linjc16/ctgov huggingface dataset:
Pregnancy Exposure Registry for Avonex (Interferon Beta-1a)

Study Overview
=================
Brief Summary
-----------------
The primary objectives of the study were to prospectively record and analyze birth defects and spontaneous fetal losses in women with multiple sclerosis (MS) exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy, where the outcome of the pregnancy was unknown prospectively and to prospectively record and analyze pregnancy outcomes in an exploratory fashion of women with MS who stopped therapy, but who may have been exposed to Avonex with approximately 1 week of conception or during the first trimester of pregnancy.

Official Title
-----------------
Avonex Pregnancy Exposure Registry

Conditions
-----------------
Prenatal Exposure Delayed Effects, Multiple Sclerosis, Pregnancy

Intervention / Treatment
-----------------
* Drug: BG9418 (interferon beta-1a)


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Have been exposed to AVONEX within approximately 1 week of conception or during the first trimester of pregnancy. Provide sufficient information to determine that the pregnancy is prospectively registered (i.e., the outcome of pregnancy must be unknown prospectively). Provide verbal consent to participate in the Registry. Verbally provide contact information for herself, her HCP, and the infant's HCP (if applicable). NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant participants<br>Pregnant participants who were exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy | Drug: BG9418 (interferon beta-1a)<br>* Exposure to Avonex during pregnancy<br>* Other names: Avonex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Record and analyze birth defects and spontaneous fetal losses |  | Prospectively, MS women exposed to Avonex within 1 week of conception or during the first trimester of pregnancy | 
| Record and analyze pregnancy outcomes |  | Prospectively, MS women who stopped therapy, but may have been exposed to Avonex within 1 week of conception or during the first trimester of pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AVONEX, Pregnancy
Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Giza Governorate

Study Overview
=================
Brief Summary
-----------------
- One single operator will assess the prevalence of molar incisor hypomineralization and its Severity among a group of Egyptian children .

Detailed Description
-----------------
the study is about the prevalance of molar incisor hypomineralization and its severity among a group of Egyptian children aged 8-12 years old in Giza Governorate schools. Participants will be randomly selected from primary and preparatory schools in Giza governorate, seated in the school lap or an empty classroom. Clinical examination will be made in the daylight using disposable diagnostic sets (mirror, and explorer). No diagnostic radiographs will be taken. Prior to performing dental examination, index teeth including incisors and 1st permanent molars will be cleaned using a cotton roll. A dental explorer will be further used for cleaning molar fissures. The examiner carefully inspect the coronal part of the 1st permanent molars and permanent incisors for demarcated opacities. A specially made examination chart will be taken for the child including his name, age, address, gender, school, date, medical health and any previous dental treatment. prevalance of molar incisor hypomineralization is measured by presence or absence. severity is measured by Modified index based on European Academy of Paediatric Dentistry (EAPD) criteria

Official Title
-----------------
Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Giza Governorate: A Cross Sectional Study

Conditions
-----------------
Molar Incisor Hypomineralization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: schools in Giza Governorate. Positive patient acceptance for participation in the study. Patients who are apparently medically free from any systemic disease. Exclusion Criteria: Uncooperative child. Children with appliances.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 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 |
| --- | --- | --- |
| molar incisor hypomineralization | prevalance of molar incisor hypomineralization | 20 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| molar incisor hypomineralization | severity of molar incisor hypomineralization | 20 mins |
Skeletal Muscle Parameters of Liver Cirrhosis in Non-invasive Imaging and Outcome

Study Overview
=================
Brief Summary
-----------------
The principal aim of this study is to analyse L3-SMI (skeletal muscle index) in a cohort of patients with decompensated liver cirrhosis and TIPS (transjugular intrahepatic portosystemic shunt), and compare the prognostic power with TPMT (transverse psoas muscle thickness). Furthermore, the role of myosteatosis, determined in CT by L3-SMI, MRI and ultrasound will be studied.

Detailed Description
-----------------
The principal aim of this study is to analyse L3-SMI (skeletal muscle index) in a cohort of patients with decompensated liver cirrhosis and TIPS (transjugular intrahepatic portosystemic shunt), and compare the prognostic power with TPMT (transverse psoas muscle thickness). Furthermore, the role of myosteatosis, determined in CT by L3-SMI, MRI and ultrasound will be studied.

Official Title
-----------------
Role of Skeletal Muscle Parameters in Imaging Analysis in the Prediction of Outcome in Patients With Liver Cirrhosis

Conditions
-----------------
Liver Cirrhosis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver cirrhosis of any etiology CT scan available Exclusion Criteria: HCC or any malignant disease

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: imaging|computed tomography, magnetic resosnance imaging, ultrasound|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival time | time of survival | up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical acute decompensations | time to occurrence of acute decompensations of liver cirrhosis (readmissions, hepatic encephalopathy, bleeding, ascites, hepatorenal syndrome, infections) | up to 60 months | 
| Time to clinical acute-on-chronic liver failure | acute-on-chronic liver failure according to EASL-CLIF-C definition (grade 1 (best) to 3 (worst) | up to 60 months | 
| Development of sarcopenia | Assessment of sarcopenia according to EASL-guideline | up to 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sarcopenia, cirrhosis, transjugular intrahepatic portosystemic shunt, TIPS, acute-on-chronic liver failure, ACLF
A f-MRI Study Of Affective Changes Associated With Four Weeks Consumption Of A Fermented Dairy Product In Healthy Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the brain activity within specific neural circuits regulating the subjective experience of emotional valence and digestive well-being.

Official Title
-----------------
A f-MRI STUDY OF AFFECTIVE CHANGES ASSOCIATED WITH FOUR WEEKS CONSUMPTION OF A FERMENTED DAIRY PRODUCT IN HEALTHY WOMEN

Conditions
-----------------
Healthy Adult Women

Intervention / Treatment
-----------------
* Other: 1-Fermented Dairy Product (test)
* Other: 2-Milk-based non-fermented dairy product(control)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women, right-handed, aged from 18 to 60 years Subject of normal body weight or with overweight i.e. not obese (body mass index between 18 and 30 kg/m2). For fertile women, complying with one of the other medically approved methods of contraception Exclusion Criteria: Subject with any current psychiatric or eating or suicidal attempt disorder, or history of such disorder. Subject with any history of chronic GI disorder or disease. Subject with any significant active or prior metabolic disorder or disease. Subject with any use of probiotic supplements or antibiotics in the previous month. Subject with current use of any medications with potential central nervous system effects (antidepressants, anxiolytics, opiate pain medications...). Subject with allergy or hypersensitivity to milk proteins or lactose intolerance or immunodeficiency Subjects with claustrophobia or other condition (such as metallic implants) that would preclude MRI scanning

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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: 1 = Tested product<br> | Other: 1-Fermented Dairy Product (test)<br>* Arm 1 - Intervention 1 (probiotics)<br>|
| Active Comparator: 2 = Control product<br> | Other: 2-Milk-based non-fermented dairy product(control)<br>* Arm 2 - Intervention 2 (control)<br>|
| No Intervention: 3 = No product<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
-----------------
probiotics, digestive well-being, fMRI, brain-gut axis
Comparing an Automated to a Conventional Sepsis Clinical Prediction Rule

Study Overview
=================
Brief Summary
-----------------
The investigators will conduct a prospective cohort study to compare an automated sepsis severity score to a conventional clinical prediction rule to risk stratify patients admitted from the emergency department (ED) with suspected infection for 28 day in-hospital mortality.

Official Title
-----------------
Comparing an Automated to a Conventional Sepsis Clinical Prediction Rule

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive adult (age 18 or older) Emergency Department (ED) patients during the study period that have been admitted from the ED and identified by the treating clinician to have a suspected infection at the time of ED disposition will comprise our study population. Exclusion Criteria: No patients will be excluded from the study.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients admitted with infection<br>All consecutive ED patients during the study period that have been admitted and identified to have a suspected infection at ED disposition using a data collection tool | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 day in-hospital mortality | The primary endpoint is the AUC of a model to predict 28 day all cause in-hospital mortality. Patients discharged or transferred to another hospital before 28 days will be assumed to be alive at 28 days. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Admission | The secondary endpoint is ICU admission from the ED or within 24 hours from the floor. |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sepsis, Clinical Prediction Rule, Clinical Informatics, Machine Learning
Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at the end of double blind treatment, comparing the group titrated to 100mg vs. the group maintained on 50mg.

Official Title
-----------------
A Prospective Multicenter, Parallel Group Study With A Single Blind Phase And A Double Blind Randomised Phase, To Evaluate The Efficacy And Satisfaction Of Viagra (Sildenafil Citrate) High Dose (100mg) Titration Compared With 50mg Dose, In Men With Erectile Dysfunction

Conditions
-----------------
Impotence

Intervention / Treatment
-----------------
* Drug: Sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented clinical diagnosis of ED by using IIEF-EF domain with score of â‰¤ 25. Subjects must be in a stable relationship with the same partner for at least 6 months and willing to attempt sexual intercourse. Exclusion Criteria: Subjects in whom sexual activity is inadvisable in the opinion of the investigator such as significant cardiovascular disease in the last 6 months; including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation. Subjects who are currently taking or are likely to be treated with nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or as aerosols) on either regular or intermittent basis.

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Sildenafil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IIEF erectile function domain score at the end of double blind treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in other IIEF domain scores; Response to other questionnaires regarding treatment satisfaction, safety and tolerability. |  |  |
Predictors of the Ability to Protect the Airway in Long-term Ventilated Patients

Study Overview
=================
Brief Summary
-----------------
First part of a 2 part study with the same IRB protocol #, and labeled 'A'. Investigators hypothesized that clinical muscle strength assessment (manual muscle testing) predicts the ability to protect the airway during swallowing in long-term ventilated subjects. More specifically, the investigators hypothesized that low muscle strength is associated with the inability to clear secretions from the peri-laryngeal area (valleculae and pyriform sinus residue scale (VPSR scale [NRS: 0-4] of > 1) and entering the materials into airway (PAS scale [1-8]> 1), which should predispose to endotracheal aspiration.

Official Title
-----------------
Determining Predictors of Adequate Upper Airway Function in Long-term Ventilated Patients

Conditions
-----------------
Aspiration, Swallowing Disorder, Long Term Ventilation

Intervention / Treatment
-----------------
* Other: Muscle Strength Measurement
* Other: Ventilator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the Respiratory Acute Care Unit and Surgical Intensive Care Unit, units with a mixed collection of long term ventilated patients in a major academic teaching hospital. Age over 18 years. Long-term ventilated patients (>10 days) with tracheotomies Exclusion Criteria: Decreased level of consciousness as defined by a Richmond Agitation Sedation Scale (RASS) of 0. Non-cooperative patient, CAM score positive for delirium. For women: pregnancy.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Long term ventilated subjects<br>Muscle Strength Measurement, ventilator | Other: Muscle Strength Measurement<br>* MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement<br>Other: Ventilator<br>* A mechanical ventilator is used to assist or replace spontaneous breathing.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Strength | We use Medical Research Council (MRC) scale (0-60) to evaluate the degree of muscle weakness in the tracheostomized patients. | Within 24 hours of fiberoptic endoscopic evaluation of swallow | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration |  | Within 3 month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PAS, FEES, VPSR, MRC
Energy Expenditure Methodology Infant

Study Overview
=================
Brief Summary
-----------------
Indirect calorimetry is valuable in determining resting energy expenditure in infants, children and adults. This measure will estimate the number of calories needed per day under resting conditions. Adding physical activity measures will help estimate total energy requirements in individuals. With the rise in obesity, numerous programs of prevention are being developed. Being able to characterize carefully energy intake and energy expenditure is one of the challenges of most of these initiatives.

Official Title
-----------------
Energy Expenditure Methodology Infant

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

Intervention / Treatment
-----------------
* Device: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3 months old +/- 2 weeks Can fall asleep easily Usually sleeps more than 30 min Accept formula as an alternative feeding Exclusion Criteria: Pulmonary or respiratory disorders

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 3 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: No intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure Resting energy expenditure in infants | We will measure resting energy expenditure in infants and then they will come back for a second visit and get the same measurement to see if there is a significant difference between the two measures. | 2 days |
Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients

Study Overview
=================
Brief Summary
-----------------
Pseudobulbar Affect is a condition characterized by frequent episodes of laughing and crying out of proportion. Other terms used to describe this condition include emotional lability, emotionalism, emotion incontinence, emotional discontrol, excessive emotionalism and pathological laughing and crying. AVP-923 is a new experimental drug that may assist in the reduction of uncontrolled episodes. This study will test the safety and efficacy of AVP-923 in the treatment of MS patients suffering from pseudobulbar affect.

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: AVP-923


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 68 years of age Confirmed diagnosis of Multiple Sclerosis Clinical history of pseudobulbar affect Exclusion Criteria: Sensitivity to quinidine or opiate drugs Recent diagnosed within 2 months with Multiple Sclerosis Patient on anti-depressants Patient with liver or kidney disease Patient with hypotension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 68 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AVP-923|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emotional control |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pseudobulbar Affect, Uncontrolled, Laughing, Crying