linjc16/ctgov huggingface dataset:
Aminoglycoside Plasma Level Measurement in Neonates With Infection

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether the plasma concentration of aminoglycoside in Indonesia neonates with infection are within safe and effective range and its association with cochlear toxicity and nephrotoxicity.

Detailed Description
-----------------
Aminoglycosides are toxic antibiotics, but they are urgently needed to treat newborns with severe infections. Aminoglycosides are well known for their nephrotoxicity and ototoxicity, meanwhile the renal function of the newborns is not yet fully developed.The aminoglycoside dosage currently applied in Indonesia is derived from studies done in Caucasian populations. The safety and efficacy of this dosage regimen, however, have never been evaluated till date. The pharmacokinetic profile of drugs may vary between populations and this may be influenced by genetic factors, lifestyle, drug interactions, etc. The detection of aminoglycoside toxicity in newborns is usually problematic. The present study aims to know the proportion of nephrotoxicity and ototoxicity in newborns in the Cipto Mangunkusumo Hospital treated with gentamicin or amikacin in relation to their trough serum concentration. The serum level of gentamicin and amikacin is assumed to be safe if the trough serum concentrations are < 2 mcg/mL and effective if its is between 5-12 mcg/mL. For amikacin the desired trough serum concentrations are <10 mcg/mL and the peak is between 20-30 mcg/mL. The nephrotoxicity was assessed by measuring the level of kidney injury molecule-1 in urine while the ototoxicity was assessed by Distortion Product Otoacoustic Emission (DPOE) instrument.

Official Title
-----------------
Aminoglycoside Plasma Level Measurement in Neonates With Infection

Conditions
-----------------
Nephrotoxicity, Ototoxicity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neonates with infection treated with gentamicin or amikacin Exclusion Criteria: neonates who hypersensitive to gentamicin and amikacin neonates who also treated with other nephrotoxic drugs (vancomycin, furosemide, amphotericin B, meropenem)

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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
-----------------
aminoglycoside, KIM-1, DPOAE, nephrotoxicity, ototoxicity
Effects of Meditation

Study Overview
=================
Brief Summary
-----------------
This research is being done to learn about the effects of doing meditation (sitting quietly and concentrating) on people's ability to pay attention and be relaxed.

Conditions
-----------------
Meditation Training

Intervention / Treatment
-----------------
* Behavioral: meditation training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18-55 currently enrolled in methadone maintenance program Exclusion Criteria: history of: a severe medical or psychiatric condition (except substance abuse; e.g., schizophrenia); brain trauma affecting cognitive functioning prior experience with meditation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Other: meditation training<br> | Behavioral: meditation training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| computerized attention task | discrimination score on the continuous performance task | within 1 week after training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stress questionnaires |  | within 1 week after training | 
| mindfulness questionnaire |  | within 1 week after training |
Metabolic Profiling of Hematopoietic Stem Cells in Clonal Hematopoiesis (CHIP)

Study Overview
=================
Brief Summary
-----------------
Bone marrow samples will be collected from patients undergoing hip arthroplasty surgery. Blood and bone marrow samples will be used for metabolic profiling and analysis of relevant CHIP mutations. Combined single-cell transcriptomics and mutation-specific single-cell genotyping (biotin-PCR using mutation-targeted primers followed by sequencing) will subsequently be performed. The gene expression profile of wildtype and mutant hematopoietic stem cells will be compared, performing both broad gene set enrichment analysis and targeted analysis of metabolic pathways.

Official Title
-----------------
Metabolic Profiling of Hematopoietic Stem Cells in Clonal Hematopoiesis (CHIP): a Prospective Observational Study

Conditions
-----------------
Osteoporosis, Osteoarthritis, Hip, Hip Fractures, Clonal Hematopoiesis of Indeterminate Potential, Aging

Intervention / Treatment
-----------------
* Other: Blood and bone marrow cell collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 65 years and older Exclusion Criteria: known haematological condition (myelodysplasia, leukemia, cancer) inability to provide written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- |
| Osteoporotic hip fracture patients<br> | Other: Blood and bone marrow cell collection<br>* Collection of blood and bone marrow<br>|
| Hip osteoarthritis patients<br> | Other: Blood and bone marrow cell collection<br>* Collection of blood and bone marrow<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene Set Enrichment Analysis (GSEA) Normalized Enrichment Score (NES) |  | One day |
Artificially Sweetened Beverage Feeding Study

Study Overview
=================
Brief Summary
-----------------
The aims of the study are to conduct a pre- and post- two week feeding study of artificial sweetened beverage consumption in middle-aged women. The study will also compare metabolic profiles before and after artificially sweetened beverage consumption.

Detailed Description
-----------------
The aims of the study are to: To conduct a pre- and post- two week feeding study of Artificially Sweetened Beverage (ASB) in women. To assess the general levels of ASB consumption. To compare metabolic profiles before and after beverage consumption

Official Title
-----------------
Artificially Sweetened Beverage Feeding Study

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Other: ASB Feeding Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Healthy women Exclusion Criteria: • Having a history of diabetes or cardiovascular disease and any other health or chronic condition that precludes participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

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 |
| --- | --- |
| Other: Active Feeding Arm<br>This is a feeding study. | Other: ASB Feeding Study<br>* Participants will undergo a washout period and then scheduled for blood draw after which ASB feeding period will begin followed by a second blood draw.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in artificial sweetener levels pre- and post- feeding | Change in metabolites pre- and post-feeding | two weeks |
The Impact of School Teachers in Care Navigation and Signposting Dental Caries in Primary School Children

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the role of school teachers in care navigation and signposting dental caries in primary school children.

Detailed Description
-----------------
Dental caries is a multifactorial disease with high prevalence in children. Dental caries is a global public health problem with detrimental impact in developing countries. Despite advances in caries management and detection poorer countries continue to suffer a high burden of disease. Advances in care navigation and sign-posting concepts are increasingly being utilized in general health care to aid early diagnosis and ease the burden of disease in poorer communities. This study aims to investigate the role of primary school teachers as care navigators with regard to dental caries in children.

Official Title
-----------------
The Impact of School Teachers in Care Navigation and Signposting Dental Caries

Conditions
-----------------
Dental Caries in Children

Intervention / Treatment
-----------------
* Diagnostic Test: Signpost caries


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy school children between the ages of 5-8 years Regular school attender Lives in the local village Co-operative Exclusion Criteria: known medical history or disability irregular school attenders

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 8 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: non-randomized parallel design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Care Navigation group<br>The teachers will signpost dental caries based on ICCMS visual criteria and refer to the nearest service. Annual monitoring of caries | Diagnostic Test: Signpost caries<br>* Identify carious lesion according to ICCMS visual criteria<br>* Other names: signpost dental caries;|
| No Intervention: No internvention<br>Caries experience (dmft) activity monitored annually | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| untreated caries increment | decay component of the Index of decayed, extracted and filled teeth for the groups (deft) | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| caries experience (deft) | deft index (for entire group) | 36 months | 
| caries experience for the most affected one third (SIC index) | SIC index (deft of the most affected one third of each group) | 36 months | 
| care index | proportion of filled and extracted teeth (df/deft) | 36 months |
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Chronic Urinary Tract Infections (UTI)

Study Overview
=================
Brief Summary
-----------------
Correlation of Microbiome to Chronic Urinary Tract Infections (UTI) via Relative Abundance Found in Microbiome Sequencing

Detailed Description
-----------------
Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific Chronic UTI types.

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Chronic Urinary Tract Infections (UTI)

Conditions
-----------------
Chronic UTI, Chronic Urinary Tract Infection

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent by patient Male or female patients age 18 and older. Diagnosis of chronic UTIs by a physician based upon urinalysis and/or urine culture. Exclusion Criteria: Refusal by patient to sign informed consent form Treatment with antibiotics within 2 weeks prior to screening Treatment with probiotics within 6 weeks prior to screening History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study.

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 |
| --- | --- |
| Chronic UTI<br>Patients who have been diagnosed with chronic urinary tract infections (UTI). | Other: No Intervention<br>* There is no intervention for this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to chronic Urinary Tract Infection (UTI) via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific chronic urinary tract infection (UTI) types. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Sequencing Methods | To validate the methods used to sequence samples | 1 year |
Glucose and Fructose Stimulated Brain Activity in Obese Subjects

Study Overview
=================
Brief Summary
-----------------
The objective is to investigate neuro-anatomical correlates of the regulation of energy intake by means of functional MRI. Administration of glucose as well as fructose is followed by functional brain MRI, and findings are correlated with serum glucagon-like peptide 1 (GLP-1) levels as an endogenous satiety signal in obese humans.

Official Title
-----------------
Effects of Acute Glucose and Fructose Ingestion on Brain Activity in Obese Volunteers

Conditions
-----------------
Exploratory Behavior

Intervention / Treatment
-----------------
* Dietary Supplement: tap water
* Dietary Supplement: Glucose
* Dietary Supplement: Fructose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: right-handed healthy males, no drugs, non-smoking Exclusion Criteria: drug abuse, smoker, left-handed, claustrophobia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PLACEBO<br>Single intragastric instillation of 300ml tap water via nasogastric tube | Dietary Supplement: tap water<br>* 300ml tap water via nasogastric tube<br>|
| Active Comparator: GLUCOSE<br>Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube | Dietary Supplement: Glucose<br>* 300ml tap water with 75g Glucose via nasogastric tube<br>|
| Active Comparator: FRUCTOSE<br>Single intragastric instillation of 25g Fructose in 300ml tap water via nasogastric tube | Dietary Supplement: Fructose<br>* 300ml tap water with 25g Fructose via nasogastric tube<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional magnetic resonance imaging (fMRI) in healthy, obese volunteers while they performed a working memory task: changes in cerebral blood flow |  | changes from baseline to one hour after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plasma insulin |  | changes from baseline to one hour after treatment | 
| Changes in plasma glucose |  | changes from baseline to one hour after treatment | 
| Changes in plasma GLP-1 |  | changes from baseline to one hour after treatment |
Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Inflatable intra medullary femoral nailing is superior to DHS in terms of blood loss, operative complications and postoperative rehabilitation in the management of pertrochanteric femur neck fractures.

Detailed Description
-----------------
patients with pertrochanteric fractures of the femur will be randomly assigned to one of 2 groups. group 1 will undergo internal fixation using a DHS device. group 2 will undergo internal fixation using an inflatable intramedullary femoral nail device post operative care will be the same including DVT prophylaxis, early mobilization. weight baring will be aloud in cases of a stable fracture (EVANS 1-3) non weight bearing until callus bridge in patients with unstable fractures (EVANS 4-6) outcomes: death within first year postoperative complications length of hospitalization time to mobilization functional score reontgenic evaluation

Official Title
-----------------
Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures

Conditions
-----------------
Femur Fracture

Intervention / Treatment
-----------------
* Procedure: internal fixation (DHS - richard nail)
* Procedure: internal fixation (inflatable PFN by DISCOTEC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pertrochanteric femur fracture Unilateral Age over 60 years Low energy trauma ASA score 0-3 Exclusion Criteria: Reverse oblique fractures Pathological fractures Severe osteoarthritis of the hip joint Previous operations on same leg ASA score 4-5

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>DHS fixation | Procedure: internal fixation (DHS - richard nail)<br>* internal fixation<br>* Other names: DHS - richard nail;|
| Active Comparator: 2<br>IMN fixation | Procedure: internal fixation (inflatable PFN by DISCOTEC)<br>* internal fixation<br>* Other names: inflatable PFN by DISCOTEC;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death within 1 year of operation |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pertrochanteric femur fracture, DHS, IMN
UHR-OCT and HD-OCT for Preretinal Membranes: ICG Versus Membrane Blue

Study Overview
=================
Brief Summary
-----------------
Using the UHR-OCT and HD-OCT to evaluate early postoperative changes in patients with diagnosis preretinal membrane after successfully performed pars-plana vitrectomy and membrane peeling with two different types of dyes.

Detailed Description
-----------------
Surgical procedures performed are pars-plana vitrectomy and membrane peeling with or without cataract extraction and IOL implantation. The type of the dyes is randomized. The study is designed to include a total of tweny cases (10 cases with ICG and 10 cases with Membrane blue) Main outcome measures are: UHR-OCT, HD-OCT distance and near visual acuity and contrast sensitivity amsler grid secondary outcome measures are: OCT Stratus 3000 and visual field. Clinical examinations: preoperative, and follow-up examinations after 1 week, 1 months, 3 months, 6 months and 12 months.

Official Title
-----------------
UHR-OCT and HD-OCT for Preretinal Membranes: Is There a Difference Between ICG and Membrane Blue? A Randomized Clinical Trial

Conditions
-----------------
Retinal Diseases

Intervention / Treatment
-----------------
* Procedure: ppVE, MP, ICG
* Procedure: ppVE, MP, MB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preretinal membrane Age between 18 and 85 years Combined surgery possible(phacoemulsification and vitreoretinal procedure) Exclusion Criteria: Age-related macular degeneration Previous retinal detachment surgery Previous laser treatment

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: ppVE, MP, ICG|surgery with ILM staining|
|Procedure: ppVE, MP, MB|Surgery with ERM staining|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UHR-OCT HD-OCT |  | 12 months | 
| Distance Visual acuity |  | 12 months | 
| Near Visual acuity |  | 12 months | 
| Contrast sensitivtiy |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT Stratus 3000 |  | 12 months | 
| Visual Field |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preretinal membrane, vitrectomy, uhr-oct, hd-oct