linjc16/ctgov huggingface dataset:
Ancillary Microbiome Collection From Mother/Infant Pairs During First Year of Life

Study Overview
=================
Brief Summary
-----------------
The investigators will be studying the development of the microbiome over the first year after birth in light of various environmental influences - e.g. mode of delivery, diet (and diet changes), antibiotic exposure, GERD medication exposure.

Detailed Description
-----------------
Microbiome samples will be collected from mother/infant pairs during post-natal hospital stay through the first year of life. Investigators will perform statistical analyses to test the hypotheses (1) that there is an association between the developing oral and gut microbiomes, and (2) that they interact in affecting childhood obesity. This study relates to the INSIGHT study (NCT01167270) and its last outcome measure; exploring oral and gut microbiome collected from that study's second born participants.

Official Title
-----------------
Ancillary Microbiome Collection From Mother/Infant Pairs During First Year of Life

Conditions
-----------------
Infant Development

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: full-term infant (> 36 0/7 weeks gestational age) without significant morbidity nursery/NICU/maternity stay of 7 days or less participant children can be (but do not have to be) twins English speaking mother care provided at an HMC affiliated clinic a working telephone number Exclusion Criteria: prenatal ultrasound presence of intrauterine growth retardation (IUGR) infant birth weight <2250 grams presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease) any major maternal morbidities and/or pre-existing condition that would affect postpartum care or her ability to care for her newborn such as cancer, multiple sclerosis, lupus, etc. plan for newborn to be adopted plan to move from Central Pennsylvania within 1 year have 2 older siblings in INSIGHT/SIBSIGHT (NIH funded study related to this ancillary study)
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 |
| --- | --- | --- |
| Microbiome outcome | Microbiome diversity within individuals (how gut and oral microbiomes are similar or different) and between individuals | birth to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic variation | Associations between genetic variation and microbiome diversity | birth to 1 year | 
| Genetic variation | Genetic variation as it relates to growth outcomes | birth to 1 year |
Automatic vs. Manual Optic Disc Planimetry

Study Overview
=================
Brief Summary
-----------------
Manually and automatically by mashing learning algorithm optic disc will be evaluated (planimetry).

Detailed Description
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Cross-Over non-randomized Case-Series. Arm 1 (Manual segmentation): Manually marking of the boundaries of the optic disc and it's excavation on color photographs of the optic disc. Arm 2 (Automated segmentation): Automatic detection of the boundaries of the optic disc and it's excavation. Calculation of cup size, size of excavation, cup-to-disc ratio, and rim area. Comparison of all parameters of both arms and computing of agreement.

Official Title
-----------------
Automatic vs. Manual Optic Cup and Optic Disc Segmentation in Glaucoma

Conditions
-----------------
Open Angle Glaucoma

Intervention / Treatment
-----------------
* Other: manual planimetry
* Other: automated planimetry


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: open-angle glaucoma Exclusion Criteria: no fundus photography of the optic disc performed

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 |
| --- | --- |
| patients with open angle glaucoma<br>patients with open angle glaucoma who had their optic discs routinely documented by fundus photography. Optic disc photographs will be analyzied by manual planimetry or automated planimetry. | Other: manual planimetry<br>* Manually marking of the boundaries of the optic disc and it's excavation on color photographs of the optic disc.<br>Other: automated planimetry<br>* Automatic detection of the boundaries of the optic disc and it's excavation on color photographs of the optic disc.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| agreement measured by kappa statistics | agreement measured by kappa statistics | Baseline visit in the outpatient department | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cup size | Cup size | Baseline visit in the outpatient department | 
| size of excavation | size of excavation | Baseline visit in the outpatient department | 
| vertical cup to disc ratio | vertical cup to disc ratio | Baseline visit in the outpatient department | 
| rim area | rim area | Baseline visit in the outpatient department |
Early Obesity Intervention Program Within GECKO Drenthe; a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether stimulating physical activity during the first year of life influences growth and body composition, and stimulates motor activity and motor development

Official Title
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Early Obesity Intervention Program Within GECKO Drenthe; a Randomized Controlled Trial

Conditions
-----------------
Overweight, Physical Activity

Intervention / Treatment
-----------------
* Behavioral: Physical activity stimulating program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: date of birth (December 2006-February 2008) area of living (around Meppel and Hoogeveen in the province of Drenthe, one of the Northern provinces of the Netherlands) Exclusion Criteria: Children under care of child physiotherapists will be excluded from the program

Ages Eligible for Study
-----------------
Maximum Age: 2 Weeks

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 |
| --- | --- |
| Active Comparator: Physical activity stimulating program<br>Advices to stimulate motor activity and motor development at the age of two weeks, two months, four months, eight months and eleven months | Behavioral: Physical activity stimulating program<br> <br> |
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | Weight, length | Regularly during the first year of life, at 2.5 years of age | 
| Body composition | Waist circumference, Hip circumference, Skin fold thickness, Bioelectrical impedance analyses (BIA) | Regularly during the first year of life, at 2.5 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor activity | Accelerometer | At the age of 5 months, 8 months and 2.5 years of age | 
| Motor development | Albertha Infant Motor Scale, Bayley Scales of Infant and Toddler Development | At the age of 5 months, 8 months and 2.5 years of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overweight, physical activity, infancy, body composition, motor development, motor activity
Biomarkers in Young Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia.

Detailed Description
-----------------
OBJECTIVES: Determine the frequency of ligand-independent phosphorylation of Stat3 in a small cohort of samples from pediatric patients with acute myeloid leukemia including, but not limited to, samples known to express mutated c-kit. Measure the level of Stat3 phosphorylation in these samples after stimulation of three key cytokine receptors expressed on hematopoietic cells IL-6R, G-CSFR, and c-kit. OUTLINE: Cryopreserved samples are analyzed for levels of various components of the Stat3 pathway via western blotting.

Official Title
-----------------
Stat3 Signaling Pathway Aberrancies in Pediatric AML

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Genetic: western blotting
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia One of the following karyotypes: t(8;21) and WT c-kit t(8;21) and mutant c-kit Normal karyotype PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: western blotting|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlations between levels of pY-Stat3 and levels of upstream cytokine receptors |  |  | 
| Association of constitutive and/or increased pY-Stat3 and c-kit genotype |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
childhood acute myeloid leukemia/other myeloid malignancies
Study of Etoposide in Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study will examine how the body handles etoposide, a drug used to treat breast cancer. The knowledge gained may lead to more effective use of the drug with fewer side effects in the future. Breast cancer patients who are receiving etoposide as part of their treatment may participate in this study. Patients will have 18 blood samples (about a teaspoon or less each) drawn over a 72-hour period during and after their infusion of etoposide. The initial blood samples cannot be taken from the same intravenous line (small tube placed in a vein) used to deliver the etoposide, so a second line may have to be placed temporarily to obtain these samples.

Detailed Description
-----------------
Etoposide is a topoisomerase II inhibitor that has a broad range of anticancer activity at conventional doses (100 mg/m(2) daily x 5 days) and is administered in high doses (greater than 1200 mg/m(2)) as a component of pre-transplant myeloablative chemotherapy regimens. Etoposide pharmacokinetics are linear over a 30-fold dose range, but disposition is highly variable. Etoposide is highly protein bound (95%) to albumin, but protein binding (and therefore free drug concentrations) vary widely in cancer patients. Etoposide is eliminated by metabolism and renal excretion, which may also contribute to the variability. The pharmacokinetics of etoposide will be studied in patients receiving high-dose etoposide as part of their pre-transplant preparative regimen, and pharmacokinetic parameters generated from pharmacokinetic modeling will be correlated with clinical and laboratory characteristics and toxicity in order to develop more rational dosing methods.

Official Title
-----------------
Pharmacokinetics of Etoposide in Patients With Breast Cancer Receiving High-Dose Etoposide

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA Age greater than or equal to 18 years. Patients with breast cancer who are entered on existing Medicine Branch protocols that include high-dose etoposide. Must be able to provide informed consent.
Sexes Eligible for Study
-----------------
Female

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
-----------------
Etoposide, Breast Cancer, Pharmacokinetics
Physical Activity and Its Impact on Colon Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
This is a prospective clinical study that studies how the physical activity level before operation of colon cancer affects the outcome of complication and histology. The hypothesis is that patients who are more physical active have less postoperative complications and different histological immunological response around the tumor. The investigators are testing the patients before the surgery with physical tests for fitness, strength and physical activity level. Questionnaires are also filled by the patients for pain, anxiety, depression and motivation for life style changes. Their body mass is analyzed with a DEXA (Dual-energy X-ray absorptiometry scan). For one years the investigators are monitoring their activity and follow up for physical tests, DEXA and questionnaires is at 6 and 12 months. The histology is analyzed after surgery to se if there is a different immunological response around the tumor.

Official Title
-----------------
Physical Activity and Its Impact on Colon Cancer Surgery: Clinical and Histological Effects

Conditions
-----------------
Colon Cancer, Physical Activity

Intervention / Treatment
-----------------
* Behavioral: Physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years. Colon cancer which is going to surgery Exclusion Criteria: Not able to do physical tests Severe disease that makes a risk to do tests. Not able to make informed consent due to psychic disease or dementia

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

| Intervention/Treatment |
| --- |
|Behavioral: Physical activity|Se their physical activity level|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of postoperative complications | To study if there are differences in postoperative complications in different active patients. | 1 year | 
| Rate of immunological response | To study if there is a difference in immunological reaction among physical active patients. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recovery in physical activity | To study if physical active patients have a faster postoperative recovery | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colon cancer, Physical activity
Registry of Celution Device for Processing ADRCs and Healing in Muscle and Ligament Sports Injuries

Study Overview
=================
Brief Summary
-----------------
This registry study will compile information about patients who are scheduled to receive or have received Adipose Derived Regenerative cells (ADRCs) prepared by Celution device to treat muscle and ligament sports injuries.

Official Title
-----------------
Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) and Healing in Muscle and Ligament Sports Injuries (ACHILLES)

Conditions
-----------------
Muscle Tear

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females > 18 of age Patients with sports related muscle tear (≥5%) with or without ligament injury as confirmed by ultrasound or MRI with onset of injury in preceding year Pain in the affected area at rest and/or movement Weakness or inability to use affected muscle Exclusion Criteria: Muscle tear <5% or unrepaired complete tears or ruptures on ultrasound or MRI Known spine or disc disease or symptomatic impingement of nerve root Known neuromuscular disease (e.g., amyotrophic lateral sclerosis, muscular dystrophy) History of documented nerve damage in the affected limb Tears involving open wounds Tears requiring surgical repair Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at screening or baseline

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Change in magnitude of muscle tear as assessed by ultrasound or MRI |  | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in magnitude of muscle tear as assessed by ultrasound or MRI |  | 21 days | 
| % of patients with complete healing as measured by ultrasound or MRI |  | Days 7, 14, 21, 42 and 90 | 
| Change in pain | Change in pain assessed via patient questionnaires | Days 7, 14, 21, 42 and 90 | 
| Change in function | Change in function assessed via patient questionnaires | Days 7, 14, 21, 42 and 90 |
Energy Expenditure of People Living With HIV/AIDS

Study Overview
=================
Brief Summary
-----------------
Background: Several studies have reported increased resting energy expenditure (REE) in people living with HIV/AIDS possibly due to changes in body composition that occurs in HIV lipodystrophy syndrome. The aim of this study was to evaluate the influence of the use of lipid-lowering drugs in resting energy expenditure (REE) and total energy expenditure (TEE) in patients seropositive for HIV in treatment of lipodystrophy.

Detailed Description
-----------------
REE was measured by indirect calorimetry. TEE was measured by doubly labeled water (DLW) technique and an activity monitor based on accelerometry (AM).

Official Title
-----------------
Influence of Lipid-lowering Drugs in Patients Seropositive for HIV With Lipodystrophy in Resting Energy Expenditure and Total Energy Expenditure

Conditions
-----------------
HIV/AIDS, HIV Lipodystrophy Syndrome

Intervention / Treatment
-----------------
* Drug: use of lipid-lowering drugs.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Use of antiretroviral therapy for at least 4 months A cluster of differentiation 4 (CD4) T-cell count of >200 cells/mm3 Use of lipid-lowering drugs for at least 1 month (group HIV-seropositive with lipodystrophy and use of lipid-lowering) Exclusion Criteria: Signs or symptoms of opportunistic infections Thyroid disease

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

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LIPO-HIPO-<br>HIV-seropositive without lipodystrophy and no use of lipid-lowering drugs. | |
| LIPO+HIPO-<br>HIV-seropositive with lipodystrophy and no use of lipid-lowering drugs. | |
| LIPO+HIPO+<br>HIV-seropositive with lipodystrophy and use of lipid-lowering drugs. | Drug: use of lipid-lowering drugs.<br>* The patients shoud be in use of a lipid-lowering drugs previouly, at least one month before of the begining of the study.<br>* Other names: statins and fibrates;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Energy Expenditure (kcal/d) |  | 14 day | 
| Resting Energy Expenditure (kcal/d) |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between doubly labeled water and accelerometer to measure total energy expenditure (ICC, 95% CI) |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, energy expenditure, doubly labeled water, accelerometer, lipodystrophy syndrome.