linjc16/ctgov huggingface dataset:
Phthalate Esters and Childhood Obesity

Study Overview
=================
Brief Summary
-----------------
Phthalate esters have been considered closely related with childhood obesity, but the existing studies revealed inconsistent results. This study was desigened to investigate the association between phthalate esters and childhood obesity in China.

Detailed Description
-----------------
The physical activity, dietary intake and the levels of urine phthalate metabolites of children were detected, and the associations between these 3 factors and childhood obesity were analyzed.

Official Title
-----------------
the Association Between Phthalate Esters and Childhood Obesity

Conditions
-----------------
Childhood Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who were classified as normal, overweight and obesity based on age, gender and BMI. Exclusion Criteria: The participants who were with endocrine disorders.

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 |
| --- | --- |
| cases<br>obesity / overweight children | |
| controls<br>normal weight children | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the levels of urine phthalate metabolites | 9 phthalate metabolites (MMP, MEP, MnBP, MiBP, MEHP, MEOHP, MEHHP, MCEPP, MCMHP) in first morning urine sample of the participants were detected | 3 months |
Home Based Exercise Program for Brain Injury Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether simple home-base aerobic exercise program have beneficial effect on walking abilities and balance performance in children with brain damage

Conditions
-----------------
Brain Injury, Cerebral Palsy

Intervention / Treatment
-----------------
* Procedure: home exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of CP or ABI Must be able to stand with or without aid. Exclusion Criteria: Can not follow simple commands

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study<br>home exercise | Procedure: home exercise<br> <br> |
| No Intervention: control<br>regular therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy

Study Overview
=================
Brief Summary
-----------------
This is a single institution, observational research study in which patients are observed using DWI/DCE MRI imaging before and after receiving neoadjuvant anti-HER2 therapy.

Detailed Description
-----------------
This is not a treatment trial. Patients will be treated according to the plan developed by their medical oncologists. Only patients planning to receive anti-HER2 therapy as part of planned systemic therapy will be eligible for this imaging study. Patients and their referring oncologist will be asked to start the anti-HER2 therapy 2-3 weeks prior to surgery and after the pre-therapy MRI.

Official Title
-----------------
Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy

Conditions
-----------------
HER2-positive Breast Cancer

Intervention / Treatment
-----------------
* Device: MRI
* Drug: Trastuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects at least 18 years of age. Have a new diagnosis of invasive breast cancer, clinical stage I - III, HER2 positive. Planning to undergo surgical resection plus adjuvant therapy to include an anti-HER2 agent. Have tissue block available for review of experimental markers. Be a candidate for MRI imaging. Be willing to comply with scheduled visits required for the trial. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Recent therapy for breast cancer prior to baseline MRI. Subjects may not receive other investigational agents during the study window for imaging. Contraindications for MRI or MRI contrast including severe claustrophobia, history of previous reaction to MRI contrast, renal disease, congestive heart failure, other significant systemic diseases or any metal in their body, including but not limited to: a brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or defibrillator, cochlear implant, ocular foreign body (e.g. metal shavings), other implanted medical devices: (e.g. Swan Ganz catheter), insulin pump, metal shrapnel or bullet. Pregnant or nursing.

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 |
| --- |
|Device: MRI|Diffusion Weighted Imaging and Dynamic Contrast enhanced MRI|
|Drug: Trastuzumab|Single dose of Trastuzumab prior to surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor infiltrating lymphocytes (TILs) | Determine whether early changes on MRI reflect the level of immune response (based on TILs) in the tumor as measured by histologic assessment after 1 cycle of anti-HER2 treatment | 10 years |
Cerebral Oxygenation in Cardiac Arrest and Hypothermia

Study Overview
=================
Brief Summary
-----------------
Data indicate that neurological prognostication is difficult after cardiac arrest if mild therapeutic hypothermia is part of the post resuscitation care. Cerebral oxygenation detected by near-infrared spectroscopy, could be a new, non-invasive index marker for outcome assessment after cardiac arrest. The investigators hypothesize that cardiac arrest survivors with a continuously low cerebral oxygenation index have a poor prognosis.

Detailed Description
-----------------
The measurement of cerebral oxygen saturation by a non-invasive near-infrared monitor, INVOS® (In-Vivo Optical Spectroscopy; Covidien) can detect changes in oxygen levels reflecting regional blood oxygen saturation of the brain tissue beneath the sensor. If this monitoring can add further information towards reliable prognostication after cardiac arrest is unknown so far.

Official Title
-----------------
Cerebral Oxygen Saturation as Outcome Predictor in Cardiac Arrest Patients Undergoing Mild Therapeutic Hypothermia

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Device: near infrared spectroscopy (INVOS®, Covidien)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years Exclusion Criteria: under 18 years

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 |
| --- | --- |
| NIRS continuous monitoring<br> | Device: near infrared spectroscopy (INVOS®, Covidien)<br>* Measurement of regional cerebral oxygen saturation with non-invasive near-infrared INVOS® (In-Vivo Optical Spectroscopy) monitor by Covidien.<br>* Other names: Covidien;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurological outcome (death; CPC: 5) | Cerebral Performance Category 5: death | participants will be followed for the duration of hospital stay, an expected average of 3-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurological outcome CPC 1-5 | CPC 1: Conscious and alert with normal function or only slight disability CPC 2: Conscious and alert with moderate disability CPC 3: Conscious with severe disability CPC 4: Comatose or persistent vegetative state CPC 5: death | participants will be followed for the duration of hospital stay, an expected average of 3-6 weeks and a 12 month follow up will be performed | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
resuscitation, hypothermia, outcome
Bile and Bile Duct/Pancreatic Duct Brushings Database for Patients With Pancreato-biliary Stricture

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a long-term storage of bile and brushings of pancreato-biliary duct in patients diagnosed with pancreato-biliary stricture for future research. Recently, a lot of research has been done to test for certain markers in the bile and brushings to detect cancer in a stricture. The samples will be used to measure biomarkers (proteins) in biliary diseases.

Detailed Description
-----------------
Recently, a lot of research has been done to test for certain markers like fluorescence in situ hybridization (FISH), digital image analysis (DIA), and quantifiable morphometric results in biliary stricture brushings. Recently, polysomy FISH has been studied as a promising marker in predicting cancer in a pancreato-biliary stricture. Many genetic, epigenetic, and protein alterations arise during pancreaticobiliary tumor process. The types of markers that have been commonly evaluated as diagnostic assays are mutations, chromosomal gains and losses, and DNA methylation alterations. However there are only a few studies in this area. Testing for these markers can help determine whether the narrowing or stricture in your bile duct is cancer or not.

Official Title
-----------------
Bile and Bile Duct/Pancreatic Duct Brushings Database for Patients With Pancreato-biliary Stricture

Conditions
-----------------
Pancreatic Duct Strictures, Biliary Duct Strictures

Intervention / Treatment
-----------------
* Other: Sample Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient diagnosed with pancreato-biliary stricture. Age >18 years Ability to provide an informed consent Exclusion Criteria: Patients with altered mental status, who will not be able to provide an informed consent Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| pancreatic/biliary strictures<br>Sample Collection: Patients with pancreatic/biliary stricture undergoing intervention will have samples of brushings and bile taken during the procedure. | Other: Sample Collection<br>* Sample Collection: bile and pancreatic duct brushings and fluid samples will be obtained from the pancreatic stricture during endoscopic retrograde cholangiopancreatic procedure.<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
-----------------
pancreas, biliary, stricture
Circulating SIRT6 Expression, Effect on Aging Quality

Study Overview
=================
Brief Summary
-----------------
This study follows the results of the COMPALICLAMP study (NCT00951392) where the investigators showed a differential expression of sirtuins protein isoforms, Sirt6, in muscle depending on the quality of aging. The investigators seek to confirm this difference in expression level of circulating leukocytes on a larger sample.

Official Title
-----------------
Circulating Expression Measurement of a Sirtuin Protein Isoform, Sirt6, as an Early Marker of Aging Quality

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Biological: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteers from the SUVIMAX 2 aging cohort Men and women Older than 60 Subject with a global aging quality score of 1 or 3 in the SU.VI.MAX. 2 study Covered by Health Insurance System Exclusion Criteria: Subject not in compliance with the recommendation of French National Law

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br> | Biological: Blood sample<br>* It is a single cross sectional study. All outcome measures will be taken during the investigation with physical examination, questionnaire and a blood sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sirt6 expression in circulating leukocytes based on the aging quality | analysis by quantitative RT-PCR method | participants will be followed for the duration of the visit, an expected average of 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hand and forearm muscular strength measurement | Hand Grip strength test | participants will be followed for the duration of the visit, an expected average of 1 day | 
| Physical examination and anthropometric measurement | Measurement of the weight, height, waist, hips, blood pressure, pulse. | participants will be followed for the duration of the visit, an expected average of 1 day | 
| Cognitive assessment | MMSE (Mini Mental State Examination), Five-word test, clock drawing | participants will be followed for the duration of the visit, an expected average of 1 day | 
| Physical Activity questionnaire | MAQ (Modifiable Activity Questionnaire) | participants will be followed for the duration of the visit, an expected average of 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sirtuins, Aging, Metabolic disease
INST 0603C Patients With Unresectable/Metastatic Pancreatic Cancer Treated in the UNM Cancer

Study Overview
=================
Brief Summary
-----------------
Chart Review of patients with pancreatic cancer treated with combination of irinotecan, oxaliplatin and cetuximab.

Detailed Description
-----------------
Chart Review to describe the clinical outcomes in patients pancreatic cancer treated with combination of irinotecan, oxaliplatin and cetuximab.

Official Title
-----------------
INST 0603C Chart Review on Patients With Unresectable/Metastatic Pancreatic Cancer Treated in the UNM Cancer

Conditions
-----------------
Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with unresectable/metastatic pancreatic cancer treated in the UNM Cancer Research and Treatment Center. Exclusion Criteria: Not specified.

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 |
| --- | --- | --- |
| Time to Death | Length of survival of patients treated with a combination of Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week. | From date of treatment until time of death |
Laparoscopic Sentinel Lymph Node Localization in Operable Cervix Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the feasibility, safety and efficacy of laparoscopic ovarian transposition in women less than 40 years of age with locally advanced cervical squamous cell carcinoma

Official Title
-----------------
Laparoscopic Sentinel Lymph Node Localization in Patients With Operable Cervical Cancer - A Pilot Study

Conditions
-----------------
Cervical Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage IAI to IIA cervix cancer undergoing primary surgical management Exclusion Criteria: Previous pelvic dissection Previous para-aortic lymph node dissection Evidence of distant mets

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

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

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
New Device to Maintain the Embryo Temperature During Transfer

Study Overview
=================
Brief Summary
-----------------
The embryo transfer implies transportation from the incubator where they have been at 37 ° C, to the transfer catheter inside a laminar flow hood whose working surface is also maintained at 37 ° C. . From the laboratory to the operating room the embryo is exposed to a temperature drop, and consequently thermal stress occurs, which may compromise its future viability. The aim of this study is to assess the possible improvement in the clinical results when the embryos are transported in a stable device to avoid the drop in temperature throughout the transfer process. With the use of this thermosetting device heated to 37 ° C, researchers expect a 15% increase in pregnancy rates.

Official Title
-----------------
A New System for Preventing Thermal Stress During Embryo Transfer

Conditions
-----------------
Embryo Transfer

Intervention / Treatment
-----------------
* Device: Thermostable device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cryo-transfer cycles: transfer of embryos vitrified in previous cycles receiving donated eggs inseminated with either conjugal or donated sperm from Instituto Bernabeu bank. Exclusion Criteria: Fresh cycles: transfer of fresh embryos (coming from donated or own eggs), and cryo-transfer cycles from vitrified embryos coming from own oocytes.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional transfer<br>This arm is the control group (conventional embryo transfer protocol) where there is no intervention. | |
| Experimental: Thermostable device transfer<br>This arm is the study group: embryo transfer protocol using a new thermostable device. | Device: Thermostable device<br>* Investigators place the catheter with the loaded embryos into a plastic device at 37ºC in order to maintain the temperature<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing Pregnancy rate | Achieving an ongoing pregnancy after embryo transfer | Ongoing pregnancy until 28th week of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miscarriage rate | To know the embryonic loss rate after implantation | Loss of pregnancy up to 12 weeks of gestation | 
| Implantation rate | To know the embryo implantation rate after the embryo transfer | Embryo implantation after 6-7 weeks of gestation |
Procalcitonin Ratio's Impact on the Decision Upon On-demand Relaparotomy in Septic Peritonitis

Study Overview
=================
Brief Summary
-----------------
Procalcitonin (PCT) serum levels are monitored in patients with secondary peritonitis after initial operative focus elimination to investigate the PCT ratio's impact on decision-making for or against early relaparotomy in the on-demand relaparotomy concept of secondary septic peritonitis.

Official Title
-----------------
Procalcitonin Ratio's Impact on the Decision Upon On-demand Relaparotomy in Septic Peritonitis

Conditions
-----------------
Secondary Peritonitis After Intestinal Perforation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years necessity for operative intervention to eliminate an infectious peritoneal / abdominal focus after organ perforation abdominal sepsis according to the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference definition Exclusion Criteria: pregnancy immunosuppressive medication

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 |
| --- | --- |
| eliminated infectious abdominal focus<br> | |
| persisting/progressing infectious abdominal focus<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prediction of focus elimination: cured patients versus patients with persisting peritonitis (definitions see below) | definition of 'focus elimination': patients with intestinal perforation or anastomotic leakage develop (local) peritonitis and consecutive abdominal sepsis. These patients need surgical intervention for focus elimination. This operative intervention aims to eradicate all infectious material and is intended to remove the leaking intestinal lesion. Whether this focus is eliminated or not can be controlled by either planned relaparotomy (normally within 48h after the first operation) or on demand relaparotomy in case of clinical deterioration. The focus can be assumed to be eliminated in all cases where either relaparotomy reveals no ongoing infection or persisting focus and whenever a patient recovers rapidly after initial surgery. | participants will be followed for the duration of hospital stay, an expected average of 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
on-demand relaparotomy, PCT, procalcitonin, peritonitis, sepsis, focus index