linjc16/ctgov huggingface dataset:
Responses of Premature Infants to Measles-Mumps-Rubella (MMR) and Varicella Vaccines

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term. A group of children who were carried full-term will be matched for age, sex, and race and will be used for comparison.

Detailed Description
-----------------
The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term. A group of children who were carried full-term will be matched for age, sex, and race and will be used for comparison. Extremely premature infants (born at <28-30 weeks gestation) have lower antibody responses than full-term infants to several vaccines given at the postnatal ages recommended for full term infants. We propose to evaluate the immunogenicity of varicella and mumps-measles-rubella (MMR) vaccines in relatively healthy 15 month-old children born at <29 weeks gestation. This is a phase IV, observational study with 2 study arms having 16 infants each. The first group will enroll infants 9-12 months old that were born premature (<29 weeks gestation). The second group will be matched for sex, race, and postnatal age, but will have been full term (>= 37 weeks gestation) at birth. Infants will be vaccinated at visit 1 and post-vaccine serology will drawn at visit 2 (4 to 6 weeks after visit 1).

Official Title
-----------------
MMR and Varicella Vaccine Responses in Extremely Premature Infants

Conditions
-----------------
Measles, Mumps, Rubella, Varicella

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature infant < 29 weeks gestation at birth or term infant >= 37 weeks gestation at birth. Postnatal age < 16 months, 0 days. Has not yet received MMR or varicella vaccines. (There are no restrictions on the administration of other vaccines at the time of MMR/varicella vaccination.) Parental permission. Agreement of primary care pediatrician/ health care provider. Receives primary pediatric care within an approximate 25-mile radius of the University of Rochester. Healthy status at enrollment. Exclusion Criteria: Known immunodeficiency. Systemic corticosteroid therapy at the time of MMR/varicella vaccination. Requiring oxygen therapy. Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion. Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject.

Ages Eligible for Study
-----------------
Maximum Age: 16 Months

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of a Simplified Geriatric Evaluation Performed by Oncologists Prior to Cancer Treatment by Radiotherapy or Chemotherapy in Subjects Aged 70 Years or Older With Inoperable Squamous Cell Cancer of the Head and Neck

Study Overview
=================
Brief Summary
-----------------
Use by Oncologists of Validated Geriatric Assessment Tools: G8 Screening Test and Certain Tests for Thorough Geriatric Evaluation

Official Title
-----------------
Study of a Simplified Geriatric Evaluation Performed by Oncologists Prior to Cancer Treatment by Radiotherapy or Chemotherapy in Subjects Aged 70 Years or Older With Inoperable Squamous Cell Cancer of the Head and Neck

Conditions
-----------------
Inoperable Squamous Cell Cancer of the Head and Neck

Intervention / Treatment
-----------------
* Other: Geriatric Screening Test G8
* Other: Geriatric fragility test GERICO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject aged 70 or over Carrier of squamous cell carcinoma of the head and neck, locally advanced undergoing treatment by radiotherapy or metastatic / recurrence not accessible to treatment curative locoregional under treatment with chemotherapy. Patient likely to be eligible for ELAN-RT or ELAN-FIT or ELAN-UNFIT trials. Patients affiliated to a social security scheme Exclusion Criteria: Person deprived of liberty or under guardianship, Presence of a neuro-psychological condition, family, social, or geographical, which may hinder the smooth running of the study. Patient expressing opposition to participation in this study

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inoperable squamous cell cancer of the head and neck<br>patients 70 years of age or older with ENT carcinoma | Other: Geriatric Screening Test G8<br>* Geriatric screening test (Oncodage-G8). The oncologist realizes it and proposes the oncological treatment which seems to him then the most adapted (treatment which can be different from that proposed after the oncological evaluation only).<br>Other: Geriatric fragility test GERICO<br>* GERICO geriatric frailty test (if possible the same day as the G8 and in any case in the same week): Realized by the oncologist, it includes: the socio-cultural evaluation scale, the ADL autonomy questionnaire, assessment of locomotor disorders, nutritional assessment, the MMSE Cognitive Function Evaluation Questionnaire, the GDS-4 mood rating scale, the comorbidity assessment test (Charlson Index)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion rate | Rate of completion of each of the geriatric fragility test questionnaires and the G8 questionnaire and duration of the geriatric evaluation performed by the oncologist | Up to 1 year |
Detecting Acetabulum Movement After Total Hip Arthroplasty From Serial Plain Radiographs

Study Overview
=================
Brief Summary
-----------------
This study mainly measures the orientation of acetabulum cup post total hip arthroplasty. Using Liaw's Version, a new and accurate standardization method, investigators are trying to analyze acetabulum cup anterversion change postoperatively.

Detailed Description
-----------------
Patients undergoing total hip arthroplasty have generally good prognosis. However, clinically there was still a minority of patients who suffered from persistent postoperative pain. Dislocations of hip leading to revision surgeries were as well observed in some patients. This study mainly measures the orientation of acetabulum cup post total hip arthroplasty. Using Liaw's Version, a new and accurate standardization method, investigators are trying to analyze acetabulum cup anterversion change postoperatively. As previously known, the anteversion of acetabulum cup determines the range of motion, stability, and the function after total hip arthroplasty. Cup malalignment increase impingement, dislocation, cup migration, and polyethylene wear. Finding a pattern may help the early diagnosis of acetabular loosening.

Official Title
-----------------
Detecting Acetabulum Movement After Total Hip Arthroplasty From Serial Plain Radiographs

Conditions
-----------------
Orthopedics

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergone total hip arthroplasty Patients undergone total hip arthroplasty with more than two postoperative X-ray plain films Exclusion Criteria: Patients with postoperative periprosthetic fracture(s) Patients with postoperative infection Patients undergone revision total hip arthroplasty

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Analyze acetabulum cup anterversion change postoperatively | Using Liaw's Version, a new and accurate standardization method developed, investigators are trying to analyze acetabulum cup anterversion change postoperatively. | 1 week |
Correlation Between Early Induction of Labor and Cesarean Delivery in Low-risk Nulliparous Women

Study Overview
=================
Brief Summary
-----------------
To elucidate whether induction of labor in primiparas with low-risk pregnancies at 38 + 0 to 40 + 6 gestational weeks will increase the cesarean rate, compared with those receiving labor induction at more than 41+0 gestational weeks.

Detailed Description
-----------------
Medical records of all consecutive primiparas with low-risk pregnancy from January 1, 2014 to August 31, 2019 were reviewed to explore the correlation between early induction of labor and caesarean birth after 38 + 0 weeks. The hypothesis of the study is that induction of labor in primiparas with low-risk pregnancies at 38 + 0 to 40 + 6 gestational weeks will increase the cesarean rate, compared with those receiving labor induction at more than 41+0 gestational weeks.

Official Title
-----------------
Correlation Between Early Induction of Labor and Cesarean Delivery in Low-risk Nulliparous Women

Conditions
-----------------
Low Risk Pregnancy

Intervention / Treatment
-----------------
* Other: Labor induction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: After 38 + 0 weeks of gestation low-risk pregnant primiparas singleton nulliparous > 20 years old Exclusion Criteria: Premature rupture of membranes

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Labor induction|Labor induction with oxytocin or prostagladin|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean rate rate |  | 10 years |
The Association Between Psoriasis and Intestinal Bacterial Population

Study Overview
=================
Brief Summary
-----------------
At least 20 psoriasis patients will be compared to at least 20 participants without psoriasis Bacterial genomic DNA will be extracted from stool samples of participants. The intestinal bacterial populations will be compared in order to examine whether there are differences between the groups.

Detailed Description
-----------------
Intestinal bacterial population has a significant influence on health and sickness conditions. It affects the development and the function of the immune system (Th2, Th1 or Th17) by bacterial protein expression and by the composition of the bacterial population. Psoriasis is an immune related dermal disease. The trigger for this disease is currently unknown but, it is possible that intestinal bacteria are a factor in its development. Study design: Participants will be divided into 3 groups: Psoriasis patients treated with topical medications Psoriasis patients treated with IV or sub-cutaneous medications (e.g biological medications) Healthy participants (control group) Bacterial genomic DNA will be extracted from stool samples of participants. The intestinal bacterial populations will be compared in order to examine whether there are differences between the groups.

Official Title
-----------------
The Association Between Psoriasis and Intestinal Bacterial Population

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dermal psoriasis patients diagnosed by a dermatologist. Exclusion Criteria: Treatment with antibiotics or probiotics within the prior 3 months. incapable of signing an inform concent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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<br>group of healthy participants | |
| Topical psoriasis treatment<br>Group of patients who are treated with topical medications for psoriasis | |
| Systemic psoriasis treatment<br>Group of patients who are treated with systematic medications for psoriasis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A significant change (P<0.05) in enteric bacterial composition of psoriasis patients (n=20) vs controls (n=20) as assessed by alpha diversity, beta diversity and taxonomic analysis. | To examine whether fecal bacterial populations of psoriasis patients (not treated by enteral medications) are different compared to healthy participants | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psoriasis, microbiota
Bipolar Cohort Neunkirchen, Final Statement

Study Overview
=================
Brief Summary
-----------------
monitoring system and data base for long term follow up of various treatment strategies in a naturalistic setting of recurrent affective disorders (unipolar, bipolar) open study design, prospective & retrospective

Detailed Description
-----------------
all hospitalized patients of a defined mixed urban and more rural area were consecutively interviewed at admission and entered into the data base. at discharge they gave written informed consent for further tracking and interviews.

Official Title
-----------------
SPICS (Secure Platform for Integrating Clinical Studies) for Recurrent (Bipolar) Affective Disorders for Long Term Follow up Treatment Regiments and Outcome in a Natural Setting

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bipolar Exclusion Criteria: all other diagnoses
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| bipolar patients<br>unselected admissions of bipolar patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapses, hospital admissions, number of participants with adverse events as a measure of safety and tolerability |  | patients from the cohort are contacted once a year (1 to 6 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bipolar disorder, naturalistic cohort study,, defined catchment area,long term treatment
Epigenetics Modifications in Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Changes in epigenetic regulation of genes involved in systemic inflammation and metabolic dysfunction in OSA are linked with accelerated cardiovascular morbidity.

Detailed Description
-----------------
Design. EPIOSA is a 5-yr non-interventional longitudinal prospective study being conducted at the Sleep Clinic of the Hospital Miguel Servet, a large teaching hospital in Zaragoza (Spain). Following a baseline visit, subjects are to be followed-up at 3 months, and then every year. Subject participation. The investigators will enroll a total 300 consecutive OSA male patients aged 20-60 yrs, with baseline apnea-hypopnea index ≥ 5 events per hour of sleep (AHI). In addition, 50 control subjects (AHI < 5) aged 20-60 yrs and matched by body mass index (BMI) are also to be recruited. Exclusion criteria will include any comorbid condition including alcohol and tobacco use. Measurements: Routine clinical assessment, full sleep study, bilateral carotid ultrasonography, biochemistry, circulating inflammatory cytokines, T cell subsets and epigenetics studies at baseline and every year until at least 5 years of follow-up.

Official Title
-----------------
Epigenetics Modifications and Subclinical Atherosclerosis in Obstructive Sleep Apnea: The EPIOSA Study

Conditions
-----------------
Sleep Apnea, Snoring

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 to 60 Exclusion Criteria: Any comorbid condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Obstructive slep apnea patients<br>Patients with OSA | |
| Control group<br>Subjects without OSA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cardiovascular events according with or without the presence of epigenetics changes in pro-inflammatory genes |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biomarkers in blood and urine that correlates with OSA severity which may serve also as markers of disease progression. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T cells, Sleep apnea, Obstructive sleep apnea, Subclinical atherosclerosis, Epigenetics
Glucose in Dialysis Water in Diabetics With Chronic Renal Failure

Study Overview
=================
Brief Summary
-----------------
The purposes are 1. to measure the effect of dialysis with glucose in dialysis water on blood pressure, pulse rate, plasma concentration of glucose, plasma concentrations og insulin, glucagon, growth hormone, renin, angiotensin II, endothelin and body temperature, and 2. to analyse the relationship between the changes in blood pressure and changes in vasoactive hormones

Detailed Description
-----------------
The relationship between blood pressure during dialysis treatment and vasoactive hormones are studied. This includes measurements of plasma concentration of glucose, plasma concentrations og insulin, glucagon, growth hormone, renin, angiotensin II, endothelin

Official Title
-----------------
Effect of Glucose in Dialysis Water in Diabetics With Chronic Renal Failure on Blood Pressure, Pulse Rate, Plasma Glucose, Plasma Concentrations of Insulin, Growth Hormone, Renin, Angiotensin II, Endothelin and Body Temperature

Conditions
-----------------
Renal Failure, Chronic, Diabetic Nephropathies

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years, Both men and women, Dialysis treatment for at least three month due to diabetic nephropathy Exclusion Criteria: Heart failure, Lung insufficiency, Chronic liver disease, Malignant disease, Nephrotic syndrome, Lack of compliance, Unwillingness to participate

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Procedure|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect og glucose in dialysis water on blood pressure, plasma glucose and hormones in plasma |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between changes in blood pressure and and changes in hormones |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, diabetes mellitus,, Chronic renal failure, dialysis ,
Breath Analysis in Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to answer the question whether a disease-specific profile of breath in patients with asthma can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.

Official Title
-----------------
Exhaled Breath Analysis by Secondary Electrospray Ionization (SESI-MS) in Patients With Asthma

Conditions
-----------------
Asthma, Exhaled Breath, Mass Spectrometry

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed asthma. Diagnosis of asthma is made with episodic chest symptoms and a documented reversibility of at least 12% and/or 200 ml in FEV1 after 200 ug of inhaled salbutamol or airway hyperresponsiveness in the case of normal lung function testing (PC20 methacholine < 4mg/ml) at the time of diagnosis. Age between 18 and 80 years at study entry. Healthy controls: never-smokers, normal spirometry (baseline FEV1 > 85% predicted and FEV1/FVC greater than 0.7). Exclusion Criteria: Asthma exacerbation within the last 6 weeks, defined as worsening of asthma symptoms requiring a change in therapy by a physician or a change in regular asthma therapy (including short course of oral corticosteroids) Any lung disease other than asthma. Acute inflammatory disease (e.g. common cold) within the last 4 weeks. Regular intake of oral steroids. Active smoking habits / positive history of smoking. Acute or chronic hepatic disease. Renal failure or renal replacement therapy. Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Asthma<br>20 patients with asthma | Other: no intervention<br> <br> |
| Controls<br>20 control subjects with no apparent lung disease and normal lung function testing. Matched for gender, age and smoking history. | Other: no intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be the asthma specific mass spectrometric profile of VOCs of exhaled breath analysis (markers of asthma in exhaled breath) |  | 1 day, single measurement, no follow up |