linjc16/ctgov huggingface dataset:
Dose-dependent Impact of Daytime Lighting on Evening Responses to Light

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to systematically examine the impact of different intensities of daytime light and the subsequent impact that such exposure has on non-image forming responses to light in the evening.

Official Title
-----------------
Dose-dependent Impact of Daytime Lighting on Evening Responses to Light

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Behavioral: Light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-65 Good health Male or female Normal color vision Exclusion Criteria: Sleep disorders Extreme chronotypes Routine smoker Significant hearing loss Depressed Alcohol use disorder Use of illegal drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low room<br>Low intensity (80 lux) room light | Behavioral: Light<br>* 10 hours of light exposure during the daytime, starting 2 hours after habitual wake time<br>|
| Experimental: Normal room<br>Normal intensity (150 lux) room light | Behavioral: Light<br>* 10 hours of light exposure during the daytime, starting 2 hours after habitual wake time<br>|
| Experimental: Bright room<br>High intensity (500 lux) room light | Behavioral: Light<br>* 10 hours of light exposure during the daytime, starting 2 hours after habitual wake time<br>|
| Experimental: Bright<br>Very high intensity (1000 lux) room light | Behavioral: Light<br>* 10 hours of light exposure during the daytime, starting 2 hours after habitual wake time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suppression of melatonin production | Difference in salivary melatonin concentrations between active arm and 3 lux control condition | 4 hours | 
| Phase shift in the timing of melatonin onset | Change in the onset of melatonin secretion after experimental stimulus | 2 days |
Tear Cytokine Analysis as a Prediction or Diagnostic Marker in Ocular GvHD

Study Overview
=================
Brief Summary
-----------------
Investigate the profiles of tear cytokines in patients who underwent stem cell transplantation (SCT) and attempted to determine the applicability of tear cytokines in the diagnosis of chronic graft-versus-host disease (GVHD). Evaluate tear cytokines as biomarkers of chronic ocular GVHD severity.

Conditions
-----------------
Chronic Graft-versus-host Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients patients aged 20-60 years who visited the clinic 3-12 months after SCT were included in the study. Exclusion Criteria: The patients with histories of ocular surgery; ocular injury; and ocular diseases such as ocular infection, allergy, and autoimmune disease, as well as patients with long-term use of topical ocular medications except artificial tears.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| With or without newly diagnosed chronic GVHD after SCT<br>The patients developed chronic GVHD after SCT/ The patients did not developed chronic GVHD after SCT | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tear cytokine | comparison of tear cytokines (IL-2,4,10,17a, INF-r, TNF-a) concentrations in patients with or without newly diagnosed chronic GVHD after SCT using a multiplex immunobead assay | 3-12 month after SCT | 
| ocular surface status |  | 3-12 month after SCT | 
| tear film break-up time |  | 3-12 month after SCT | 
| conjunctival injection |  | 3-12 month after SCT | 
| Schirmer's test I |  | 3-12 month after SCT | 
| ocular surface disease index |  | 3-12 month after SCT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stem cell transplantation (SCT)
Health2010-14: Monitoring Biomarkers of Chronic Diseases in the General Population

Study Overview
=================
Brief Summary
-----------------
The overall aim of the Health2010-14 is to monitor the prevalence and trends of common chronic diseases (osteoporosis, diabetes, cardiovascular disease, asthma, allergy, and eczema) that are often un-diagnosed in the general population as well as biomarkers of micronutrient status. Specific aims include identification of novel lifestyle and genetic risk factors for the above diseases by investigating gene-lifestyle interactions.

Detailed Description
-----------------
Over a 5-year period a series of population-based studies are carried out including a total of up to 10,000 persons aged 18-69 years selected from the general population of Copenhagen, Denmark. The study also include a follow-up of a previous population study (the Health2006). Participants complete questionnaires on health, lifestyle, and social factors and undergo a health examination including measurements of metabolic biomarkers, allergy tests, anthropometric measures, bioimpedance, biomarkers of micronutrients, spirometry.

Official Title
-----------------
Health2010-14: Monitoring Biomarkers of Chronic Diseases in the General Population

Conditions
-----------------
Cardiovascular Disease, Type 2 Diabetes, Asthma, Allergy, Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: persons living in 10 municipalities of Copenhagen Exclusion Criteria: pregnancy, non-Danish citizenship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 72 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 |
| --- | --- |
| Health2010<br>Cross-sectional general population study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year change in prevalence of biomarkers of chronic diseases (e.g. diabetes, asthma, allergy) and micronutrient status (e.g. vitamin D status). |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| significant interaction (on a additive scale) between Vitamin D status and genetic variants in the Vitamin D receptor in relation to selected chronic disease biomarkers |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epidemiology, risk factors, micronutrients
VEGF Gene Association With Response to Neovascular Age-related Macular Degeneration With Anti-VEGF Agents

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to investigate the association between VEGF gene polymorphism and the response to intravitreal drugs in neovascular age-related macular degeneration. This is a retrospective review of patients treated between 2008 and 2012 at the Institute of Vision, in Belo Horizonte, Brazil.

Official Title
-----------------
VEGF Gene Polymorphism and Response to Intravitreal Anti-VEGF Agents in Neovascular Age-related Macular Degeneration

Conditions
-----------------
Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of neovascular age-related macular degeneration Visual acuity better than 20/400 Loading dose with three intravitreal injections of anti-VEGF agents, administred one per month over three months Follow-up period of at least six months Exclusion Criteria: Choroidal neovascularization secondary to any other cause than age-related macular degeneration Eyes with polypoidal choroidal vasculopathy Eyes previously submitted to posterior vitrectomy Other diseases that could affect visual acuity

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- | --- |
DNA Methylation and Hydroxymethylation Levels in Patients With Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to investigate the relationship between DNA methylation and hydroxymethylation and the expression of DNMTs, TET family gene and the degree of coronary heart disease.

Detailed Description
-----------------
To determine the levels of DNA methylation and hydroxymethylation with coronary heart disease. To investigate the relationship between DNA methylation and hydroxymethylation and the degree of coronary atherosclerosis.

Official Title
-----------------
DNA Methylation and Hydroxymethylation Levels in Patients With Coronary Heart Disease

Conditions
-----------------
Coronary Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female. Patients older than 65 years old who are willing to participate in the study. CHD patients was defined as at least one lesion in a coronary artery or branches in coronary angiograms. Control group was defined as people with negative findings in coronary angiograms. Exclusion Criteria: Patients with concurrent infection or any documented inflammatory illness, such as arthritis or connective tissue diseases, or any other malignancy. Patients with a history of cardiomyopathy. Pregnant women. Severe hepatic dysfunction or End-stage renal failure. Uncontrolled hypertension.

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Control group<br>Control group was defined as people with negative findings in coronary angiograms. | |
| Coronary Heart Disease group<br>CHD patients was defined as at least one lesion in a coronary artery or branches in coronary angiograms. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA Methylation and Hydroxymethylation Levels | Collection of blood samples and measuring the samples by PCR and ELISA | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methylation, hydroxymethylation, atherosclerosis, coronary heart disease
The Prevelance of Pulmonary Manifestation in Patients With Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
Bronchopulmonary manifestations signs and symptoms are variable extraintestinal manifestations of IBD.

Detailed Description
-----------------
Several cases like bronchiactsis, bronchitis, tracheobronchitis and broncholitis. None of this complications are specific for either crohns or ulcerative , however the majority of cases are related to ulcerative colitis.

Official Title
-----------------
The Prevelance of Pulmonary Manifestations in Patients With Inflammatory Bowel Disease

Conditions
-----------------
The Prevelance and Complications of Pulmonary Manifestations in Patients With Inflammatory Bowel Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:All patients diagnosed ulcerative colitis and crohns disaese on conventional treatment and biological treatment - Exclusion Criteria:no exclusion criteria -

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of pulmonary manifestations in IBD patients |  | 1 year |
Evaluation of the Functionality of a Fluid Filled Single Breast Pump

Study Overview
=================
Brief Summary
-----------------
This study is an early (during the product development process) feasibility study. It shall evaluate the device design concept with respect to device functionality of a new fluid filled breast pump in a small number of subjects.

Official Title
-----------------
C88- Pilot Study A Prospective Case Series for Evaluation of the Functionality of a Fluid Filled Single Breast Pump Applied on a Lactating Breast

Conditions
-----------------
Lactation

Intervention / Treatment
-----------------
* Procedure: Fluid filled breast pump


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Female over 18 years Participant has an established milk flow, general rule: approx. 50 ml per breast per pumping session The participant is pumping at least 2 times a week The participant is 1-6 months after giving birth (postpartum) at the day of data assessment The participant agrees to pump or feed the last time a minimum of 3 hours before the start of the pumping sessions The participant agrees that the pumped breast milk cannot be fed to her infant (will be disposed) The participant agrees to photograph and video record the breast and upper body (no face) The participant agrees to the presence of up to 3 men in the room during the pumping session Exclusion criteria: Participant or their baby is dependent on life-sustaining electric devices (e.g. heart pacemaker, insulin pump, etc.) Participant has an medical condition of the breast Participant is allergic to plastics or silicone

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pumping with a fluid filled breast pump<br>Participants pump (each breast 25 min) with the new fluid filled breast pump | Procedure: Fluid filled breast pump<br>* breast milk pumping with a fluid filled breast pump<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast pump vacuum (mmHg) | Vacuum will be continuously recorded during a single 25 Minute pumping session. The recorded units will be in mmHg. Each participants data will be assessed for the Minimum value, the Maximum value and the Mean value over 25 minutes. | Measured during a single 25 minute pumping session |
Metoclopramide Versus Ketorolac for Tension-type Headache

Study Overview
=================
Brief Summary
-----------------
Occasionally, episodic tension-type headache may be severe enough to require an emergency department (ED) visit. The purpose of this study is to compare two commonly used medications to see which is better for tension type headache. Patients who present to the ED with an acute tension-type headache requiring treatment with injectable medication will be randomized to metoclopramide or ketorolac.

Official Title
-----------------
An RCT of Metoclopramide/Diphenhydramine vs. Ketorolac Alone for Tension-type Headache

Conditions
-----------------
Headache

Intervention / Treatment
-----------------
* Drug: Metoclopramide
* Drug: Ketorolac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute tension type headache Exclusion Criteria: Contraindications to investigational medications Secondary cause of headache

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketorolac<br>Ketorolac 30mg IVSS | Drug: Ketorolac<br>* ketorolac 30mg IVSS<br>* Other names: Toradol;|
| Active Comparator: Metoclopramide<br>metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS | Drug: Metoclopramide<br>* metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS<br>* Other names: Reglan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Score | At baseline at at 60 minutes, all patients were asked to describe their pain on a scale from 0 to 10, with 0 representing no pain and 10 the worst imaginable. The primary outcome is the 60 minute score subtracted from the baseline score | Baseline, 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction Scores | 24 hours after the emergency department visit, patients were asked, The next time you come to the Er with this type of headache, do you want to receive the same medication? Affirmative answers are tabulated here. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
headache, tension-type headache
Pulmonary Hypertension Prevention in Hemodialysis

Study Overview
=================
Brief Summary
-----------------
Pulmonary hypertension is a new complication described in hemodialysis patients. in the last year these patients were treated by calcium carbonate orally to control serum phosphor. Calcium phosphor deposits in pulmonary artery can explain this phenomena. The investigators want to investigate the new phosphor non calcium containing agents in hemodialysis patients and to measure the pulmonary pressure.

Detailed Description
-----------------
The investigators will measure pulmonary blood pressure before and after treatment with new phosphor binders, non calcium containing.

Official Title
-----------------
New Phosphore Binders in Prevention of Pulmonary Hypertension

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemodialysis Patients without fistula Exclusion Criteria: Heart Disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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
-----------------
Calcium Phosphore, Renagel
Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5 days in children with acute otitis media (AOM). Secondary objectives are to assess Efficacy, Pharmacokinetics and Acceptability of telithromycin 20 mg/kg qd for 5 days in children with AOM.

Official Title
-----------------
Evaluation of the Safety, Efficacy, Pharmacokinetics, and Acceptability of HMR3647 20 mg/kg qd for 5 Days With Acute Otitis Media (AOM) in Children (Multicenter, Open Label, Non Comparative Study)

Conditions
-----------------
Otitis Media

Intervention / Treatment
-----------------
* Drug: Telithromycin (HMR3647)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are weighing 40 kg or less. If female, premenarchal status is required. Subjects with signs of infection according to middle ear signs and general signs or symptoms such as otalgia, fever, sleep disturbance, irritability, inconsolability. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Telithromycin (HMR3647)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy: tympanic signs |  |  | 
| Acceptability: compliance and willingness to take medication |  |  | 
| Pharmacokinetics: plasma concentrations of telithromycin |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Otitis Media, AOM, children, Child
Retrospective Data Analysis in Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify prognostic parameters about efficacy of Mesalazine in recently diagnosed patients with Morbus Crohn by retrospective data collection.

Official Title
-----------------
Retrospective Data Analysis of Newly Diagnosed Crohn's Disease Patients in Gastroenterological Surgeries

Conditions
-----------------
Crohn's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: therapeutic need according to SPC written 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Crohn's disease<br>Patients with initially diagnosed Crohn's disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to Mesalazine: measured by time to step up therapy |  | 12 to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification and characterisation of the responding sub-population | measured by: (a) Age at diagnosis, (b) Proportion of patients with minor endoscopic lesions, (c) Lack of severe mucosal lesions (Adapted Rutgeerts Score < 2) | 12 to 48 months |