linjc16/ctgov huggingface dataset:
Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis

Study Overview
=================
Brief Summary
-----------------
The study population concerns adolescent patients with idiopathic scoliosis which requires surgical management and who have a longer waiting period of 6 months. The aim of this study is to research the predictive factors of an improvement in the quality of life of adolescents who have had surgery.

Official Title
-----------------
Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis: Observational Study

Conditions
-----------------
Scoliosis; Adolescence, Arthrodesis

Intervention / Treatment
-----------------
* Behavioral: Quality of life questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient between 12 and 20 years old Scoliosis in adolescents for whom surgery has been proposed based on radiological criteria (Cobb angle> 25 ° for thoracolumbar and lumbar scoliosis,> 35 ° for thoracic scoliosis and> 40 ° for double major scoliosis) Patient affiliated or beneficiary of a social security scheme or attached to a beneficiary of a social security scheme Patient and legal representative having been informed and not opposing this research Exclusion Criteria: Patient over 20 years old Non-surgical scoliosis Refusal to participate in the study by the child or parents

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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 |
| --- | --- |
| Idiopathic scoliosis in adolescents requiring surgery<br> | Behavioral: Quality of life questionnaires<br>* Different questionnaires to fill : SRS-22r, SF-36 score, TAPS, KIDSCREEN10<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors associated with an improvement in the SRS-22r score | Factors associated with an improvement in the SRS-22r score, 1 year after surgery, will be sought among the initial characteristics (before surgery) and within 3 months after surgery. An improvement in SRS-22r score is defined as an increase in the total score at 1 year of at least 10% from value. | 1 year |
Influence of Parents and Friends on Children and Adolescents

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to directly compare the effects of parents and friends on overweight and non-overweight children and adolescents' food intake and food selection using a cross-sectional design. Overweight and non-overweight children (5-6 year-old) and adolescents (13-14 year-old) will share a meal with a friend and with a parent on separate occasions. Participants' food selection and the amount of food they consumed will be compared across conditions. Hypothesis 1: The investigators hypothesize that overweight children and adolescents will select more unhealthy food items and eat more in the presence of an overweight friend than when eating with a lean friend; whereas lean participants eating with an overweight friend will eat a similar amount of food than lean youth eating with a lean friend. Hypothesis 2: The investigators predict that overweight children and adolescents (but not lean children and teens) will consume more food in the presence of their mother than in the presence of a friend. Hypothesis 3: The investigators also predict that overweight youth's energy intake will be related to parental prompts. Hypothesis 4: The investigators expect greater similarities in terms of food selection and food intake between adolescents and their friend than between adolescents and their parent.

Official Title
-----------------
Influence of Parents and Friends on Children and Adolescents

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Boys and girls ages 5-6 yrs and 12-14 yrs and their mothers Children must have a BMI greater than or equal to 15th percentile for their age Children and their mothers must have at least a moderate liking of the study foods used Exclusion Criteria: Participants should not have any food allergies Participants should have no dietary restraints Participants should have no psychopathology that can limit food choice and alter eating Participants should have no developmental disabilities that can limit food choice and alter eating Participants cannot have a cold or upper respiratory distress that could influence taste, appetite or olfactory sensory responsiveness Participants cannot be on any medications that could influence taste, appetite or olfactory sensory responsiveness

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 14 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 |
| --- | --- | --- |
| amount of food consumed |  | Measured once with a friend and once with a mother, both occurring within a week of each other. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
social influences, meals, obesity, amount of food consumed
Suspected Cases of Carbon Monoxide Poisoning

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect non-invasive opportunity sample data in suspected or known cases of carbon monoxide poisoning.

Official Title
-----------------
Data During Emergency Medical Transport in Suspected Carbon Monoxide Poisoning

Conditions
-----------------
Carbon Monoxide Intoxication

Intervention / Treatment
-----------------
* Device: Observational data collection.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Known or suspected carbon monoxide poisoning. Exclusion Criteria: Less than 18 years of age

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

| Intervention/Treatment |
| --- |
|Device: Observational data collection.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Values from the test device will be compared to the values from the reference device. |  | Through study completion, an average of 1 year. |
Influence of Trabeculectomy and Phaco-trabeculectomy on Corneal Astigmatism

Study Overview
=================
Brief Summary
-----------------
This study investigates the effects of trabeculectomy and combined phacoemulsification plus trabeculectomy on corneal astigmatism.

Detailed Description
-----------------
Prospectively, consecutive patients at the University Hospital of Zurich undergoing either trabeculectomy (trab) or phaco-trabeculectomy (phaco-trab) are included in this study between January and December 2017. The study interventions takes place 6 months after surgery and include examination of refraction, biometry and corneal topography in order to assess the patient's astigmatism. The values are compared to the preoperative baseline values, which are available from patient records.

Official Title
-----------------
Einfluss Der Trabekulektomie Und Der Kombinierten Phako-Trabekulektomie Auf Den Kornealen Astigmatismus

Conditions
-----------------
Astigmatism, Glaucoma

Intervention / Treatment
-----------------
* Device: Biometry
* Device: Refraction
* Device: Corneal Topography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Trabeculectomy or Phaco-Trabeculectomy between 01/2017 and 12/2017 Age ≥18 years Exclusion Criteria: Acute or chronic corneal diseases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All Eyes<br>All eyes undergo the same interventions. These are the following examinations: Biometry, Refraction and Corneal Topography. The examinations take place 6 months after surgery | Device: Biometry<br>* All patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery<br>Device: Refraction<br>* All patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery<br>Device: Corneal Topography<br>* All patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Astigmatism [Diopters (dpt)] |  | preoperative astigmatism compared to 6 months postoperatively |
Epidemiology of TNBC in Asyut Clinical Oncology Department

Study Overview
=================
Brief Summary
-----------------
Epidemiological Study about behavior of TNBC in Clinical oncology department in 8 y in Asyut university hospital

Detailed Description
-----------------
Breast Cancer )BC) is the most Common malignancy in women in 2020, there were 2.3 million women diagnosed with breast cancer and 685.000 deaths globally. Breast cancer rates are 88% higher in developed countries compared to developing countries . TNBC represents accounts for approximately 24% of all breast cancer in 2020 .While in Egypt it accounts for 11.05% according to Egyptian national BC (5). By gene expression profiling ,4 subtypes of TNBC emerged : luminal androgen receptor (LAR), mesenchymal stem-like (MSL), immunomodulatory (IM), basal-like (BL1 and BL2) . Most of cases are advanced with median survival about 14 months . Brain and visceral organs represent common sites of distant metastasis . So it is considered the worst prognosis . In addition , chemotherapy is only option in treatment with no available targeted options for decades. Now we have Immunotherapy (IO ) and PARP inhibitors in neoadjuvant (NAT) and metastatic setting For example : Key note 355 which add Pembrolizumab in NAT which lead to marked improvement in pathological complete response ( PCR ) And in high risk patient and have marked results in disease and event free survival(8) .Poly (ADP-ribase) poly merase -1 (PARP-1) inhibitors appear to particularly effective in BRCA 1/2 mutation carries (9) .As reviewed by rodleret al. emerging data suggest that BRCA 1/2 carriers with TNBC disease may respond favorably to cisplatin therapy .

Official Title
-----------------
Epidemiology of Triple Negative Breast Cancer in Asyut Clinical Oncology Department From 2015 to 2022 ( A Hospital Based Study)

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- Age ≥ 18 Male or female Diagnosed as TNBC from ( 2015- 2022 ) confirmed by pathology Adjuvant or metastatic Exclusion Criteria:- Have other type of malignancy HER2 , ER, PR positive

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of TNBC | Incidence of TNBC in clinical oncology department from 2015-2022 | Baseline | 
| Behavior of the disease and stage | Behavior of the disease and stage of presentation | baseline | 
| Types of treatment | Types of treatment | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS | Disease free survival | Baseline | 
| PFS | progression free survival | Baseline | 
| OS | overall survival | Baseline |
SINGULAIR (R) as Complementary Therapy to Fixed Association Regimen (0476-363)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the treatment effect of montelukast 10mg on the primary endpoint of Asthma Control Questionnaire(ACQ), over a 8-week period, in persistent asthma patients with or without allergic rhinitis.

Official Title
-----------------
An Open Label, Observational Study to Assess The Efficacy, Safety and Tolerability of Added Singulair in Persistent Asthma Patients With or Without Allergic Rhinitis and Long Acting B-Agonist

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

Intervention / Treatment
-----------------
* Drug: MK0476, montelukast sodium / Duration of Treatment: 8 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is currently a nonsmoker and has been a nonsmoker for at least 1 year Patient with clinical evidence of mild/moderate asthma with or without allergic rhinitis Exclusion Criteria: Patient has been treated in an emergency room for asthma within 4 weeks or has been hospitalized for asthma within 3 months prior to visit 1 Patient with severe asthma, upper respiratory infection, sinusitis, infectious rhinitis, non-allergic rhinitis Patient has any active, acute, or chronic pulmonary disorder that is documented by history, physical examination

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0476, montelukast sodium / Duration of Treatment: 8 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the asthma control questionnaire scores taken over 8 weeks |  |  |
ONO-7746 Study in Healthy Adult Subject

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the safety and tolerability of NON-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746 and to evaluate the food effect on the PK profile of ONO-7746 when administered with or without a meal.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-7746 in Healthy Adult Subjects

Conditions
-----------------
Healthy Adult Subjects

Intervention / Treatment
-----------------
* Drug: ONO-7746
* Drug: ONO-7746


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy non-smoking male or female subjects (18-55 inclusive) Body mass index (BMI) of 19-35 kg/m2 (inclusive) For females, postmenopausal, non-lactating, and non-pregnant Exclusion Criteria: History or presence of clinically significant disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: P<br> | Drug: ONO-7746<br>* 1mg, 2mg, 4mg, 8mg, 16mg, once daily for multiple-dose study; 4mg at a single dose for food effect study.<br>|
| Experimental: E<br> | Drug: ONO-7746<br>* 1mg, 2mg, 4mg, 8mg, 16mg once daily for multiple-dose study; 4mg at a single dose for food effect study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment | (evaluations of physical examinations, vital signs, 12-lead ECG, slit lamp examinations, safety laboratory tests, and surveillance for adverse events) | up to 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of PK and PD profiles, including platelet count changes of ONO-7746 |  | up to 42 days | 
| Effect of food on ONO-7746 pharmacokinetics |  | up to 42 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-7746, Healthy adult subjects
A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using zolpidem (Myslee) as a comparative drug

Official Title
-----------------
FK199B (Zolpidem MR Tablet) Phase III Clinical Study -A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia -

Conditions
-----------------
Sleep Initiation and Maintenance Disorders, Sleep Disorders

Intervention / Treatment
-----------------
* Drug: Zolpidem MR
* Drug: Zolpidem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of nonorganic insomnia. Must be able to swallow tablets Exclusion Criteria: Allergic reactions to zolpidem (Myslee) Serious cardiac disorders; Serious hepatic impairment; Serious renal diseases, etc.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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> | Drug: Zolpidem MR<br>* Oral<br>|
| Active Comparator: 2<br> | Drug: Zolpidem<br>* Oral<br>* Other names: Myslee;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean wake time after sleep onset during the double-blind period |  | 2 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean total sleep time during the double-blind period |  | 2 Weeks | 
| Mean number of nightly awakenings during the double-blind period |  | 2 Weeks | 
| Mean sleep latency during the double-blind period |  | 2 Weeks | 
| Patient impression during the double-blind period |  | 2 Weeks | 
| Safety |  | 2 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
zolpidem, sleep initiation and maintenance disorders Hypnotics and sedatives, double-blind study, comparative study
The Influence of Acute Hyperglycaemia on Brain in T1D

Study Overview
=================
Brief Summary
-----------------
The study is going to include 20 adolescents, 5-10 years after onset of T1D, aged 12-20 years, on insulin pump. The participants are going to have MRI of the head in euglycaemic and hyperglycaemic state. During both MRI, the participants are going to preform Flanker test, Tower of London test and Spatial memory test. The investigators are going to evaluate the response of inflammation markers and oxidative stress marekers in blood during hypreglycaemia.

Detailed Description
-----------------
The study is going to include 20 patientswith T1D. The group of patients is going to be homogeneous. The inclusion criteria are going to be: duration of T1D approximately 5 - 10 years, age between 10 and 24 years, without associated clinical complications of T1D, similar value of HbA1c and BMI within the normal range (depending on the percentile for age and sex), treatment with an insulin pump. Only the patients who are going to give written consent to participate in the form Declaration of conscious and free consent are going to be included. All selected clinical data to determine the phenotypic characteristics of the patient will be obtained from available medical records or. at their regular outpatient reading. After 12-hour fasting overnight, the patients will undergo 2h hyperglycaemic clamp. During hyperglycemia a sample of venous blood for the evaluation of oxidative stress, inflammatory response and the expression of non-coding RNA is going to be drawn. Subjects will have 1H-MRS in hyperglycaemic and euglycaemic state and evaluation of executive function (using psychological tests) is going to be preformed. For 1H-MRS, the MRI of the head in order to obtain anatomical data is going to be preformed at first .

Official Title
-----------------
The Influence of Acute Hyperglycaemia on Oxidative Stress, Inflammation, Neurochemical Profile in Brain and Executive Functions of Adolescents With Type 1 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Other: hyperglycaemic clamp


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T1D on insulin pump, no diabetic complication, normal BMI and blood pressure Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hyperglycaemic clamp<br> | Other: hyperglycaemic clamp<br>* 2h hyperglyceamic clamp<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prolonged reaction time |  | during the MRI in hyperglycaemia |