linjc16/ctgov huggingface dataset:
Ultrafine Particles and Fetal Contamination

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the transplacental passage of fine and ultrafine particles (nanoparticles) inhaled by the mother.

Detailed Description
-----------------
Epidemiological studies have demonstrated the harmful effects of particulate air pollution on the progress of pregnancy and postnatal health. Experimental studies have suggested the transplacental passage of asbestos fibers, but despite the strong growth in the use and production of fine and ultrafine particles, no study has examined the permeability of the placenta to these compounds or the exposures fetuses that may result. The objective of this study is to evaluate the transplacental passage of fine and ultrafine particles (nanoparticles) inhaled by the mother.

Official Title
-----------------
Study of the Permeability of Atmospheric Particles Placenta (Fine and Ultrafine Particles): Analysis of Fetal Retention

Conditions
-----------------
Lung; Premature, Pollution; Exposure

Intervention / Treatment
-----------------
* Procedure: Pulmonary Tissue Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All women volunteers for whom a medical termination of pregnancy is proposed for a fetus older than 22 weeks (weight over 500g). Exclusion Criteria: Refusal of participation of the patient. Fetus with malformation syndrome affecting pulmonary perfusion.
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pulmonary Tissue Collection|Pulmonary Tissue Collection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of fine particles in fetal lung samples yes/no | Analysis in electron microscopy | At the screening | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atmospheric particles
Antimicrobial Efficacy of 2% CHG (Chlorhexidine Gluconate)

Study Overview
=================
Brief Summary
-----------------
Pilot study to evaluate and compare activity of preoperative preparation with comparator

Detailed Description
-----------------
Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using TFM criteria.

Official Title
-----------------
Pilot Trial Assessment of the Antimicrobial Efficacy of Medline 2% CHG Cloth Preoperative Skin Preparation

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: CHG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy No dermatological conditions Exclusion Criteria: Sensitivity to CHG Sensitivity to natural latex rubber or adhesive skin products

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHG 1 min<br>1 min application time | Drug: CHG<br>* Varied application times<br>* Other names: Chlorhexidine Gluconate;|
| Experimental: CHG 2 min<br>2 min application time | Drug: CHG<br>* Varied application times<br>* Other names: Chlorhexidine Gluconate;|
| Active Comparator: Comparator CHG<br>Marketed CHG | Drug: CHG<br>* Varied application times<br>* Other names: Chlorhexidine Gluconate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Log Reduction of Bacterial Flora on the Abdomen and Groin | Evaluate the Log Reduction of normal flora at various timepoints. | 10 min, 6 hr and 8 hr |
Eyelash Line Resection for Entropion Associated With Down's Syndrome

Study Overview
=================
Brief Summary
-----------------
Surgical outcome of entropion associated with Down's syndrome was evaluated. Grading scale of superficial punctate keratopathy and score of wearing glasses to correct refractive errors were measured.

Official Title
-----------------
Eyelash Line Resection for Entropion Associated With Down's Syndrome

Conditions
-----------------
Down's Syndrome

Intervention / Treatment
-----------------
* Procedure: Eyelash line resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients with entropion with Down's syndrome Exclusion Criteria: The patients of Down's syndrome who do not have entropion.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 90 Years

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

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

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 |
| --- | --- |
| Active Comparator: Entropion with Down's syndrome<br>Eyelash resection surgery was performed for entropion with Down's syndrome | Procedure: Eyelash line resection<br>* Eyelash resection surgery was performed for entropion with Down's syndrome<br>* Other names: Lid plastic surgery;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grading scale of superficial punctate keratopathy | The degree of superficial punctate keratopathy was assessed by the area and density classification which was scored with the area of superficial punctate keratopathy graded from A0 through A3, and the density graded from D0 through D3. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of wearing glasses | The score of wearing glasses was graded 2; all day, 1; more than half day, 0; none of the day. | one ear | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Down's syndrome, entropion, lid plasty
Three Combinations Of Docetaxel And Irinotecan For Recurrent Or Metastatic Non Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
A multicenter randomized phase II study evaluating the activity and tolerability of three different combinations of docetaxel (taxotere) and irinotecan (campto) as second line therapy for recurrent or metastatic non small cell lung cancer (NSCLC)

Official Title
-----------------
A Multicenter Randomized Phase II Study Evaluating The Activity And Tolerability Of Three Different Combinations Of Docetaxel (Taxotere) And Irinotecan (Campto) As Second Line Therapy For Recurrent Or Metastatic Non Small Cell Lung Cancer (NSCLS)

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: Irinotecan
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically proven NSCLC Recurrent or metastatic NCSLC Exclusion Criteria: Prior malignancies; except for cured non melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer adequately treated an with non evidence of disease for at least 5 years History or presence of brain or meningeal metastases

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Irinotecan|nan|
|Drug: Docetaxel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the activity and tolerability of the association of irinotecan and docetaxel according to three different schedules as second line treatment for recurrent or metastatic NSCLC. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate, in each arm, the time to progression, the duration of response and the survival |  |  |
Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Study RNLC3131 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

Conditions
-----------------
Hepatic Encephalopathy

Intervention / Treatment
-----------------
* Drug: Rifaximin SSD
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Diagnosis of liver cirrhosis with medically controlled ascites (>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past). Conn (West Haven Criteria) score of < 2. Mini-Mental State Examination (MMSE) score > 24 at screening. ≥ 18 and ≤ 85 years of age. Key Exclusion Criteria: Active COVID-19 that is unresolved History of SBP History of EVB or AKI-HRS within 6 months History of OHE episode (Conn score ≥ 2)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifaximin SSD-40mg IR<br> | Drug: Rifaximin SSD<br>* Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo Twice Daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first event of overt hepatic encephalopathy requiring hospitalization |  | 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first Conn score ≥ 2 |  | 72 weeks | 
| Time to all-cause hospitalization |  | 72 weeks | 
| Time to first event of OHE that requires hospitalization, or all-cause death |  | 72 weeks |
Diffusion-tensor Imaging in Brain Tumors Evaluation

Study Overview
=================
Brief Summary
-----------------
Primary and secondary brain tumors are challenging pathologies regarding diagnosis and treatment. MRI is widely used in the imaging evaluation and surgical planning, due to its spatial resolution and ability of tissular characterization. In this study patients with suspected brain tumors, confirmed by routine MRI evaluation (T1, T2, T2*, FLAIR, T1 with contrast sequences) will undergo DWI and DTI evaluation. By analyzing collected data from MRI evaluation and patient records regarding surgical and histopathological data our aim is to investigate derived imaging biomarkers with impact in the surgical planning and rehabilitation of the patients.

Official Title
-----------------
Contribution of Diffusion Tensor Imaging and Tractography in Primary and Secondary Brain Tumors Evaluation

Conditions
-----------------
MRI, Diffusion Tensor Imaging, Tractography

Intervention / Treatment
-----------------
* Diagnostic Test: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: brain tumors confirmed by routine MRI evaluation surgical treatment with histopathological diagnosis Exclusion Criteria: MRI contraindications past or present neurological or neurosurgical condition, beside the tumor pregnancy

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 primary brain tumors<br> | Diagnostic Test: MRI<br>* In this study patients with suspected primary and secondary brain tumors, confirmed by routine MRI evaluation (T1, T2, T2*, FLAIR, T1 with contrast sequences) will undergo DWI and DTI evaluation.<br>|
| Patients with secondary brain tumors<br> | Diagnostic Test: MRI<br>* In this study patients with suspected primary and secondary brain tumors, confirmed by routine MRI evaluation (T1, T2, T2*, FLAIR, T1 with contrast sequences) will undergo DWI and DTI evaluation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tract damage | Assess the damage of tracts at baseline preoperative | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craniotomy size | Assess the size of craniotomy in patients with postoperative CT follow-up | 3 months |
Pulse CO-Oximetry Noninvasive Monitoring and Laboratory Measurements of Subject Blood Samples

Study Overview
=================
Brief Summary
-----------------
Characterize Masimo noninvasive technology in spot check reading on subjects and make comparison to invasive blood sampling tested on reference analyzers.

Detailed Description
-----------------
Noninvasive readings from subjects done according to manufacturer's directions of use compared to simultaneously derived blood samples measured on in vitro analyzers

Official Title
-----------------
Noninvasive Parameter Testing With Pulse CO-Oximetry and Measurement of Blood Constituents With In-Vitro Analyzers

Conditions
-----------------
Various Comorbidities

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of any age ≥ 3 kg. Subjects may include healthy volunteers, outpatient or inpatient populations Exclusion Criteria: Subjects with skin abnormalities at the planned application sites that may interfere with sensor application or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, etc. Subjects deemed not suitable for study at the discretion of the investigator
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>All subjects will be enrolled in the test group and will receive the noninvasive device | Device: Noninvasive device<br>* Noninvasive device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Heterozygous Individuals for AGXT and Kidney Stones

Study Overview
=================
Brief Summary
-----------------
This study seeks to examine the effects of a heterozygous mutation of the AGXT gene in a stone forming population on endogenous oxalate production. Participants will consume a controlled low-oxalate diet and provide blood and urine samples to measure the amount of oxalate in their bodies. Subjects will then be administered an intravenous (IV) load of glycolate, providing additional blood and urine samples afterwards to measure any increase in oxalate levels.

Official Title
-----------------
Heterozygous Individuals for AGXT and Kidney Stones

Conditions
-----------------
Kidney Stone

Intervention / Treatment
-----------------
* Other: Controlled Diet
* Other: Glycolate Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years of age history of calcium oxalate stones heterozygous mutation of the AGXT gene, as evidenced by results from the Invitae Nephrolithiasis Panel willingness to comply with a controlled diet for five days Exclusion Criteria: pregnant individuals individuals who are currently breast feeding

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Controlled Dietary Study<br>Participants will consume the controlled diet for five days and be administered an intravenous (IV) load of glycolate. Participants will provide urine and blood samples both before the glycolate load to establish baseline levels and after the glycolate load to measure oxalate levels afterwards. | Other: Controlled Diet<br>* Participants will consume a controlled low oxalate diet for five days.<br>Other: Glycolate Administration<br>* Participants will come to the UAB Clinical Research Unit (CRU) and be administered a glycolate load via intravenous (IV) catheter.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Oxalate Excretion | Urinary oxalate excretion from urine samples will be measured as mg/day | Baseline through Day 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney stone, oxalate
Diagnostic Accuracy of the Vegetative and Minimally Conscious State

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate diagnostic accuracy of the vegetative and minimally conscious state: Clinical consensus versus standardized neurobehavioral assessment

Detailed Description
-----------------
In this study, DOC patients with clinical consensus of DOC were enrolled. The investigators used Coma Recovery Scale-revision (CRS-R) to assess consciousness levels for all DOC patients during ten days.

Official Title
-----------------
Diagnostic Accuracy of the Vegetative and Minimally Conscious State: Clinical Consensus Versus Standardized Neurobehavioral Assessment

Conditions
-----------------
Disorder of Consciousness, Minimally Conscious State

Intervention / Treatment
-----------------
* Diagnostic Test: Coma Recovery Scale-revision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion at least 18 years old; acquired brain injury; no neuromuscular blockers or sedatives were used within 48 hours of enrollment. Exclusion Criteria: there are functional disorders caused by progressive mental diseases; persistent seizures; unstable vital signs; double upper limb frustration, fracture.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with disorders of consciousness<br> | Diagnostic Test: Coma Recovery Scale-revision<br>* Patients were assessed by Coma Recovery Scale-revision to detect the DOC patients enrolled by clinicians.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessed by the Coma Recovery Scale-Revised | All patients were assessed by the Coma Recovery Scale-Revised within 10 days to detect the consciousness level. CRS-R consists of six sub-scales with 23 items, which evaluate the patients' auditory, visual, motor, Oromotor/Verbal, communication and arousal functions. For each subscale, the lower score reflected reflexivity related to the brain stem, while the higher score reflected non-reflexivity related to higher cortical functions (0-23). | Within 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Disorders of consciousness, Coma Recovery Scale-revision, Diagnostic accuracy