linjc16/ctgov huggingface dataset:
A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin

Study Overview
=================
Brief Summary
-----------------
This trial was conducted in the United States of America (USA). The aim of this clinical trial was to investigate the pharmacokinetics of somatropin in healthy Japanese and Caucasian subjects, and to identify somatostatin-related adverse events.

Official Title
-----------------
A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group, Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Norditropin® (Norditropin® PenSet® 24)

Conditions
-----------------
Growth Hormone Disorder, Adult Growth Hormone Deficiency, Healthy

Intervention / Treatment
-----------------
* Drug: somatropin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent before any trial related activities Japanese and Caucasian males respectively Healthy subjects based upon medical history, physical examination, vital signs, ECG, serum biochemistry and haematology and urinalysis Body Mass Index (BMI) between 17 and 30 m2/kg, inclusive

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: somatropin|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the hGH concentration-time curve (GH AUC0-24h) |  | from 0 to 24 hours following injection | 
| Maximum hGH concentration (GH Cmax) |  | from 0 to 24 hours following injection | 
| Treatment Emergent Adverse Events |  | from 0 to 24 hours following injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to maximum hGH concentration (GH tmax) |  |  | 
| Area under the hGH concentration-time curve GH AUC0-∞) |  |  | 
| Elimination half-life (GH t½) |  |  | 
| Growth Factors (IGF-I and IGFBP-3) |  |  | 
| Non-treatment Emergent Adverse Events |  |  |
Long Term Effects of Diabetes of Very Young Children

Study Overview
=================
Brief Summary
-----------------
To investigate neurocognitive and behavioral measures in 25 children aged 6-10 years diagnosed with diabetes for > 5 years who have received long-term insulin pump therapy (> 3 years) compared to a group of children matched for age, sex, glycemic control, and diabetes duration treated with insulin injections. Outcome measures will assess: clinical variables, cognitive status (intelligence, neuropsychological functioning), academic achievement, behavior, parenting stress, and quality of life. It is hypothesized that long term insulin pump therapy initiated during early childhood can delay the progression of neurocognitive complications of diabetes, decrease parental stress, and improve school performance and quality of life, as compared to insulin injections.

Official Title
-----------------
Long Term Effects of Diabetes of Very Young Children

Conditions
-----------------
Type 1 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have type 1 diabetes for at least 5 years, diagnosed prior to the age of 5 years Children recruited on pumps must have used pump therapy for at least 3 years Parents/guardians must be understand the protocol and be able to give consent, with assent obtained from all children over the age of 7 years. Exclusion Criteria: Children will be excluded if they have additional medical problems requiring treatment with agents known to affect blood glucose such as steroids or L-asparaginase. Children must not have any other chronic illness in addition to diabetes with the exception of treated autoimmune hypothyroidism.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 10 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 |
| --- | --- |
| Insulin Pump Therapy<br>Children on insulin pumps for at least three years. Subjects must have type 1 diabetes for at least five years and diagnosed under the age of 5. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Control | HbA1c, number of severe low events, frequency of moderate and mild hypoglycemia, blood glucose averages, and variance of reported blood sugar | Data Collected at each study visit | 
| Ease of Injections versus Insulin pump Therapy | Mechanical issues, site infections and errors of insulin administration | Conclusion of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 1 diabetes, neurocognitive measures, behavioral measures
Sienna+MR Long-term Uptake

Study Overview
=================
Brief Summary
-----------------
In a previous study in 2012/2013 patients were injected a superparamagnetic iron oxide for sentinel lymph node detection. In this follow up study we want to investigate how much of this tracer is still detectable.

Official Title
-----------------
Feasibility of Breast MRI After Sentinel Procedure for Breast Cancer With Superparamagnetic Tracers

Conditions
-----------------
Breast Cancer Female

Intervention / Treatment
-----------------
* Procedure: Native 1,5 Tesla breast MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
inclusion: participation in previous study informed consent no contraindications for MRI scan exclusion: contraindications for MRI scan
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Native 1,5 Tesla breast MRI group<br>From all patients a 1,5 Tesla MRI of the breast will be obtained | Procedure: Native 1,5 Tesla breast MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| I) Analysis if the supraparamegnetic Tracer is still detectable | Analysis by two expert radiologists | 04/2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis to which degree of impairment of Imaging is detected | Description as no impairment, impairment, but Interpretation of Images possible, impairment, Image Interpretation impossible | 04/2017 |
Clinical Benefit of Cognitive Behaviour Therapy (CBT) for Insomnia in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct a formal controlled evaluation of the potential benefits of CBT for insomnia in cancer patients.

Official Title
-----------------
Randomised Controlled Clinical Effectiveness Trial of Cognitive Behaviour Therapy (CBT) Versus Treatment as Usual (TAU) for Insomnia in Cancer Patients

Conditions
-----------------
Insomnia, Cancer

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behaviour Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets clinical criteria for insomnia. Diagnosis of breast, prostate, colorectal or gynaecological cancer. In follow-up phase with no further anti-cancer therapy planned. Exclusion Criteria: Anti-cancer chemotherapy or radiotherapy within 4 weeks of trial entry. Evidence of sleep apnoea or other sleep disorder. Evidence of untreated major depressive disorder.

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

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

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

| Intervention/Treatment |
| --- |
|Behavioral: Cognitive Behaviour Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Mapping of the Epileptic Brain

Study Overview
=================
Brief Summary
-----------------
This study aims improving the outcome after brain resective surgery of epileptic patients by improving presurgical evaluations. In particular the specific goal is to evaluate the ability of non invasive neuroimaging (functional magnetic resonance imaging and electroencephalography) to provide presurgical maps of the functional areas of the brain and of the epileptogenic networks.

Official Title
-----------------
Mapping of the Eloquent Cortex and of Epileptic Networks Using Functional Magnetic Resonance Imaging and Electroencephalography in Epileptic Patients

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Epilepsy Exclusion Criteria: MRI incompatible Pregnancy

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy, MRI, EEG, Neuroimaging
Needs Assessment of Long-Term Care for Psychiatric Patients

Study Overview
=================
Brief Summary
-----------------
The quantity and quality of inpatient services for persons with psychiatric illness have been enhanced in the last two decades. Following the enforcement of nationwide health insurance and the Physically and Mentally Disabled Citizens Protection Act, the financial pressure of medical care for psychiatric patients is relieved, and actions related to the protection of patients' human rights have been taken. Nonetheless, problems related to psychiatric illness are not limited to symptoms. Patients' daily functions are affected and it causes continuous pressure on the family. Currently, psychiatric care places more emphasis on inpatient services. Once the patient is discharged from the hospital, related psychiatric services are not widely available, which leads to symptom exacerbation, repeated hospital admissions, increased burden to the family, etc. A provision of continuous long-term care that meets the various needs of psychiatric patients is a critical issue in current psychiatric care. Based on a three-phase needs assessment model, the purpose of the study is to evaluate the needs of long-term care for psychiatric patients. The first phase will identify the current status of needs from the perspectives of patients and the family, psychiatric professionals, and the system. The second phase will identify the goals of long-term care for psychiatric patients. The goals will be identified by a nominal group, composed of experts related to the field of psychiatric long-term care. The third phase will determine the objectives of long-term care services for psychiatric patients. That is to determine the proper contents of long-term care services for the patients based on the goals identified in the previous phase. The three-phase needs assessment will be carried out in a two-year period. The results of the study will provide important information to the future planning of long-term care for psychiatric patients.

Detailed Description
-----------------
First, the participants were informed about how to fill in the self-report survey questionnaire. Then the participants began to complete the questionnaire. After finishing it, the participants gave the questionnaire back to the examiner.

Conditions
-----------------
Mental Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Psychiatric patient Must be able to read Chinese Caregivers of psychiatric patients

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?
-----------------
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
-----------------
Psychiatrists
Study of Topical Calcitriol in Children With Psoriasis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the therapeutic efficacy and safety of topical calcitriol in children with psoriasis.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients apply topical calcitriol in petrolatum on a psoriatic lesion daily. Patients also apply petrolatum without calcitriol to another psoriatic lesion daily. Patients have both lesions photographed prior to therapy, monthly during therapy, and at the completion of therapy. Lesions are assessed weekly for 1 month and then every 2 weeks while on study. Blood samples are collected every 1 to 2 months and urine samples are collected every 2 weeks while on study.

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: calcitriol


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of psoriasis At least 2 lesions with area at least 30-50 cm2 --Prior/Concurrent Therapy-- No other concurrent therapy for psoriasis No concurrent calcium supplements greater than 1,000 mg/day No concurrent prednisone or other drugs affecting serum or urine calcium levels --Patient Characteristics-- Renal: No high blood or urinary calcium levels Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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
-----------------
dermatologic disorders, psoriasis, rare disease
Rivaroxaban Evaluation in Real Life Settings

Study Overview
=================
Brief Summary
-----------------
To discover outcomes of patients treated with Rivaroxaban with atrial fibrillation with at least one additional investigator-determined risk factor for stroke in real-life practice.

Detailed Description
-----------------
This large global registry focuses on studying Atrial Fibrillation (AF) and evaluating characteristics, management and outcomes of patients treated with Rivaroxaban. The RIVER registry is observational, decisions on patient management are determined by the health care professional and the patient and not by the protocol. Patients are therefore treated according to normal local practice and the drug label/relevant product information of any drugs administered to them.

Official Title
-----------------
Rivaroxaban Evaluation in Real Life Settings

Conditions
-----------------
Atrial Fibrillation, Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Age 18 years and over New diagnosis of non-valvular atrial fibrillation (diagnosed within the last 6 weeks) with at least one additional investigator-determined risk factor for stroke Initial treatment with Rivaroxaban following AF diagnosis Exclusion Criteria: No further follow-up envisaged or possible within enrolling hospital or with associated primary care physician. Patients with transient AF secondary to a reversible cause. Patients participating in an interventional study that dictates treatments, visit frequency or diagnostic procedures Not treated with Rivaroxaban as first treatment

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 |
| --- | --- | --- |
| Rate of Stroke in Registry participants | To assess the rate of stroke and systemic embolisation in registry participants | 2 years | 
| Rate of Systemic Embolisation in Registry participants | To assess the rate of stroke and systemic embolisation in registry participants | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, Rivaroxaban, Stroke
Thirdhand Smoke Contamination in a Neonatal Intensive Care Unit (NICU)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to quantify the efficacy of hand washing (HW) and ethyl alcohol-based hand sanitizer (S) for third-hand smoke (THS) removal in a sub-sample of non-staff smokers using nicotine wipes on adjacent fingers before and after HW/S. The hypotheses are that detectable levels of surface nicotine will remain on participants' fingers, regardless of hand washing (HW) and ethyl alcohol-based hand sanitizer (S) attempts and that greater finger levels of surface nicotine will remain after alcohol sanitization compared to hand washing.

Official Title
-----------------
Thirdhand Smoke Contamination in a Neonatal Intensive Care Unit (NICU)

Conditions
-----------------
Nicotine Exposure

Intervention / Treatment
-----------------
* Drug: 2% Chlorohexidine Gluconate soap
* Drug: 62% ethyl alcohol-based hand sanitizer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (): Any non-staff participants visiting the NICU (including friends and family members of the infants' caregivers) Consented to and provided a finger wipe Report being a smoker Smoking status verified by an exhaled carbon monoxide (CO) level of >7 parts per million Exclusion Criteria: Unwilling to comply with research procedures (i.e., finger wipes) Does not speak English.
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hand washing with soap for thirdhand smoke removal<br> | Drug: 2% Chlorohexidine Gluconate soap<br>* Participants will wash hands for 30 seconds with 2% Chlorohexidine Gluconate soap.<br>|
| Active Comparator: Ethyl alcohol-based sanitizer for thirdhand smoke removal<br> | Drug: 62% ethyl alcohol-based hand sanitizer<br>* Participants will apply 62% ethyl alcohol-based hand sanitizer for 30 seconds<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nicotine level on finger #1 | Nicotine will be sampled from one finger of each participant's dominant hand (thumb, index, or middle finger). Finger will be wiped and nicotine level will be quantified. | baseline | 
| Nicotine level on finger #2 | Nicotine will be sampled from one finger of each participant's dominant hand (thumb, index, or middle finger). Finger will be wiped and nicotine level will be quantified. | 5 minutes after hand washing or sanitizing | 
| Nicotine level on finger #3 | Nicotine will be sampled from one finger of each participant's dominant hand (thumb, index, or middle finger). Finger will be wiped and nicotine level will be quantified. | 1 hour after hand washing or sanitizing |
Study Evaluating Streptococcus Pneumoniae Serotype Carriage Rate for Nasopharyngeal Carriage in Filipino Children

Study Overview
=================
Brief Summary
-----------------
Evaluation of the carriage rate of Streptococcus pneumoniae in the nasopharynx of healthy children and the carriage rate and distribution of Streptococcus pneumoniae serotypes

Official Title
-----------------
An Evaluation of Streptococcus Pneumoniae Serotype Carriage Rate For Nasopharyngeal Carriage in Filipino Children Attending Well Baby Clinic in Hospitals and Primary Care Centers

Conditions
-----------------
Pneumonia, Bacterial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children aged between 2 months and 5 years attending the well baby clinic in hospital. Informed consent obtained from parents or legal guardian.

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 5 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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Streptococcus pneumoniae serotype carriage rate based on a nasopharyngeal swab. |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bacterial otitis media, pneumoniae, sepsis, bacteremia, meningitis, Streptococcus pneumoniae carriage rate