linjc16/ctgov huggingface dataset:
Open Versus Endoscopic Surgery of Craniomaxillofacial (CMF) Condylar Neck Fractures

Study Overview
=================
Brief Summary
-----------------
This study is a comparison of open surgery versus an endoscopic approach in condylar neck fractures; it will look at functional outcome, cosmetic outcome and patient satisfaction.

Detailed Description
-----------------
The primary outcome measure is functional outcome based on the Helkimo dysfunction index.

Official Title
-----------------
Open Versus Endoscopic Surgery of Condylar Neck Fractures

Conditions
-----------------
Condylar Neck Fractures

Intervention / Treatment
-----------------
* Procedure: Endoscopic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient > 18 years Unilateral or bilateral fracture of the condylar neck Inclination of the condyle > 30% Severe dislocation Severe pain upon palpation/movement Eligible for open reduction and internal fixation of the fracture Amenable to endoscopic as well as open surgery Exclusion Criteria: High or intracapsular condylar neck fracture Very low fractures that can be reduced intraorally CMF malfunctioning Drug or alcohol abuse General or local conditions that adversely affect bone physiology Physical or mental incapacity to sign 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: Endoscopic surgery<br>* Open surgical intervention compared to endoscopic intervention<br>|
| Other: 2<br> | Procedure: Endoscopic surgery<br>* Open surgical intervention compared to endoscopic intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome based on the Helkimo dysfunction index |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate |  | 24 months | 
| Cost effectiveness |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Condylar neck, fractures, endoscopic, Helkimo Dysfunction index
Long-term Outcome of Newborns With an Isolated Small Cerebellum

Study Overview
=================
Brief Summary
-----------------
The decreased cerebellar biometry during second and third trimester ultrasound examination is the main parameter to diagnoses cerebellar and pontocerebellar hypoplasia. Investigators already described that a transverse cerebellar diameter (TCD) below the 5th centile at second or third trimester scan is related to a high rate of fetal malformations, severe intrauterine restriction in growth, chromosomal anomalies and genetic disorders, therefore when facing a TCD below the 5th centile, patients should be referred for oriented sonogram, fetal MRI (Magnetic resonance imaging) and fetal karyotyping. However, prenatal counseling in case of an isolated decreased cerebellar biometry remains challenging since there are no data in the literature regarding the neurodevelopmental outcome of these newborns. The aim of this work is to evaluate the neurodevelopmental outcome of newborns with a prenatal isolated decreased cerebellar biometry, in order to improve prenatal counseling.

Official Title
-----------------
Perinatal and Long-term Outcome of Newborns With an Isolated Small Transverse Cerebellar Diameter

Conditions
-----------------
Cerebellar Hypoplasia

Intervention / Treatment
-----------------
* Other: Evaluation of the long term neurodevelopmental outcome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 2nd or the 3rd trimester ultrasound examination realized at the hospital Femme Mère Enfant in Lyon between 2008 and 2015 Isolated Transverse cerebellar diameter <5th centile Parents who received the information and did not object to participate to the study Exclusion Criteria: Decreased Transverse cerebellar diameter with associated malformations diagnosed during prenatal period Family history of neurodevelopmental delay or cognitive impairment Preterm delivery (< 28 WG) Severe restriction in growth at birth (<3e centile) Neonatal asphyxia (pH blood cord < 7) Apgar score < 7 at 5 min of live with transfer to the neonatal intensive care unit

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 |
| --- |
|Other: Evaluation of the long term neurodevelopmental outcome|Evaluation of the long-term neurodevelopmental outcome of newborns who have an isolated transverse cerebellar diameter < 5th centile during the second or the third trimester of pregnancy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development Quotient. | Development Quotient of each child established from CDI questionnaire (Child Development Inventory). | between 3 and 10 years after birth |
Morbidity, Mortality and Gender Differences in Patients With Pacemakers

Study Overview
=================
Brief Summary
-----------------
Previous publications suggest gender difference in outcome parameters after pacemaker implantation. Aim of this study is to investigate gender differences in patients with pacemaker. Implanted devices, indication for implantation and pacemaker follow up data of patients will be included. Survival data including cause of death will be documented. Prevalent comorbidities and relevant laboratory data will be recorded.

Official Title
-----------------
Morbidity, Mortality and Gender Differences in Patients With Pacemakers; a Large-scale Single-center Cohort Study

Conditions
-----------------
Cohort Studies, Pacemaker, Artificial, Arrhythmias Requiring Therapy, Cardiac Pacing, Artificial

Intervention / Treatment
-----------------
* Other: No intervention, retrospective analysis only.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients registered in the pacemaker database of the Department of Cardiology at the Medical University Vienna. Patients get registered when clinical follow up of an implanted Pacemaker is done. Exclusion Criteria: For survival analysis: No valid match of first name AND surname AND date of birth with patients' insurance data. For analysis of comorbidities: Not a single documented diagnose was found in our electronic clinic-wide patients' information system.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with implanted pacemaker<br>Patients with implanted cardiac pacemaker registered in pacemaker database of the Department of Cardiology at the Medical University Vienna were included. | Other: No intervention, retrospective analysis only.<br>* No intervention, retrospective analysis only.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival after pacemaker implantation | Null hypothesis: There is no survival difference between women and men after pacemaker Implantation. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rates of single- or dual-chamber Pacemaker in women/men. | Null hypothesis: Women and men have equal implantation rates of single- and dual-chamber pacemakers. | Data obtained: April 30th, 2015 | 
| Survival of women/men after single- or dual-chamber pacemaker implantation. | Null hypothesis: Survival after single- or dual-chamber pacemaker implantation is equal. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pacemaker, Gender differences, Survival, Retrospective
Differences in Ovarian Reserve Markers and Vitamin D Between Infertile Indian, Arabian and Caucasian Population

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to confirm the difference in ovarian reserve markers and serum vitamine D levels between infertile indian, arabian and caucasian population.

Detailed Description
-----------------
200 caucasian, indian, and arab patients

Official Title
-----------------
Differences in Ovarian Reserve Markers, Vitamin D Serum Levels and Reproductive Outcomes Between Infertile Indian, Arabian and Caucasian Population

Conditions
-----------------
Female Infertility Due to Diminished Ovarian Reserve, Vitamin D Deficiency, Hormone Deficiency, Follicular Cyst of Ovary

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: WOMEN BETWEEN 21-43 YEARS FIRST OR SECOND IN VITRO FERILIZATION TREATMENT DUE TO TUBAL, MASCULINE OR PREVIOUS INTRAUTERINE INSEMINATION FAIL TREATMENT Exclusion Criteria: POLYCYSTIC PATIENTS ENDOMETRIOSIS GRADE III OR IV INFLAMMATORY PELVIC DISEASE

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 43 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infertile Indian Population<br>200 Infertile Indian population | |
| Infertile arabian population<br>200 Infertile Arabian population | |
| Infertile caucasian population<br>200 Infertile Caucasian population | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian reserve markers: antimullerian hormone, FSH, antral follicle count |  | beginning of the treatment cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum vitamin D levels |  | Beginning of their treatment cycle | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMH, ACF, VIT D, Ethnicity
Pesticides--Health Fertility and Reproductive Risk

Study Overview
=================
Brief Summary
-----------------
This project is designed to establish whether pesticides or other environmental agents have a role in the excess birth defects identified in the Red River Valley of Minnesota. In this human study, laboratory based health parameters will be used to key in health survey data. In vitro data will be developed to mechanistic information. Concordant results among these study features will provide a weight of evidence approach.

Conditions
-----------------
Birth Defects, Miscarriages, Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Pesticide applicators and their spouses

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
population studies, laboratory evaluation, hormone analysis, semen analysis, chromosome studies
Anemia and Pneumonia

Study Overview
=================
Brief Summary
-----------------
Assess prevalence of anemia among pneumonic children aged two months up to two years.

Detailed Description
-----------------
Pneumonia is an infection via one or both lungs . bacteria and viruses are the most common causes. pneumonia can be medical emergency especially among high risk group like children less than five years Iron deficiency anemia is one of the major health problem in young children. It may be associated with increased risk of pneumonia (1). A study conducted by Bhaskaram reported high frequency of anemia 83 % in children with pneumonia (2). Iron functions in the immune system are essential, among which are included: the maintenance of the activity of phagocyte oxidase, an iron excess can be used by bacteria to improve its growth (3). Anemia was found to be independently associated with fatal outcome in pneumonic children (4). The risk of development of pneumonia in children with anemia increases approximately by four times in comparison with children who have no anemic syndrome (5). Breast-feeding protects against lower respiratory tract infection because of breast milk's unique antiinfective properties (6). Infants who were not being breast fed were 17 times more likely than those being breast fed without formula milk to be admitted to hospital for pneumonia (7). one of the factors that affects severe malnutrition is wrong parenting as parents can play an important role in their children's growth through proper, adequate feeding (8). There's no available studies that examine the association between anemia and pneumonia in our locality.

Official Title
-----------------
Association of Anemia With Pneumonia in Children up to Two Years Attending Assiut University Children 's Hospital .

Conditions
-----------------
Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria: Children aged two months up to two years who attend to Assiut University Hospital with pneumonia in the outpatient pediatric clinic, emergency unit and from inpatient . Exclusion Criteria: . Exclusion criteria: All patients with other comorbidities will be excluded from our study as: severe sepsis & localized infection e.g endocarditis, empyema, autoimmune diseases,renal diseases and congenital anomaly

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 2 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 |
| --- | --- | --- |
| Determine association between anemia and pneumonia in children aged two months up to two years Secondary (subsidiary): Study other associated factors as nutrition and sociodemographic factors |  | 6 months duration |
Measures of Obesity and Co-Morbid Conditions in Maori

Study Overview
=================
Brief Summary
-----------------
It has been proposed that a higher cut off for BMI (body mass index) is to be used in Maori to define overweight and obesity. However, no one has assessed the prevalence of co-morbid conditions associated with BMI. It is well known that Maori are at greater risk of diabetes and cardiovascular disease compared to non-Maori and a delay in the identification of those who are overweight and obese may be detrimental for Maori. We will assess BMI, other measures of adiposity and prevalence of co-morbid conditions with a comparison with a similar matched non-Maori population.

Detailed Description
-----------------
This is a body composition analysis study of people self-identifying Maori and non-Maori participants from both Dunedin and Invercargill. The study consists of a clinical visit for anthropometry and oral glucose tolerance test (OGTT), followed by a single Dexa Scan visit. Participants meeting all the inclusion criteria were invited to participate in the study. Outcome will be determined by examining Dexa Scan data and surrogate clinical endpoints. The clinical endpoints include: anthropometric measurements, Dexa analysis, bioelectric impedance, and BP measurements, and the biochemical measures of: lipid profile, fasting insulin and glucose, liver functions and uric acid levels.

Conditions
-----------------
Body Composition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self identify as Maori and non-Maori aged between 18-68 years Male and female Non-diabetic Resident of Dunedin and Invercargill Exclusion Criteria: The presence of diabetes, renal or liver failure, or any other medical condition which is unstable and for which they are currently having active treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 68 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Maori, Body Composition, DEXA, Cardiovascular disease, Diabetes
Earset Healthy Volunteer Study

Study Overview
=================
Brief Summary
-----------------
The study will recruit healthy volunteers to undergo the Iontophoresis procedure using the Acclarent Iontophoresis System with Earset (IPSES).

Official Title
-----------------
Performance of the Acclarent Iontophoresis System With Earset (IPSES) in Healthy Volunteers

Conditions
-----------------
Otitis Media

Intervention / Treatment
-----------------
* Device: Iontophoresis System With Earset


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 12 months old Exclusion Criteria: Pregnant or lactating females Subjects with history of sensitivity or reaction to lidocaine, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution Significantly atrophic or perforated tympanic membrane Otitis externa Damaged or denuded skin in the auditory canal Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.) Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure.

Ages Eligible for Study
-----------------
Minimum Age: 12 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anesthetization<br>Anesthetization | Device: Iontophoresis System With Earset<br>* iontophoresis of lidocaine-based solution for numbing tympanic membrane<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects anesthetized as assessed by Wong-Baker scale |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with serious adverse events |  | Day 1 |
CMR Features in Patients With Suspected Myocarditis

Study Overview
=================
Brief Summary
-----------------
Presentation of myocarditis is heterogeneous, often ranges from being asymptomatic, to chest pain, dyspnoea, palpitations, and even sudden cardiac death. Diagnosing myocarditis is challenging with no current uniform clinical gold-standard. CMR is a key investigative tool, however the predictive value of CMR features is unknown. In this study we assess 670 consecutive patients with suspected myocarditis who were referred for CMR between 2002 and 2015 at the BWH. CMR features such as late gadolinium sizing, T1 mapping, extracellular volume fraction assessment, strain analysis (feature tracking), clinical data, labortory tetsings and electrocardiogramm are linked to the outcome in order to assess its predictive value.

Official Title
-----------------
Predictive Value of CMR Features in Patients With Suspected Myocarditis

Conditions
-----------------
Outcome, Fatal

Intervention / Treatment
-----------------
* Diagnostic Test: CMR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients referred by their treating physician to undergo CMR for suspected myocarditis as the primary clinical question Exclusion criteria evidence of coronary artery disease hypertrophic cardiomyopathy arrhythmogenic right ventricular cardiomyopathy cardiac sarcoidosis cardiac amyloidosis takotsubo cardiomyopathy constrictive pericarditis Loeffler endocarditis ventricular non-compaction cardiac tumor pulmonary embolism severe valve disease

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 |
| --- |
|Diagnostic Test: CMR|Outcome analysis of CMR features in suspected myocarditis patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events | Heart failure hospitalization; all cause death; sustained ventricular arrhythmia; recurrent myocarditis; transplantation | through study completion, an average of 2 years |