linjc16/ctgov huggingface dataset:
Prevalence of Undernutrition in Assiut University Children Hospital

Study Overview
=================
Brief Summary
-----------------
To describe the prevalence of undernutrition in infants and children admitted to Assiut university children hospital and to describe risk group and decrease length of stay in hospital.

Detailed Description
-----------------
Malnutrition is defined as a state in which a deficiency (or excess) of energy, protein, and other nutrition causes measurable adverse effects on the body and on growth (in children), and may impact clinical outcome. Recent studies in developed countries have estimated the prevalence of malnutrition in hospitalized children as 12% to 24%. Causes of malnutrition: There are many types of malnutrition, and they have different causes. Some causes include: Poor diet, Starvation due to food not being available , Eating disorders, Problems with digesting food or absorbing nutrients from food , Certain medical conditions that make a person unable to eat Malnourished children were classified according to the type of malnutrition into: Acute malnutrition (wasting) , Chronic malnutrition (stunting) , Micronutrient malnutrition. Malnourished children experience more complications, such as infections after surgery, than well-nourished children, also leading to increased length of stay. In infants, early malnutrition is associated with delayed physical as well as intellectual development.

Official Title
-----------------
Prevalence of Undernutrition in Assiut University Children Hospital

Conditions
-----------------
Undernutrition

Intervention / Treatment
-----------------
* Diagnostic Test: Anthropometric measures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All infants and children from 2 months to 6 years admitted to Assiut university children hospital . Exclusion Criteria: Infants less than month ,Children over the age of 6 years .

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 6 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Anthropometric measures|Weight (kg),Height (cm)Body mass index(kg/m²),Mid-upper arm-circumference(cm), tricipital skinfold (cm)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the prevalence of undernutrition in all infants and children admitted to Assiut university children hospital | Analysis of the prevalence of undernutrition (undernutrition rate) among pediatric patients at the time of hospital admission throughout a calendar year in Assiut university children hospital and identify types of undernutrition among those pediatric patients. | Baseline |
Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity

Study Overview
=================
Brief Summary
-----------------
The aim of this clinical study is to investigate the efficacy and safety of Dysport® in patients with early onset of upper limb spasticity within 2-12 weeks after stroke.

Official Title
-----------------
A 24-week Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study of Dysport® Injection for the Treatment of Upper Limb Spasticity in Early Stroke.

Conditions
-----------------
Muscle Spasticity, Cerebrovascular Accident

Intervention / Treatment
-----------------
* Biological: Botulinum toxin type A
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First-ever stroke according to the World Health Organisation criteria (previous transient ischaemic attack or clinically silent infarct on CT/MRI is not counted as previous stroke) CT/MRI scan required to classify ischaemic / haemorrhagic stroke Patient recruited 2-12 weeks after stroke Modified Ashworth Spasticity Score 1+ or above in either elbow or wrist joint Exclusion Criteria: The patient has bleeding disturbances or having used coumarin derivatives The patient is currently receiving drugs affecting neuromuscular transmission Co-existing severe systemic illness which may adversely affect the functional outcome Pre-existing neuromuscular junction disease or any neurogenic disorders which can interfere with spasticity

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dysport | Biological: Botulinum toxin type A<br>* 1 injection, 500 U at day 0. The study will last for 6 months in each patient.<br>* Other names: AbobotulinumtoxinA (Dysport®);|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* 1 injection at day 0. The study will last for 6 months in each patient.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of spasticity assessed by changes of the Modified Ashworth Spasticity Score from baseline of elbow and wrist flexors in supine anatomical position |  | week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of neurologic outcome (mobility and function), evaluated by Modified Ashworth Scale, Barthel Index, Modified Rankin scale, Functional scale (Motor Assessment Scale) |  | weeks 4, 8, 12 & 24 | 
| Voluntary and passive joint range of motion goniometer assessment |  | weeks 4, 8, 12 & 24 | 
| Pain Assessment using visual analogue scale for pain |  | weeks 4, 8, 12 & 24 |
Dental Malocclusion and Craniofacial Development in OI

Study Overview
=================
Brief Summary
-----------------
Osteogenesis imperfecta (OI) is a rare inherited disorder that causes bones to break easily. Individuals with osteogenesis imperfecta break bones often and may have other problems, including hearing loss and pain and difficulty getting around. People with moderate to severe OI may also be diagnosed with dentinogenesis imperfecta (DI). DI is characterized by grey or brown teeth that may chip and wear down and break easily. People with DI may also have skull and neck defects. These patients may have severe teeth misalignment resulting in clinically significant chewing problems. Teeth misalignment in OI is very hard to treat because of the quality and quantity of bone. The overall goal of this study is to improve dental health to improve the quality of life of people with OI.

Detailed Description
-----------------
Investigators will look at dental health in people with OI and will describe teeth misalignment and head and neck defects in individuals with moderate to severe Osteogenesis Imperfecta (OI). Investigators will look at results from the Longitudinal study of OI to complete the study evaluations. Several x-rays will be performed for this study. Participants will have a 3D scan of the mouth and a Cone Beam CT scan of the jaw at a baseline visit and at 3 years after the baseline visit. These study visits can be at the same time as the Longitudinal Study of OI study visits.

Official Title
-----------------
Dental Malocclusion and Craniofacial Development in OI

Conditions
-----------------
Osteogenesis Imperfecta

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females with Clinical diagnosis of OI other than OI type I Individuals 10 years or older Participant of the Brittle Bone Disease (BBD) Longitudinal Study (7701) Exclusion Criteria: Individuals who cannot be correctly positioned for valid radiographic analysis (e.g., due to severe scoliosis or short neck secondary to basilar invagination) Women who are pregnant

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Teeth Misalignment | Measure teeth misalignment in individuals with moderate to severe OI using scans of the teeth. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Defects | Determine neck defects in individuals with moderate to severe OI using scans of the neck and jaw. | 5 years |
E-learning to Prevent Wrong Site Surgery in Anesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to assess the efficiency of an e-learning in order to put into practice some preventive measures to avoid wrong site surgery during anesthesia.

Detailed Description
-----------------
Before the study, the investigators selected 7 preventive measures to avoid wrong site surgery during regional anesthesia combined or not with general anesthesia . These measures were learned to the entire anesthesia team (nurse, resident and anesthesiologist) during conventional meetings. An initial evaluation of the application of these measures will be carried out before the introduction of e-learning. This assessment will be conducted by nurses without the knowledge of the anesthetic team evaluated. After this initial evaluation, e-learning will be broadcast on the hospital intranet. Then a second evaluation of the application of the preventive measures will be carried out 6 month and 1 year after the introduction of e-learning.

Official Title
-----------------
Evaluation of an E-learning to Prevent Wrong Site Surgery in Anesthesia.

Conditions
-----------------
Medical Errors : Wrong Site Surgery in Regional Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: patient undergoing regional anesthesia with or without general anesthesia Exclusion criteria: general anesthesia without regional anesthesia perimedullar anesthesia bilateral surgery

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the application of each of the 7 preventive measures using a questionnaire filled by a nurse not involved in the regional anesthesia procedure | Evaluation of the application of each of the 7 preventive measures using a questionnaire filled by a nurse not involved in the regional anesthesia procedure. This questionnaire simply indicates whether a measure has been applied or not | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wrong site surgery in regional anesthesia
To Evaluate Safety and Effectiveness of RovatitanTab.

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and effectiveness of a fixed-dose combination containing valsartan and rosuvastatin (Rovatitan® Tablet) in patient with hypertension and hypercholesterolemia

Detailed Description
-----------------
Effectiveness: the ratio of patients who reach target BP or LDL-cholesterol Safety: we will collect safety data

Official Title
-----------------
A Multicenter, Single-arm, Prospective, Observational Study to Evaluate the Safety and Effectiveness of a Fixed-dose Combination Containing Valsartan and Rosuvastatin (Rovatitan® Tablet) in Patient With Hypertension and Hypercholesterolemia

Conditions
-----------------
Hypertension, Hyperlipidemias

Intervention / Treatment
-----------------
* Drug: Rosuvastatin/Valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have hypertension and hyperlipidemia and older than 19 years Patients who undertstand purpose and method of study, agree with study Exclusion Criteria: Patients who have been administered Rosuvastatin/Valsartan as a anti- hyperlipiddemic/anti-hypertensive drugs Uncontrolled hypertension (SBP>=180mmHg or DBP>=110mmHg) Patients who participated another clinical study or observational study 3 months ago.

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Treatment<br>Rovatitan 5/80mg (Rosuvastatin 5mg/Valsartan 80mg) Rovatitan 5/160mg (Rosuvastatin 5mg/Valsartan 160mg) Rovatitan 10/80mg (Rosuvastatin 10mg/Valsartan 80mg) Rovatitan 10/160mg (Rosuvastatin 10mg/Valsartan 160mg) Rovatitan 20/80mg (Rosuvastatin 20mg/Valsartan 80mg) Rovatitan 20/160mg (Rosuvastatin 20mg/Valsartan 160mg) | Drug: Rosuvastatin/Valsartan<br>* Rovatitan QD for 12 weeks<br>* Other names: Rovatitan Tab.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ratio of patients who reach the target BP | SBP/DBP<140/90mmHg (<60years), SBP/DBP<150/90mmHg (>=60years) | 12weeks | 
| The ratio of patients who reach the target LDLcholesterol | target LDL refered to Hyperlipidemia pharmacotherapy | 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ratio of patients who reach the target BP and LDL-c | SBP/DBP<140/90mmHg (<60years), SBP/DBP<150/90mmHg (>=60years), target LDL | 12weeks |
The Validity of Kleinhauer Betke in Women With Known Hemoglobinopathy for Fetal-maternal Hemorrhage

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the validity of Kleinhauer Betke in women with known hemoglobinopathy for fetal-maternal hemorrhage.

Official Title
-----------------
The Validity of Kleinhauer Betke in Women With Known Hemoglobinopathy for Fetal-maternal Hemorrhage

Conditions
-----------------
Fetal-Maternal Hemorrhage

Intervention / Treatment
-----------------
* Diagnostic Test: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant with singleton fetus Gestational age 34-42 With or without known hemoglobinopathy Exclusion Criteria: Known risk factor for fetal maternal hemorrhage

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pregnant with hemoglobinopathy<br>Standard of care with blood test before active labor | Diagnostic Test: Blood test<br>* Standard blood test<br>|
| Active Comparator: Pregnant without known hemoglobinopathy<br>Standard of care with blood test before active labor | Diagnostic Test: Blood test<br>* Standard blood test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of Kleinhauer Betke test in Pregnant Women | Comparison of Kleinhauer Betke results with electrophoresis results to determine presence of F-hemoglobin. This would indicate the validity of the Kleinhauer Betke test in women with hemoglobinopathy | 24 hours |
PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze the safety and feasibility of direct administration intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients with femoral osteonecrosis.

Official Title
-----------------
PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells

Conditions
-----------------
Osteonecrosis of the Femoral Head

Intervention / Treatment
-----------------
* Procedure: bone marrow aspirate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 70 years Clinical diagnosis and imaging (Rx and NMR) of idiopathic osteonecrosis of the femoral head Stadiums <IIIC ARCO ranking Exclusion Criteria: Those on investigator judgment not in a good position to tolerate the procedure. Clinical criteria and anesthetics that contraindicate surgery (eg ASA IV-V) Serious illness uncontrolled Pregnant women Patients with HIV infection + Acute infection (in the previous 15 days) or chronic (other than HIV) Previous treatments of osteonecrosis Active or previous neoplastic disease (last 5 years) except for patients undergoing allogeneic haematopoietic progenitors who are in complete remission after 2 years after transplantation. Lack of informed consent or revocation thereof.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal Stem Cell<br>Cell suspension mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products. They employ a minimum dose of 0.5 x 106 MSC / kg and a maximum of 1, 0x106 CSM / kg of patient weight. Pharmaceutical form: Suspension cell Route of administration: local implant intraosseous injection with trocar in the femoral head. | Procedure: bone marrow aspirate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteonecrosis of the femoral head, Stem Cell, Mesenchymal Stem Cells, Femoral Head
T-cell-immunity During Standard Radiotherapy in Localised Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Immunological effects of radiotherapy have been described before, but not evaluated in a time-dependant manner. In order to identify a possible time frame for combination therapies, white blood cells are isolated of samples taken at different time points before during and after standard radiotherapy in patients with localised prostate cancer. The overall activity of the T-cell-system as well as tumor-specific T-cell-response are evaluated.

Official Title
-----------------
Changes of T-cell-immune-status During Curative Radiotherapy in Prostate Cancer

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Localised prostate cancer (node negative) definitive radiotherapy informed consent Exclusion Criteria: medication including steroids or immunosuppressants

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

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

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 |
| --- | --- | --- |
| T-cell-immunity in time-course |  | During and 3-6 months after radiotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
localised, prostate cancer, radiotherapy, immunology
Study on Pharmacodynamic Parameter and Tolerability With Subcutaneous Immunotherapy in Grass Pollen Allergic Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to test the pharmacodynamic equivalence with respect to IgE-blocking factor and to compare the tolerability of two different updosing schedules with ALK-Flex SQ

Official Title
-----------------
A Multicentre Randomised Phase II Clinical Trial to Demonstrate Equivalent Pharmacodynamic Efficacy and Tolerability of Two Updosing Schedules for ALK-Flex SQ

Conditions
-----------------
Rhinitis, Conjunctivitis, Asthma

Intervention / Treatment
-----------------
* Biological: subcutaneous immunotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season Lack of adequate relief with symptomatic medication during the previous grass pollen season Positive Skin Prick Test (SPT) response to Phleum pratense (wheal diameter >= 3mm) currently performed or not older than 60 days before screening Exclusion Criteria: FEV1 < 70% of predicted value at screening Bronchial asthma corresponding to GINA step 3 or more, even if controlled History of asthma exacerbation or emergency visit or admission for asthma in the previous 12 months Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years Exclusion criteria in accordance with contraindications in the SPC of ALK-Flex SQ

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: subcutaneous immunotherapy<br>subcutaneous immunotherapy using a slow updosing schedule | Biological: subcutaneous immunotherapy<br>* 7 injections<br>* Other names: AVANZ;|
| Active Comparator: subcutaneous injections<br>subcutaneous immunotherapy using a fast updosing schedule | Biological: subcutaneous immunotherapy<br>* 7 injections<br>* Other names: AVANZ;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgE-blocking factor |  | start of treatment and 1 week after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of two different updosing schedules |  | throughout treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allergen immunotherapy, allergy to grass pollen