Tablet<br>* Other names: Montelukast;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 9 days |
Troponin Elevation in the Elderly Patient With Hip Fracture

Study Overview
=================
Brief Summary
-----------------
Elevated troponin is powerful and independent adverse prognostic marker in patient with ACS. However, non specific (non cardiac) troponin elevation is a common finding among hospitalized patients and worse prognosis too. The aim of this study is examine the prevalence of incidental cardiac troponin rise in a group of patient aged 65 and over admitted to geriatric department with hip fracture, and influence of troponin elevation on outcomes like ACS, death, motor and cognitive function.

Detailed Description
-----------------
data collection will include epidemiological data (age, gender, living arrangement, basic functional status, fracture date, surgery date, surgery type, length of stay) as well as previous comorbidities. in addition, routine blood tests and baseline ECG will be recorded. troponin levels will be studied within 24 hours from admission, and 24 hours following surgery. in case of elevated troponin levels, ECG will be repeated, and echocardiography together with a cardiologist evaluation will be carried out. data regarding in-hospital complications, motor and cognitive function (by FIM scale) and lab will be recorded. after discharge. followup will be recorded every 3 months, up to 1 year period, recoding the above mentioned data.

Official Title
-----------------
Correlation Between Troponin Level and Rehabilitation Outcome in Elderly Patient With Hip Fracture

Conditions
-----------------
Hip Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 65 and over with hip fracture Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| 1<br> | |
| 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality, motor and cognitive function |  | one year |
A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with placebo on periodic leg movements (PLMS) arousl index and sleep efficiency in patients with RLS. Also, additional objective and subjective sleep parameters and quality of life will be assessed.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled Multicenter Efficacy Study for the Treatment of Patients With Restless Legs Syndrome (RLS)

Conditions
-----------------
Restless Legs Syndrome

Intervention / Treatment
-----------------
* Drug: Cabergoline
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic RLS Moderate to severe symptoms as indicated by an IRLS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4 In a baseline polysomnography, patients had to have periodic leg movements during sleep arousal index greater than 5/hour of total sleep time Exclusion Criteria: Patients suffering from seconadry RLS, due to causes such as iron deficiency or renal disease, or suffering from secondary RLS while taking drugs suspected of causing secondary forms of RLS

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: 1<br> | Drug: Cabergoline<br>* Cabergoline oral tablets administered once daily in the evening: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14, followed by a stable dose for an additional 3 weeks<br>|
| Experimental: 2<br> | Other: Placebo<br>* Placebo oral tablets administered daily for 5 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency |  | Week 5 | 
| PLMS-arousal index (PLMS-AI) |  | Week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Questionnaire Form A |  | Weeks 2 and 5 | 
| Quality of Life for RLS questionnaire |  | Weeks 2 and 5 | 
| Clinical Global Impressions |  | Weeks 2 and 5 | 
| Safety including type and frequency of adverse events, changes in laboratory data and abnormalities observed in electrocardiography |  | Weeks 2 and 5 | 
| Total score of the severity rating scale of the International RLS (IRLS) Study Group |  | Weeks 2 and 5 | 
| RLS-6 severity scales |  | Weeks 2 and 5 |
Efficacy of Propafenone Versus Dronedarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
the purpose of this study is to compare the ability of propafenone and dronedarone to maintain sinus rhythm after DC cardioversion

Detailed Description
-----------------
Atrial fibrillation is the most common arrhythmia requiring continuous therapy. Conversion to and maintenance of sinus rhythm is important. Propafenone and dronedarone has been used as treatment for maintenance of sinus rhythm after DC cardioversion. But there are no direct comparison study. The purpose of this study is to compare the ability of propafenone and dronedarone to maintain sinus rhythm after DC cardioversion.

Official Title
-----------------
Efficacy of Propafenone Versus Dronedarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation After DC Cardioversion

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Propafenone
* Drug: Dronedarone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a patient with persistent atrial fibrillation who received successful DC cardioversion Exclusion Criteria: prior amiodarone use NYHA class III or IV heart failure Left ventricular ejection fraction < 35% second or third AV block sick sinus syndrome heart rate < 50 beat per minute myocardiac infarction within 3 months pregnant women severe hepatic dysfunction QT prolongation > 500ms or PR interval > 180ms history of hypersensitivity for drug

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propafenone<br>Propafenone group | Drug: Propafenone<br> <br> |
| Active Comparator: Dronedarone<br>Dronedarone group | Drug: Dronedarone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence of atrial fibrillation |  | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Propafenone, Dronedarone
Childhood Uveitis Initial Management and One-year Outcomes

Study Overview
=================
Brief Summary
-----------------
The investigators wish to establish a robust estimate of the incidence of inflammation inside the eye (uveitis) in children age 0-16 years in the UK, which hospitals children present to, where they are referred to, which treatment they receive during the first year after diagnosis, and how well they can see at the end of the first year.

Detailed Description
-----------------
The investigators therefore propose to run a high quality surveillance study, together with the British Ophthalmological Surveillance Unit (BOSU) at the Royal College of Ophthalmologists and with the Scottish Ophthalmological Surveillance Unit (SOSU). BOSU and SOSU operate a monthly reporting card scheme. All UK consultant ophthalmologists and associate specialists receive a monthly 'report card' with a list of conditions being surveyed. Reporting clinicians will tick a box if they have seen a case of childhood uveitis in the preceding month, and return the card to BOSU/SOSU, who will inform us, the study investigators. Following reporting of a new case, the investigators will directly contact reporting clinicians and send them a clinical proforma to collect clinical details about the case. At 12 months, a follow up questionnaire will be sent. The investigators will use only information available from patient case notes, with no direct patient contact. The investigators principal aim is to determine incidence of childhood uveitis in the UK. Secondary aims are to identify presentation patterns, referral pathways, associated medical conditions, management, and outcomes.

Official Title
-----------------
Childhood Uveitis Not Associated With Juvenile Idiopathic Arthritis: Incidence, Initial Management and One-year Outcomes

Conditions
-----------------
Uveitis

Intervention / Treatment
-----------------
* Other: Surveillance card


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any child (aged 0-16 years) with a new diagnosis of uni or bilateral uveitis. Exclusion Criteria: In England/Wales/Northern Ireland, children who are known to have pre existing juvenile idiopathic arthritis (joint inflammation) will be excluded. No exclusions will apply to the Scotland cohort.

Ages Eligible for Study
-----------------
Maximum Age: 16 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 |
| --- | --- |
| 1<br>Any child (aged 0-16 years) with a new diagnosis of uni or bilateral uveitis. | Other: Surveillance card<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure will be the total number of reported cases of uveitis. | A clinical proforma will be sent to the investigators collect clinical details about the case. At 12 months, a followup questionnaire will be sent. | 1 year |
Clinical Validation of Embryo Cinematography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the multivariable model for embryo selection (Meseguer et al. 2012) together with undisturbed controlled conditions obtained by a time-lapse incubator system is effective in improving ongoing pregnancy rate in comparison with standard incubator and an embryo selection process based exclusively in morphology.

Official Title
-----------------
Clinical Validation of Embryo Culture and Selection by Morphokinetic Analysis; a Randomized Controlled Trial by Time-lapse System

Conditions
-----------------
Embryo Diagnosis and Selection

Intervention / Treatment
-----------------
* Device: Observe embryo development with Unisense FertiliTech A/S (EC Certificte DGM - 673)
* Device: Observe embryo development


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients undergoing assisted reproduction with ICSI, first or second cycle 20 to 38 yers old BMI (18-25) No endometriosis, > 6 Metaphse II oocytes Basal FSH < 12 UI AMH > 7pmol/L Exclusion Criteria: Hydrosalpinx Recurrent pregnancy loss Severe male factor

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Incubator<br> | Device: Observe embryo development<br>* Observe embryo development in the traditional manner<br>|
| Experimental: ESD Time-lapse Monitoring system<br> | Device: Observe embryo development with Unisense FertiliTech A/S (EC Certificte DGM - 673)<br>* Observation of exact timing of embryo cleavages together with other morphology dynamics parameters.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing Pregnancy Rate |  | confirmed 16-18 weeks after embryo transfer |
A Study of JR-141 in Patients With Mucopolysaccharidosis Type II

Study Overview
=================
Brief Summary
-----------------
The purpose of this study in patients with mucopolysaccharidosis type II (MPS II) is below, to collect the safety information of JR-141 to evaluate the plasma pharmacokinetics of JR-141 to explore the efficacy of JR-141 on MPS II-related central nervous system symptoms and general symptoms

Official Title
-----------------
A Phase I/II Study of JR-141 in Patients With Mucopolysaccharidosis Type II

Conditions
-----------------
Mucopolysaccharidosis II

Intervention / Treatment
-----------------
* Drug: JR-141


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 6 years or older at the time of informed consent. Patients diagnosed with MPS II. Patients who have received idursulfase (0.5 mg/kg/week) continuously for at least 12 weeks until the initial dose of JR-141. Exclusion Criteria: Patients with a history of hematopoietic stem cell transplantation, excluding those who need enzyme replacement therapy even after hematopoietic stem cell transplantation. Patients in whom lumbar puncture cannot be performed. Patients who have developed serious drug allergy or hypersensitivity that is inappropriate for participation in the study. Patients who have received other investigational products within 4 months before enrollment in the study.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: JR-141<br> | Drug: JR-141<br>* IV infusion (lyophilized powder), 0.01-2.0 mg/kg/week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events | Adverse events Laboratory tests Vital signs 12-lead electrocardiogram Antibody Infusion associated reaction | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Pharmacokinetic parameter [Maximum Plasma Concentration [Cmax]] | Plasma concentration of JR-141 | 4 weeks | 
| Plasma Pharmacokinetic parameter [Area Under the Curve [AUC]] | Plasma concentration of JR-141 | 4 weeks | 
| Urinary and serum heparan sulfate (HS) /dermatan sulfate (DS) |  | 4 weeks | 
| HS/DS in CSF | JR-141 concentration in CSF | 4 weeks | 
| Urinary total GAG |  | 4 weeks | 
| Liver and spleen volumes |  | 4 weeks | 
| Cardiac function |  | 4 weeks |