linjc16/ctgov huggingface dataset:
Central and Peripheral Adiposity and Iron Absorption

Study Overview
=================
Brief Summary
-----------------
Adiposity is a state of sub-clinical inflammation, thus hepcidin is increased in adiposity, often leading to iron deficiency in this population group. Central adiposity is generally considered having a greater negative effect on health compared to peripheral adiposity. Whether this can be also seen in hepcidin and thereby in iron absorption is uncertain.

Official Title
-----------------
Relation Btw Adiposity, Inflammation & Iron Absorption:Comparison Btw Central & Peripheral Adiposity

Conditions
-----------------
Adiposity, Iron-deficiency

Intervention / Treatment
-----------------
* Other: Stable iron isotopes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: either normal-weight (BMI 18-25kg/m2) or overweight/obese (BMI 28-50kg/m2) with either central or peripheral fat deposits based on DEXA Exclusion Criteria: Iron Supplement or antibiotic intake within 2 weeks before study start diagnosed chronic disease or gastrointestinal disorders regular use of medication (except contraceptives) pregnancy lactation smoking blood donation or surgery within the last 4 months.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: normal-weight<br> | Other: Stable iron isotopes<br>* Participants have to consume a test meal containing stable iron isotopes in order to determine iron absorption<br>|
| Experimental: peripheral adiposity<br> | Other: Stable iron isotopes<br>* Participants have to consume a test meal containing stable iron isotopes in order to determine iron absorption<br>|
| Experimental: central adiposity<br> | Other: Stable iron isotopes<br>* Participants have to consume a test meal containing stable iron isotopes in order to determine iron absorption<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional and total iron absorption |  | 14days after the administration of the test meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Hepcidin |  | at baseline | 
| Serum ferritin | iron status | at baseline | 
| Serum TfR | iron status | at baseline | 
| Serum CRP | inflammation status | at baseline | 
| Serum AGP | inflammation status | at baseline | 
| Serum IL-6 | inflammation status | at baseline |
Tamoxifen Dose Adjustment on Indonesian Female ER+ Breast Cancer Patients Based on CYP2D6 Genotype and Endoxifen Levels

Study Overview
=================
Brief Summary
-----------------
The objectives of this study is to perform CYP2D6 genotyping and metabolite concentrations analysis on ER+ breast cancer patients who are taking tamoxifen and give dose recommendations based on the CYP2D6 genotypes and endoxifen levels.

Official Title
-----------------
Tamoxifen Dose Adjustment on ER+ Breast Cancer Patients Based on Genomic and Metabolite Concentrations Analysis

Conditions
-----------------
ER+ Breast Cancer

Intervention / Treatment
-----------------
* Drug: Tamoxifen dose adjustment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with ER+ breast cancer Have taken tamoxifen daily for at least 2 months Exclusion Criteria: Have not taken tamoxifen daily for at least 2 months

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

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

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 |
| --- | --- |
| Experimental: Personalized dosing of tamoxifen<br>Increase tamoxifen dose into 40 mg/day for patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype. | Drug: Tamoxifen dose adjustment<br>* Patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype will receive tamoxifen dose escalation into 40 mg/day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of genotype and phenotype of CYP2D6 on plasma and serum concentration of tamoxifen and its metabolites |  | 8 weeks after initial tamoxifen intake | 
| Effects of dose recommendation of tamoxifen based on CYP2D6 genotyping results on endoxifen levels |  | 8 weeks after dose recommendation | 
| Frequencies of CYP2D6 alleles in female Indonesian population |  | Baseline, pre-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, tamoxifen, CYP2D6, endoxifen
HErnias REparation After Kidney Transplantation Study

Study Overview
=================
Brief Summary
-----------------
Correlation between hernias reparation in patients who have received a kidney transplant. The investigators will analyze the data of patients who have been treated for reparation of incisional hernia after kidney transplantation with or without the placement of a prosthesis.

Detailed Description
-----------------
In the scientific literature, the percentage of post incisional hernia in kidney transplanted patients is very variable, and not too well-argued, especially in the context of prevention and individuation of risk factors. The increase of surgical management of hernias reparation in renal transplant patients justifies the start of a mon-centric type study. The investigators will look for risk factors with a retrospective, observational study, by analyzing the type of surgical repair of their post-surgical wall defect. The analysis of costs/benefits on postoperative, intraoperative, or preoperative prevention will be taken into account.

Official Title
-----------------
A Retrospective Observational Study of Hernias Reparation in Patients Who Have Received a Kidney Transplant

Conditions
-----------------
Prosthesis User, Renal Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - hernia post renal transplantation Exclusion criteria: - underage

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 |
| --- | --- |
| Renal Transplantation<br>Renal Transplantation | |
| Hernias reparation post renal transplantation<br>Hernias reparation post renal transplantation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disembowelment number in FIG / D | disembowelment number in FIG / D | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| type of wall closure technique in the context of a kidney transplant | type of wall closure technique in the context of a kidney transplant | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal transplantation, post incision hernia
A Study Investigating Properties of the Transversus Abdominis Plane Block

Study Overview
=================
Brief Summary
-----------------
In this study we investigate the following properties of the transversus abdominis plane block in healthy volunteers: Cutaneous analgesic distribution Muscular affection Reproducibility

Official Title
-----------------
Transversus Abdominis Plane Block: A Placebo-controlled Study in Healthy Volunteers

Conditions
-----------------
Anesthesia, Local

Intervention / Treatment
-----------------
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Capable American society of anesthesiologists classification 1 or 2 Written informed consent Exclusion Criteria: Age below 18 years American society of anesthesiologists classification above 2 Body weight below 50 kg Body mass index > 35 kg/m2 Previous abdominal surgery Acute or chronic pain Use of pain medication less than 24 h prior to study start Allergy to local anesthetics Pregnancy Breastfeeding

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: Basic Science
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine<br>Unilateral transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml) | Drug: Ropivacaine<br>* Unilateral, single shot, ultrasound-guided, transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml)<br>* Other names: Naropin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cutaneous analgesic distribution | Cutaneous analgesic distribution 90 min after transversus abdominis plane block administration | 90 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscular affection of the transversus abdominis plane block | Abdominal wall muscle affection of the transversus abdominal plane block measured by ultrasonography under standardized conditions | 90 min | 
| Reproducibility of the transversus abdominis plane block | Reproducibility of the transversus abdominis plane block with respect to: Cutaneous analgesic distribution Abdominal wall muscle affection measured in the same individual separated by at least 2 days | At least 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transversus abdominis plane block, Ultrasound guided nerve block
Causes and Mechanisms of Space Hemolysis at High Altitudes

Study Overview
=================
Brief Summary
-----------------
Anemia is a lack of red blood cells (RBCs) in the circulation. Because RBCs carry the oxygen your body needs to function, anemia can affect one's ability to stay awake, alert, and perform physical activities. Anemia may happen for several reasons, including increased RBC destruction. Anemia often occurs in people who have been in bed for long periods (e.g., if they are very sick) or have decreased mobility (anemia of immobility). Interestingly, astronauts who have left Earth and traveled in space also return anemic. In fact, 5 decades of NASA data showed that astronauts' anemia was more severe the longer they were in space. In another study, astronauts aboard the International Space Station were shown to destroy 54% more of their RBCs in space. RBC destruction may be the culprit of space anemia as well as anemia of immobility on Earth. The ANEMIA Study proposes to measure key aspects of RBC destruction in astronauts in space. These measures will test critical hypotheses on the effects of spaceflight on red blood cells.

Official Title
-----------------
Causes and Mechanisms of Space Hemolysis at High Altitudes (ANEMIA)

Conditions
-----------------
Anemia, Weightlessness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Astronauts selected to fly on a space mission. Exclusion Criteria: Astronauts not selected to fly on a space mission.

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 55 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group<br>The group is a cohort of 4 persons. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemolysis in astronauts is assessed using exhaled breath samples. |  | Before spaceflight. | 
| Change from baseline hemolysis in astronauts is assessed during spaceflight using exhaled breath samples. |  | Baseline and during spaceflight. | 
| Change from baseline hemolysis in astronauts is assessed after spaceflight, up to 1 month, using exhaled breath samples. |  | After spaceflight, up to 1 month. | 
| Hemolysis in astronauts is assessed using blood markers CBC, reticulocytes, haptoglobin, bilirubin (total+direct), LDH, ferritin, iron, and TIBC. |  | Before spaceflight. | 
| Change from baseline hemolysis in astronauts is assessed during spaceflight using blood markers CBC, reticulocytes, haptoglobin, bilirubin (total+direct), LDH, ferritin, iron, and TIBC. |  | Baseline and during spaceflight. | 
| Change from baseline hemolysis in astronauts is assessed after spaceflight, up to 1 month, using blood markers CBC, reticulocytes, haptoglobin, bilirubin (total+direct), LDH, ferritin, iron, and TIBC. |  | After spaceflight, up to 1 month. |
Safety And Efficacy Results of Percutaneous Renal Stent Implantation in Ectatic and Aneurysmatic Coronary Arteries

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the efficacy and safety of renal stents implanted in ectatic/aneurysmatic coronary arteries.

Detailed Description
-----------------
In total, 18 patients (renal stent group) who underwent renal stent implantation in ectatic/aneurysmatic coronary arteries requiring percutaneous coronary intervention (PCI) and 45 patients who underwent large-sized bare metal coronary stent (BMCS) implantation (BMCS group) at our centre between 2015 and 2020 were included in the study. Control coronary angiography (CAG) was performed during the follow-up of these patients, and angiography-guided quantitative measurements were performed during PCI. The primary endpoints were myocardial infarction and cardiovascular mortality, and the secondary endpoints were restenosis and all-cause mortality.

Official Title
-----------------
Safety And Efficacy Results of Percutaneous Renal Stent Implantation in Patients With Acute Coronary Syndrome With Ectatic and Aneurysmatic Coronary Arteries

Conditions
-----------------
Coronary Artery Ectasia

Intervention / Treatment
-----------------
* Drug: Renal stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute coronary syndrome patients 18 year age ectatic/aneurysmatic coronary arteries Exclusion Criteria: Patients who underwent elective procedures, experienced unsuccessful attempts referred to surgical revascularization

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: renal stent group<br>Acute coronary patients treatment with renal stent | Drug: Renal stent<br>* renal stent implantation in ectatic/aneurysmatic coronary arteries<br>* Other names: Renal stent for coronary artery;|
| Active Comparator: BMCS group<br>Acute coronary patients treatment with bare-metal stent | Drug: Renal stent<br>* renal stent implantation in ectatic/aneurysmatic coronary arteries<br>* Other names: Renal stent for coronary artery;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary endpoints | Rate of myocardial infarction and cardiovascular mortality | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary endpoints | Rate of restenosis and all-cause mortality | 2 year |
First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum - International Study

Study Overview
=================
Brief Summary
-----------------
First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum

Official Title
-----------------
First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum - International Study

Conditions
-----------------
Colonic Neoplasms, Rectal Neoplasms

Intervention / Treatment
-----------------
* Radiation: First-Line Bevacizumab and Chemotherapy
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with metastatic cancer of colon or rectum
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: First-Line Bevacizumab and Chemotherapy|Chemotherapy|
|Drug: Bevacizumab|Chemotherapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness |  | overall | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | overall | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colon and Rectum Cancer
Study of Intracranial Pressure (ICP) Monitoring in Critically Ill

Study Overview
=================
Brief Summary
-----------------
The SIM City study seeks to explore for the variance in practice that is associated with nursing and medical care of patients with brain pressure (ICP) monitors. The underlying hypothesis is that there is not a consistent pattern of care throughout the U.S., rather, there is a wide range of practice patterns that are used to monitor and treat ICP.

Official Title
-----------------
Study of ICP Monitoring in Critically Ill

Conditions
-----------------
Intracranial Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (18 years of age or older) Admitted to an Intensive Care Unit (ICU) Exclusion Criteria: Prisoners

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 |
| --- | --- |
| Dyad<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
-----------------
Intracranial Pressure (ICP) Monitoring, Admission to Intensive Care Unit (ICU)
Onlay vs. Inlay Patellofemoral Arthroplasty

Study Overview
=================
Brief Summary
-----------------
There is currently no sufficient evidence if there is superiority of one of the two available types (onlay type, inlay type) of patellofemoral arthroplasty. Therefore, it is the aim of this study to compare the two types in a prospective comparative setting. Patients on the waiting list for patellofemoral arthroplasty are randomized to either onlay or inlay type patellofemoral arthroplasty. The KOOS - knee score serves as the primary outcome parameter. Secondary outcome parameters are the Marx Activity Scale, the HSS patella score, the Kujala Score, radiographic loosening, progression of tibiofemoral degeneration, revision surgery and parameters of patellofemoral tracking. Inferential statistics will be performed at 1-year follow up data-sets.

Official Title
-----------------
Onlay- vs. Inlay-Type Patellofemoral Arthroplasty: a Prospective, Comparative Study

Conditions
-----------------
Patellofemoral Joint, Osteoarthritis

Intervention / Treatment
-----------------
* Device: Patellofemoral Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patellofemoral osteoarthritis, waiting list for patellofemoral arthroplasty Exclusion Criteria: systemic inflammatory arthropathy tibiofemoral joint degeneration IKDC grade C or worse severe degeneration of also the trochlea margins (inlay PFA not adequate) patellectomy previous implantation of tibiofemoral metal implants extension loss >5 degree knee flexion of less than 100° planned concomitant tibiofemoral procedures (eg. coronal plane osteotomies, tibiofemoral cartilage procedures, tibiofemoral ligament procedures)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Inlay<br>specific technical type of patellofemoral arthroplasty | Device: Patellofemoral Arthroplasty<br> <br> |
| Other: Onlay<br>specific technical type of patellofemoral arthroplasty | Device: Patellofemoral Arthroplasty<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS knee score |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kujala Score |  | 1 year | 
| Marx Activity Scale |  | 1 year | 
| HSS patella Score |  | 1 year |