linjc16/ctgov huggingface dataset:
An Observational Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®)

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to evaluate real-world safety and efficacy of pegfilgrastim (Neulasta) administered as secondary prophylaxis in Korean female patients with breast cancer receiving chemotherapy regimens recently covered under national health insurance. This is a prospective, observational, open-label trial with a target enrollment of 1400 subjects. Primary endpoint The primary aim of this study is to determine the incidence of febrile neutropenia. Secondary endpoint Major secondary endpoint include a) Incidence of bone pain, b) All adverse events, c) Percentage of patients with RDI (relative dose intensity) ≥ 85%

Official Title
-----------------
An Observational, Prospective, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®) as Secondary Prophylaxis to Decrease the Incidence of Febrile Neutropenia in Korean Female Patients With Breast Cancer.

Conditions
-----------------
Breast Cancer Female, Breast Neoplasm Female

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 19 years old, and ≤ 64 years old, and Female patients with breast cancer receiving chemotherapy recently covered under national health insurance (only chemotherapy regimens in the table below), and Patients with neutropenic events (febrile neutropenia or grade 4 neutropenia) in any previous cycle that did not use G-CSF for the prevention of neutropenia Exclusion Criteria: Patients with any of the followings are excluded. Patients with a history of allergic reactions to E-coli derived proteins, human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim Uses for off-label indications such as chronic myelogenous leukemia, myelodysplastic syndrome

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 64 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Korean female breast cancer patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of febrile neutropenia after secondary prophylaxis with pegfilgrastim |  | From the cycle of chemotherapy before administration of next cycle of chemotherapy (approximately 3weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of bone pain, or percentage of patients with relative dose intensity (RDI) or all adverse events as assessed by CTCAE |  | During the study period (  1months follow-up) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
febrile neutropenia, neutropenia
Knowledge and Behavior Toward Early Childhood Caries

Study Overview
=================
Brief Summary
-----------------
400 mothers are at least 18 years of age who have at least a child with minimum age of 6 years or even younger will be selected from the outpatient clinics of October University for Modern Sciences and arts (MSA). The questionnaire will be administrated to obtain socio demographic information and to assess their oral health beliefs, knowledge, behaviors and the possible barriers for their accessing oral health care.

Official Title
-----------------
Oral Health Beliefs, Knowledge, and Behavioral Attitudes of Egyptian Mothers Towards Early Childhood Caries

Conditions
-----------------
Early Childhood Caries

Intervention / Treatment
-----------------
* Behavioral: early childhood caries


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mothers are at least 18 years of age who have at least a child with minimum age of 6 years or even younger Exclusion Criteria: mothers are refuse to participate in the study or sign the consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: early childhood caries|a questionnaire evaluates the oral health beliefs, knowledge, and behaviors of a sample representing Egyptian mothers toward early childhood caries|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of the oral health beliefs, knowledge, and behavioral attitudes towards early childhood caries | data collected from the questionnaire | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knowledge, behaviors, Early childhood caries
A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to learn about the safety and tolerability of daily BMS-275183 in patients with advanced cancer.

Official Title
-----------------
A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies

Conditions
-----------------
Tumors

Intervention / Treatment
-----------------
* Drug: BMS-275183


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-hematologic malignancy that has progressed or no standard therapy is known Four weeks from last chemotherapy or two weeks from last non-cytotoxic therapy Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 No more than 3 prior chemotherapy regimens in advanced/metastatic setting Absolute neutrophil count >=1,500/mm3 and platelets >=100,000/mm3 Bilirubin <=1.5 x Upper Limit of Normal (ULN), Aspartate aminotransferase <=2.5 x ULN Serum creatinine <=1.5 x ULN Men and women >=18 years Women of Child Bearing Potential (WOCBP) must use adequate method of contraception throughout and up to 4 weeks after the study Exclusion Criteria: WOCBP and men not using adequate method of birth control WOCBP who are pregnant or breastfeeding Prior radiation >=25% of bone marrow containing skeleton Uncontrolled, significant, or active cardiovascular or pulmonary disease or infection or psychiatric disorder Neuropathy Active brain metastases Inability to swallow capsules History of gastrointestinal disease, surgery or malabsorption, or requiring use of a feeding tube Concurrent chemotherapy, hormonal therapy, immunotherapy, or radiotherapy

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: BMS-275183|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK, preliminary evidence of antitumor activity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with advanced solid tumors
Pharmacogenetics of Antiretroviral Drugs

Study Overview
=================
Brief Summary
-----------------
In this research project, we will study the genetic determinants that influence the pharmacokinetics of antiretroviral drugs used in the treatment of diseases caused by the HIV.

Detailed Description
-----------------
The development of new active substances is a continuous source of progress in pharmacotherapy. However, the search for an optimal use of existing molecules constitutes another possible way of progress. In the particular field of anti-infectious therapy, an optimization of treatments could minimize the emergence of resistance phenomena that require the continuous development of new active molecules. Pharmacogenetics is the scientific discipline seeking to improve the response to drug therapies (better clinical efficiency and reduction of side effects) by taking into consideration the genetic characteristics of the patient. Drugs with a narrow therapeutic index constitute a main target of this emerging field. The combination of therapeutic drug monitoring and pharmacogenetics already allows to optimize the use of some drugs among which oral anticoagulants, immunosuppressants, antiepileptics, antidepressors, antibiotics or antivirals…. In this research project, we will study the genetic determinants that influence the pharmacokinetics of antiretroviral drugs used in the treatment of diseases caused by the HIV. We will put a particular emphasis on viral protease inhibitors (atazanavir, saquinavir, lopinavir, ritonavir)and non-nucleosides reverse transcriptase inhibitors (nevirapine and efavirenz). For those drugs, the clinician often faces a double therapeutic risk, either of insufficient dosing (clinical inefficacy and emergence of resistance) or of excessive dosing (toxicity). The optimization of drug dosing is especially crucial because some of these drugs often represent the last choice in multi-resistant patients.

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected patients Exclusion Criteria: pregnant women

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human immunodeficiency virus
Technique for Localization of Caries Associated Bacteria on Tooth Surfaces.

Study Overview
=================
Brief Summary
-----------------
There is a simple laboratory technique for localization of caries associated bacteria on tooth surfaces by taking an impression of the teeth with a material containing sucrose. The purpose of this study is to check whether the technique can be incorporated into dental clinics as diagnostic tool comparing to other diagnostic methods available.

Official Title
-----------------
Usage of Laboratory Technique for Localization of Caries Associated Bacteria on Tooth Surfaces as Clinical Measurement to Caries Diagnosis and Treatment Efficiency.

Conditions
-----------------
Caries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult/ patient of the student clinic in Hadassa, Jerusalem. Exclusion Criteria: children/ antibiotic taken in the last month.

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?
-----------------
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
-----------------
Caries Diagnosis, Replica technique
Effect of Cyclic Tensional Force on Osteogenic Differentiation of Human Periodontal Ligament Stem Cells

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe cyclic tensional force on the osteogenic differentiation of human periodontal ligament stem cells.

Detailed Description
-----------------
This study is to investigate the effect of the cyclic mechanical strain on the osteogenic differentiation of mesenchymal stem cells. Mesenchymal stem cells will be cultured from the periodontal ligament tissue of the premolars extracted due to orthodontic reason.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Orthodontic patients who need to have premolars extracted

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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
-----------------
stem cells, periodontal cells, mechanical stress, differentiation, periodontal ligament
The Effect of Propofol Infusion on Total Antioxidant Status During Tourniquet-Induced Ischemia-Reperfusion Injury

Study Overview
=================
Brief Summary
-----------------
The release of tourniquet produces reactive oxygen species which can cause injury. Propofol is chemically similar to phenol-based free radical scavengers. Plasma total antioxidant capacity is a well-established marker of the overall protective effect of antioxidants in body fluids.The aim of the study is to investigate the effects of propofol on ischemia-reperfusion injury in total knee arthroplasty (TKA).

Official Title
-----------------
The Effect of Propofol Infusion on Total Antioxidant Status During Tourniquet-Induced Ischemia-Reperfusion Injury in Total Knee Arthroplasty

Conditions
-----------------
Total Knee Arthroplasty, Tourniquet-Induced Ischemia-Reperfusion Injury

Intervention / Treatment
-----------------
* Drug: Propofol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II physical status Unilateral total knee arthroplasty Age 18 years to 80 years Exclusion Criteria: Severe central nervous system disorders Severe cardiopulmonary,renal,metabolic, or hepatic disease, Blood volume deficits, Coagulopathy, Allergy to local anesthetics, Peripheral neuropathies, Body mass index > 35, History of antioxidant drug use

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>Propofol infusion group: Under spinal anesthesia, a continuous intravenous infusion (2mg/kg/h) of propofol will be use during the operation | Drug: Propofol<br>* Propofol :Propofol is an anesthetic agent, has structure similar to that of known such as alfa tocopherol.<br>|
| Placebo Comparator: Control group<br>Placebo group: Under spinal anesthesia, a continuous intravenous infusion of volume-equivalent placebo will use during the operation | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The perioperative alternation of the venous blood total antioxidant capacity levels of the arms | T1 : Before the spinal anesthesia performed T2 : At 30th min of tourniquet inflation T3 : At 2nd hours of tourniquet deflation | T1,T2,T3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Propofol, antioxidant capacity, total knee arthroplasty, Propofol,antioxidant
Metric Properties of de Morton Mobility Index

Study Overview
=================
Brief Summary
-----------------
Metric properties (convergent validity, predict validity, known-groups validity, responsiveness, floor and ceiling effects, minimal clinically important difference) of the de Morton Mobility Index (DEMMI) in patients with musculoskeletal impairments undergoing impatient rehabilitation will be investigated.

Detailed Description
-----------------
Convergent validity of DEMMI will be assessed in terms of correlations with the other outcome measures. Known-groups validity will be demonstrated by differences in DEMMI scores between patients who were not able to walk and those who were able to walk with or without walking aid. Predictive validity of DEMMI at admission for functional independence at discharge from rehabilitation will be estimated. The minimal clinically important difference of DEMMI, responsiveness and floor or ceiling effects will also be estimated.

Official Title
-----------------
Metric Properties of de Morton Mobility Index in Rehabilitation Patients With Musculoskeletal Impairments

Conditions
-----------------
Musculoskeletal Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admission to inpatient rehabilitation written informed consent Exclusion Criteria: associated impairments of the central nervous system or other severe health conditions

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 |
| --- | --- | --- |
| de Morton Mobility Index - change | DEMMI is a unidimensional 15-item measure of mobility for adults | Approximately 30 days (difference between admission and discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ten-meter Walk Test | 10mWT assesses comfortable walking speed over the distance of 10 meters | Approximately 30 days (difference between admission and discharge) | 
| Six-minute Walk Test - change | 6mWT assesses assess aerobic capacity and endurance | Approximately 30 days (difference between admission and discharge) | 
| Functional Independence Measure - change | FIM is an 18-item two-dimensional instrument that explores physical and psychosocial functioning | Approximately 30 days (difference between admission and discharge) | 
| EQ-5D-3L - change | EQ-5D-3L is a patient-reported instrument for measuring HRQOL | Approximately 30 days (difference between admission and discharge) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DEMMI, outcome measurement, physiotherapy, clinimetric properties
Effect of Ketamine on BIS Values

Study Overview
=================
Brief Summary
-----------------
Aim of this trial is to define if Concentration at the effector site (Ce) of Ketamine, calculated with DOMINO model infusion pump are correlated with Bispectral Index BIS values during general anaesthesia for breast surgery.

Detailed Description
-----------------
Correlation between Concentration at the effector site (Ce) of Ketamine and Bispectral Index (BIS) values during general anaesthesia for breast surgery has not been defined yet. We want to analyze this correlation during general anaesthesia conducted using Propofol, ketamine and remifentanil. All of these drugs will be delivered with Targeted-ControlledInfusion pumps (in particular Eleveld for Propofol, Minto for Remifentanil and Domino for Ketamine).

Official Title
-----------------
Correlation Between Concentration at the Effector Site of Ketamine (Calculated With DOMINO Pump) and Bispectral Index Values During General Anaesthesia for Breast Surgery.

Conditions
-----------------
Anesthesia Brain Monitoring, Ketamine

Intervention / Treatment
-----------------
* Device: Bispectral Index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergo gneral anaesthsia with Targted Controlld Infusion of Ketamine (Domino model), Propofol (Schnider model) and Remifentanil (Minto model) Exclusion Criteria: Neurological disease Psychiatric disease Benzodiazepiones absuntion Obesity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Bispectral Index|Comparing Bispectral index values (usually adopted during general anaesthesia monitoring) to Ketamine concenetration at the effector site calculated with Domino model pump (usually adopted for Ketamine infusion during general anaesthesia)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between Concentration at the effector site of Ketamine and BIS values | Discover if there is linear correlation between Concentration at the effector site of Ketamine and BIS values during standard general anaesthesia conducted with Propofol, remifenatnil and ketamine delivered with targeted controlled infusion pumps, usually adopted in our Hospital to delivery general anaesthesia | We will collected data about Drugs concentration and BIS values during general anaesthesia. We will collect BIS and TCI Ketamine values during all the duration of anesthesia, form the start of ketamine bolus until the emergence from anesthesia |