linjc16/ctgov huggingface dataset:
Determination of Carboplatin's Optimal Plasmatic Exposure

Study Overview
=================
Brief Summary
-----------------
To determine Carboplatin's optimal exposures(optimal AUCs)and parameters they depend on.

Official Title
-----------------
Determination of Carboplatin's Optimal Plasmatic Exposure

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Carcinoma histologically proved and which must be treated by Carboplatin, excepted weekly administered Carboplatin treatments Age > 18 years Neutrophils > 1500/mm3, blood-platelets > 100000/mm3 Patient with intravenous administration route for chemotherapy independent of the one used for blood samples ( for Investigators centers achieving pharmacokinetic examination) Well-informed written consent, signed by the patient Exclusion Criteria: Carboplatin treatment's contra-indication Patient with clinically detectable cerebral metastasis Pregnant or nursing women Patient under guardianship or trusteeship Patient whose venous status don't permit a peripheral intravenous administration route's placing (for Investigators centers achieving pharmacokinetic examination)

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

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Carboplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine Carboplatin's optimal exposures (optimal AUCs) and parameters they depend on. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assign a standardization method for Carboplatin doses's calculation in chemotherapy's protocol including this drug. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neoplasms, Carboplatin, optimal exposure, AUC
Analysis of the Early Development of the Visual Function in Extreme Premature Infants Under 28th Weeks of Gestation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to collect data on the early visual development of extreme premature infants. The method is the measurement of flash visual evoked potentials and the study population includes premature infants under the 28th weeks of gestation, who have normal cranial ultrasound examinations, normal aEEG, no clinical neurological symptoms and who have a normal ophthalmological status. fVEP measurements were recorded from the first week of life every second week until term. The fVEP recordings were performed in active sleep, in stable premature infants, who were continuously monitored. The Nihon Kohden Neuropack 8 was used, the stimulus frequency was 0,5 Hz, artefact free averages were analyzed. The measurements were analyzed according to the presence and absence of known waveforms, their latencies and amplitudes. Longitudinal analysis was performed to analyse the effect of extrauterine visual development on fVEP with growing gestational ages.

Official Title
-----------------
Analysis of the Early Development of the Visual Function in Extreme Premature Infants Under 28th Weeks of Gestation. - A Prospective Study to Identify Normal Values of Flash Visual Evoked Potentials in This Population

Conditions
-----------------
Vision

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All premature infants under the 29th week of gestation entering our ward. Exclusion Criteria: Infants with intracranial abnormalities, cerebral malformations, neurological symptoms or known eye pathology.

Ages Eligible for Study
-----------------
Minimum Age: 23 Weeks
Maximum Age: 29 Weeks

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>Extreme premature infants under the 28th week of gestation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency and Amplitude of Visual Evoked Potential waveforms measured in the first week of life than every second week prospectively until term. |  | Until term |
Culturally Relevant Exercise for Diabetes (CURE-D)

Study Overview
=================
Brief Summary
-----------------
The Culturally Relevant Exercise for Diabetes (CURE-D) study will determine whether a culturally-sensitive dance intervention is an accepted and effective physical intervention for South Asian women with type 2 diabetes mellitus. The CURE-D study will determine if Bollywood dance exercise improves diabetes outcomes in South Asian women.

Official Title
-----------------
Culturally Relevant Exercise for Diabetes (CURE-D)

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Bollywood Dance Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sex: Females Ethnicity: South Asian Hemoglobin A1c ≥ 6.0 mg/dL A PAMF patient for ≥ 24 months Able and willing to enroll and meet the requirements of the study. Exclusion Criteria: BMI > 35 Insulin dependent Current atrial fibrillation Active treatment for cancer Diagnosis of a terminal illness and/or in hospice care Any serious medical condition which would prevent long-term participation or which would contraindicate physical activity Pregnant, lactating, or planning to become pregnant during the study period Inability to speak, read, or understand English No longer a PAMF patient or planning to transfer care outside of PAMF during the study period Investigator discretion for clinical safety or protocol adherence reasons.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br> | |
| Experimental: Bollywood Dance Exercise<br>Participants in the Bollywood Dance Exercise group will take part in an 8-week dance intervention. The dance classes will take place 2 times per week, approximately 60 minutes per class, for 8 weeks total. | Behavioral: Bollywood Dance Exercise<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c |  | Baseline | 
| Hemoglobin A1c | Change from Baseline in Hemoglobin A1c level at 8 weeks | 8-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index |  | Baseline, 8-week follow-up | 
| Blood Pressure |  | Baseline, 8-week follow-up | 
| Physical Activity | Assessed by accelerometers | Baseline, 8-week follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
South Asian
PREdiction of CEphalosporinase Producing Enterobacteria During Ventilator-associated Pneumonia for Therapeutic Stewardship

Study Overview
=================
Brief Summary
-----------------
Ventilator-associated pneumonia is the leading cause of nosocomial infection in the ICU. Cephalosporinase-producing Enterobacteriaceae have an increasing incidence. Infections in cephalosporinase-producing patients require the use of Cefepime during probabilistic antibiotic therapy, the repeated use of which will lead to a significant risk of selection of resistant mutants. The involvement of cephalosporinases being infrequent, the prediction of their presence during a VAP would make it possible to reduce the consumption of Cefepime and thus to take part in the prevention of selection of bacterial mutants resistant to beta-lactams. The main objective of the research is to determine the risk factors for the involvement of cephalosporinase-producing enterobacteria during episodes of ventilator-associated pneumonia (VAP) in hospitalized patients. The secondary objectives are to describe the epidemiology of cephalosporinase-producing enterobacteria in the ICU and to compare the risk factors for the presence of a cephalosporinase-producing germ not without its production being derepressed with those present in situations of cephalosporinase derepression.

Official Title
-----------------
PREdiction of CEphalosporinase Producing Enterobacteria During Ventilator-associated Pneumonia for Therapeutic Stewardship

Conditions
-----------------
Ventilator Associated Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient 18 years and older Patient on mechanical ventilation for more than 48 hours Patient with a diagnosis of ventilator-associated lung disease during management according to American Thoracic Society criteria French speaking patient Exclusion Criteria: Tracheostomized patient at the time of inclusion Limitation of therapies before inclusion in the study Patient under guardianship or curatorship Patient deprived of liberty Patient under court protection Patient objecting to the use of his/her data for this research

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 |
| --- | --- | --- |
| Prevalence of cephalosporinase-producing enterobacteria during episodes of ventilator-associated pneumonia | This outcome corresponds to the the number of ventilator-associated pneumonias involving cephalosporinase-producing enterobacteria. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiology of cephalosporinase-carrying enterobacteria in the ICU | This outcome corresponds to the number of pathogens identified in ventilator-associated pneumonia. | 1 month |
The Natural History Study of Mitochondrial NeuroGastroIntestinal Encephalopathy (MNGIE)

Study Overview
=================
Brief Summary
-----------------
This is a multi-center natural history study of Mitochondrial NeurogastroIntestinal Encephalopathy (MNGIE). Patients will be followed over time to assess clinical symptoms. The investigators hope to learn more about the disease of MNGIE as well as develop useful measures of disease status for use in future clinical trials. Additional clinical centers will be listed as they become available.

Detailed Description
-----------------
The investigators will examine a total of 20 patients at six month intervals for up to five years. The investigators will evaluate gastrointestinal function, lean body mass, neuropathy, neuropsychological capability, quality of life, nutrition, motor function and biochemical parameters.

Official Title
-----------------
The Rare Disease Clinical Research Network Natural History Study of MNGIE

Conditions
-----------------
Mitochondrial NeuroGastroIntestinal Encephalopathy (MNGIE)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thymidine Phosphorylase (TP) defect: homozygous or compound heterozygous mutations in the TYMP gene, and/or TP enzyme activity of <20% of normal. Increased plasma Thd > 3 micromole/L Increased plasma dUrd > 7.5 micromole/L Age requirement of at least 5 years of age. Exclusion Criteria: Participation in an interventional (study medication or other experimental intervention) study (within 1 month of participation in this study). Unable to travel to site for research visits. Unwillingness to sign informed consent form. Substance abuser

Ages Eligible for Study
-----------------
Minimum Age: 5 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 MNGIE<br>Patients of all races of any gender who are at least 5 years of age with a defect in thymidine phosphorylase may participate in this natural history study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Water Swallow | The timed water swallow test evaluates the time it takes to swallow a small cup of water | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Neuropathy | A general neurological exam will be performed to assess the degree of neuropathy. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MNGIE, Mitochondrial, Mitochondrial Neurogastrointestinal encephalopathy
Identification of Changes in Gastric Volume and Content by Ultrasound Before and After Chewing Gum

Study Overview
=================
Brief Summary
-----------------
To identify by ultrasound the possible changes in gastric volume and content after chewing gum for an hour in volunteers with complete fasting (more than 8 hours).

Official Title
-----------------
Ultrasound Assessment of Changes in Gastric Volume and Content Before and After Chewing Gum

Conditions
-----------------
Gastric Volume

Intervention / Treatment
-----------------
* Other: Gum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults older or equal than 18 years old Minimum of 8 hours of fasting must work/study at Fundacion Santa Fe Exclusion Criteria: Comorbidities such as obesity, renal failure, diabetes Gastrointestinal Disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound (case only)<br>Subjects will fast for a minimum of 8 hours. Ultrasound assessment of gastric volume and content will determine basal conditions. Next, subjects will chew gum for one hour with changes of gum every 20 minutes (a total of 3 gums will be chewed per subject). Once the last gum is chewed, the gum will be disposed in the trashcan. Three more ultrasound assessments will take place: immediately after one hour of chewing gum, and at the first and second hour after chewing gum has stopped. The content will be classified as empty, with fluids, or with solid. In case of fluids, volume will be measured. | Other: Gum<br>* Subjects will fast for a minimum of 8 hours. A baseline ultrasound assesment will be performed to evaluate gastric content. Next, subjects will chew sugarless gum for one hour with changes of gum every 20 minutes (a total of 3 gums will be chewed per subject). Once the last gum is chewed, the gum will be disposed in the trashcan. Three more ultrasound assessments will take place: immediately after one hour of chewing gum, and at the first and second hour after chewing gum has stopped. The content will be classified as empty, with fluids, or with solid. In case of fluids, volume will be measured.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric volume change in mL |  | 2 hours |
Monitoring of Biopsy-Proven Interstitial Polyomavirus Nephritis in Kidney and Kidney Pancreas Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Evaluate techniques for monitoring the course of interstitial therapy for polyomavirus nephritis in kidney and kidney pancreas transplant recipients by monitoring blood, urine, and renal transplant biopsies of patients affected by polyomavirus.

Detailed Description
-----------------
Evaluate techniques for monitoring the course of interstitial therapy for polyomavirus nephritis in kidney and kidney pancreas transplant recipients by monitoring blood, urine, and renal transplant biopsies of patients affected by polyomavirus.

Official Title
-----------------
Monitoring of Biopsy-Proven Interstitial Polyomavirus Nephritis in Kidney and Kidney Pancreas Transplant Recipients

Conditions
-----------------
Polyomavirus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recipients of a kidney or kidney pancreas transplant diagnosed with biopsy proven interstitial nephritis due to polyomavirus. Age 18 to 70 years. Capable of providing written informed consent. Exclusion Criteria: Age less than 18 years or greater than 70 years. Patient is on chronic warfarin or heparin therapy or has a disease that puts them at risk of bleeding.

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?
-----------------
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
-----------------
Monitoring, Polyomavirus, Kidney, Pancreas, Transplant
Message Testing in Older Adult Smokers

Study Overview
=================
Brief Summary
-----------------
This study is examining different messages to motivate older smokers to quit smoking. Participants will be current smokers, between the ages of 50-80 years old, who do not have a history of cognitive impairment or dementia. Participants can expect to take part in a one-time 30 minute online survey.

Official Title
-----------------
Message Testing in Older Adult Smokers (MCAS-2)

Conditions
-----------------
Smoking, Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: Flyer and video


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current smoker (smoking at least some days per week) Ability to read and write English Between the ages of 50 and 80 years old Exclusion Criteria: History of Mild Cognitive Impairment or dementia

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hope message<br>Participants will view a hope-based video message and flyer. | Behavioral: Flyer and video<br>* Participants will view a flyer and video<br>|
| Active Comparator: Fear message<br>Participants will view a fear-based video message and flyer. | Behavioral: Flyer and video<br>* Participants will view a flyer and video<br>|
| Placebo Comparator: Control message<br>Participants will view a water advertisement video and flyer. | Behavioral: Flyer and video<br>* Participants will view a flyer and video<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional response | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). Emotionality will be presented together summarizing the mean presentation of these emotions by the different groups. | Through study completion, approximately 30 minutes | 
| Motivation to quit | Measure participants' motivation to quit after viewing the flyer and video, using a 1 item scaled measurement of motivation to quit (1-7 scale, 7 indicating higher motivation). | Through study completion, approximately 30 minutes |
Addressing Proven Factors in HIV Prevention for Latino Youth

Study Overview
=================
Brief Summary
-----------------
This study tests the effectiveness of the bilingual Health and Success program, which aims to support Latino parents and schools in their efforts to promote the academic success and healthy choices of youth, with the goal of reducing barriers that lead to elevated levels of HIV/AIDS in urban Latino communities.

Official Title
-----------------
Health and Success: Addressing Proven Factors in HIV Prevention for Latino Youth

Conditions
-----------------
HIV, Sexually Transmitted Infections

Intervention / Treatment
-----------------
* Behavioral: audio-CD parent education
* Behavioral: health and success parent and school


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: youth attend school selected as study site youth in 6-7th grade Exclusion Criteria: parent/youth non-English or Spanish speakers

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 14 Years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: parent education<br>audio-CD parent EDC supporting positive parenting practices | Behavioral: audio-CD parent education<br>* audio CD stories in English and Spanish that support positive parenting practices<br>* Other names: health and success;|
| Experimental: parent and school intervention<br>health and success parent and school intervention | Behavioral: health and success parent and school<br>* Parenting education and school intervention<br>|
| No Intervention: print materials<br>brochures to parents | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in risk behavior | The study will examine whether there is a reduction in risky sexual behavior among youth exposed to the two treatment conditions compared to the control condition. | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
parenting, prevention, HIV/AIDS, adolescents, Latino