linjc16/ctgov huggingface dataset:
Insulin Delivery Using Microneedles in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine if microneedles can effectively and painlessly deliver insulin to children and young adults with type 1 diabetes.

Official Title
-----------------
Insulin Delivery Using Microneedles in Type 1 Diabetes

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

Intervention / Treatment
-----------------
* Device: Microneedle
* Device: Subcutaneous insulin catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 8 years of age <19 years of age Type 1 Diabetes for at least 2 years Uses a conventional, FDA-approved insulin pump for the past year Uses Lispro insulin Mean hemoglobin A1C ≤ 8.5 % for the past year Body mass index ≤ 85th percentile for age Understand and be willing to adhere to the study protocol Exclusion Criteria: Type 2 Diabetes Acanthosis nigricans Clinically significant major organ system disease On glucocorticoid therapy Insulin requirement ≥ 150 U/day Illness on the day of the study Cognitive impairment (IQ < 85 or > 2 grades behind age-appropriate grade) Pregnant or breast-feeding (if female).

Ages Eligible for Study
-----------------
Minimum Age: 8 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microneedle<br>Microneedle used to deliver insulin at a depth less than 900 micrometers | Device: Microneedle<br>* Microneedle used to deliver insulin at a depth less than 900 micrometers<br>|
| Active Comparator: Subcutaneous insulin catheter<br>Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers) | Device: Subcutaneous insulin catheter<br>* Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)<br>* Other names: subcutaneous insulin infusion catheter;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset Time (Tmax) | Average time to peak insulin concentration | 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microneedle continuous subcutaneous insulin infusion
Effectiveness of Cultural Sensitive Collaborative Treatment of Depressed Chinese

Study Overview
=================
Brief Summary
-----------------
This study is a randomized controlled trial to test whether Culturally Sensitive Collaborative Treatment (CSCT) would improve the outcome of depressed patients visiting non-psychiatric settings in Taiwan.

Official Title
-----------------
Effectiveness of Cultural Sensitive Collaborative Treatment of Depressed Chinese in Primary Care

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Other: Culturally Sensitive Collaborative Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who attend non-psychiatric clinics at the above site. Patients with Major Depressive Disorder (MDD), defined as a positive screen using the PHQ-9, confirmed with the SCAN interview. Men or women aged 18 or older. Able to participate in a clinical diagnostic interview in either Mandarin or Fukienese dialects. Individuals who are willing to be followed up concerning their depression symptoms. Individuals who have completed a written consent form. Exclusion Criteria: Women who are pregnant, breast-feeding, or planning pregnancy within the next year. Patients with serious suicidal risk. Patients with unstable medical illnesses. Clinical or laboratory evidence of hypothyroidism. Patients with comorbid severe mental disorders Patients with history of treatment by a psychiatrist in the past 4 months.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSCT<br> | Other: Culturally Sensitive Collaborative Treatment<br>* a collaborative care model, for treating depressed patients in general medical care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressed patients who receive CSCT have improved treatment outcomes compared to patients who receive usual care. |  | 2wk,6 wk,10 wk,14 wk,18 wk,22wk,26wk | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-psychiatric, clinics
Stroke and Rehabilitation in North of Norway and Central Denmark

Study Overview
=================
Brief Summary
-----------------
Post-stroke prospective multicenter cohort study. The objectives of the study was to compare functioning and health related quality of life in the two study regions, in relation to known predictors and to differences in organization of treatment- and rehabilitation. The inclusion was of consecutive acute stroke patients with ICD10 diagnosis I.63 and I.61 from a regional part of Northern Norway and Jylland Denmark. All were referred to stroke units. At baseline national stroke registry data were collected in each country. A questionnaire package was mailed to the participants 3- and 12-months post stroke. Telephone interviews at 3 months post stroke added information on functioning and rehabilitation.

Detailed Description
-----------------
Post-stroke prospective multicenter cohort study. The objectives of the study was to compare functioning and health related quality of life in the two study regions, in relation to known predictors and to differences in organization of treatment- and rehabilitation. The inclusion was of consecutive acute stroke patients with ICD10 diagnosis I.63 and I.61 from a regional part of Northern Norway and Jylland Denmark. All were referred to stroke units. At baseline national stroke registry data were collected in each country. Telephone interviews at 3 months post stroke added information on functioning and rehabilitation. A questionnaire package was mailed to the participants 3- and 12-months post stroke. These included validated Questionnaires like QOLIBRI-OS, HADS, SS-QOL and EQ5D. Validity studies on QOLIBRI-OS and SS-QOL has been published, along with several other papers. Synne Garder Pedersen and Guri Heiberg have finished their PhDs.

Official Title
-----------------
Comparing Post-stroke Functioning and Rehabilitation Pathways in a Region of North of Norway and a Region of Denmark. A Prospective Cohort Study.

Conditions
-----------------
Stroke, Acute

Participation Criteria
=================
Eligibility Criteria
-----------------
Clinical diagnosis acute ischemic or hemmorhagic stroke Inclusion period Mars 2014 to January 2016 Hospitalised in Stroke Units Living in a defined geographic area in North of Norway or in Central Denmark

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 |
| --- | --- | --- |
| HRQOL | HRQOL measured by QOLIBRI-OS | 2014- 2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation, Health related quality of life, Stroke, Observational study
Role of Fat Tissue in Vitamin D Metabolism

Study Overview
=================
Brief Summary
-----------------
Vitamin D is a fat soluble vitamin that has important effects on calcium (including absorption of calcium from the diet) and bone metabolism. Vitamin D is known to be stored in fat tissue, and it is also present in the circulation. The purpose of this study is to investigate the relationship between levels of vitamin D in fat tissue and in blood.

Detailed Description
-----------------
Although vitamin D is known to be stored in fat tissue, researchers are not sure about the role that fat tissue plays in vitamin D metabolism. This study will help develop the methodology necessary to further investigate the role of fat tissue in vitamin D metabolism and will assess the relationship between levels of vitamin D in fat tissue and in blood. 50 subjects who are referred for gastric bypass surgery will be enrolled in this study. Subjects will complete questionnaires about their medical history, travel history and food intake. Prior to or during surgery, subjects will be asked to provide a blood sample for selected chemistries related to vitamin D metabolism. During gastric bypass surgery, the surgeon will collect small pieces of fat tissue from the fat under the skin and within the abdomen by surgical biopsy. These samples will be used to refine the methodology for determining the levels of vitamin D in blood and fat tissue and for comparing levels of vitamin D in various tissues.

Official Title
-----------------
The Role of Adipose Tissue in Vitamin D Metabolism

Conditions
-----------------
Vitamin D, Adipose Tissue

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese patients referred for gastric bypass surgery Exclusion Criteria: Patients must not be taking bile acid-sequestering medications or anti-seizure medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Adipose tissue, Metabolism
Intra Uterine Growth Restriction

Study Overview
=================
Brief Summary
-----------------
Intrauterine growth restriction (IUGR) is associated with an increase in perinatal mortality and morbidity, as well as longer-term neurological, cognitive, cardiovascular and endocrine complications. In Europe, about 400,000 pregnancies per year are complicated by IUGR. However, antenatal diagnosis seems insufficient in clinical practice, making it impossible to recognize up to 75% of foetuses with IUGR. At a time when the use of good clinical practice has demonstrated a significant improvement in neonatal survival without severe morbidity, foetuses with IUGR are less likely to receive optimal care. Our hypothesis is that the rate of IUGR diagnosed underestimates the rate of actual IUGR.

Official Title
-----------------
Intra Uterine Growth Restriction. Minimum Required Evidence-based Care and Neonatal Prognosis: Impact of Healthcare Pathways

Conditions
-----------------
Intrauterine Growth Restriction

Intervention / Treatment
-----------------
* Other: Intrauterine growth restriction (IUGR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All birth more than 24 + 0 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2011 to 31 december 2017. Exclusion Criteria: Infants born out of the hospital and secondarily hospitalized in the hospital Femme-Mère-Enfant . Multiple pregnancies, children with congenital fetal anomalies pregnancies without first trimester ultrasound (to date the pregnancy)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HFME births.<br>All birth more than 24 + 0 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2011 to 31 december 2017. | Other: Intrauterine growth restriction (IUGR)<br>* Collection of number of patient's diagnosed with IUGR as defined in accordance with the consensus-based definition for early and late IUGR : birthweight < 3rd centile using French AUDIPOG curves adjusted for term and sex or estimated fetal weight < 10th centile combined with umbilical artery pulsatility index > 95th centile or breakage of growth.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients diagnosed with Intrauterine growth restriction | IUGR was defined in accordance with the consensus-based definition for early and late IUGR : birthweight < 3rd centile using French AUDIPOG curves adjusted for term and sex or estimated fetal weight < 10th centile combined with umbilical artery pulsatility index > 95th centile or breakage of growth. | Between 2011 and 2017 |
Does a Nitrofurazone Coated Bladder Catheter Reduce the Number of Urinary Tract Infections in Trauma

Study Overview
=================
Brief Summary
-----------------
Urinary tract infections occurs in trauma. We investigate whether a nitrofurazone coated can reduce the number of urinary tract infections.

Detailed Description
-----------------
Urinary tract infection occurs in one in five patients as a complication following severe trauma. A new and approved urinary bladder catheter (Releen NF) has been introduced by the Danish company Coloplast A/S. Releen NF is expected to reduce the number of urinary tract infections, but this effect has not been investigated in trauma patients.

Conditions
-----------------
Trauma, Urinary Tract Infections

Intervention / Treatment
-----------------
* Device: Nitrofuranzone coated bladder catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical suspicion of multiple trauma Age >/= 18 years Direct referral from scene of accident Indication for urinary bladder catherization Exclusion Criteria: Major burn injury HIV positiv 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?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Nitrofuranzone coated bladder catheter|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary tract infections |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay |  |  |
Evaluation of Effects of Bracket's Slot System on the Quantity and Quality of Teeth Movements During Orthodontic Leveling and Alignment Stage

Study Overview
=================
Brief Summary
-----------------
Evaluation of effect of bracket slot system on the quality and quantity of tooth movement during leveling and alignment stage

Official Title
-----------------
Evaluation of Effects of Bracket's Slot System on the Quantity and Quality of Teeth Movements During Orthodontic Leveling and Alignment Stage : A Prospective Clinical Study

Conditions
-----------------
Moderate and Severe Crowding in Lower Dental Arch

Intervention / Treatment
-----------------
* Device: Bracket slot 0.018
* Device: Bracket slot 0.022


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An age range from14 to18 years. All permanent teeth are erupted(3rd molar not included). Angle class I malocclusion with normal facial proportions. Moderate to severe crowding in the lower dental arch asassessed by lett irregularity Index that require treatment with fixed appliance using extraction approach. There is no previous orthodontic treatment. Exclusion Criteria: Poor oral hygiene or periodontally compromised teeth. Craniofacial anomalies or previous history of trauma, bruxism, or Parafunctions. Uncooperativepatient.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bracket slot 0.018<br> | Device: Bracket slot 0.018<br>* That includes12 patients who will be treated using the bracket slot 0.018×0.025-inch system.<br>|
| Active Comparator: Bracket slot 0.022<br> | Device: Bracket slot 0.022<br>* Includes12 patients who will be treated using the bracket slot 0.022×0.028-inch system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of tooth movement by different bracket slot system | Amount of tooth movement | At 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bracket, Slot 0.018, Slot 0.022, Leveling, Alignment
The Effects of Sex Hormones on Cognition and Mood in Older Adults

Study Overview
=================
Brief Summary
-----------------
This study is investigating the effects of hormone replacement therapy on memory, mental abilities and mood in older adults aged 65-90. During the nine month long study, men will take testosterone for three months and women will take estrogen for three months. At four points during the study (once every three months), participants will complete a test battery and have blood drawn.

Detailed Description
-----------------
Double-blind, placebo-controlled, crossover study investigating the effects of estrogen replacement and testosterone replacement on cognition and mood in older adults. Women who have not had a hysterectomy will be given Prempro (estrogen with progesterone to protect the uterine lining), and hysterectomized women will be given Premarin (estrogen only).

Conditions
-----------------
Cognition Disorders, Mood Disorders

Intervention / Treatment
-----------------
* Drug: Estrogen
* Drug: Testosterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women and men aged 65-90 who have not received hormone replacement for the last three months. Exclusion Criteria: Previous head injury with loss of consciousness for more than one hour. Men with a history of prostate cancer. Men on testosterone replacement within the past three months. Women with a history of breast or uterine cancer. Women on estrogen replacement within the past three months.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Estrogen|nan|
|Drug: Testosterone|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
-----------------
Emotions, Cognition, Aging, Memory
Neural Correlates of Empathogenic and Affiliative Actions of Oxytocin

Study Overview
=================
Brief Summary
-----------------
Mounting evidence indicates that the intranasal administration of the neuropeptide oxytocin has prosocial effects. However, the neural substrates of these effects are still unclear. The investigators hypothesized that a single dose administration of oxytocin should increase empathogenic and affiliative responses and that these effects are mediated by an increased insula activity.

Official Title
-----------------
Neural Correlates of the Empathogenic and Affiliative Actions of Oxytocin

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers In a heterosexual relationship Exclusion Criteria: Current or past psychiatric disease Current or past physical illness Psychoactive medication Tobacco smokers

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin<br>24 IU Oxytocin, intranasal application 45 min prior to the experiment | Drug: Oxytocin<br>* 24 IU; 3 puffs per nostril, each with 4 IU OXT<br>* Other names: Oxytocin: Syntocinon-Spray, Novartis;|
| Placebo Comparator: Placebo<br>Intranasal application, sodium chloride solution, 3 puffs per nostril | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Empathy ratings and their neural correlates | All subjects are scanned while they view emotional and neutral faces and rate their empathy for these stimuli. | About one hour after the intranasal administration of oxytocin | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural correlates of pair-bonding | All subjects are scanned while they view a picture of their mate and and an unknown female. | About one hour after the intranasal administration of oxytocin | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Male Volunteers