linjc16/ctgov huggingface dataset:
Risk of Celiac Disease and Age at Gluten Introduction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether age at introduction of gluten-containing cereals (e.g. wheat) plays a role in influencing the risk of celiac disease (CD) development in infants with a first-degree relative affected by CD.

Detailed Description
-----------------
We undertook a prospective study to establish the incidence of CD autoimmunity related to the timing of gluten exposure in at-risk infants. Infants at family risk for CD (at least one first-degree relative affected) are enrolled in this prospective, multicentre, intervention study conducted in Italy. Infants are randomly assigned to introduce gluten at either 4-6 or 12 months (groups A and B, respectively) and then enter a follow-up period of 5 years. Duration of breastfeeding and types of formulas, adherence to the dietary plan, amount of gluten administered, and clinical data are collected by phone or direct interview at 4, 7, 9, and 12 months of age. HLA (Human Leucocyte Antigene) status and CD serology (anti-transglutaminase and other autoantibodies) are tested at 15, 24, 36 and 60 months of age.

Official Title
-----------------
Infant Nutrition and Development of Celiac Disease in Genetically At-risk Babies: a Dietary Intervention Study at Weaning

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Dietary Supplement: gluten-free, normocaloric diet from 6 to 12 months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborn in a family where a first-degree relative is already affected with biopsy-proven CD

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 6 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gluten free diet<br>the intervention in this group is keeping a gluten-free diet from 0 to 12 months | Dietary Supplement: gluten-free, normocaloric diet from 6 to 12 months<br>* Gluten-containing cereals (wheat, rye and barley) will be replaced by gluten-free starchy food (rice, corn, tapioca-based, etc) in a normocaloric diet<br>* Other names: gluten-free products;|
| No Intervention: Gluten containing diet<br>infants in this group are started on gluten-containing cereals at 6 months (control group) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of active CD |  | 5 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of CD-related autoantibodies (IgA anti-transglutaminase) |  | age 2, 3 and 5 years |
Study of the Loss of AV Synchrony at Maximum Exercise

Study Overview
=================
Brief Summary
-----------------
Investigators will identify a group of patients with complete heart block and a dual chamber pacemaker who will be expected to be able to exercise on a treadmill. Investigators will utilize symptom logs, cuff and continuous blood pressure monitoring. It is planned to study the symptomatic impact of loss of AV synchrony at significant levels of exercise.

Official Title
-----------------
SLAVSME - Study of the Loss of AV Synchrony at Maximum Exercise

Conditions
-----------------
Exercise, Pacemaker, Blood Pressure

Intervention / Treatment
-----------------
* Other: Stress Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complete AV Block Age less than 60 Easily programmable dual chamber pacemaker Exclusion Criteria: Age > 60 Significant Heart Failure Significant angina History of claudication Significant orthopedic issues Evidence of sinus node dysfunction Taking beta blockers or non-dihydropyridine calcium channel blockers

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with AV block with pacemaker<br>Participants will have a stress test, and results will be collected and recorded. | Other: Stress Test<br>* Participants will reach maximum exercise on a treadmill and results will be collected and recorded.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with Loss of AV synchrony at maximum exercise |  | Baseline to end of stress test approximately 60 minutes. |
A Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma (P08650)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic solution.

Official Title
-----------------
A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Ascending Dose Study of INS117548 Ophthalmic Solution in Subjects With Bilateral Ocular Hypertension or Early Primary Open Angle Glaucoma

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: INS117548
* Drug: INS117548
* Drug: INS117548


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a diagnosis of bilateral ocular hypertension or early primary open angle glaucoma Have best corrected visual acuity in both eyes of at least +0.5 or better Exclusion Criteria: Are diagnosed with closed angle glaucoma, exfoliation syndrome or exfoliation glaucoma, and pigment dispersion or secondary glaucoma Have a history of any type of intraocular surgery, except for cataract surgery Have had cataract surgery within three months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Placebo Comparator: Arm 1<br>One drop in each eye every 12 hours for seven days | Drug: Placebo<br>* One drop in each eye every 12 hours for seven days<br>|
| Experimental: Arm 2<br>One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days | Drug: INS117548<br>* One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days<br>|
| Experimental: Arm 3<br>One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days | Drug: INS117548<br>* One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days<br>|
| Experimental: Arm 4<br>One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days | Drug: INS117548<br>* One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | 15 | 
| Rate of discontinuation |  | 15 | 
| Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters |  | 15 | 
| Compliance |  | 15 |
Nonmyeloablative Stem Cell Transplant in Elderly

Study Overview
=================
Brief Summary
-----------------
The study aimed to evaluate the efficacy of a nonmyeloablative conditioning consisting of fludarabine and total body irradiation in patients older than 60 years of age

Detailed Description
-----------------
A total of 35 patients with hematological malignancies were treated with fludarabine (30 mg/m2 x 3-5 days) and 200 cCy TBI followed by allogeneic hematopoietic stem cell transplantation (HSCT) from a matched-sibling donor. Neutrophil recovery occurred in 89% of the patients at a median time of 15 days. On day +30, 10 patients had > 95% donor chimerism, and 21 patients had mixed chimerism. The cumulative probabilities of grade II-IV acute GVHD and chronic GVHD were 51% and 84% respectively. Transplant-related mortality at 100 days and 1 year was 5% and 9% respectively. The probabilities of 1-year overall (OS) and progression-free survival (PFS) were 55% and 47% respectively. The estimated 1-year probability of OS and PFS for patients in early disease stages were 87% and 74% respectively , which were significantly higher than the survival and PFS estimates of 12% obtained in patients with advanced disease stages at the time of transplant

Official Title
-----------------
Nonmyeloablative Allogeneic Stem Cell Transplantation in Elderly Patients With Hematological Malignancies:Results From the GITMO (Gruppo Italiano Trapianto Midollo Osseo)Multicenter Prospective Clinical Trial

Conditions
-----------------
Hematological Malignancies

Intervention / Treatment
-----------------
* Procedure: stem cell transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with myeloid or lymphoid malignancy who were > 60 years old potentially treatable with stem cell transplant Exclusion Criteria: lack of an HLA-identical sibling donor

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- |
|Procedure: stem cell transplant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  |  | 
| progression-free survival |  |  | 
| transplant-related mortality |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute GVHD |  |  | 
| chronic GVHD |  |  |
Prevalence ， Associated Factors and Influences of Prenatal Mental Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find the incidence of mental disorders during different periods of pregnancy and its associated factors and consequences.

Conditions
-----------------
Mental Disorder During Pregnancy - Baby Not Yet Delivered

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged at least 18 years of age 8 to 12 weeks of pregnancy There is no history of mental illness Had perinatal health care in a Women's & Children's Health Hospital Exclusion Criteria: The obvious body disease Having anxiety, phobia, hypochondriasis, obsessive-compulsive disorder or depression before pregnancy Having severe complications during pregnancy Fetal malformation or abortion Can't understand the questionnaire Without informed consent More than 13 weeks of pregnancy Less than 18 years of age

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prenatal mental disorders<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of mental disorders during different periods of pregnancy | We would like to find the incidence of mental disorders in early (8-12 weeks),middle (18-22 weeks) and later(32 weeks to delivery) period of pregnancy | from 8 weeks of pregnancy to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy outcomes | We would like to explore which period of mental disorders had the most significant infuences on pregnancy outcomes including obstetrical complications(e.g.gestational diabetes mellitus(GDM),hypertensive disorder complicating pregnancy(HDCP)),outcome of fetus(e.g.preterm,low birth weight and fetal anomaly) and health of infant and puerpera. | from 8 weeks of pregnancy to 6 months after delivery |
Cognitive Training to Improve Cognitive Function Following Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to improve cognitive dysfunction following chemotherapy, the investigators investigated to see whether a cognitive training for memory and concentration skills can improve cognitive performance in patients following cancer treatment.

Detailed Description
-----------------
Patients following chemotherapy invited for a cognitive training. Before and after cognitive function will evaluate.

Official Title
-----------------
Training of Cognitive Function of Patients After Chemotherapy

Conditions
-----------------
Cognitive Dysfunction

Intervention / Treatment
-----------------
* Behavioral: cognitive training
* Other: control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with cancer 6 weeks after chemotherapy Exclusion Criteria: patients with neurological or psychiatric disorders patients without compliance

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: training<br>Patients in this group start the cognitive training over 6 weeks directly after randomization. | Behavioral: cognitive training<br>* cognitive training over 6 weeks, consist of 6 meetings (a 45minutes), three sessions focus on concentration tasks and three sessions on memory problems.<br>* Other names: training group;|
| Placebo Comparator: control<br>In this control group begin the training in a cross-over design 7 weeks after randomization. | Other: control group<br>* no intervention<br>* Other names: controll group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| several cognitive tests (TAP, VLMT, TMT, Stroop, RWT, D2, LGT-3) |  | one weeks following the end of the cognitive training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life and subjective perception of cognitive problems |  | 7 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive dysfunction chemotherapy
Iris Colors in Neonates: Do They Really Change? Prevalence, Predicting Factors and Associated Characteristics

Study Overview
=================
Brief Summary
-----------------
The goal of our study is to examine eye color at birth and the longitudinal change in eye color of preterm and full-term newborns.

Official Title
-----------------
Iris Colors in Neonates: Do They Really Change? Prevalence, Predicting Factors and Associated Characteristics

Conditions
-----------------
Eye Color

Intervention / Treatment
-----------------
* Other: Photograph


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any baby born between the 24-42 week of gestation admitted to the well-baby nursery or the NICU whose parents have signed an informed consent. Exclusion Criteria: Neonatal conjunctivitis Neonatal sepsis Inborn error of metabolism or genetic syndrome Eye abnormalities Parental refusal

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 2 Months

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blue eyes<br>50 babies born with blue eyes will be photographed and followed-up at baseline; 3 months and 12 months of age | Other: Photograph<br>* Babies will be photographed and eye color will be observed and documented at birth, 3 months and one year of age<br>|
| Active Comparator: Brown eyes<br>50 babies born with brown eyes will be photographed and followed-up at baseline; 3 months and 12 months of age | Other: Photograph<br>* Babies will be photographed and eye color will be observed and documented at birth, 3 months and one year of age<br>|
| Active Comparator: Green eyes<br>50 babies born with green eyes will be photographed and followed-up at baseline; 3 months and 12 months of age | Other: Photograph<br>* Babies will be photographed and eye color will be observed and documented at birth, 3 months and one year of age<br>|
| Active Comparator: Hazel eyes<br>50 babies born with hazel eyes will be photographed and followed-up at baseline; 3 months and 12 months of age | Other: Photograph<br>* Babies will be photographed and eye color will be observed and documented at birth, 3 months and one year of age<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in eye color | Change will be measured according to a validated classification of blue/hazel/green or brown | One year |
Impact of Pulsatile Cardio-Pulmonary Bypass (CPB) on Vital Organ Recovery

Study Overview
=================
Brief Summary
-----------------
This research study is about the effect heart-lung bypass procedures have on the vital organs (brain, heart, lungs, and kidneys) during open-heart surgery in pediatric patients. There are two types of heart pumps used in surgery requiring heart-lung bypass; one pumps the blood continuously through the body and the other pumps the blood with repeated pulses. Both pumps are approved for clinical use by the FDA. Although 90% of institutions still use non-pulsatile flow, some studies show there may be benefits to using pulsatile flow during surgery. The investigators want to learn whether the vital organs (brain, heart, lungs, and kidneys) respond differently to one method than they do to the other. Approximately 300 children will take part in this research at the Hershey Medical Center.

Official Title
-----------------
Impact of Pulsatile CPB on Vital Organ Recovery

Conditions
-----------------
Cardio-Pulmonary Bypass

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients recruited from Penn State Children's Hospital undergoing cardiac surgery with cardiopulmonary bypass. Exclusion Criteria: Patients older than 17 years will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 17 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 |
| --- | --- |
| 1<br>Non-pulsatile Group (conventional) | |
| 2<br>Pulsatile group (Alternate) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plasma proteins |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiopulmonary bypass, Non-pulsatile perfusion, Pulsatile perfusion, plasma proteins
High Flow Nasal Oxygenation and Gastric Insufflation in Anesthetized Patients

Study Overview
=================
Brief Summary
-----------------
Transnasal humidified rapid-insufflation ventilatory exchange(THRIVE), or also termed high flow nasal oxygenation (HFNO) is a method of supplying heated, humidified high concentrations of oxygen via nasal cavity. The purpose of this study is to investigate the effect of HFNO on gastric insufflation in paralyzed anesthetized patients undergoing laryngologic surgery.

Detailed Description
-----------------
HFNO can be used during intraoperative period. HFNO reduces the risk of desaturation and prolongs the safe apnea time, compared with conventional oxygenation. In laryngeal microsurgery, HFNO therapy make possible to perform tubeless anesthesia, providing perfect exposure of structure of the vocal cords. HFNO have a risk for low level of positive pressure can make gastric distension, but gastric reflux or aspiration were not occurred during rapid sequence induction for emergency operation. The purpose of this study is to investigate the effect of HFNO on gastric insufflation in paralyzed anesthetized patients undergoing laryngologic surgery.

Official Title
-----------------
The Effect of High Flow Nasal Oxygenation on Gastric Insufflation in Paralyzed Anesthetized Patients Undergoing Laryngologic Surgery

Conditions
-----------------
Gastric Distention

Intervention / Treatment
-----------------
* Device: THRIVE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiology physical status classification I and II Patients scheduled for laryngeal microsurgery under general anesthesia Exclusion Criteria: gastroesophageal reflux gastric pathology pregnancy major cardiovascular, pulmonary, or cerebrovascular disease severe obesity (body mass index>35 kg/m2)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFNO arm<br>Patients will receive HFNO therapy during laryngomicrosurgery. | Device: THRIVE<br>* Patients will receive HFNO therapy during laryngomicrosurgery. Patients will undergo a gastric ultrasound examination after HFNO therapy.<br>* Other names: Optiflow;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of gastric volume | Ultrasound exam will measure the antral cross-sectional area of gastric antrum | before HFNO application (baseline), immediately after HFNO application |