linjc16/ctgov huggingface dataset:
How Infant Diets Would Affect Growth in Early Childhood

Study Overview
=================
Brief Summary
-----------------
The investigators research group conducted a feeding study in 2012 (IRB 07-0003) that included breastfed infants consuming different infant solid foods. The investigators results showed that different solid foods, especially the protein content of the food, is important on infant's gut bacteria profile and growth. Although the first year of life is critical in obesity development later in life, data are very limited on the effect of protein from solid foods, an important component of infant diet, especially in breast-fed infants. In this study, the investigators will re-contact these participants, who are now in their early childhood ( 5 years old), to evaluate the long-term effect of various macronutrient quantities in solid foods, by assessing the participants' growth, body composition, and gut bacteria profile.

Official Title
-----------------
Effect of Complementary Feeding With Different Macronutrient Quantities on Growth and Body Composition: a Follow-up Trial

Conditions
-----------------
Body Composition, Gut Health, Growth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those participants who completed the initial trial when they were infants. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 7 Years

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 |
| --- | --- | --- |
| Age adjusted height | observational, one time assessment. The hospital visit is scheduled according to the participant's availability. | Day 1: one time assessment during the participant's visit to Colorado Children's hospital | 
| Age adjusted weight | observational, one time assessment. The hospital visit is scheduled according to the participant's availability. | Day 1: one time assessment during the participant's visit to Colorado Children's hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent body fat | Body composition using DEXA scan will be assessed during the hospital visit | Day 1: one time assessment during the participant's visit to Colorado Children's hospital |
Be SMART NIS, Moderate to Servere Asthma Patient Observation

Study Overview
=================
Brief Summary
-----------------
Screen for moderate to severe asthma patients with suboptimal asthma control (as defined by GINA-Guidelines). Document current asthma control status. Re-evaluate asthma therapy and document new therapy if applicable.

Official Title
-----------------
Be SMART NIS, Moderate to Servere Asthma Patient Observation

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe asthma with suboptimal control Exclusion Criteria: Intermittent or mild asthma, patient with good asthma control
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, NIS
CSF Pharmacokinetics of Ondansetron

Study Overview
=================
Brief Summary
-----------------
Serotonergic 5-HT3 receptors in the central nervous system are involved in pain processing after nerve injury. We are interested in learning if 5-HT3 receptor antagonist ondansetron might be an appropriate drug for treating pain after nerve injury (neuropathic pain), by investigating its bio-distribution in the cerebro-spinal fluid, and the genetic variability that may affect that distribution. Study procedures will include iv ondansetron administration, serial blood draws, cerebrospinal fluid (CSF) sampling, pregnancy testing, and possible ECG.

Official Title
-----------------
Investigation of Cerebrospinal Fluid (CSF) Pharmacokinetics of Ondansetron

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Ondansetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 70 years old; Patients planned to undergo hip or knee arthroplasty with spinal anesthesia; Ability to provide informed consent Exclusion Criteria: Not giving consent to participate in the study; Patients with history of or current hepatic or renal insufficiency; Patients with BMI ≥ 33; Patients with heart failure or active arrhythmias; Patients with severe systemic disease that is a constant threat to life; Contraindication or allergy to ondansetron; Pregnancy or lactation. Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: open label infusion ondansetron<br>A single 4-mL CSF sample per subject. Serial blood sampling at 0 (pre-infusion), 15, 30, 60, 120, and 180 min after ondansetron administration | Drug: Ondansetron<br>* A single 15-min intravenous infusion of ondansetron<br>* Other names: Zofran;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSF to Plasma Concentration Ratio | CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample | 0-180 min from the beginning of infusion |
Rapid and Accurate Detection of Major Mycobacterium Species in Pulmonary Infection Based on GenSeizer Platform

Study Overview
=================
Brief Summary
-----------------
Comparison of rapid detection methods of mycobacterial pathogens, GenSeizer v.s. PCR reverse hybridization.

Detailed Description
-----------------
The investigators developed a new platform called GenSeizer, which combines bioinformatics analysis of a large dataset with multiplex PCR-based targeted gene sequencing, to identify eleven major Mycobacterium species implicated in human disease. Simultaneous detection of certain antibiotic resistance genotypes, i.e., erm(41) and rrl in M. abscessus, is also feasible. This platform detected both reference strains and clinical isolates with a high degree of specificity and sensitivity. In this study, the investigators plan to verify the detection efficiency of GenSeizer in clinical samples (sputum, alveolar lavage fluid) and compare it with existing methods on the market (PCR reverse hybridization) and gold standard method (target sequencing after incubation)

Official Title
-----------------
Rapid and Accurate Detection of Major Mycobacterium Species in Pulmonary

Conditions
-----------------
Mycobacterium Pulmonary Infection

Intervention / Treatment
-----------------
* Diagnostic Test: Detection method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected cases of mycobacterial lung infection Exclusion Criteria: No sputum Refused or unable to tolerate bronchoscopy

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 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 |
| --- | --- |
| GenSeizer<br>Sputum and lavage fluids are tested for pathogens using GenSeizer | Diagnostic Test: Detection method<br>* Different methods for pathogen diagnosis<br>|
| PCR reverse hybridization<br>Sputum and lavage fluids are tested for pathogens using PCR reverse hybridization | Diagnostic Test: Detection method<br>* Different methods for pathogen diagnosis<br>|
| Target sequencing after incubation<br>Sputum and lavage fluids are tested for pathogens using Target sequencing after incubation | Diagnostic Test: Detection method<br>* Different methods for pathogen diagnosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection accuracy |  | through study completion, an average of 3 years |
A Study to Assess the Metabolism, Excretion, and Mass Balance of Radio-Labeled Plazomicin

Study Overview
=================
Brief Summary
-----------------
This is a single-center, open label, non-randomized metabolism, excretion, and mass balance study of a single IV infusion of [14C]-plazomicin in healthy, adult male subjects.

Official Title
-----------------
A Phase 1, Open-Label Study to Assess the Metabolism, Excretion, and Mass Balance of [14C]-Plazomicin Following a Single IV Infusion in Healthy Adult Male Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: [14C]-plazomicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Medically healthy, with no clinically significant medical history, physical examination findings, vital signs or ECG findings Key Exclusion Criteria: Use of tobacco- or nicotine-containing products Has received radio-labeled substances or has been exposed to radiation sources within 12 months of dosing or is likely to receive radiation exposure or radioisotopes within 12 months of dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe History of hearing loss or a family history of hearing loss, or a prior diagnosis of sensorineural hearing loss or Ménière's disease History in the past 90 days of prior trauma to the outer or internal structures of the ear or tinnitus History or family history of vestibular disorder, chronic vertigo (sensation of spinning), chronic dizziness

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: [14C]-plazomicin<br>* single intravenous dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of percent of total radioactivity recovered in urine and feces relative to the administered radioactive dose minus any radioactivity lost due to emesis |  | 15 days | 
| Total radioactivity concentration equivalents in plasma and blood |  | 15 days | 
| Plazomicin concentrations in plasma and urine |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events |  | 21 days | 
| Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure) |  | 1 day | 
| Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis) |  | 4 days | 
| Physical examination |  | Screening |
Neuro-ophthalmology and Autoimmune Encephalitis (NODE)

Study Overview
=================
Brief Summary
-----------------
Autoimmune encephalitis represents a group of rare and heterogeneous neurological disorders. Pathophysiological mechanisms in these diseases are still unknown. Recently, oculomotor and neurovisual disorders have been described. Cerebral areas and neuronal networks associated with these abnormalities are well described. The investigator proposes to study and describe such neuro-ophthalmological disorders in a prospective cohort of patients with a autoimmune encephalitis, to better understand the pathophysiological basis of this neurological condition.

Official Title
-----------------
Study of Neuro-ophthalmology Disorders in Autoimmune Encephalitis (NODE)

Conditions
-----------------
Autoimmune Encephalitis

Intervention / Treatment
-----------------
* Other: oculomotor movement recordings, neurovisual assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of autoimmune encephalitis With or without pathological antibody Aged from 18 to 70 years old Able to understand the aims and methods of this project Non opposed to the participation of this study Exclusion Criteria: Other neurological, psychiatric or systemic conditions, which could induce neuro-ophthalmological signs Cognitive impairment, which is not linked to autoimmune encephalitis Ophthalmological condition, which could modify the interpretation of neuro-ophthalmological data Inability to remain seated Pregnancy or breast feeding Adults under guardianship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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>Patients in the study group have a diagnosis of autoimmune encephalitis, are 18 to 70 years old, and have no significant comorbidity such as psychiatric, neurological conditions and able to understand the aim of this study. | Other: oculomotor movement recordings, neurovisual assessment<br>* Each participant will have a neurovisual assessment and an oculomotor movement recording with an eye tracker (infra red cameras).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients presenting a neuro-ophthalmological abnormality. | A neuro-ophthalmological disorder is defined as an abnormality in the oculo-motor movement recording or/and the presence of a neurovisual impairment. | Day 0 | 
| Percentage of patients presenting neuro-ophthalmological abnormality. | A neuro-ophthalmological disorder is defined as an abnormality in the oculo-motor movement recording or/and the presence of a neurovisual impairment. | At 6 months if an abnormality is found |
Sodium Management in Acute Neurological Injury

Study Overview
=================
Brief Summary
-----------------
This multicenter, observational, study will enroll severe neurologically injured patients both prospectively and retrospectively. The aims are to identify the percent of neurocritical care patients with sodium levels ≤ 135 mEq/L, describe treatment strategies employed, determine the correlation of clinical factors (i.e. GCS, ICP) with serum sodium concentrations in patients prior to sodium altering therapy, and evaluate outcomes through evaluation of length of stay, discharge disposition, and modified Rankin score (mRS).

Official Title
-----------------
Sodium Management in Patients With Acute Neurological Injury

Conditions
-----------------
This Study is to Understand the Current Practice of Sodium Management in Acute Neurological Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years of age admitted to an intensive care unit for more than 48 hours ICD-9 codes for aneurysmal SAH, TBI, IPH, or intracranial tumor. Exclusion Criteria:

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 |
| --- | --- |
| traumatic brain injury<br> | |
| aneurysmal subarachnoid hemorrhage<br> | |
| intracerebral hematoma<br> | |
| brain tumor<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
-----------------
Sodium Management, Neurointensive Care, Hyponatremia
Predicting Colorectal Cancer - Tissue Samples to Evaluate Tumour Characteristics and Treatment Response

Study Overview
=================
Brief Summary
-----------------
All adult patients with colorectal cancer presenting within the Sahlgrenska University Hospital or treated at any time at Sahlgrenska University Hospital are eligible and will be asked to participate. We already have biopsies taken at surgery in patients that receive surgery, but this study will include all patients and the biopsies will be taken during endoscopy for diagnosis of the primary tumour. Biopsies will then be taken during follow-up exams prior surgery but after neoadjuvant treatment. Biopsies will also be taken during surgery and in cases where surgery is not necessary biopsies will be taken regularly during follow-up exams. Blood samples and in relevant cases urinary samples and mouth swabs will be taken at all timepoints when biopsies are taken. If it is not possible to take biopsies prior treatment blood samples will still be drawn.

Official Title
-----------------
Predict - a Translational Study to Predict Tumour Response to Neoadjuvant Treatment

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Other: No intervention, just observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colorectal cancer Exclusion Criteria: Not colorectal cancer

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 without neoadjuvant treatment<br> | Other: No intervention, just observation<br>* No intervention, just observation of the differences between groups and within patients.<br>|
| Patients with short course radiotherapy<br> | Other: No intervention, just observation<br>* No intervention, just observation of the differences between groups and within patients.<br>|
| Patients with long course chemoradiotherapy<br> | Other: No intervention, just observation<br>* No intervention, just observation of the differences between groups and within patients.<br>|
| Patients with short course radiotherapy and deferred surgery<br> | Other: No intervention, just observation<br>* No intervention, just observation of the differences between groups and within patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour response to treatment | Tumour microenviroment changes | 1-2 months after initiated treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal tissue response to treatment | Extra cellular matrix changes | 1month -3 years after treatment |
Studies of Biological Changes Related to Weight Loss After Gastric Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
Weight loss achieved by dieting induces multiple changes. These changes include a decrease in metabolic rate (the rate in which the body burns its calories), an increase in appetite and other physiological and hormonal changes that may be the cause of failure in dieting. Many of these parameters that have never been evaluated when weight is lost after gastric bypass surgery will be tested in this study.

Detailed Description
-----------------
While gastric bypass surgery (GBS) is known to be highly effective in achieving significant weight loss, it is also associated with other biologic changes that occur in the body when weight is lost. In this study, subjects undergoing gastric bypass surgery will be followed throughout the weight loss period. They will undergo four detailed medical evaluations to assess changes in several biological systems that occur in the body when weight is lost. The initial assessment will be performed before the surgery (testing period 1). After surgery is completed, subjects will attend clinic visits at the Rockefeller University outpatient clinic. During these visits, weight and leptin levels will be monitored. Two additional assessments will be performed during weight loss, when subjects lose 10% and 20% of their initial weight (testing periods 2 and 3 respectively). A final evaluation will be performed after weight is stabilized, about 18 months after the surgery is completed (testing period 4). Each testing period will be performed over a 2 week period in an inpatient setting at the Rockefeller University Hospital. During testing periods subjects will undergo a series of metabolic, behavioral, hormonal, immune and molecular tests to evaluate changes that occur in the body after weight loss. Subjects will receive monetary compensation for participating in the study.

Official Title
-----------------
A Gene Expression and Metabolic Profile of Weight Loss: Studies of Patients Following Gastric Bypass Surgery

Conditions
-----------------
Obesity, Morbid Obesity, Weight Loss

Intervention / Treatment
-----------------
* Procedure: Gastric Bypass Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 65 years old Subjects approved for gastric bypass surgery Exclusion Criteria: Subjects not approved for gastric bypass surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Gastric Bypass Surgery|nan|

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
-----------------
weight loss surgery, gastric bypass surgery