linjc16/ctgov huggingface dataset:
Mitomycin-c Application for PRK

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of 5 seconds mitomycin-C (MMC) application during photorefractive keratectomy (PRK) for patients with low myopia.

Official Title
-----------------
Mitomycin-c Application for Photorefractive Keratectomy

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Drug: mitomycin-C
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria was ablation depth less than 65 µm, a stable refractive error for at least 1 year corrected distance visual acuity (CDVA) of 0.1 LogMAR or better. Exclusion Criteria: Patients with keratoconus suspect, excessive dry eyes, impaired wound healing processes, lenticular changes, corneal dystrophy, history of ocular surgery, anterior or posterior uveitis, glaucoma and retinal diseases were excluded.
Sexes Eligible for Study
-----------------
All

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MMC group<br>One eye of each patient was randomly assigned to receive intraoperative topical 0.02% MMC for 5 seconds. | Drug: mitomycin-C<br> <br> |
| Placebo Comparator: BSS group<br>One eye of each patient was randomly assigned to receive balanced salt solution (BSS) with the same manner. | Drug: Placebo<br>* balanced salt solution (BSS)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central corneal endothelial cell density (ECD) 6 months after the PRK |  | 6 months |
Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether a behavioural intervention changes attitudes, knowledge, intake or blood levels of vitamin D in young adults. The hypothesis is that an educational component and use of a mobile smartphone 'app' will increase knowledge and/or intake of vitamin D.

Official Title
-----------------
Knowledge, Attitudes, Intake and Blood Levels of Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Behavioral: an educational video
* Other: wait listed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women aged 18-25 years Must be fluent in English Must be currently living in Canada Must own iPhone, iPad or iPod Touch running iOS 7.0 or higher (handheld 'app' used in intervention is only available in Apple Store; not available for Android or Blackberry platforms at this time) Exclusion Criteria: Outside age group Not fluent in English Not living in Canada Does not own the specified Apple device

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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 |
| --- | --- |
| Experimental: Behavioural intervention<br>Behavioural intervention consisting of an educational video component and use of a handheld mobile app to track vitamin D intake. | Behavioral: an educational video<br> <br> |
| Placebo Comparator: Control group<br>Wait-list control group | Other: wait listed<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D blood levels | Blood will be collected by finger prick at baseline and after the 12-week behavioural intervention to measure 25(OH)D. | 12 weeks | 
| Vitamin D Intake | Vitamin D intake will be assessed using a food frequency questionnaire before and after the 12-week intervention. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge & attitudes regarding vitamin D | General knowledge & attitudes regarding vitamin D will be assessed via online questionnaire before, mid-way and after the 12-week intervention. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Intervention, Behaviour, Mobile app
Obstructive Apnea in Patients Submitted to Partial Laryngectomy

Study Overview
=================
Brief Summary
-----------------
The investigators intend to study the prevalence of obstructive apnea in patients submitted to partial laryngectomy by larynx cancer. Volunteers will be evaluated using polissonografy. We will try to correlate the residual glotic area with the number of apneas per hour.

Detailed Description
-----------------
We are trying to avaliate the residual glotic area using spirometry e laryngoscopy

Official Title
-----------------
Obstructive Apnea in Patients Submitted to Partial Laryngectomy

Conditions
-----------------
OBSTRUCTIVE SLEEP APNEA

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PARTIAL LARINGECTOMY, OVER 18 YEARS, Exclusion Criteria: TRACHEOSTOMY DEPRESSION USE OF DRUGS SEVERE DPOC CANCER RECURRENCE

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 |
| --- | --- |
| level of apnea<br>patients will be separated depending on the iah(apnea hypopnea index) in mild, moderate and severe | |

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
-----------------
OBSTRUCTIVE SLEEP APNEA LARINGECTOMY CPAP
The Effect of Erythromycin on Occurrence of Leaks From Cervical Esophageal-Gastric Anastomosis After Trans-Hiatal Esophagectomy

Study Overview
=================
Brief Summary
-----------------
Cervical anastomotic leak is one of the most common complications after trans-hiatal esophagectomy. Hypothesis: An early post operative administration of a pro-kinetic dosage of erythromycin will reduce leak occurrence. Design: This is a prospective, randomized, double blind, placebo controlled study. Number of patients: 30. Inclusion Criteria: Patients after trans-hiatal esophagectomy Exclusion Criteria: Allergy to erythromycin Use of phenothiazine QT prolongation Liver function test (LFT) abnormalities Myasthenia gravis Cardiomyopathy

Conditions
-----------------
Esophagectomy, Postoperative Complications

Intervention / Treatment
-----------------
* Drug: intravenous (IV) administration of erythromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients after trans-hiatal esophagectomy Exclusion Criteria: Allergy to erythromycin Use of phenothiazine QT prolongation Liver function test (LFT) abnormalities Myasthenia gravis Cardiomyopathy

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: intravenous (IV) administration of erythromycin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Is Serum YKL-40 Capable of Predicting Intrauterine Growth Restriction (IUGR) and Preeclampsia?

Study Overview
=================
Brief Summary
-----------------
Objective: To investigate the role of maternal serum YKL-40 and uterine artery doppler, at gestational age 12, 20, 25 and 32 weeks, and the relation to preeclampsia and intrauterine growth restriction. The serum marker YKL-40 is related to conditions involving inflammation, infection, tissue remodeling, fibrosis and cancer. IUGR and preeclampsia are known to be related to inflammation and tissue remodeling. Methods: women attending screening for downs syndrome is scanned with uterine artery doppler and delivered blood samples at GA 12, 20, 25 and 32 respectively. When pregnancy outcome is registered by medical records blood samples are retrieved and analyzed for serum YKL-40. Serum YKL-40 are correlated to the presence of bilateral notching, preeclampsia and different degrees of intrauterine growth restriction.

Official Title
-----------------
Kan IUGR og præeclampsi Forudsiges ud Fra YKL-40 målt i Serum? Metoder Til at Vurdere om Den Gravide Har Risiko for at Udvikle Svangerskabsforgiftning og/Eller væksthæmning Hos Fosteret.

Conditions
-----------------
Intrauterine Growth Restriction, Preeclampsia

Intervention / Treatment
-----------------
* Procedure: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant danish speeking women Exclusion Criteria: Conditions/diseases involving chronical inflammation, or immunological activity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| 1<br>Pregnant women are included when they attend nuchal transcluency examination and will during their pregnancy be examined 4 times with ultrasound | Procedure: ultrasound<br>* 4 ultrasound examinations during pregnancy and every time a blood sample is colletted. blood sample from the mother and the umbilical cord is collected as well<br>|

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
-----------------
IUGR, Preeclampsia, ultrasound, YKL-40
Evaluation of the Health Related Quality of Life and Disease Prevalence of Children From Spain at 6-8 Years of Age Who Participated in a Qualifying Infant Formula Study at Birth

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the influence of the type of feeding in the first year of life on the behavior and health-related quality of life at 6-8 years of age.

Conditions
-----------------
Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Father, mother or legal representative of a child who was included in the qualifying study Child 6 - 8 years of age Written informed consent of the father, mother or legal representative Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 8 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 |
| --- | --- |
| Feeding with milk with DHA and ARA<br> | |
| Feeding with milk without DHA and ARA<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of the type of feeding from the first year of life on the quality of life in the same children at 6 - 8 years of age |  |  |
The Effects AZD8529 on Cognition and Negative Symptoms in Schizophrenics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess if AZD8529 improves performance on neurobehavioral probes of attention, working memory and affective reactivity in patients with schizophrenia.

Official Title
-----------------
A Single Center, Double-Blind, Randomized, Placebo-Controlled, Two-Period Crossover Study to Access an Early Signal of Efficacy for Cognition and Negative Symptoms With AZD8529 in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: AZD8529
* Drug: Placebo to match AZD8529


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV diagnosis of schizophrenia or schizoaffective disorder Exclusion Criteria: ECT in the last 6 months Substance abuse or dependence History of claustrophobia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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: 1<br>80 mg AZD8529 | Drug: AZD8529<br>* 2 capsules by mouth for 3 days<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo to match AZD8529<br>* 2 capsules by mouth for 3 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional magnetic resonance imaging (fMRI) |  | 1 fMRI on Day 4; 1 fMRI on Day 21 | 
| Computerized neurocognitive tests |  | 1 on Day -1; 1 on Day 1 and on Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale (PANSS) |  | Day-1; Day 4; Day 17; Day 21 | 
| Electroencephalography (EEG) |  | Day 4; Day 21 | 
| Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs, |  | Labs at screening and on Days -1, 4, 17, 21, and 35; ECG at screening and Day 35; Physical Exam at screening and Day 35; Vital signs at screening and Days -1,4, 17, 21, and 35 | 
| Suicidality assessment, collection of adverse events |  | Suicidality assesment at screening; and Days -1, 4, 17, 21, and 35 Adverse events at screening, and Days -1,4,17,21, and 35 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, early phase trials
Bone-biomarkers of Spinal Cord Injury Patients

Study Overview
=================
Brief Summary
-----------------
Patients with spinal cord injury have a high prevalence of osteoporosis due to chronic skeletal unloading. Recently, various treatment drugs for osteoporosis have been developed. In particular, romosozumab, a sclerostin inhibitor, has been reported to have a high therapeutic effect as an inhibitor of bone resorption while promoting bone formation. However, there are a few research concerning sclerostin of spinal cord injuries patients. Therefore we want to analyze the change of sclerostin as well as factors indicating bone formation and absorption marker in spinal cord injury patient.

Official Title
-----------------
Changes of Bone-biomarker According to the Severity of Spinal Cord Injury.

Conditions
-----------------
Spinal Cord Injuries, Bone Resorption, Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: spinal cord injury patients Functional ambulatory category index of 3 or less Exclusion Criteria: history of using bone absorption medication within the effective period

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Serum sclerostin level | Serum sclerostin level in spinal cord injury patients | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sclerostin, osteoporosis, Spinal cord injury, Unloading
Regional Anesthesia of Cesarean Section

Study Overview
=================
Brief Summary
-----------------
Beta trace protein assay is an indicator of post-spinal CSF leak that predicts the degree of post-spinal headache.

Detailed Description
-----------------
Beta trace protein is specific for CSF only and it is a quantitative analytic test.

Official Title
-----------------
Role of Beta Trace Protein Assay During Spinal Anesthesia of Cesarean Section

Conditions
-----------------
Anesthesia, Obestetric

Intervention / Treatment
-----------------
* Device: spinal needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-45 years old free medical history. free obstetric history. Exclusion Criteria: high risk pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: spinal needle 27 gauqge<br>It is a device used to penetrate the dura to take CSF sample before injecting the drugs used for spinal anesthesia for cesarean section. | Device: spinal needle<br>* It is a spinal needle with 'QUINCKE' Bevel. It is inserted in the lumbar region at the inter-space L4-L5, L4-L3 ,or L3-L2 lumber spaces, while the patient is put in the sitting position then CSF sample is taken then 2.5 ml of a local anesthetic(0.5 ml of 25 ug fentanyl and 2 ml of 8 mg heavy bupivacaine) is given intrathecal then the needle is withdrawn.<br>|
| Other: spinal needle 25 gauage<br>It is a device used to penetrate the dura to take CSF sample before injecting the drugs used for spinal anesthesia for cesarean section. | Device: spinal needle<br>* It is a spinal needle with 'QUINCKE' Bevel. It is inserted in the lumbar region at the inter-space L4-L5, L4-L3 ,or L3-L2 lumber spaces, while the patient is put in the sitting position then CSF sample is taken then 2.5 ml of a local anesthetic(0.5 ml of 25 ug fentanyl and 2 ml of 8 mg heavy bupivacaine) is given intrathecal then the needle is withdrawn.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSF sample: serum sample | After insertion of an intravenous line 4 ml serum will be collected, then 0.5 ml CSF sample will be collected after insertion of the dura by the selected spinal needle before injecting the anesthetic drugs used for spinal anesthesia. Beta trace protein assay will be measured through ELISA technique in both CSF and serum samples and the ratio will be calculated and measured. This ratio will be measured for the three arms aiming at the comparison between the three devices regarding the CSF : Serum ratio. | One year |
Stem Cells for Bronchopulmonary Dysplasia

Study Overview
=================
Brief Summary
-----------------
Very preterm infants are at high risk to develop to bronchopulmonary dysplasia (BPD) for the lack of effective measures to prevent or ameliorate this common and serious disorder. BPD remains a major cause of mortality and lifelong morbidity in preterm infants

Detailed Description
-----------------
Several studies have shown that transplantation of mesenchymal stem cells (MSCs) in immunocompetent animals attenuates lung injury, such as impaired alveolarization, inflammatory response, increased apoptosis, and fibrosis. Human umbilical cord blood (hUCB) is considered a better source of MSCs because of their ready availability and greater proliferative capacity and less antigenicity than other cell types. transplantation of hUCB-derived MSCs should be effective in treating BPD. The safety and efficacy of MSC transplantation for prevention of BPD has not been tested previously, however.

Official Title
-----------------
Stem Cells for Bronchopulmonary Dysplasia: a Cohort Study

Conditions
-----------------
Bronchopulmonary Dysplasia

Intervention / Treatment
-----------------
* Drug: transplantation of mesenchymal stem cell
* Drug: no transplantation of mesenchymal stem cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with BPD Exclusion Criteria: parents' rejection

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 3 Months

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transplantation of mesenchymal stem cell<br>transplantation of mesenchymal stem cell will be given to the infants with BPD. | Drug: transplantation of mesenchymal stem cell<br>* allogeneic human umbilical cord blood (hUCB)-derived mesenchymal stem cell (MSC) transplantation will be given to preterm infants<br>|
| Active Comparator: no transplantation of mesenchymal stem cell<br>transplantation of mesenchymal stem cell will be not given to the infants with BPD. | Drug: no transplantation of mesenchymal stem cell<br>* MSC transplantation will be not given to preterm infants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death | the infant is dead due to lung disease | within two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bayley Scales of Infant Development | scores of Bayley Scales of Infant Development at 2 months old and 2 years old | 30 months after birth |