linjc16/ctgov huggingface dataset:
Body Composition Measurements in Pneumonia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate and standardize bioelectrical impedance analysis (BIA, Maltron BioScan touch i8) for estimating body composition in hospitalized elderly patients with pneumonia. Body composition assessments with BIA and dual-energy x-ray absorptiometry (DXA,

Detailed Description
-----------------
Holigic Discovery) was performed on 36 non-fasting patients over 65 years of age. 29 patients had BIA performed within 24 hours after hospital admission and at the date of discharge. 17 patients had BIA performed in fasted state and one hour after an intake of 300 ml glucose solution.

Official Title
-----------------
Body Composition in Patients With Acute Pneumonia Measured by Bioimpedance and DXA

Conditions
-----------------
Acute Infection Respiratory

Intervention / Treatment
-----------------
* Diagnostic Test: BIA and DXA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute pneumonia, Accept participation (informed consent) Understand the given instructions and information Exclusion Criteria: None

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: BIA and DXA|Patients with acute pneumonia measured simultaneously with DXA-scan and BIA-impedance|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between LBM (lean body mass) with DXA and BIA | At admittance both methods. | within 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development in lean-body-mass during hospital stay | Repeated measurement with BIA during the state of acute infection | 3-10 days (hospital stay) | 
| BIA measured before and after oral glucose load test | To investigate for the effect of fasting on the determination of total body water with BIA | 1 hour |
Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish whether RA patients with moderate to severe disease activity with unsustainable response to infliximab 3 mg/kg every 8 weeks have better efficacy with adalimumab 40 mg s.c. eow compared to infliximab 3 mg/kg i.v. every 6 weeks.

Official Title
-----------------
Randomised, Multicenter, Open-label, Parallel-group Study Comparing Adalimumab 40 mg s.c. Eow Versus Infliximab 3 mg/kg i.v. Every 6 Weeks in Rheumatoid Arthritis Patients With Unsustainable Clinical Response to Infliximab 3 mg/kg Every 8 Weeks

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Infliximab
* Drug: Adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ACR criteria fulfilled,DAS28-3(CRP > 3.2 > 6 months prior treatment with infliximab 3 mg/kg i.v. every 8 week with initial response Fading clinical response to infliximab Negative pregnancy test (women with childbearing potential) Use of reliable method of contraception (women with childbearing potential) Informed consent Exclusion Criteria: Age less than 18 years Lack of co-operability Positive serology for hepatitis B or C History of positive HIV status History of TB or untreated latent TB Histoplasmosis or Listeriosis Pregnancy or breastfeeding Persistent or recurrent infections History of cancer Uncontrolled diabetes Ischaemic heart disease Congestive heart failure (NYHA 3-4) Active inflammatory bowel disease Recent stroke (within 3 months) History of or current inflammatory joint disease other than RA Previous diagnosis or signs of central nervous system demyelinating disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Infliximab|Remicade|
|Drug: Adalimumab|Humira|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving combined good or moderate EULAR responses at week 24 |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20/50/70 response at week 2, 6, 12, 18 and 24 |  | six months |
Risk Factors for Barrett's Esophagus in Patients With BE, Gastroesophageal Reflux, or Gastrointestinal Bleeding

Study Overview
=================
Brief Summary
-----------------
RATIONALE: A study that evaluates DNA changes and other disease-related health information in patients with Barrett's esophagus, gastroesophageal reflux, or gastrointestinal bleeding may help doctors learn more about the risk factors for Barrett's esophagus. PURPOSE: This clinical trial is looking at DNA changes and other disease-related health information as risk factors for Barrett's esophagus in patients with Barrett's esophagus, gastroesophageal reflux, or gastrointestinal bleeding.

Detailed Description
-----------------
OBJECTIVES: Assess the role of several genetically determined factors that, in combination with CagA status, cigarette smoking, alcohol, and diet to varying degrees, result in an increased risk for Barrett's esophagus. OUTLINE: This is a controlled study. Patients complete questionnaires about demographics, medical history, smoking and alcohol history, current medications, frequency and chronicity of gastroesophageal reflux symptoms, and diet history. Blood and tissue are collected and analyzed by DNA-based assays and enzyme-linked immunosorbent assay for CagA status and polymorphisms in detoxifying enzyme systems, other xenobiotic metabolism pathways (e.g., CYP1A1, CYP2E1, CYP3A4, CYP3A5, NQO, NAT-2), inflammatory gene pathways (e.g., IGF, IGFBF3), and in DNA repair genes or p53 pathways (e.g., XRCC1, p53 gene). PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.

Official Title
-----------------
Molecular Epidemiology of Barrett's Esophagus

Conditions
-----------------
Precancerous Condition

Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Undergoing elective esophagogastroduodenoscopy for any of the following reasons: Surveillance of Barrett's esophagus Evaluation of severe or refractory gastroesophageal reflux disease or chest pain thought to be due to reflux Gastrointestinal bleeding PATIENT CHARACTERISTICS: Not pregnant PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Polymorphisms in detoxifying enzyme systems such as glutathione S-transferases (e.g., mu, theta, pi) |  | 2000-2013 | 
| Polymorphisms in other xenobiotic metabolism pathways (e.g., CYP1A1, CYP2E1, CYP3A4/5, NQO1, mEH, NAT-2) |  | 2000-2013 | 
| Polymorphisms in inflammatory gene pathways (e.g., MPO, MnSOD, IGF, IGFBF3, Il1-beta) |  | 2000-2013 | 
| Polymorphisms in DNA repair genes or the p53 pathways (e.g., ERCC2, XRCC1, p53, p73, CCND1, p21) |  | 2000-2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barrett esophagus
Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in Obsessive-compulsive Disorder(OCD) Patients

Study Overview
=================
Brief Summary
-----------------
To modeling the pharmacokinetic-pharmacodynamic(PK-PD) simulation with the plasma concentration and the transporter occupancy from OCD patients treated with escitalopram. To examine the effect of G2677T/A single nucleotide polymorphism(SNP) of ABCB1 gene to the PK-PD modeling in OCD patients treated with escitalopram.

Detailed Description
-----------------
To measure plasma concentration of escitalopram in OCD patients treated with escitalopram. To measure serotonin transporter occupancy by escitalopram in OCD patients treated with escitalopram. To genotype G2677T/A SNP of ABCB1 gene in OCD patients treated with escitalopram.

Official Title
-----------------
Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in Obsessive-compulsive Disorder(OCD) Patients

Conditions
-----------------
OCD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of OCD based on Diagnostic and Statistical Manual(DSM)-IV criteria no change of escitalopram dosage in 6 weeks Exclusion Criteria: psychiatric comorbidity other than OCD History of head injury, epilepsy, other general medical disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OCD patients<br>OCD patients being treated with any dose of escitalopram | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serotonin transporter occupancy |  | 72hr after oral administration of escitalopram | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genotype |  | baseline | 
| Yale-Brown Obsessive Compulsive Scale(Y-BOCS) Score | scale for the severity of Obsessive-compulsive symptoms | baseline | 
| serotonin transporter occupancy | serotonin transporter occupancy measured at 5 hour and 24 hour after oral dose of escitalopram | within the first 24hrs after oral administration of escitalopram | 
| escitalopram plasma concentration | plasma concentration of escitalopram at baseline, 1, 2, 3, 5, 8, 10, 24, 48, 72 hour after oral dose of escitalopram | within 72 hours after oral administration of escitalopram |
The Analysis of Immuno-Nutrition Index in Advanced Gastric Cancer Receiving Preoperative Treatments

Study Overview
=================
Brief Summary
-----------------
Based on multiple studies, the immune (systemic inflammation) and nutrition index were correlated with short- and long-term prognosis for gastric cancer. With the increasing application of preoperative treatments (chemotherapy and chemoradiotherapy), the issues concerning how are the immuno-nutrition index be altered under the effects of perioperative treatments and what are the clinical values of these index should be clarified.

Detailed Description
-----------------
The immune (systemic inflammation) index includes: NLR (Neutrophil-to-Lymphocyte Ratio); PLR (Platelet-to-Lymphocyte Ratio); SII (Systemic Immune-Inflammation Index); GPS (Glasgow Prognostic Score); mGPS (modified Glasgow Prognostic Score); PI (Prognostic Index); The nutrition index includes: NRS2002; PNI (Prognostic Nutrition Index);

Official Title
-----------------
The Analysis of Immuno-Nutrition Index in Advanced Gastric Cancer Receiving Preoperative Treatments: Observational Cohort Study

Conditions
-----------------
Gastric Cancer, Neoadjuvant Chemotherapy, Neoadjuvant Chemoradiotherapy, Systemic Inflammatory Response Syndrome (SIRS), Nutrition Aspect of Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed adenocarcinoma Received neoadjuvant (preoperative) chemotherapy or chemoradiotherapy Diagnosed clinical advanced gastric cancer or esophagogastric cancer Exclusion Criteria: Lack of immuno-nutrition data
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| naCT<br>Advanced gastric cancer or esophagogastric cancer receiving neoadjuvant (preoperative) chemotherapy. | |
| naCRT<br>Advanced gastric cancer or esophagogastric cancer receiving neoadjuvant (preoperative) chemoradiotherapy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological response | Pathological response | One month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-years overall survival | 3-years overall survival | Three years after surgery | 
| 3-years disease-free survival | 3-years disease-free survival | Three years after surgery | 
| Postoperative morbidity | Postoperative morbidity | One month after surgery | 
| yp TNM Stage | yp TNM Stage | One month after surgery |
To Compare the Progressive Cracking Technique and Conventional Chop Technique on Corneal Endothelial Cells in Patients With Hard Nucleus Cataract

Study Overview
=================
Brief Summary
-----------------
Approximately 60 participants at Eye Hospital of Wenzhou Medical University during January,2017 to June 2021 will be enroll in our study. And dived them randomly into 2 groups:Progressive Cracking Technique (30 eyes) and Conventional Chop Technique (30 eyes) .

Official Title
-----------------
To Compare the Progressive Cracking Technique and Conventional Chop Technique on Corneal Endothelial Cells in Patients With Hard Nucleus Cataract

Conditions
-----------------
Hard Nuclear Cataract, Corneal Endothelial Cell, Progressive Cracking Technique

Intervention / Treatment
-----------------
* Procedure: Progressive Cracking Technique
* Procedure: Conventional Chop Technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cataract with Grade IV V nucleus sclerosis Cataract surgery is planned The operation was successful without any complications Exclusion Criteria: Patients with other diseases that affect the corneal endothelium Has a history of anterior segment surgery Failure to cooperate with follow-up

Ages Eligible for Study
-----------------
Minimum Age: 60 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progressive Cracking Technique<br>Patients with hard nucleus cataract were treated with Progressive Cracking Technique. | Procedure: Progressive Cracking Technique<br>* Performing the cataract surgery with our phaco chop-progressive cracking technique.<br>|
| Experimental: Conventional Chop Technique<br>Patients with hard nucleus cataract were treated with Conventional Chop Technique. | Procedure: Conventional Chop Technique<br>* Performing the cataract surgery with Conventional Chop Technique.<br>* Other names: stop and chop;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal endothelial cell density | the number of corneal endothelial cells per unit area. | up to 1 months | 
| Coefficient of variation of endothelial cells | represents the variation coefficient of cell area | up to 1 months | 
| percentage of hexagonal cells of the cells marked | represents the percentage of hexagon cells,the ideal value is above 50% | up to 1 months | 
| central corneal thickness | thickness in micrometer | up to 1 months |
Depiction of Prostate Cancer Treatment Alternatives in Greece

Study Overview
=================
Brief Summary
-----------------
A retrospective, registry analysis of the socio-economic and demographic characteristics of patients suffering from locally advanced or metastatic prostate cancer, as well as the depiction of the therapeutic algorithms followed in the Greek clinical practice. Target Group: Patients with locally advanced or metastatic prostate cancer. The first 10 consecutive patients records that meet the entry criteria.

Official Title
-----------------
Depiction of Prostate Cancer Treatment Alternatives in Greece

Conditions
-----------------
Locally Advanced or Metastatic Prostate Cancer.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Locally advanced or Metastatic Prostate Cancer after 2002. Patients that received Hormonal therapy. Exclusion Criteria: Males that are aged less than 18 years

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

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

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 |
| --- | --- | --- |
| Percentage of patients treated by each treatment alternative. |  | Between 2002 - 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To depict sociodemographic characteristics and comorbidities. |  | Between 2002 - 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Treatment alternatives, Metastasis
Multicenter Study of the Safety and Performance of Fabian-PRICO for Saturation Targeting Routine Use in the NICU

Study Overview
=================
Brief Summary
-----------------
This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product. The purpose of the study is to demonstrate, in a routine clinical environment across a number of centers, that the fabian-PRICO can adequately maintain oxygen saturation, with minimal staff intervention.

Detailed Description
-----------------
This is a randomized cross-over study. Subjects will be assigned to two, nominally 24-hour interventions, one with standard manual titration of FiO2 and the other with automated adjustment (PRICO). The order of these two interventions will be random. In addition to the ventilators data, basic demographics (i.e., gestational age, birth weight, age, weight at study) of the participating infants will be recorded in the eCRF. This study has no additional follow-up visits.

Official Title
-----------------
Multicenter Study of the Safety and Performance of Fabian-PRICO for Saturation Targeting Routine Use in the NICU

Conditions
-----------------
Respiratory Insufficiency in Children

Intervention / Treatment
-----------------
* Device: fabian HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO function
* Other: Manual Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Respiratory insufficiency of infants in the neonatal unit who require respiratory support and supplemental oxygen in one of 4 the therapeutic categories (Intubated HFO, Intubated CMV, Non-Invasive nasal mask, nasal cannula). <30 kg at study entry Informed Consent Form obtained as per EC requirement Exclusion Criteria: Not expected to complete 48 hours of the current respiratory support therapeutic category Congenital anomalies Uncontrolled hemodynamics Severe airflow obstruction Intracranial hypertension Start of caffeine therapy within 12 hours Attending physician does not believe participation of the patient is in their best interest.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: fabian HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO function|24 hours of automated control of FiO2|
|Other: Manual Control|24 hours of manual control of FiO2|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Range Compliance: | Percent-Time with SpO2 a) <80% and b) with >98% SpO2 with FiO2>21% | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Avoidance of SpO2 Extremes: | Percent-Time with SpO2 a) <80% and b) with >98% SpO2 with FiO2>21% | 24 hours |
Phase I Clinical Trial of DA-6886 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
DA-6886_IBS_I is a phase I, dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose escalation clinical trial with open-labelled food effect study of single dose to investigate the safety, tolerability and pharmacokinetics of DA-6886 after oral administration in healthy male subjects.

Official Title
-----------------
A Phase I, Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose Escalation Clinical Trial With Open-labelled Food Effect Study of Single Dose to Investigate the Safety, Tolerability and Pharmacokinetics of DA-6886 After Oral Administration in Healthy Male Subjects

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: DA-6886
* Drug: Placebo of DA-6886


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20   45 years old 27kg/m2 ≥ BMI ≥ 20kg/m2 Healthy Male Informed consent Exclusion Criteria: Clinically significant medical history smokers Clinically significant hypersensitivity of Drugs Clinically significant cutaneous disorder QTcB > 450msec have a history of drug abuse or show positive for drug abuse or cotinine at urine screening

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA-6886<br> | Drug: DA-6886<br>* single dose study : DA-6886 1mg,2.5mg,5mg,10mg,20mg dosage (Dose-escalation) multiple dose study : DA-6886 2.5mg,5mg,10mg or 5mg,10mg,20mg dosage (Dose-escalation)<br>|
| Placebo Comparator: DA-6886 placebo<br> | Drug: Placebo of DA-6886<br>* DA-6886 placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety | Adverse Events Laboratory Results Vital sign, Physical Examination, EKG | up to 7 days (single dose study, single dose study for food effect), 15 days (multiple dose study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics and Pharmacodynamics | Cmax, Tmax, AUClast, Ae, Cssmax, Cssmin | up to 48 hours after last dosing of DA-6886 |