linjc16/ctgov huggingface dataset:
Sleep, Glycemic Control, and Insulin Resistance in Adolescents With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Despite advancements in care, most adolescents with T1D have higher BMI and significantly higher HbA1c than recommended and are markedly IR, placing them at increased risk for CVD1,2. Thus, alternative approaches to improve and maintain glycemic control, IR, and BMI for adolescents with T1D are urgently needed. This proposal moves beyond the current insulin and carbohydrate counting-focused lifestyle change paradigm to focus on sleep and circadian misalignment, which will allow for identification of new mechanisms that can be directly translated into future intervention and prevention trials. The goal of the current study is to utilize multiple objective measures of sleep duration, timing (actigraphy), and circadian rhythm (melatonin) in adolescents with type 1 diabetes (T1D; N = 40) and examine relationships with glycemic control, IR, vascular health, and BMI. Further, qualitative methodology will be used to identify barriers and facilitators to healthy sleep in adolescents with T1D.

Official Title
-----------------
Sleep, Glycemic Control, and Insulin Resistance in Adolescents With Type 1 Diabetes

Conditions
-----------------
Type1diabetes, Adolescent Behavior, Sleep

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: attending high school diagnosis of type 1 diabetes >1 year Exclusion Criteria: current diagnosis of a sleep disorder (e.g., insomnia, OSA) or abnormal scores on sleep disorders screening measures regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin, other sleep aids) HbA1c ≥11 or >14% for the previous 2+ measurements IQ<70 or severe mental illness

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 19 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| adolescents with type 1 diabetes<br>Adolescents ages 14-19 with type 1 diabetes | Other: observation<br>* observation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | HbA1c | at 60 days | 
| glycemic variability | CGM glucose SD | at 2 weeks | 
| insulin sensitivity from hyperinsulinemic euglycemic clamp | Si | at study entry (baseline) | 
| BMI | body mass index | at study entry (baseline) |
Evaluation of Objective Perimetry Using Pupillometer

Study Overview
=================
Brief Summary
-----------------
Objective perimetry can better monitor visual field defects in RP and Glaucoma patients than conventional subjective perimetry.The PLR ( Pupil Light Reflex ) of the short and long wave ratio should be significantly higher in areas of visual field defects in RP and Glaucoma patients.

Detailed Description
-----------------
Pupil light reflex will be measured by a pupillometer in response to short and long wavelength light small spot stimulus in different area of the visual field. The PRL will be measured in four quadrant, central, 10, 20, and 30 degree from the visual axis. Stimulus duration will be 1000 ms (1 sec), with intervals of 890 ms between stimuli. The stimuli size V with light intensity of 39.8 cd-s/m2 for both short wavelength stimuli (peak 485 nm) and long wavelength stimuli (peak 620nm).

Official Title
-----------------
Objective Perimetry in Normal Subjects,Glaucoma Patients and Retinitis Pigmentosa Patients .

Conditions
-----------------
Retinitis Pigmentosa, Glaucoma, Visual Field

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 Sign on informed consent Papillary response to light. Groups of : Normal , Glaucoma patients with early glaucoma damage on HVF (nasal step ect. ), Glaucoma patients with advanced glaucoma damage on HVF (arcuate , tubular vision ) and RP patients (Early VF damage , ring scotoma ) . Refractive correction up to -3.5 D. Exclusion Criteria: Cloudy corneas. Surgical intraocular ophthalmic procedure within the past 30 days. Nonreactive pupils. Synechia of the iris to the lens after surgery or inflammation . Neovascularization. Iris coloboma. Sphincter damage due to ischemia or trauma (tears of sphincter or diffuse damage to muscle). Sphincter damage due to high intraocular pressure . Iris tumor or cyst . Ectropion uvea . Adie's pupil . Optic neuropathy with the potential for producing a positive RAPD (Relative Afferent Pupillary Defect ). Chronic use of myotics or mydriatics. Systemic Medication which affect on papillary response . Any condition preventing accurate measurement or examination of the pupils.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Glaucoma<br>Glaucoma Patients with visual field defects | |
| Retinitis Pigmentosa<br>Retinitis Pigmentosa Patients with visual field defects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PLR response amplitude and latency |  | Not defined yet | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pupillometer, Retinitis Pigmentosa, Glaucoma, Objective perimetry
Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with Bipolar l Disorder (Manic or Mixed).

Official Title
-----------------
Four Week, Double Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Ziprasidone Oral Capsules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for Bipolar I disorder (manic or mixed) At the screening and baseline visits, subjects must have a Young Mania Rating Scale (YMRS) score of at least 17. The subject must have a Body Mass Index (BMI) z score between -1.65 and +2.00, inclusive Exclusion Criteria: Imminent risk of suicide or homicide, as judged by the site investigator Any history of serious or unstable illness Risk for prolonged QT

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo matching the oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dose design with minimal dose range of 40 mg twice a day (BID) to maximum dose range of 80 mg BID (weight specific- < 45kg max dose 40 mg BID).<br>|
| Active Comparator: 1<br> | Drug: Ziprasidone Oral Capsules<br>* Oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dose design with minimal dose range of 40 mg twice a day (BID to maximum dose range of 80 mg BID (weight specific- < 45kg max dose 40 mg BID).<br>* Other names: Geodon, Zeldox;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Week 4 in Young Mania Rating Scale (YMRS) total score. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Clinical Global Impression of Severity (CGI S) score. |  | 4 weeks | 
| Clinical Global Impression of Improvement (CGI I) score |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, bipolar
Mucinex Exploratory Cold Study

Study Overview
=================
Brief Summary
-----------------
This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex in patients with colds. Patients will receive 7 days of treatment with either Mucinex or placebo. The study will assess the effects of Mucinex on sputum and cold symptoms.

Official Title
-----------------
Double Blind, Randomized, Placebo Controlled Study of Mucinex® for the Treatment of Symptoms of an Acute Respiratory Tract Infection When Two 600 mg Tablets Are Given Every 12 Hours for 7 Days

Conditions
-----------------
Common Cold

Intervention / Treatment
-----------------
* Drug: guaifenesin (Mucinex)
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: common cold symptoms meet symptom severity females of child-bearing potential must have negative pregnancy test and use effective birth control Exclusion Criteria: chronic respiratory conditions significant heart, kidney, liver, or lung disease, uncontrolled hypertension or diabetes, cystic fibrosis, thyroid disorder pregnant or lactating known malignancy participation in any other clinical trial within 30 days of baseline related to another enrolled patient or persons involved directly or indirectly with the conduct of this study

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mucinex<br> | Drug: guaifenesin (Mucinex)<br>* bid 7 days<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* bid 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's End of Study Assessment of Treatment | Yes the investigator would use this treatment for cold symptoms in the future. | 7 days | 
| Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough. | Mean change from baseline in a 6 point severity scale between treatment groups(0 = None, 1 = Very mild, 2 = Mild or slight, 3 = Moderate, 4 = Severe or 5 = As bad as it can be) for cough. | Baseline and Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Adverse Events | Total number of patients with adverse events that were possibly or probably related. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
common cold
Oral Stent Device for Radiation Treatments of Oral Cancers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine that ability of the experimental oral stent device to reduce the volume of mandible receiving >55 Gy by 50%during radiation treatment as assessed duri radiation treatment planning. Patients will have CT scans at three time-points during their standard of care radiation treatment. During these visits patients will receive scans via CT or cone beam CT scan, with both the standard and experimental oral stent devices. During radiation treatment patients will receive the standard oral stent device.

Official Title
-----------------
A Pilot Study Assessing an Oral Stent Device for Radiation Treatments of Oral Cancers

Conditions
-----------------
Tongue Tumor, Tongue Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: CT Scan
* Device: Experimental Oral Stent Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 year old at the time of informed consent Ability to provide written informed consent and HIPAA authorization Accepted for curative radiation treatment of a tongue tumor, either intact or postoperatively Signed consent to study participation No history of bleeding disorder Platelets within normal limits (150-450 k/cumm) Exclusion Criteria: History of bleeding disorder History of allergy to dental grade material

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 |
| --- | --- |
| Oral Cancer<br>Patients receiving curative radiation treatment for an oral cancer. | Diagnostic Test: CT Scan<br>* An additional cone beam CT will be repeated at midcourse of therapy (3rd week) and during the end of therapy (5th week)<br>Device: Experimental Oral Stent Device<br>* Patients undergoing standard of care planning for head and neck tongue cancer will have a radiation plan of the body imaged via CT scan construction with the experimental oral stent device in place<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The volume of mandible irradiated to >55 Gy |  | volume irradiated at Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The position of the fiducial marker | Fiducial coordinate measured (mm) on XYZ on planning CT | Change in position at Day 0, Week 3, Week 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tongue tumor, tongue cancer, oral cancer
Vaginal and Oral Microbiome Crosstalk

Study Overview
=================
Brief Summary
-----------------
To study the vaginal and oral microbiome by swab samples. On selected cases, also papa smear will be studied.

Detailed Description
-----------------
To study the vaginal and oral microbiome by swab samples and on selected groups, by papa smear test, to find out the constitution of normal and vaginal microbiome and the cross-talk between oral and vaginal mucosa. To find out about the impact of human papilloma virus on the microbiome and vice versa.

Official Title
-----------------
EMMI - Emättimen Mikrobiomi - Emättimen ja Suun Limakalvojen Vuorovaikutus

Conditions
-----------------
Healthy, Vaginal Discharge

Intervention / Treatment
-----------------
* Other: vaginal and oral swab sample, questionnaire
* Other: papa smear


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients coming to Turku University Hospital Dermato-Venereology or Gynaecology Departments for previously mentioned reasons Exclusion Criteria: those not meeting the criteria

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| symptomless<br>vaginal and oral swab sample, questionnaire | Other: vaginal and oral swab sample, questionnaire<br>* vaginal and oral swab sample and questionnaire<br>|
| vaginal discharge<br>vaginal and oral swab sample, questionnaire | Other: vaginal and oral swab sample, questionnaire<br>* vaginal and oral swab sample and questionnaire<br>|
| atypical papa smear<br>vaginal and oral swab sample, questionnaire, papa smear | Other: vaginal and oral swab sample, questionnaire<br>* vaginal and oral swab sample and questionnaire<br>Other: papa smear<br>* Papnicolaou Papa Smear test<br>|
| no atypical papa smear<br>vaginal and oral swab sample, questionnaire, papa smear | Other: vaginal and oral swab sample, questionnaire<br>* vaginal and oral swab sample and questionnaire<br>Other: papa smear<br>* Papnicolaou Papa Smear test<br>|
| lichen planus<br>vaginal and oral swab sample, questionnaire, papa smear | Other: vaginal and oral swab sample, questionnaire<br>* vaginal and oral swab sample and questionnaire<br>Other: papa smear<br>* Papnicolaou Papa Smear test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiome, papa smear | Differences in microbiome and papa smear | 5 years |
Moyo; strap-on Fetal Heart Rate Monitoring in an Urban Setting

Study Overview
=================
Brief Summary
-----------------
Annually, an estimated 2.6 million still births occur half of which die during labor and delivery (fresh stillbirths). In addition, around 750,000 newborns die shortly after birth due to intrapartum-related hypoxia or birth asphyxia. Almost 99% of these perinatal deaths take place in low-income countries where the provider/patient ratio is low and fetal monitoring is inadequate. Poor intrapartum fetal heart rate monitoring, failure to identify fetal distress, and subsequently intervene, is a common pathway to perinatal deaths in these low-resourced settings. Recently, an innovative fetal heart rate monitoring device, called Moyo, using ultrasound technology, was developed to be strapped on the mother during labour. This project will compare the effectiveness of automatic use of Moyo versus intermittent use of hand-held Doppler in detection of abnormal fetal heart rate, through a randomized control study, at the University hospital, Dar es Salaam, Tanzania.

Official Title
-----------------
Evaluation of an Innovative Fetal Heart Rate Monitoring Device (Named Moyo) to Improve Perinatal Outcome in Dar es Salaam, Tanzania

Conditions
-----------------
Fetal Monitoring

Intervention / Treatment
-----------------
* Device: Moyo strap-on
* Device: Hand-held Doppler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women admitted in labor Exclusion Criteria: Women scheduled for elective cesarean section, women with abnormal fetal heart rate on admission, multiples, and critically ill patients with no measurements of fetal heart rate on admission
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moyo strap-on<br>Continous fetal heart rate monitoring | Device: Moyo strap-on<br>* Continous monitoring<br>|
| Active Comparator: Hand-held Doppler<br>Intermittent fetal heart rate monitoring | Device: Hand-held Doppler<br>* Intermittent monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of abnormal fetal heart rate detection |  | Up to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery: vaginal versus operative |  | Up to delivery | 
| Time interval from abnormal fetal heart rate detection to delivery in minutes |  | Up to delivery | 
| Neonatal outcome dead versus alive |  | Up to 24 hours |
Drug Interaction Study - Assess Pharmacokinetics of Both AZD5672 and Atorvastatin

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the pharmacokinetics of both AZD5672 (steady-state) and atorvastatin (single dose) when co administered in healthy volunteers

Official Title
-----------------
A Phase I, Single Centre, Open-label Study to Assess the Pharmacokinetics of Both AZD5672 (Steady-state) and Atorvastatin (Single Dose) When Co Administered in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers, Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: AZD5672
* Drug: atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent prior to any study specific procedures. Females should not be of childbearing potential Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results Exclusion Criteria: Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate Known allergy to atorvastatin (or other statins) or previous complications to atorvastatin therapy. Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: 1<br>AZD5672 + atorvastatin | Drug: AZD5672<br>* 100 mg once daily, 10 days<br>Drug: atorvastatin<br>* one single dose of 40 mg on day 10<br>* Other names: Lipitor®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables |  | Frequent sampling occasions during study periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, blood pressure, pulse, safety lab) |  | During the whole treatment periods | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atorvastatin, AZD5672