linjc16/ctgov huggingface dataset:
Pharmacokinetics and Pharmacodynamics of an Anti-HIV Drug in Israeli Ethiopian and Non-Ethiopian Populations

Study Overview
=================
Brief Summary
-----------------
The objective of this proposal is based on the assumption that the HIV infected Ethiopian population responded in a different way in comparison to the Caucasian subjects to Lopinavir therapy. Our preliminary data demonstrated that Ethiopian's have different Lopinavir serum concentration in comparison to non-Ethiopian's. For these reasons the plan of this study is to investigate the pharmacokinetic/pharmacodynamic (PK/PD) profile in both populations. The results will allow to establish a better personalised medicine for HIV infected individuals.

Detailed Description
-----------------
The objective of this proposal is based on the assumption that the HIV infected Ethiopian population responded in a different way in comparison to the Caucasian subjects to Lopinavir therapy. Our preliminary data demonstrated that Ethiopian's have different Lopinavir serum concentration in comparison to non-Ethiopian's. For these reasons the plan of this study is to investigate the pharmacokinetic/pharmacodynamic (PK/PD) profile in both populations. The results will allow to establish a better personalised medicine for HIV infected individuals.

Official Title
-----------------
Pharmacokinetics and Pharmacodynamics of Lopinavir an Anti-HIV Drug in Israeli Ethiopian and Non-Ethiopian Populations

Conditions
-----------------
AIDS, HIV Infection

Intervention / Treatment
-----------------
* Drug: Lopinavir pharmacokinetic/pharmacodynamic analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All HIV infected Ethiopian and Non-Ethiopian subjects AIDS diseased Ethiopian and Non-Ethiopian individuals Exclusion Criteria: Individuals who are unable to sign the informed concent Individuals unable to take oral medications Individuals who described Lopinavir allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lopinavir pharmacokinetic/pharmacodynamic analysis|nan|

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
-----------------
Lopinavir, Pharmacokinetic, Pharmacodynamic, Ethiopian population, Caucasian population
HOPE-Epilepsy Trial

Study Overview
=================
Brief Summary
-----------------
This a multi-center study to examine whether supplementation with omega 3 fatty acids will reduce seizure frequency in patients with epilepsy .

Official Title
-----------------
High Dose Omega 3 Fatty Acids Supplementation in Patients With Epilepsy : The HOPE-Epilepsy Trial

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Dietary Supplement: Omega 3 fatty acids
* Dietary Supplement: corn oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with active Epilepsy Exclusion Criteria: pregnant women or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: corn oil<br>* Placebo<br>|
| Experimental: Omega 3 fatty acids supplementation<br>Omega 3 fatty acids capsules | Dietary Supplement: Omega 3 fatty acids<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure Frequency | number of seizures during the treatment period | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| categorized seizure frequency | number of crises categorized as: generalized, focal with disconnection and focal without disconnection | 18 months | 
| Percentage of overall seizure frequency modification | percentage of reduction or increase in seizure frequency from baseline til the end of treatment period | 18 months | 
| Time Free of seizures during treatment |  | 12 months | 
| Reduction in seizure frequency |  | 12 months | 
| Quality of Life |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy, Omega 3 fatty acids
EFFECT OF ANESTHESİA TECHNIQUES ON POSTOPERATİVE COGNİTİVE DYSFUNCTION FOR MMSE AND NSE LEVEL

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the effects of total intravenous anesthesia and inhalation anesthesia methods on postoperative cognitive dysfunction according to Mini Mental State Examination scores and Neuron Specific Enolase levels in lumbar disc herniectomy operations.

Official Title
-----------------
THE EFFECT OF TOTAL INTRAVENOUS ANESTHESIA AND INHALATION ANESTHESIA TECHNIQUES FOR MINI MENTAL STATE EXAMINATION TEST AND NEURON SPECIFIC ENOLASE LEVEL IN LUMBAR DISK HERNIECTOMY OPERATIONS

Conditions
-----------------
Postoperative Cognitive Dysfunction, NEURON SPECIFIC ENOLASE, MINI MENTAL STATE EXAMINATION TEST

Intervention / Treatment
-----------------
* Behavioral: POSTOPERATIVE COGNITIVE DYSFUNCTION


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Lumbal disc herniectomy operation 18-65 age Exclusion Criteria: Patients before and after the coronary artery bypass graft surgery patients in the last trimester of pregnancy patients with severe heart failure liver failure kidney failure malignant hyperthermia lactating patients patients with vision or hearing problems patients having difficulty in understanding and speaking Turkish Parkinson's and Alzheimer's disease alcohol and drug addicts morbidly obese patients intraoperative hypotension, hypertension and hypoxemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| TOTAL INTRAVENOUS ANESTHESIA<br> | Behavioral: POSTOPERATIVE COGNITIVE DYSFUNCTION<br>* NEURON SPECIFIC ENOLASE LEVELS IN LUMBAR DISC HERNIECTOMY WITH GENERAL ANESTHESIA MODALITIES<br>|
| INHALATION ANESTHESIA<br> | Behavioral: POSTOPERATIVE COGNITIVE DYSFUNCTION<br>* NEURON SPECIFIC ENOLASE LEVELS IN LUMBAR DISC HERNIECTOMY WITH GENERAL ANESTHESIA MODALITIES<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MINI MENTAL STATE EXAMINATION TEST | BELOW 27 SCORE IS ASSOSIATED WITH POSTOPERATIVE COGNITIVE DYSFUNCTION | 1 MONTH |
BEOVU Versus Eylea in the Treatment of Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
Diabetic macular edema degeneration occur is a vision threatening condition. The investigators compare the efficacy of BEOVU and Eylea intravitreal treatment in the management

Detailed Description
-----------------
Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination was done. Procedure included randomized intravitreal injection of Brolucizumab(BEOVU®, Genentech, South Francisco, CA) and of aflibercept (Eylea;Regeneron, Tarrytown,NY)

Official Title
-----------------
Outcome of Brolucizumab-dbll and Aflibercept Intravitreal Injection in the Treatment of Diabetic Macular Edema

Conditions
-----------------
Macular Edema

Intervention / Treatment
-----------------
* Drug: BEOVU intravitreal injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic macular edema Exclusion Criteria: other causes of macular edema other macular diseases

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BEOVU<br>Intravitreal injection of BEOVU 3 loading injections( monthly) then under treat and extent regimen | Drug: BEOVU intravitreal injection<br>* BEOVU intravitreal injection<br>* Other names: Brolucizumab-Dbll intravitreal injection;|
| Active Comparator: Eylea<br>Intravitreal injection of Eylea 3 loading injections( monthly) then under treat and extent regimen | Drug: BEOVU intravitreal injection<br>* BEOVU intravitreal injection<br>* Other names: Brolucizumab-Dbll intravitreal injection;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity (BCVA) | Change in BCVA in LOG MARS(logarithm minimum angle of resolution | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BEOVU, Eylea, diabetic macular edema
Study of T900607-Sodium in Subjects With Previously Treated Gastric Cancer or Adenocarcinoma of the Esophagus

Study Overview
=================
Brief Summary
-----------------
This is a clinical research study of T900607-sodium to determine if it is effective and safe in treating gastric cancer and adenocarcinoma of the esophagus. Patients will be treated on a weekly basis with an intravenous injection of the study drug.

Conditions
-----------------
Gastric Cancer, Esophageal Neoplasms

Intervention / Treatment
-----------------
* Drug: T900607-sodium intravenous


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Histologically or cytologically confirmed diagnosis of gastric cancer or adenocarcinoma of the esophagus Subjects must have received 1-2 regimens of prior chemotherapy At least 18 years of age Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size. Karnofsky performance status of at least 70% Estimated life expectancy of at least 12 weeks Females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive Subject must be able to comply with study procedures and follow-up examinations. Signed written informed consent Lab Values (obtained ≤ 7 days prior to study enrollment): ANC at least 1.5x10e9/L, * Platelet count at least 100x10e9/L, Creatinine within 2 times upper limit of normal * AST and ALT within 5 times upper limit of normal Bilirubin within 1.5 times upper limit of normal Albumin great than 2.5 g/dL Exclusion Criteria Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of <50%, or acute anginal symptoms Patients who have received any investigational agent within 4 weeks of enrollment Patients who are pregnant or breast-feeding History of prior malignancy other than gastric cancer or adenocarcinoma of the esophagus within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix History of central nervous system metastases or carcinomatous meningitis Major surgery within 4 weeks of enrollment

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: T900607-sodium intravenous|nan|

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
-----------------
adenocarcinoma of the esophagus
Representation of the Body for Patients With Cancer

Study Overview
=================
Brief Summary
-----------------
The project aims to understand better how patients live the event of cancer and live its consequences on their bodily representations. In the study, the dynamic of the body image is not restricted to appearance but include sensations and visions of the inner body, what explains the choice of peritoneal cancer, and the treatment by cytoreductive surgery and HIPEC. The three objectives of the study are: identifying the impact of the representations of the treated body on the psychological strategies to cope with the disease, the bodily changes and the prospects of life; making explicit the positive or negative impacts of these representations on the relationship between patients and health professionals (easing factors, misunderstandings, negotiations, etc.); associating the health professionals with the study in its course and evaluation in order to elaborate a methodological collaborative approach between patients, health professionals and researchers in social sciences.

Official Title
-----------------
Representation of the Body and Treatment of Peritoneal Cancer by Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) - A Collaborative Approach Between Professionals of Health / Patients / Researchers

Conditions
-----------------
Peritoneal Carcinomatosis

Intervention / Treatment
-----------------
* Behavioral: Interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients eligible to treatment of cancer by cytoreductive surgery and HIPEC Primary (pseudomyxoma, mesothelioma) and secondary (colorectal, gastric, ovarian) peritoneal cancer Free consent Male or Female Age > 18 years Affiliate to social security Exclusion Criteria: Age < 18 years, no french speaking Cerebrals metastasis Psychiatrics diseases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treated by HIPEC<br>Patients treated by HIPEC for peritoneal cancer | Behavioral: Interviews<br>* Interviews will be done with patients<br>|
| Other: Standard chemiotherapy<br>Patients treated by standard chemiotherapy for peritoneal cancer | Behavioral: Interviews<br>* Interviews will be done with patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body representations | Comprehensive knowledge concerning the way the patients are living cancer event, treatment, changes in their body representations and conceptions of their lives. This qualitative study do not include outcome measures. Its purpose is restricted to the meanings | 3 months |
Post-Approval Study of PROMUS Element™ in China

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compile real-world clinical outcomes data for the PROMUS Element™ and PROMUS Element™ Plus Everolimus-Eluting Coronary Stent System (PROMUS Element and PROMUS Element Plus Stent System) in routine clinical practice in China.

Detailed Description
-----------------
Everolimus-eluting stents have been studied extensively in ongoing clinical studies. The safety and effectiveness of the everolimus drug and polymer combination have been studied extensively in the SPIRIT Clinical Trial Program. The PROMUS Element stent is currently being studied in the PLATINUM Clinical Trial Program. The PROMUS Element stent is also being evaluated in PROMUS Element Plus US post-approval studies and the ongoing Platinum China study. This study is designed to provide post-market surveillance information on the PROMUS Element™ and PROMUS Element™ Everolimus-Eluting Coronary Stent System (PROMUS Element and PROMUS Element Plus Stent System) after it has been approved by SFDA (State of Food and Drug Administration) in China. The study will evaluate clinical outcomes for subjects receiving the PROMUS Element and PROMUS Element plus stents over 5 years in a real world setting according to post approval requirements from SFDA.

Official Title
-----------------
PROMUS Element™ China Post-Approval Study

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be at least 18 years of age Subject understands and provides written informed consent Subject who is clinically indicated and will have an attempt of at least one PROMUS Element stent OR Subject who is clinically indicated and was implanted with at least one PROMUS Element stent Subject is willing to comply with all protocol-required follow-up evaluation Exclusion Criteria: Exclusion criteria is not required in the PROMUS Element China Post-Approval study which is an all comers 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF) rate | The primary endpoint is the 12-month target lesion failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death. | 12-month |
Clinical-genetic Investigations in Children With Early Infantile Epilepsies

Study Overview
=================
Brief Summary
-----------------
The project strives to discover novel genetic defects that cause monogenic epilepsy or that genetically modify a preexisting epileptic phenotype. Our main aim is to find genetic causes for the idiopathic West Syndrome (infantile seizures) that are not caused by known cerebral malformation, lissencephaly or metabolic disorders and which have a comparatively benign prognosis. The investigators hypothesize that mutations in genes coding for ion channels or genes that modify the action of ion channels might be causative. For that the investigators will perform a sequence analysis of the coding exons of a large set of genes in all recruited patients and verify found mutations in their parents.

Official Title
-----------------
Clinical-genetic Investigations in Children With Early Infantile Epilepsies

Conditions
-----------------
Epilepsy, Seizures, Infantile

Intervention / Treatment
-----------------
* Genetic: DNA preparation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypsarrhythmia in the first year of life Infantile seizures in the first year of life Freedom of seizures at the age of 5 years Exclusion Criteria: brain malformation metabolic disorder intracranial hemorrhage lissencephaly

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 10 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 |
| --- | --- |
| West Syndrome (idiopathic)<br>Patients with idiopathic infantile seizures | Genetic: DNA preparation<br>* Taking blood or saliva from the patient to prepare DNA therefrom<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discovery of a pathogenic mutation in an ion channel gene |  | 4 weeks after taking of the DNA specimen |
Prevalence of Partial Edentulism Among Patients of Faculty of Dentistry Cairo University

Study Overview
=================
Brief Summary
-----------------
The patterns of tooth loss are evaluated in many selected populations in numerous countries and so the frequency of partial edentulism seems to vary widely between different countries. The prevalence of various patterns of partially edentulous arches should be frequently revised and updated . This could help identify the changing treatment needs of the population and provide guidelines to prevent tooth loss emphasis should be placed on dental education, improve the quality of prosthodontic care being provided to patients oral and general health promotion which should highlight the control of common oral diseases such as caries at their various stages of progression and periodontal diseases. Additionally, regular dental check-ups should be made mandatory at schools, colleges and workplaces and community field trips should be conducted in order that increase in oral health awareness can also discourage patients attitude waiting until acute symptoms develop. According to our knowledge, no available studies investigated the prevalence of partial edentulism among patients in faculty of dentistry Cairo university. Therefore, this study wouldbe of valuable information to oral health planners for proposing strategies that will help dentalhealth care management in faculty of dentistry Cairo,

Detailed Description
-----------------
study will be conducted on Patients above age of 20 years irrespective of sex, race, socioeconomic status having partially edentulism in either or both the arches to detect incidence and occurence of partial edentlism then detect its prevalance

Official Title
-----------------
Prevalence of Partial Edentulism Among Patients of Faculty of Dentistry Cairo University

Conditions
-----------------
Partial-edentulism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study population who satisfied following criteria were included in the study: Patients above age of 20 years irrespective of sex, race, socioeconomic status having partially edentulism in either or both the arches Individuals who are willing and cooperative for study Exclusion Criteria: Completely edentulous patients, patients with teeth extracted for orthodontic purpose Patients with an only missing third molar, un erupted or congenitally missing teeth, root tips,and loose teeth that were indicated for extraction were not included in the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Different Kennedy classes | Prevalence of partial edentulism among patients of Faculty of Dentistry Cairo University | through study completion, an average of 1 year |