linjc16/ctgov huggingface dataset:
A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy of 0.3% OPA-15406 ointment when administered twice daily for 4 weeks in infants younger than 2 years of age with Atopic Dermatitis

Official Title
-----------------
A Phase 3, Multicenter, Open-label, Uncontrolled Trial to Evaluate the Efficacy and Safety of OPA-15406 Ointment in Infants Younger Than 2 Years of Age With Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis (AD)

Intervention / Treatment
-----------------
* Drug: OPA-15406


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are diagnosed with AD in accordance with the criteria of the Japanese Dermatological Association Subjects whose AD affects 5% to 40% of BSA (excluding scalp) at the screening and baseline examinations Subjects who have an IGA score of 2 or 3 at the screening and baseline examinations Exclusion Criteria: -Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 2 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: OPA-15406<br> | Drug: OPA-15406<br>* 0.3% or 1% ointment, topical, twice daily, for 52 weeks<br>* Other names: difamilast;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate in Investigator's Global Assessment (IGA) | The investigator or subinvestigator assessed the skin symptoms using IGA. The investigator or subinvestigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week 4. Incidence of success in IGA is defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline. | Week 4 |
Short Term Postoperative Tamponade Using Perfluorocarbon Liquid for Giant Retinal Tears

Study Overview
=================
Brief Summary
-----------------
The purpose of the article is, to investigate the efficacy and safety of perfluorocarbon liquid (PFCL) ,as a short term postoperative tamponade for treating retinal detachment ,associated with giant retinal tears.

Detailed Description
-----------------
a retrospective study wich compared 2 groups that had giant tear repair in one group, PFCL was left for few days as an intermediate measure until silicone oil or SF6 gas was used to reattach the retina ,and in the control group SF6 or Silicone oil were used, with no PFCL.

Official Title
-----------------
Short Term Postoperative Tamponade Using Perfluorocarbon Liquid for Giant Retinal Tears

Conditions
-----------------
Retinal Detachment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above 18 years of age retinal tear at least of 3 clock hours. Exclusion Criteria: less than 18 years of age Retinal tear less than 3 hours

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCFL GROUP<br>patients in this group had the PFCL for a period of 7-10 days before it was replaced by SF6 gas or silicone oil | |
| control group<br>in thos group no PFCL was left in the eye and either SF6 or silicone oil was the definitive treatment at the time of the retinal detachment surgery repair. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Bleeding, Cardio- and Cerebrovascular Complications in Head and Neck Surgery

Study Overview
=================
Brief Summary
-----------------
In this retrospective registry trial, the investigators sought to assess the incidence and predictors of cardiovascular and cerebrovascular complications as well as their derivatives (acute coronary syndrome, decompensated heart failure, an episode of atrial fibrillation requiring cardiologist consultation, stroke, pulmonary embolism and venous thromboembolism) in cohort of patients undergoing head and neck surgery.

Detailed Description
-----------------
Inclusion criteria consisted of all the consecutive patients (n=456) diagnosed with head and neck cancer at Turku University Hospital between 1999 and 2008. Patients receiving palliative procedures were also included. Patients whose treatment had started in other institute or whose treatment was not finished in the investigators institute and patients with primary diagnosis of skin cancer were excluded from this study. All head and neck surgery operations (n=591) were assessed. Information was collected by the first author of this article from referral letters, patient files, anesthesiology reports, intensive care unit reports, laboratory database, radiology database, electrocardiograms and pathology reports. Death was certificated from national authority for collecting and compiling statistics on various fields of society and economy.

Official Title
-----------------
A Retrospective Registry of Bleeding, Cardio- and Cerebrovascular Complications in Patients Treated for Head and Neck Cancer

Conditions
-----------------
Head and Neck Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with head and neck cancer in Turku University hospital between 1999-2008 Exclusion Criteria: skin cancer, treatment started in other institute or not finished in our institute

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | 5 years | 
| myocardial infarction |  | 5 years | 
| stroke |  | 5 years | 
| bleeding |  | 30 days | 
| decompensated heart failure |  | 5 years | 
| new onset atrial fibrillation |  | 5 years |
Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The Division of Kidney Urology and Hematology Disease (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) funded a cooperative agreement (UO1) for a consortium of participating clinical centers (PCCs) and a data coordinating and imaging analysis center (DCIAC) to develop and implement studies to test whether imaging techniques can provide accurate and reproducible markers of progression of renal disease in patients with polycystic kidney disease. The awarded participating clinical centers are Emory University, University of Kansas, and Mayo Foundation (with a subcontract to the University of Alabama). The awarded DCIAC is Washington University in St. Louis. Due to the relocation of the DCIAC P.I. from Washington University to the University of Pittsburgh, the DCIAC for CRISP II is located at the University of Pittsburgh.

Detailed Description
-----------------
The goal of the CRISP Study is to conduct a prospective, longitudinal trial to evaluate the accuracy and validity of magnetic resonance imaging to determine disease progression in ADPKD defined as a change in both renal and renal cyst volumes and renal function over time.

Official Title
-----------------
Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) II

Conditions
-----------------
Autosomal Dominant Polycystic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. CRISP I participants will be invited to participate in CRISP II. At entry into CRISP I participants met a number of inclusion and exclusion criteria. Exclusion Criteria: Current psychiatric or addiction or non-compliance disorder that in the discretion of the principal investigator indicates that the subject will not successfully complete the study; Current medical problem that in the discretion of the principal investigator would make unsafe the participation in the study; Inability to provide written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kidney volume |  | three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autosomal dominant polycystic kidney disease, ADPKD, kidney, Biomarker, MRI
Use of a Peptide-based Formula in an Adult Population

Study Overview
=================
Brief Summary
-----------------
The study is designed to observe the use of a peptide-based oral nutrition supplement in adults with chronic malabsorption or maldigestion who require supplemental nutrition as assessed by a clinician.

Official Title
-----------------
An Evaluation of the Use of a Peptide-based Formula in an Adult Population

Conditions
-----------------
Malabsorption

Intervention / Treatment
-----------------
* Other: Nutritional Study Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is ≥ 18 years of age. Subject has chronic malabsorption or maldigestion. Subject requires supplemental nutrition as assessed by a clinician. Subject agrees to consume 2 servings of the study product a day for at least 16 consecutive days during Treatment period. Exclusion Criteria: Subject is currently taking or has taken antibiotics within 2 weeks prior to enrollment in the study. Subject has current active malignant disease or was treated within the last 6 months for cancer. Subject has a history of diabetes mellitus. Subject is pregnant as demonstrated by a urine pregnancy test. Subject has severe auto immune disease and is on immuno-modulating therapy. Subject has a history of allergy to any of the ingredients in the study product. Subject has active HIV. Subject has a known aversion to flavor of product being tested. Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption. Subject has an obstruction of the gastrointestinal tract precluding ingestion or absorption of the study product. Subject is taking part in another non-Sponsor approved clinical trial.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional Study Product<br>A ready-to-drink peptide-based liquid formula for patients with impaired gastro-intestinal function. | Other: Nutritional Study Product<br>* Two 220 ml servings per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Product Consumption | Subject Diary | Day 1 to Day 23 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index | Calculated from Height and Weight | Change from Screening to Day 23 | 
| Medication Use | Subject Interview of Dose, Unit and Frequency | Screening to Study Day 23 | 
| Adverse Events |  | Screening to Day 25 |
Cobalamin Absorption From Fortified Food

Study Overview
=================
Brief Summary
-----------------
To determine B12 bioavailability from 14C-B12 fortified bread in healthy subjects and in subjects with proton pump inhibitor induced achlorhydria.

Detailed Description
-----------------
Cobalamin (vitamin B12) deficiency is highly prevalent in the US and worldwide. Deficiency is most common in the elderly, with an average prevalence ≈25% over age 60 y. About 40% of older persons with low serum cobalamin have food cobalamin malabsorption (F-CM), in which gastric atrophy/achlorhydria and/or dysfunction is implicated. Because of the prevalence of deficiency in those over age 60 y, it is generally recommended that the elderly consume a higher proportion of their cobalamin from fortified foods than what is recommended for younger people. However there is considerable debate about whether crystalline cobalamin is absorbed as well by the elderly with F-CM as it is by younger people, especially if it is added as a fortificant to food. The data to be collected in this study will provide information useful to on-going deliberations concerning the future fortification of wheat flour with vitamin B12 in the United States.

Official Title
-----------------
Cobalamin Absorption From Fortified Food in Older Adults With and Without Proton Pump Inhibitor Induced Achlorhydria

Conditions
-----------------
Vitamin B-12 Deficiency, Achlorhydria

Intervention / Treatment
-----------------
* Other: 14C-B12 fortified bread


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: good overall health normal absorptive capacity (controls) or with a serum B12 <300 pg/mL and a pepsinogen I level >100 μg/L (ACs). All subjects must be available to complete the protocol Exclusion Criteria: Any chronic health disorder Anemia of any kind Renal insufficiency excessive alcohol consumption Prior GI surgery Use of OTC or prescription drugs that interfere with B-12 absorption or metabolism Use of vitamin supplements Pregnancy or lactation

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fortified Bread<br>A single serving of 14C-B12 fortified bread | Other: 14C-B12 fortified bread<br>* A single serving of 14C-B12 fortified bread<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| B12 bioavailability | B12 bioavailability from 14C-B12 fortified bread | 8 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin B-12
The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine whether oxytocin and oxytocin receptor gene polymorphism affect the development of intrusive memories, a cardinal symptom of PTSD.

Official Title
-----------------
The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories: A Model to Understand the Development of Posttraumatic Stress Disorder

Conditions
-----------------
Intrusive Memories

Intervention / Treatment
-----------------
* Drug: Oxytocin nasal spray
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy female volunteers German on a native level Exclusion Criteria: former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) any physical illnesses any medication intake (except oral contraceptive) history of traumatic experience, e.g. history of sexual abuse or rape pregnancy or lactation period follicular phase of menstrual cycle for all women not using oral contraceptives

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 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: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin and trauma film paradigm<br> | Drug: Oxytocin nasal spray<br> <br> |
| Placebo Comparator: Placebo and trauma film paradigm<br> | Drug: Placebos<br>* Placebo nasal spray<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrusive memories | Influence of oxytocin on the development of intrusive memories measured with an intrusion diary | four consecutive days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Noradrenergic System (measured with salivary alpha-amylase - u/ml) | Influence of oxytocin on the noradrenergic system measured with salivary alpha-amylase | Day 1 | 
| Genetic polymorphism | Influence of genetic polymorphism of the oxytocin receptor on intrusive memories measured with an intrusion diary | four consecutive days | 
| Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L) | Influence of oxytocin on the HPA-axis measured with salivary cortisol | Day 1 |
Topical Therapy for Prevention of Infections in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how to best take care of the skin of preterm infants in order to prevent infections through the skin.

Detailed Description
-----------------
The skin of babies who are born too early is not mature, which means they are at risk for infections of the skin or in the body. Their skin also become very dry, leading to cracking and breakdown, and this may feel painful or uncomfortable for the infant.

Official Title
-----------------
Topical Emollient Therapy for Prevention of Infections in Preterm Infants

Conditions
-----------------
Skin Diseases

Intervention / Treatment
-----------------
* Drug: Aquaphor
* Drug: Sunflower Seed Oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants Exclusion Criteria: Full-term infant

Ages Eligible for Study
-----------------
Minimum Age: 7 Months
Maximum Age: 8 Months

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aquaphor|nan|
|Drug: Sunflower Seed Oil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three weeks after application of the intervention, blood will be drawn from those enrolled in the control group. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atleast four additional times over the first four weeks of the child's life, the skin will be studied by lightly rubbing the skin with a cotton swab to detect germs on the skin and observing and recording the condition of the baby's skin. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pre-term infants, skin infections, infant skin, Aquaphor, sunflower seed oil, nutrition, skin care
Virtual LV Lead Navigation in Patients With Ischemic Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
Presently, the left ventricular lead is placed in a similar position for all patients. It is not known whether placing this lead in different positions in the heart will make the heart pump better. In this study, the investigator will collect measurements of the heart's electrical activity during an Electrophysiology Study (EP study or EPS). The hope is that these measurements will provide the know how to develop an individualized left ventricular lead placement prescription for patients referred for left ventricular lead pacing.

Official Title
-----------------
Virtual Left Ventricular Lead Navigation in Patients With Ischemic Cardiomyopathy

Conditions
-----------------
Cardiomyopathy, Ischemic Cardiomyopathy

Intervention / Treatment
-----------------
* Other: Collection of measurements during LV pacing during electrophysiology study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemic cardiomyopathy Intrinsic QRS duration >120 milliseconds LV ejection fraction <40% Exclusion Criteria: Persistent atrial tachyarrhythmia Active cardiac ischemia Cerebrovascular accident within 6 months Surgical or percutaneous cardiac revascularization procedure within 3 months Under 18 years of age Pregnant Participating in a clinical study that would preclude enrollment Unable to provide 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Electrophysiology Study<br>This is a single arm study, all study participants will be referred for an Electrophysiology Study | Other: Collection of measurements during LV pacing during electrophysiology study<br>* During the electrophysiology study, measurements will be obtained while pacing from different left ventricular regions in context to scar as determined by SPECT-CT testing.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dP/dt measurements observed during pacing from different left ventricular regions | During the electrophysiology study, the dP/dt measurements will be observed during pacing from different left ventricular regions. | Measurements will be observed at the time of the electrophysiology study (EPS) at enrollment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ischemic cardiomyopathy, cardiomyopathy, left ventricular lead, cardiac electrophysiologic studies