linjc16/ctgov huggingface dataset:
Age-related Longitudinal Changes in Aviator Performance

Study Overview
=================
Brief Summary
-----------------
Our overall goal has been twofold: 1) to evaluate whether there are significant age-related changes in flight simulator performance near age 60, and 2) to assess whether there is an alternative model that can explain longitudinal flight simulator performance on the basis of measures of cognitive function and expertise.

Detailed Description
-----------------
Our overall goal has been twofold: 1) to evaluate whether there are significant age-related changes in flight simulator performance near age 60, and 2) to assess whether there is an alternative model that can explain longitudinal flight simulator performance on the basis of measures of cognitive function and expertise. Such a model might be able to predict change in aviator performance better than what could be predicted by chronological age alone.

Official Title
-----------------
Age-related Longitudinal Changes in Aviator Performance

Conditions
-----------------
Memory Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1) licensed aircraft pilot 2) 45 to 70 years of age 3) at least 100 hours of total flight experience 4) current FAA (Federal Aviation Administration) medical certificate of class III or higher Exclusion Criteria:1) taking psychotropic medications 2) taking other medications with arousal or sedative effects

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 Years

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 |
| --- | --- |
| Pilots<br>No intervention; observational study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aviation-related performance over time. | Participants fly in our computerized flight simulator and perform a set of brief tasks designed to measure reaction time and attention span. The study is longitudinal, collecting information about aviation-related performance over time. There is an initial training period, followed by annual visits. During the training period participants learn how to fly the simulator, and performance on certain standard maneuvers will be measured during a maximum of 6 simulated flights. At each annual visit, participants fly two 75-minute simulated flights and may be asked to perform up to four holding patterns and instrument landings. | longitudinal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Memory, Aviation
Evaluation of the Efficacy of an Amino Acid Based Formula in Infants

Study Overview
=================
Brief Summary
-----------------
This clinical trial will evaluate the efficacy of an amino acid formula in infants with allergic manifestations.

Official Title
-----------------
Evaluation of the Efficacy of an Amino Acid Based Formula in Infants

Conditions
-----------------
Cow's Milk Allergy

Intervention / Treatment
-----------------
* Other: Amino Acid formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight loss within the past 4 weeks Infants 1-12 months of age feeding a hypoallergenic formula for at least 2 weeks Birth weight greater than or equal to 1500 grams Solely enteral fed Infants with at least one persistent allergy symptom No change in medication within 10 days of beginning the study and no plans for change during the first 10 days of the study Signed informed consent Exclusion Criteria: History of underlying condition which, in the Investigator's opinion, could interfere with normal growth, development, or assessment of the participant Metabolic disease requiring special attention

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 12 Months

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

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

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

Design Details

Intervention Model: Single Group Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Amino Acid formula|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergic manifestations |  | 12 weeks |
Clinical Performance of Advanced Self- Adhesivee Resin Composite Hybrid Restorations.

Study Overview
=================
Brief Summary
-----------------
Clinical performance according to modified USPHS criteria of advanced self-Adhesive resin composite hybrid restorations is evaluated for 1 year versus conventional resin composite restorations in posterior teeth.

Official Title
-----------------
Clinical Performance of Advanced Self-Adhesive Resin Composite Hybrid Restorations Versus Conventional Resin Composite Restorations in Posterior Teeth (1y Randomized Clinical Trial).

Conditions
-----------------
Caries Class II, Caries,Dental

Intervention / Treatment
-----------------
* Other: Advanced Self-Adhesive resin composite hybrid restorations (Surefil one (Dentsply Sirona)).
* Other: Conventional resin composite restoration. (Sphere Tec, (Dentsply Sirona


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with carious proximal cavities in molars Good oral hygiene. Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth. Exclusion Criteria: Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis. Severe periodontal problems.

Ages Eligible for Study
-----------------
Minimum Age: 17 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advanced Self-Adhesive resin composite hybrid restorations<br>(Surefil one (Dentsply Sirona)). | Other: Advanced Self-Adhesive resin composite hybrid restorations (Surefil one (Dentsply Sirona)).<br>* Hybrid resin composite that doesn't need bonding system and releases calcium and flouride.<br>|
| Active Comparator: Conventional resin composite restoration.<br>Sphere Tec, (Dentsply Sirona) | Other: Conventional resin composite restoration. (Sphere Tec, (Dentsply Sirona<br>* Conventional Nanohybrid resin composite<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance | Post operative Hypersensitivity, Secondary caries, Gross fracture, Cavo-surface marginal discoloration, Proximal contact. All these outcomes are measured by a score Alpha is excellent, Bravo is acceptable, Charlie is not accepted | Change from baseline at 6, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
self-Adhesive resin composite hybrid restorations, Posterior resin composite, Surefil One
Management of Direct Oral Anti-Coagulants (DOACs) for Gastrointestinal Endoscopy Procedures

Study Overview
=================
Brief Summary
-----------------
The use of Direct Oral Anti-Coagulants (DOACs) is expanding, but their proper management in patients undergoing endoscopic procedures is still not completely clear. Current European guidelines are based on weak data. This observational study aims to evaluate the peri-endoscopic management of DOACs in clinical practice and the incidence of adverse events.

Detailed Description
-----------------
This observational study is aimed at evaluating the peri-endoscopic management of DOACs in patients undergoing elective gastrointestinal endoscopy procedures and the adverse events (bleeding and thromboembolic events) associated with. All consecutive patients undergoing elective procedures and providing informed consent will be included. Primary end-point: incidence of major bleeding events according to International Society Thrombosis Haemostasis (ISTH) criteria and clinically relevant non-major bleeding events occuring during the endoscopy procedures or within 30 days, according to International Society Thrombosis Haemostasis (ISTH) criteria in patients in which DOACs have been managed according to European Society of Gastrointestinal Endoscopy (ESGE) guidelines Secondary end points: incidence of major bleeding and clinically relent non-major events in the overall patient population incidence of bleeding events in the overall patient population incidence of thromboembolic events in the overall patient population and in patients in which DOACs have been managed according to ESGE guidelines compliance with ESGE guidelines

Official Title
-----------------
Management of Direct Oral Anti-Coagulants (DOACs) for Gastrointestinal Endoscopy Procedures: an Observational, Cross-sectional Study

Conditions
-----------------
Anticoagulant Disorders

Intervention / Treatment
-----------------
* Other: endoscopic procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients (both inpatients and outpatients) undergoing endoscopic procedures during DOACs therapy Exclusion Criteria: inform consent not possible to obtain not willing patient
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: endoscopic procedure|Evaluation of adverse events in patients on DOACs undergoing GI endoscopy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of hemorrhagic events after endoscopic procedures | incidence of hemorrhagic events after endoscopic procedures when the European Guidelines (ESGE) are followed | 12 months |
Safety and Efficacy Study of Artificial Cornea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the stability of artificial cornea manufactured by Aurolab and to assess its visual outcomes.

Detailed Description
-----------------
The keratoprosthesis, also know as an artificial cornea plays a significant role in combating corneal blindness in patients who are no longer candidates for penetrating keratoplasty.The global incidence of corneal blindness is estimated to be 6-8 million. In India there are approximately 6.8 million cases of unilateral corneal blindness and 1.3 million people with bilateral corneal pathology. Eligible subjects after getting informed consent will be included in this study. All the subjects will have pre-operative evaluation which includes history, visual acuity, Intraocular pressure (IOP), evaluation of tear film and ultrasound A and B scan. Ocular inflammation will be controlled prior to surgery. Keratoplasty will be performed with keratoprosthesis under local anesthesia. Patients will be followed up at regular interval to assess the outcome variables.

Official Title
-----------------
Clinical Assessment of Auro KPro

Conditions
-----------------
Corneal Transplantation

Intervention / Treatment
-----------------
* Device: Auro KPro (Keratoprosthesis)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 20 years Willing to participate and review on schedule Multiple failed grafts with poor prognosis for regrafting Adequate tear film and lid function Projection of light in all quadrants Bilateral blind Exclusion Criteria: Reasonable chance of success with keratoplasty Autoimmune disease such as Stevens Johnson Syndrome, Pemphigoid End stage glaucoma Retinal detachment

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Keratoprosthesis<br> | Device: Auro KPro (Keratoprosthesis)<br>* Front plate with optical cylinder, a back plate and a titanium ring to hold the complex together<br>* Other names: Auro KPro;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity |  | 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention of the device |  | 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cornea, Transplantation, Cornea, Keratoplasty, Grafting, Corneal
Lower Urinary Tract Symptoms in Women and Adjustment Disorder

Study Overview
=================
Brief Summary
-----------------
Our hypothesis that the prevalence of AD in uro-gynecologic patients with LUTS who are seeking medical help for their condition is higher than that of the general population (indicated by high scores at the ADNM-20; score above 48). Taking into consideration that affective disorders, anxiety and depression among patients with LUTS present with a prevalence of 17-23% [20] as well as through long personal experience, we hypothesize that the prevalence of AD in this group is 20%.

Official Title
-----------------
Do Women Seeking Medical Assistance for Lower Urinary Tract Symptoms Have a High Prevalence of Adjustment Disorder?A Questionnaire Based Study

Conditions
-----------------
Lower Urinary Tract Symptoms, Adjustment Disorders

Intervention / Treatment
-----------------
* Other: ICIQ-FLUTS, ADMN-20


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients seeking medical help for lower urinary tract symptoms German speaking Exclusion Criteria: Pelvic floor Prolapse symptoms or Stage III or more by medical examination Inability to understand the purpose of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: ICIQ-FLUTS, ADMN-20|Questionnaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of adjustment disorders among women with lower urinyry tract symptoms |  | 9 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between ICIQ-FLUTS and ADNM-20 scores |  | 9 Months |
Optimisation and Quantification of Contrast Enhanced Computed Tomography Myocardial Fibrosis Imaging

Study Overview
=================
Brief Summary
-----------------
Detecting scarred heart muscle is important to diagnose and treat of a wide variety of heart conditions. Magnetic resonance imaging (MRI) can assess scarred heart muscle but it is time consuming, contraindicated for some patients and not tolerated by others. Computed tomography (CT) imaging has the potential to provide a rapid comprehensive assessment of the heart. This study will assess CT imaging of the heart muscle of patients who have previously undergone MRI of their heart. Using a state of the art CT scanner the investigators will develop a low radiation dose protocol to identify scarred heart muscle. The investigators will use and develop software techniques to analyse these images. This will enable us to develop a new way to identify and measure scarred heart muscle that will benefit patients with heart disease.

Official Title
-----------------
Optimisation and Quantification of Contrast Enhanced Computed Tomography

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Radiation: Computed tomography late enhancement imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of late enhancement on magnetic resonance imaging Exclusion Criteria: age less than 40 inability or unwillingness to undergo CT renal failure (serum creatinine >200 umol/l or estimated glomerular filtration rate <30 ml/min) hepatic failure allergy to iodinated contrast pregnancy breast feeding inability to undergo informed consent fast atrial fibrillation

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Participants<br>Participants will have previously had an MRI scan and will undergo a CT scan. | Radiation: Computed tomography late enhancement imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial late enhancement | The amount of myocardial late enhancement measured on computed tomography as compared to magnetic resonance imaging. | Immediate |
Chart Review Study of Medical Abortion

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to document the rates of success and serious complications among women having outpatient medical abortions with 200 mg mifepristone + 800 buccal misoprostol at 64-70 days of gestation.

Detailed Description
-----------------
The study will be conducted at US abortion clinics that have offered medical abortion with 200 mg mifepristone + 800 mcg buccal misoprostol to at least 20 women at 64-70 days of gestation. Designated staff at each site will review clinic records to identify and record data from every patient treated in that gestational week. Once data collection is completed, if the rate of success or serious complications at any clinic is substantially discordant from rates documented in the published literature, we may collect additional data on patients seeking medical abortion at 57-63 days, to aid in explaining results found in the 64-70 days group. In this situation, for each patient in the 64-70 days group, site staff will identify and record data from the next consecutive patient treated with this regimen at 57-63 days.

Official Title
-----------------
Chart Review Study of Medical Abortion at 64-70 Days of Gestation

Conditions
-----------------
Abortion, Medical

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women at 64-70 days of gestation Received 200 mg mifepristone + 800 mcg buccal misoprostol for a medical abortion Exclusion Criteria: Does not meet the inclusion criteria
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Abortion Success | Defined as a complete abortion without use of surgery | 1 week | 
| Serious complications | Defined as admission to hospital, receipt of parenteral antibiotics, surgery (laparoscopies, laparotomies, hysterectomies), transfusion, or death | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of ongoing pregnancies | Proportion of ongoing pregnancies after the initially dispensed mife-miso | 1 week | 
| Proportion of complete abortions without additional treatment | Proportion of complete abortions without additional treatment other than the initially dispensed mife-miso | 1 week | 
| Proportion of significant abortion complications | Proportion of significant abortion complications, including diagnosis of receipt of treatment for an abortion-related problem at an emergency department or urgent care center | 1 month |
Oxytocin Effects on the Prosocial Learning

Study Overview
=================
Brief Summary
-----------------
To investigate whether intranasal oxytocin (24 IU) treatment can influence prosocial learning behavior in males.

Detailed Description
-----------------
In a double-blind, within-subject, placebo controlled design, investigators plan to investigate the effect of oxytocin treatment on prosocial learning. Before the self-administration, participants need to finish several questionnaires including IRI, AAS, BASBIS, SPSRQ, SES, PTM, STAI, BDI, ASQ and PNAS. They would finish the PANAS again before the scanning. Participants are informed that they perform the reward learning task either for themselves, another (unknown) person or no one (control). In the probabilistc reward learning task, associations with two stimuli with different reward probabilities are learned via monetary feedback (reward ￥1 or no reward ￥0). After the experiment, participants need to finish the PANAS.

Official Title
-----------------
Oxytocin Effects on the Prosocial Learning

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: without past or current psychiatric or neurological disorders Exclusion Criteria: history of head injury medical or psychiatric illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: male oxytocin group<br>male subjects with oxytocin treatment | Drug: Oxytocin<br>* intranasal administration of oxytocin (24 IU)<br>|
| Placebo Comparator: male placebo group<br>male subjects with placebo treatment | Drug: Placebo<br>* intranasal administration of placebo (24 IU)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural processing during feedback based on prosocial learning assessed by fMRI scanner | fMRI BOLD indices of neural processing learning related brain regions will be compared between the treatment administrations. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral learning performance measured by E-prime | Learning performance will be compared between the treatment administrations by calculating the accuracy of learning. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxytocin, prosocial learning