linjc16/ctgov huggingface dataset:
Efficacy and Safety of Insulin Detemir in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.

Official Title
-----------------
Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart to Insulin NPH Plus Insulin Aspart in Adults With Type 1 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin NPH
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Duration of type 1 diabetes for at least 12 months BMI below 35 kg/m2 HbA1c between 7.0-12.0% Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator Exclusion Criteria: Known or suspected allergy to trial product or related products Previous participation in this trial Receipt of any investigational products within the last 2 months prior to this trial Drug or alcohol dependence Pregnancy, breast-feeding or intention of becoming pregnant

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

| Intervention/Treatment |
| --- |
|Drug: insulin detemir|nan|
|Drug: insulin NPH|nan|
|Drug: insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 26 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose profiles |  |  | 
| Change in body weight |  |  | 
| Quality of Life |  |  | 
| Incidence of adverse events |  |  | 
| Incidence of hypoglycaemic episodes |  |  |
Stroke-like Migraine Attacks After Radiation Treatment (SMART) Syndrome Language Intervention

Study Overview
=================
Brief Summary
-----------------
Stroke-like migraine attacks after radiation therapy-also known as SMART syndrome-constitute a rare condition typically characterized by headache, seizures, vision abnormalities, hemiparesis, and aphasia. The condition usually resolves within a few days or weeks of onset with no residual impairments. However, resolution in some cases extends over a period of months rather than weeks and may be incomplete. The purpose of this case report is to provide an in-depth description of the progression of changes in cognitive and language functioning for a person exhibiting SMART syndrome characterized by slow recovery.

Official Title
-----------------
Stroke-like Migraine Attacks After Radiation Treatment (SMART) Syndrome Language Intervention

Conditions
-----------------
Migraine Disorders, Aphasia

Intervention / Treatment
-----------------
* Behavioral: Language treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: exhibit cognitive and language deficits secondary to SMART syndrome be a former or current client of Quality Living, Inc., Omaha, Nebraska be a native speaker of English Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Language treatment|Individual speech-language therapy sessions totaling 1.5 to 2.5 hours five days per week. Intervention activities include performing oral and written confrontation and responsive naming, writing single words to dictation, reading single words and sentences aloud, and generating written and spoken picture descriptions.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized assessment | Aphasia Quotient of the Western Aphasia Battery - Revised | Change from baseline at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spoken picture description | Spoken language sample elicited through a request to describe events depicted in a Norman Rockwell drawing. | Change from baseline at 6 weeks, 10 weeks, 14 weeks, 20 weeks, and 26 weeks | 
| Written picture description | Written language sample elicited through a request to write about events depicted in a Norman Rockwell drawing. | Change from baseline at 6 weeks, 10 weeks, 14 weeks, 20 weeks, and 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive Impairment
ASP8825 - Study in Patients With Restless Legs Syndrome

Study Overview
=================
Brief Summary
-----------------
To demonstrate the superiority of ASP8825 over placebo and the dose response in patients with restless legs syndrome

Detailed Description
-----------------
Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with restless legs syndrome

Official Title
-----------------
ASP8825 Phase ⅡStudy-A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP8825 in Patients With Restless Legs Syndrome

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

Intervention / Treatment
-----------------
* Drug: ASP8825
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with RLS, based on the International RSL Study Group Diagnostic Criteria History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started Documented RLS symptoms for at least 4 of the 7 consecutive evenings/ nights during the baseline study period Exclusion Criteria: A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS A history of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias and dystonias

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose 1 | Drug: ASP8825<br>* oral<br>* Other names: XP13512;|
| Experimental: 2<br>Dose 2 | Drug: ASP8825<br>* oral<br>* Other names: XP13512;|
| Experimental: 3<br>Dose 3 | Drug: ASP8825<br>* oral<br>* Other names: XP13512;|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of the International Restless Legs Syndrome rating scale score |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator-related Clinical Global Impression of Improvement |  | 12 weeks | 
| Patient- related Clinical Global Impression of Improvement |  | 12 weeks | 
| The Pittsburgh sleep quality index |  | 12 weeks | 
| The SF-36 Health Survey |  | 12 weeks | 
| The Restless Legs Syndrome QOL Questionnaire |  | 12 weeks | 
| The Medical Outcomes Study sleep scale |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASP8825, Restless legs Syndrome, XP13512
Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the clinical outcome of using direct esthetic composite restorations and the use of preformed metal crowns in managing MIH cases among a group of Egyptian children.

Official Title
-----------------
Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial (Part I)

Conditions
-----------------
Molar Incisor Hypomineralization

Intervention / Treatment
-----------------
* Procedure: restoration of permanent molars affected with MIH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with MIH in one fully erupted molar or more. Age ranging from 7-12 years. Cooperative children Good general health. Exclusion Criteria: patients participating in other experiments. Patients with parents planning to move away within the following year. Patients with only mildly affected MIH molars that do not require extensive restorative treatment. MIH-affected molars that have a very poor prognosis and require extraction. First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 12 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: direct composite restorations<br> | Procedure: restoration of permanent molars affected with MIH<br>* restore MIH affected molars using direct composite or preformed metal crowns<br>|
| Active Comparator: preformed metal crowns<br> | Procedure: restoration of permanent molars affected with MIH<br>* restore MIH affected molars using direct composite or preformed metal crowns<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treating hypersensitivity associated with MIH affected permanent molars by questioning the patient | questioning the patient about hypersensitivity after performing treatment ( direct composite restorations and preformed metal crowns) | one year |
The Effectiveness of Metoprolol in the Prevention of Syncope Recurrence in Children and Adolescents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to evaluate the effectiveness of metoprolol versus conventional treatment in the prevention of syncope recurrence in children and adolescents.

Detailed Description
-----------------
Syncope is often a frustrating clinical problem seen in pediatric patients. Most pediatric syncope is benign, and vasovagal syncope (VVS) is the most common type of syncope seen in children . The diagnosis of VVS is established by history, often confirmed by tilt tests. A wide range of drugs has been proposed for VVS , with β-adrenergic blocking agents being first-line therapy. However, clinical studies have shown conflicting results in terms of therapy effectiveness. β-blockers have been claimed to be effective for 60% to 100% of young patients in many uncontrolled studies but not in most short- and long-term controlled studies . Sheldon et al., in a recent multicenter, double-blinded, placebo-controlled, randomized study of adult patients, reported that metoprolol was not effective in preventing VVS. To our knowledge, no pediatric randomized controlled trials with long-term follow-up have demonstrated the efficacy of β-blockers for the prevention of syncope.

Conditions
-----------------
Syncope, Vasovagal

Intervention / Treatment
-----------------
* Drug: metoprolol
* Drug: conventional treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with a history of syncope were included if they had had at least three syncopal episodes per year and had a positive head-up tilt test result. Exclusion Criteria: Patients were excluded if they had: Other causes of syncope; Cardiovascular and/or systemic disease; Systolic blood pressure >130 mm Hg or diastolic blood pressure >90 mm Hg； or History of asthma, impaired liver function, Ⅱ to Ⅲ degrees of atrioventricular block, sinus bradycardia < 40 beats/min, or other contraindications for β-blockers.

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

| Intervention/Treatment |
| --- |
|Drug: metoprolol|nan|
|Drug: conventional treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Our primary outcome variable was recurrence of syncope. |  | The primary endpoint was recurrence of syncope within 2 weeks after beginning therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metoprolol and Syncope
Measuring the Electrical Properties of Malignant Tissues In Vivo

Study Overview
=================
Brief Summary
-----------------
Previously published studies have indicated that there exist difference in electrical properties (EPs), i.e., the conductivity and relative permittivity, between malignant and adjacent normal tissue, which will be useful in the early detection of cancers. However the EP information mainly based on ex vivo measurement of cancer tissues, and few data in vivo were published. The purpose of this study is to in vivo measure the electrical properties of the malignant tissues.

Detailed Description
-----------------
The measurements were safety guaranteed and were conducted during the cancer surgeries. Before the tissue was excised from the patient,the pathologist assisted the operator (already at the operating room) responsible for the measurement.The measurement of malignant and corresponding normal tissues were both performed. The tissues for dielectric properties measurement were classified as normal or malignant by the pathologist based on his own expertise and decision criteria (visual inspection, anatomy) and the per-operative histological examination. The measurements were directly performed on the tissue before excision.The sites of the measured malignant tissues were marked,doubletracked according to the pathological report to make sure the marked sites are malignant. The patient age and tissue temperature at the time of measurement were recorded.

Official Title
-----------------
Measuring the Electrical Properties of the Malignant Tissues During Cancer Surgeries

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Device: network analyzer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of cancer Disease Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: network analyzer|The dielectric properties of the tissues were measured using the open-ended coaxial line method. The measurement system consisted of a network analyzer (Model 4395A, Agilent Corp., Santa Clara, CA) associated with an S-parameter test set (Model 87511A, Agilent Corp., Santa Clara, CA). A semi-rigid coaxial line with a diameter of 3.58 mm was connected to the network analyzer system by using a Bayonet Neill-Concelman connector. The other tip of the coaxial line (probe) was placed on the flat bare surface of the tissue.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conductivity of the Malignant Tissues measured In Vivo |  | one year | 
| Relative Permittivity of the Malignant Tissues measured In Vivo |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
electrical properties, malignant tissues, in vivo
Safety Study on IdeS in Healthy Volounteers

Study Overview
=================
Brief Summary
-----------------
This is a first in man study to assess safety and tolerability of the IgG cleaving enzyme Immunoglobuli G degrading enzyme of streptococcus pyogenes (IdeS).

Detailed Description
-----------------
A phase I study (11-HMedIdeS-01, EudraCT no. 2012-000 969-21) first in man single ascending dose study in 29 healthy subjects to investigate if IdeS is safe and well tolerated in doses up to 0.24 mg/kg body weight (BW).

Official Title
-----------------
A Phase i Single Center Study to Evalute the Safety, Tolerability and Pharmacokinetics of Intravenous IdeS After Administration of Single Ascending Doses in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: IdeS
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to understand and sign informed consent BMI 19-30 Exclusion Criteria: Clinically significant disease Positive HIV, hepatistis B or C Drug abuse Smoking Use of medication except paracetamol

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IdeS<br>Intravenous infusion | Drug: IdeS<br> <br> |
| Placebo Comparator: PBS Buffer<br>Intravenous infusion | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by adverse events |  | 64 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration of IdeS |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteers
Study Evaluating the Safety and Ability to Produce Immune Response of Prevenar and Meningitec Given at the Same Time

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and immunogenicity of concomitant Prevenar and Meningitec compared to Prevenar alone and Meningitec alone when used as part of the routine vaccination series in healthy infants

Official Title
-----------------
A Randomised Open Label Phase 4 Study to Evaluate the Safety and Immunogenicity of Concomitant Prevenar and Meningitec Compared to Prevenar Alone and Meningitec Alone When Used as Part of the Routine Vaccination Series in Healthy Infants

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: Prevenar and Meningitec
* Biological: Prevenar
* Biological: Meningitec


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy infants aged 6 to 9 weeks

Ages Eligible for Study
-----------------
Minimum Age: 42 Days
Maximum Age: 63 Days

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Prevenar and Meningitec | Biological: Prevenar and Meningitec<br>* 1 dose of Prevenar at 2,3.5,6 and 12 months and 1 dose of Meningitec at 2,6 and 12 months<br>|
| Experimental: 2<br>Prevenar | Biological: Prevenar<br>* 1 dose at 2,3.5,6 and 12 months<br>|
| Experimental: 3<br>Meningitec | Biological: Meningitec<br>* 1 dose at 2,6 and 12 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pneumococcal and meningococcal responses achieved after the infant series |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pneumococcal and meningococcal responses achieved after the toddler dose |  | 13 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Meningococcal disease, pneumococcal disease, meningitis