linjc16/ctgov huggingface dataset:
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.

Official Title
-----------------
A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous Ferric Carboxymaltose (FCM) vs. Iron Dextran in Treating Iron Deficiency Anemia

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Ferric Carboxymaltose
* Drug: Iron Dextran


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects ≥18 years of age and able to give informed consent Iron deficiency is the primary etiology of anemia History of intolerance or an unsatisfactory response to oral iron Screening Visit central laboratory Hgb ≤11 g/dL Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30% Exclusion Criteria: Previous participation in a FCM trial Known hypersensitivity reaction to FCM or iron dextran Requires dialysis for treatment of chronic kidney disease Current anemia not attributed to iron deficiency Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase Anticipated need for surgery during the 30 day period prior to screening or during the study period AST or ALT greater than 1.5 times the upper limit of normal Received an investigational drug within 30 days of screening Women who are breastfeeding Pregnant or sexually-active females who are not willing to use an effective form of birth control

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 |
| --- | --- |
| Experimental: Ferric Carboxymaltose (FCM)<br>15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg. | Drug: Ferric Carboxymaltose<br>* 15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.<br>|
| Active Comparator: Iron Dextran<br>As determined by the investigator to a maximum cumulative dose of 2,250 mg. | Drug: Iron Dextran<br>* As determined by the investigator to a maximum cumulative dose of 2,250 mg.<br>* Other names: Dexferrum, INFeD;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's) |  | Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longer |
Can Airflow Limitation in Chronic Obstructive Pulmonary Disease (COPD) be Reversible by Drugs?

Study Overview
=================
Brief Summary
-----------------
Critical combination of various approved drugs in management for patients suffering with COPD.

Official Title
-----------------
Combination of Approved Drug in COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: Macrolid, Theophylline, Inhaler Corticosteroids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: current or past smoker COPD Exclusion Criteria: history of significant occupational or other environmental exposures or a connective tissue disease

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 86 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Macrolid, Theophylline, Corticosteroids<br>Approved drug in this setting | Drug: Macrolid, Theophylline, Inhaler Corticosteroids<br>* we have no permission to include them in detail because of privacy policy of mentioned journal for publication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 15% increasing in forced expiratory volume in 1 second |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Macrolid, reversibility, Theophylline, Corticosteroids, symptoms PFT
MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in Oncogeriatric?

Study Overview
=================
Brief Summary
-----------------
This study concerns elderly patients with cancer with onco-geriatric assessment. This study propose to associate the collection of the results with the Mini-Cog and the CODEX with the passing of the MoCA and the MMS tests, as well as a neuropsychological assessment, in order to determine if the patients have cognitive impairments, to evaluate the sensitivity of these 4 screening tests in elderly patients seeking treatment for their cancer. The results of this study will make it possible, where appropriate, to adapt the practice in the context of oncogeriatric assessment.

Official Title
-----------------
MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in Oncogeriatric?

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

Intervention / Treatment
-----------------
* Other: Passation of neuropsychological test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged over 70 years Patient with cancer (solid tumor or haemopathy) for whom a first line treatment is envisaged (whatever it is). Surgery and radiotherapy are allowed before entry into the study. Patient candidate for oncogeriatric assessment Patient agree to participate in the study Using the French language Exclusion Criteria: Primary central nervous system or cerebral metastasis Evolutionary psychiatric pathology known (e.g. schizophrenia) Severe Visual and / or Auditory Impairment Patients unable to respond to cognitive tests Patient (s) deprived of liberty, under guardianship or curatorship Refusal of participation

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Passation of MMS and MoCA tests associated to passation of neuropsychological test
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Passation of neuropsychological test|Passation of MoCA and MMS tests associated with neuropsychological test|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the sensitivity of MoCA test | MoCA is considered clinically relevant if its sensitivity to identify patients with cognitive impairment is at least 75% | Up 2 months after inclusion, before initiation of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MMS, oncogeriatric, MoCA
KMC Implementation Research for Accelerating Scale-up in Oromia Region, Ethiopia

Study Overview
=================
Brief Summary
-----------------
The main objective is to implement Kangaroo Mother Care (KMC) at selected facilities in Addis Ababa and Oromia Regions to achieve high effective coverage in the catchment population.

Detailed Description
-----------------
To achieve the objective summarized above, the investigators will engage in an iterative process using program learning and quantitative data to continuously improve models in order to enhance uptake of KMC in two phases. In phase 1, the model will undergo an iterative process whereby every three months, the investigators will analyze the data collected and improve the model until it is reached at a model that achieves effective KMC coverage of at least 80%. In phase 2, we will scale the successful model to all selected facilities. The investigators' primary outcomes will be effective coverage of KMC at 7 days of age, and effective coverage of KMC at 7 days after discharge from the facility. Effective coverage will be defined as adoption of skin to skin care for at 8 least hours and exclusive breastfeeding in the 24 hours prior to assessment

Official Title
-----------------
KMC Implementation Research for Accelerating Scale-up in Oromia Region, Ethiopia

Conditions
-----------------
Low Birth-weight

Intervention / Treatment
-----------------
* Other: Kangaroo mother care (KMC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All newborns who are less than 2000 gm born within the study facilities during the study period. Exclusion Criteria: Newborns who are sick per predefined criteria will not be provided KMC until they have been stabilized. Criteria for delay of initiation include: critical illness including apnea, decreased respiratory rate <20 breaths per minute, grunting, cyanosis, severe chest in-drawing, convulsions, unconsciousness, and severe hypothermia <32°F.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 Days

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Kangaroo mother care (KMC)|Skin to skin contact of newborns with mothers and exclusive breast feeding|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective coverage of KMC at 7 days of age. | Effective coverage will be defined as adoption of skin-to-skin care for at least 8 hours and exclusive breastfeeding in the 24 hours prior to assessment. | Seven days of age |
The Relationship of Relative Corneal Refractive Power Shift and Axial Length in Adolescents With Orthokeratology Lens

Study Overview
=================
Brief Summary
-----------------
Orthokeratology lens is an effective method for myopia control. This study analyzed the relationship between the relative corneal refractive power shift and change of axial length in adolescents with orthokeratology lens.

Detailed Description
-----------------
Orthokeratology lens is an effective method for myopia control. This study aimed to investigate the relationship between the relative corneal refractive power shift and changes of axial length in adolescents with orthokeratology lens in 1 year. Other factors that may affect axial growth were also analyzed.

Official Title
-----------------
The Relationship of Relative Corneal Refractive Power Shift and Axial Length in Adolescents With Orthokeratology Lens

Conditions
-----------------
Myopia, Orthokeratology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age from 8 to 15years spherical equivalent(SE) was range from -1.00D to -5.00D conform to the standard of wearing orthokeratology lens Exclusion Criteria: ocular diseases and systemic diseases visual acuity was less than 20/20 unable to follow visitors on time

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 15 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 |
| --- | --- | --- |
| The change of axial length | The axial length was measured by AL-scan, its expressed in mm | The change of baseline and 1years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative corneal refractive power shift(RCRPS) | The value of RCRPS was obtained and calculated from a corneal topography | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myopia, Orthokeratology, Axial length
Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the emotional well being of mothers to preterm infants with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress levels will be taken into consideration. In addition, the correlation between the infant's development and the mother's emotional state will be analyzed.

Detailed Description
-----------------
Medical records of the children will be used for information in four categories: prenatal, birth, development,and demographic information. Parents will be contacted and interviewed regarding the child's development. In addition, they will complete the following questionnaires: PPQ-II Perinatal PTSD Questionnaire- modified, PTGI -The Posttraumatic Growth Inventory,Parental Stress Index- Short Form- PSI-SF, and Life Events questionnaire.

Official Title
-----------------
The Long-Term Developmental Outcomes of Extreme Prematurity: Correlations With Maternal Post-Traumatic Symptoms, Parental Stress and Post-Traumatic Growth, 5-15 Years Postpartum

Conditions
-----------------
Emotional Stress, Preterm Infants, Post Traumatic Stress Disorder, Infant, Very Low Birth Weight

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm Infant Very low birth weight or extremely low birth weight Exclusion Criteria: Missing information regarding birth week and weight
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal Development<br>The infant's development level will be assessed using a phone interview with parents | |
| Abnormal Development<br>The infant's level of development will be assessed using a phone interview with parents | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Not relevant |  | Not relevant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, Preterm, Premature, VLBW
Analysis of the Posterior Wall Fracture of the Acetabulum

Study Overview
=================
Brief Summary
-----------------
Assessement,evaluation of postoperativ reduction of posterior wall acetabular fractures in Assiut University Hospital

Detailed Description
-----------------
Posterior wall fracture of the acetabulum resemble 30% of acetabular fracture,surgical treatement is the 1st choice now for most of these fractures as it aimes to restore joint conjuroity and decreases the possibelities of osteoarthrities of the hip joint,in this study investigators will make analysis and assessement of the quality of postoperative reduction which is the main indicator of outcome of acetabular fractures in adult patients in Assiut University Hospitsls

Official Title
-----------------
Analysis of the Posterior Wall Fracture of the Acetabulum

Conditions
-----------------
Acetabular Fracture

Intervention / Treatment
-----------------
* Device: X.ray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients of both sexes with posterior acetabular wall fracture either isolated or associated with other fractures Exclusion Criteria: other types of acetabular fractures not associated with posterior wall fracture

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: X.ray|Surgical treatement of posterior acetabular wall fractures|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the posterior wall fractures of the acetabulum | Analysis and assessement of the quality of postoperative reduction of posterior wall fractures of the acetabulum using postoperative x.ray by MATTA Score | Basline |
Safety and Efficacy of Insulin Detemir in Combination With OAD in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.

Official Title
-----------------
Safety and Efficacy of Insulin Detemir Combined With OAD Versus Insulin NPH Combined With OAD in Type 2 Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes for at least 12 months since diagnosis Insulin naive subjects OAD treatment for at least 4 months alone or combined with no more than two OADs Body mass index (BMI) below 35.0 kg/m2 HbA1c between 7.5-10.0% Able and willing to use twice a day injections for the entire trial period Exclusion Criteria: Current or previous treatment with thiazolidiones within the last 6 months OAD treatment with three or more OADs within the last 6 months Acute insulin treatment for longer than 7 days in a row within the last 6 months Secondary diabetes Known maturity onset of diabetes of young (MODY) Known or suspected allergy to trial product or related products

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|

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 |
| --- | --- | --- |
| Fasting plasma glucose |  |  | 
| Within-subject variation |  |  | 
| Incidence of total hypoglycaemic episodes |  |  | 
| Body weight |  |  | 
| Incidence of adverse events |  |  | 
| Insulin antibodies |  |  |
Procalcitonin Monitoring Sepsis Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the relationship between a procalcitonin decrease over 72 hours and outcome in patients who have severe sepsis or septic shock.

Official Title
-----------------
Procalcitonin Decrease Over 72 Hours and Outcome in Patients With Severe Sepsis or Septic Shock

Conditions
-----------------
Severe Sepsis, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (i.e. >18 years of age) diagnosed with severe sepsis or septic shock as defined in Appendix 1, who are already in the ICU or come from the ED, other wards or directly from out of hospital Blood sample collection within 12 hours after diagnosis severe sepsis or septic shockNo prior enrollment into this study Written informed consent

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 day all cause mortality | participants will be followed up for 28 days | within 28 day safter inlclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause in-hospital mortality | count all death through out stay in the hospital | mortality during hospital stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
procalcitonin, decrease over 72 hours, severe sepsis, septic shock
Aorta Calcium Scoring

Study Overview
=================
Brief Summary
-----------------
Calcium scoring of the coronary arteries is use as a predictor of coronary stenosis. The aim of this study is to measure the calcium scoring of the abdominal aorta using an helicoidal fast scan and to correlate this measurement with classical cardiovascular risk factors and newer parameters reflecting vascular rigidity, like pulse velocity measurement.

Official Title
-----------------
Measurement of an Abdominal Aorta Calcium Scoring and Its Correlation With Cardiovascular Risk Factors

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Device: Helicoidal fast scann


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Patients with at least one cardiovascular risk factor Ambulatory or hospitalized patients Exclusion criteria : Significant cardiovascular complications

Ages Eligible for Study
-----------------
Minimum Age: 45 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>There is only one arm and all patients will have their aortic calcium scoring by CT scan. | Device: Helicoidal fast scann<br>* Each patient will have an computed aortic tomodensitometric scan without contrast injection. This procedure lasts few minutes and irradiation is low. The aortic calcium scoring is calculated using a specific program included in the scan machine<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
-----------------
Calcium scoring/aorta/ cardiovascular risk factor/scann, Patients with at least one cardiovascular risk factor