linjc16/ctgov huggingface dataset:
A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The purpose of this trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of different formulations of NN1218.

Official Title
-----------------
A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: Faster-acting insulin aspart
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitus for more than 12 months Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months Body mass index (BMI) between 18.0-28.0 kg/m^2 (both inclusive) Exclusion Criteria: Subjects who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NN1218<br> | Drug: Faster-acting insulin aspart<br>* Each subject will randomly be allocated to a treatment sequence consisting of 9 dosing visits during which the subject will receive 8 single doses of different formulations. For all investigational medicinal products the dose levels will be 0.2 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).<br>* Other names: NN1218;|
| Active Comparator: insulin aspart<br> | Drug: insulin aspart<br>* At one of the scheduled visits, the subject will receive a single dose of insulin aspart. The dose level will be 0.2 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin aspart concentration-time curve |  | From 0 to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin aspart concentration-time curve |  | From 0 to 12 hours | 
| Maximum observed serum insulin aspart concentration |  | From 0 to 12 hours | 
| Time to maximum observed serum insulin aspart concentration |  | From 0 to 12 hours |
A Human Factors Study to Evaluate a Novel Intracanalicular Insertion Device in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This is an open-label, multi-center, bilateral, human factors study designed to evaluate the utilization and safety of a novel intracanalicular insertion device in healthy subjects and to evaluate the concentration of DEXTENZA in tears. Each subject's participation is expected to last for approximately 1 month from the DEXTENZA insertion.

Official Title
-----------------
An Open-label, Multi-center, Bilateral, Human Factors Study to Evaluate the Utilization and Safety of a Novel Intracanalicular Insertion Device in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Dexamethasone Ophthalmic
* Device: Dilator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are a healthy adult subject aged 18 years or older with no known significant health problems Are willing to refrain from wearing contact lens for the duration of the study Are willing and able to comply with clinic visits and study related procedures Are willing and able to sign the informed consent form Exclusion Criteria: Have known significant health problems Are women of reproductive potential Are breastfeeding Are a known steroid responder Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye Have a history of complete punctal occlusion in one or both punctum Currently use topical ophthalmic steroid medications Are unwilling or unable to comply with the study protocol Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel Intracanalicular Insertion Device<br> | Drug: Dexamethasone Ophthalmic<br>* Insertion Device: A handheld mechanical device used by the clinician to dilate the punctum and deliver the DEXTENZA insert into the canaliculus; designed to be single-use and pre-loaded with a single DEXTENZA insert.<br>Device: Dilator<br>* Intracanalicular Dilator Device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of insertion as assessed by Post-Insertion Investigator Questionnaire |  | Assessed at Visit 1 (Day 1) |
Phenotypic Clinical, and Genetic Characteristics of Patients With Nontuberculosis Mycobacteria

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to elucidate phenotypic, clinical, and genetic characteristics of Korean Nontuberculosis Mycobacteria (NTM) patients.

Detailed Description
-----------------
To elucidate phenotypic, clinical, and genetic characteristics of Korean NTM patients. Especially, to compare body mass index, positive rate of IGRA, and CFTR mutation with general Korean population.

Official Title
-----------------
Characteristics of Patients With Nontuberculosis Mycobacteria in Korean Population

Conditions
-----------------
Nontuberculosis Mycobacterial Lung Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons met diagnostic criteria of NTM lung disease by ATS/IDSA on 2007 Exclusion Criteria: Already on treatment for NTM lung disease Appropriate exclusion of other lung diagnosis
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NTM Lung disease, NTM Lung disease patients enrolled in SNUH
Clinical Assessment of Burns in Norway

Study Overview
=================
Brief Summary
-----------------
Clinical assessment of burn depth and area can be challenging even for experienced surgeons. Still, the assessment is fundamental for the treatment, as it determines the fluid treatment and indication for escharotomy and need for referral to a burn centre.There are few studies comparing the initial evaluation of burn depth and surface with that of a specialist burn centre. The aim of this study was to make such a comparison for a cohort of patients admitted to a specialist burn centre during one year.The cohort was defined as patients transferred to the burn unit at Haukeland university hospital during 2014.

Official Title
-----------------
Accordance of Clinical Assessment of Burn Depth and %TBSA Between Referring Hospitals and the National Norwegian Burn Centre

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Procedure: Clinical assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients transferred to the burn unit at Haukeland university hospital during 2014 Exclusion Criteria: Readmissions Patients transported to Haukeland directly from the site of the accident
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Referring hospital<br>Burn assessments performed in referring hospitals | Procedure: Clinical assessment<br>* Clinical assessment of burn depth and the percentage of total body surface area (TBSA) burnt with any method<br>|
| Burn centre<br>Burn assessments performed in the national burn centre | Procedure: Clinical assessment<br>* Clinical assessment of burn depth and the percentage of total body surface area (TBSA) burnt with any method<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burn depth | Burn depth measured with any described clinical method.Clinical assessment of depth is a subjective evaluation based on visual and tactile characteristics, that is, wound appearance, capillary refill and wound sensibility to touch and pin prick. | 1 year | 
| The percentage of total body surface area (TBSA) burnt | TBSA measured with any described clinical method, for example, Wallace's Rule of Nines, Lund and Browder charts, and Palmar Surface Measurement ('rule of palm') | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clinical assessment, TBSA, national burn centre
In Vitro Maturation With in Vitro Fertilization (IVF) Compared to Mild in Vitro Fertilization

Study Overview
=================
Brief Summary
-----------------
Methods of infertility treatment may involve in vitro fertilization or IVF. Though effective, IVF is complex and expensive. Methods using no gonadotropin hormone stimulation of the ovaries are being compared to mild stimulation doses. The goal of the research is to determine which of these if more suitable as a low cost approach for varying individual patients.

Detailed Description
-----------------
Low cost environment is utilized, but fees are charged.

Official Title
-----------------
Clinical Research Study on in Vitro Maturation With IVF Compared to Mild Stimulation IVF

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: In vitro maturation and in vitro fertilization
* Procedure: Low doses of gonadotropin stimulation.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Under age 42 female, normal uterine cavity, BMI 18-34kg/m2, Exclusion Criteria: Donor eggs, donor sperm, myoma over 5 cm Current hydrosalpinx, abnormal uterine cavity.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 41 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVM<br>Early egg retrieval, in vitro maturation, then IVF | Procedure: In vitro maturation and in vitro fertilization<br>* No gonadotropin, eggs harvested early<br>* Other names: assisted reproduction;|
| Active Comparator: Mild IVF<br>Mild gonadotropin and conventional IVF | Procedure: Low doses of gonadotropin stimulation.<br>* Gonadotropin followed by conventional IVF<br>* Other names: Assisted reproduction, IVF.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost effectiveness |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rates per cycle |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polycystic ovaries,, Tubal occlusion, Unexplained infertility, Low ovarian reserve, Male factor infertility
Amino Acid Profile in the Fetus and the Neonate

Study Overview
=================
Brief Summary
-----------------
Up-to-date, the preterm newborn nutrition is based on human breast milk or it's imitations. However, the growth rate is known to be reduced compared to the fetal growth rate. In order to attempt a better growth rate of the preterm newborn infants it is important to evaluate the metabolic components of the fetal blood and try to find components that might influence its growth. Little is known of the metabolic components of the fetal blood, including amino acid profile. The aim of the study is to evaluate amino acid profile in the fetus blood in different gestational ages and compare it to post natal period.

Conditions
-----------------
Cord Blood Amino Acid Profile, Fetal Amino Acid Profile in Different Gestational Ages, Infant Amino Acid Profile at Day 3 and Discharge

Intervention / Treatment
-----------------
* Other: Blood sample on Guthrie paper from cord blood, and day 3 of life and before discharge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All new-born infants 5 of each gestational age Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 6 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 |
| --- | --- |
| Term and preterm newborn infants<br>5 infants of each gestational age of 24-42 weeks | Other: Blood sample on Guthrie paper from cord blood, and day 3 of life and before discharge<br>* Mass spectroscopy on the blood sample that are taken as routine for the national inborn errors survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia

Study Overview
=================
Brief Summary
-----------------
This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.

Detailed Description
-----------------
This is an open label, Phase III, randomized, active controlled study of intravenous iron vs oral iron in anemic post partum patients.

Official Title
-----------------
Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in Subjects Who Display Postpartum Anemia

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

Intervention / Treatment
-----------------
* Drug: Oral iron tablets
* Drug: VIT-45


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Subjects able to give consent Post partum patients Baseline Hbg< /= 10 Agree to practice birth control Demonstrate willingness to comply with protocol restrictions Exclusion Criteria: Known hypersensitivity reaction to oral or IV iron (VIT-45) Documented history of discontinuing oral iron Significant bleeding History of anemia other that iron deficiency anemia Severe Psychiatric disorders Active severe infection Known Hepatitis B antigen or Hep C viral antibody or active hepatitis Known HIV antibody Received investigational product within 30 days Alcohol abuse Hemochromatosis or other iron storage disorder
Sexes Eligible for Study
-----------------
Female

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: VIT-45<br>A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered | Drug: VIT-45<br>* A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered<br>|
| Active Comparator: Oral iron tablets<br>325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42 | Drug: Oral iron tablets<br>* 325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42<br>* Other names: Ferrous Sulfate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin |  | anytime between baseline and the end of study or time to intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia, postpartum, Postpartum anemia
Brain-imaging and Adolescent Neuroscience Consortium

Study Overview
=================
Brief Summary
-----------------
This is a multi-site study of adolescents 12-21 years-of-age to evaluate the long and shorter-term effect of adolescent alcohol use on the developing brain.

Detailed Description
-----------------
The overall specific aims of this study are to: 1) assess the short and long-term consequences of alcohol exposure on brain, cognitive, and emotional/regulatory development during preadolescence and adolescence; 2) determine the effects of timing, dose, and duration of alcohol on brain and cognitive development; 3) assess recovery of neural and behavioral function to determine if the plasticity of the adolescent brain makes it more or less vulnerable to alcohol's acute and chronic effects; 4) understand how other key covariates (e.g., existing or emerging psychopathology, family history of alcoholism, demographics, pubertal development) factor into alcohol's effects on the brain; and 5) identify early neural, cognitive, and affective markers that may predict alcohol abuse and dependence during adolescence and/or adulthood.

Official Title
-----------------
Brain-imaging and Adolescent Neuroscience Consortium

Conditions
-----------------
Alcohol Abuse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: able to read and understand English available for follow-up parental consent/adolescent assent for those 12-17 years consent for those 18-21 years Exclusion Criteria: Weight > 300 lbs braces or unremovable embedded metal claustrophobia or inability to lie still in MRI machine current or past 12-mos pregnancy (females) requires urgent medical/mental health care

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 21 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 |
| --- | --- |
| Alcohol-naive adolescents<br>A general population longitudinal cohort of alcohol-naïve (or h/o minimal recent-onset drinking) adolescents in three specific age-groups: early (12-14 y/o), middle (15-17 y/o), and late (18-21 y/o). | |
| Treatment sample<br>A sample of adolescents who have a >1 year history of heavy drinking but have agreed to stop drinking as part of their treatment plan | |
| High risk sample<br>High-risk adolescents who have a family history of alcohol-use disorder and other risk factors (symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD), Conduct Disorder, or Mood Disorder) | |

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
-----------------
Alcohol abuse
COVID-19 Patients Characterization, Biobank, Treatment Response and Outcome Predictor

Study Overview
=================
Brief Summary
-----------------
Collection and analysis of demographic, clinical, radiographic and laboratory characteristics of CoViD-19 patients to identify predictors of disease severity, mortality and treatment response, and to identify subgroup of patients that might benefit from specific therapeutic interventions

Official Title
-----------------
Study to Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response

Conditions
-----------------
Coronavirus Infections

Intervention / Treatment
-----------------
* Other: Observational Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to hospital with biological samples positive for SARS-CoV-2 Patients admitted to hospital with negative test but clinical and radiological characteristics highly suggestive of SARS-CoV-2 disease Patients discharged from emergency department with biological samples positive for SARS-CoV-2 Exclusion Criteria: None

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 |
| --- | --- |
| COVID-19 patients<br> | Other: Observational Study<br>* Not required<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response | Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response | Hospital stay (2-3 weeks) |