linjc16/ctgov huggingface dataset:
Perfusion Index (PI) and Pleth Variability Index (PVI) in Patients With Interscalene Blocks in Orthopedic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to: To describe effects of interscalene nerve blocks on perfusion index (PI) and pleth variability index (PVI) (Radical 7, Masimo Cooperation, Irvine, CA) before and after induction of general anesthesia. To compare effects of fluid-bolusing on PI and PVI of the anesthetized and non-anesthetized limb.

Official Title
-----------------
An Evaluation of PI and PVI (Masimo) in Patients With Interscalene Blocks in Orthopedic Surgery

Conditions
-----------------
Perfusion Index and Pleth Variability Index, Interscalene Blocks, Orthopedic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for shoulder or upper arm surgery ASA 1-3 written informed consent approval from the local ethics committee Exclusion Criteria: arrhythmia patients suffering from severe vascular disease, coronary artery (CCS IV) disease anaemia (haemoglobin < 7mg/dl) patients in whom a tidal volume of 8ml/kg cannot be delivered safely

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?
-----------------
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
-----------------
PI, PVI, Interscalene block
Clopidogrel Response in Acute Ischemic Stroke. The Bochumer CRISP Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to determine the prevalence rate and risk factors for chemical laboratory clopidogrel low-response (CLR) in the acute phase after an ischemic stroke.

Official Title
-----------------
Prevalence of Low Response to Clopidogrel in Patients After Acute Ischemic Stroke.

Conditions
-----------------
Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute ischemic stroke admittance to stroke unit clopidogrel medication Exclusion Criteria: no consent prior bleeding disorders severe liver disorders current gastrointestinal disorders congestive heart failure life-threatening malignancies

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 |
| --- | --- |
| acute ischemic stroke<br>Determing cardiovascular risk factors or medication on clopidogrel response rates after an acute ischemic stroke | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Result of platelet function test | Aggregometry result of antiplatelet therapy | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Clopidogrel, Aggregometry, Antiplatelet therapy, Platelet function tests
Personality Type as a Predictor to Develop Depression and Reduction in Quality of Life Among Stroke Survivals.

Study Overview
=================
Brief Summary
-----------------
Personality type as a predictor to develop depression and reduction in quality of life among stroke survivals.

Official Title
-----------------
Personality Type as a Predictor to Develop Depression and Reduction in Quality of Life Among Stroke Survivals.

Conditions
-----------------
Stroke, Depression, Quality of Life, Personality Type

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any stroke, age 40-90, able to sigh informed concent, able to fill in the questionnaires. Exclusion Criteria: non stroke, previous depression, not able to give consent or answer the questions.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- |
| 1. Harm Avoidance<br>Personality type | |
| 2. Reward Dependence<br>Personality type | |
| 3. Novelty Seeking<br>Personality type | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression |  | 1-3 month post stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL post stroke |  | 1-3 month post stroke |
Effects of Folic Acid Supplementation on Arsenic Lowering

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether folic acid supplementation are effective on arsenic lowering in a chronic, low-level arsenic exposed population.

Detailed Description
-----------------
Outcome measure: Changes of arsenic metabolites at baseline and week 8 Methods High-performance liquid chromatography (HPLC)

Official Title
-----------------
Efficacy and Safety of Folic Acid Supplementation Lowering Arsenic in a Chronic, Low-level Exposed Arsenic Population: a Randomized, Double-blind, Placebo Controlled Clinical Trial.

Conditions
-----------------
Arsenic Poisoning, Toxic Effect of Arsenic and Its Compounds

Intervention / Treatment
-----------------
* Drug: folic acid supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women more than 18 years of age and chronically exposed to arsenic (arsenic concentration of the drinking water >10ug/L); Population who had no folic acid supplementation in the 2 weeks before the study; Women of childbearing age agreed to use a reliable contraception method during the study; Everyone volunteered to participate and signed informed consent. Exclusion Criteria: Pregnant or breast-feeding women; Allergic to folic acid; Having clearly defined allergic history; Reported long-term use of folic acid and other vitamins B; Having obvious signs or laboratory abnormalities which could affect the efficacy of folic acid; Unsuitable to participate in the study based on the judgment of the investigators; Not agree to cancel the medications which may affect serum folate concentration during the study period; Subjects who plan to become pregnant during the study or move out of the area within the study period;

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: Prevention
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: folic acid<br>folic acid supplementation placebo controlled | Drug: folic acid supplementation<br>* 0.8mg folic acid/day<br>* Other names: placebo controlled;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of urine arsenic metabolites between baseline and week 8 |  | baseline, week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clinical trial, folic acid, arsenic induced health problem, modifying effects, oxidative damage
Short Course Radiation Therapy in Palliative Treatment

Study Overview
=================
Brief Summary
-----------------
The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation treatment in patients with symptomatic advanced head and neck cancer.

Detailed Description
-----------------
The study wants to define the maximum tolerated dose (MTD) of a conformal short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of metastatic or locally advanced head and neck cancer.

Official Title
-----------------
Short Course Accelerated Radiation Therapy in Palliative Treatment of Advanced Head and Neck Malignancies

Conditions
-----------------
Palliative Care

Intervention / Treatment
-----------------
* Radiation: Short course radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically proven locally advanced or metastatic H&N cancer excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status age > 18 years Eastern Cooperative Oncology Group (ECOG) performance status < 3 Exclusion Criteria: prior RT to the same region.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short course radiotherapy<br>The radiotherapy is delivered over two days with accelerated hypo-fractionation was delivered | Radiation: Short course radiotherapy<br>* An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with metastatic or locally advanced head and neck cancer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose | The maximum tolerated dose is defined as the dose level below the highest administered dose associated with dose limiting toxicity (DLT) in at least one third of patients | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity | Acute toxicity after treatment is evaluated with CTCAE scale | 1 year | 
| Quality of life | Quality of life after the treatment is evaluated according to CLAS scale | 1 year | 
| Pain relief | Pain after the therapy is evaluated with the visual analogic scale | 1 year | 
| Late toxicity | Late toxicity after the treatment is evaluated with EORTC-RTOG scale | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
palliative care, head and neck cancer, radiotherapy, pain, quality of life
Effects of Intranasal Oxytocin on Striatal Functional Connectivity

Study Overview
=================
Brief Summary
-----------------
To investigate whether 40 IU of intranasal oxytocin treatment can influence the resting-state functional connectivity in healthy males.

Detailed Description
-----------------
In a double-blind, between-subject, placebo controlled design, investigators plan to investigate the effects of oxytocin treatment on resting-state functional connectivity. Subject will receive either intranasal oxytocin or placebo administration and go through a seven-minute resting-state scan in MRI scanner to test whether oxytocin changes functional connectivity in the brain. Trait anxiety and mood questionnaires will be administered as control variables.

Official Title
-----------------
Effects of Intranasal Oxytocin on Striatal Functional Connectivity in Healthy Males

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

Intervention / Treatment
-----------------
* Drug: Oxytocin
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects without past or current psychiatric or neurological disorders Exclusion Criteria: with MRI Contraindications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin<br> | Drug: Oxytocin<br>* Oxytocin, intranasally administrated<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebos<br>* Saline, intranasally administrated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Striatal functional connectivity alterations after drug administration | fMRI-based resting state connectivity of the striatum will be compared between the oxytocin and the placebo group | 45 minutes after drug administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxytocin, Resting-state, Functional connectivity, BOLD
Fetal Heart Interventricular Septum in Fetuses of Diabetic Mothers

Study Overview
=================
Brief Summary
-----------------
The investigators asume that the measurement of the fetal heart interventricular septum can serve as a good tool to predict glucose control in pregnant patients with diabetes mellitus. The investigators will measure the septum width in patients with Diabetes and will correlate to standard measurements of the glucuse levels.

Detailed Description
-----------------
In this study the investigators will follow patients with Diabetes Mellitus - mainly gestational. the investigators will measure the width of the interventricular septum and correlate with conventional measures of blood glucose measurements in this population. The investigators will try to assess whether measurement of the septum can be an earlier and better predictor of glucose control in this population.

Official Title
-----------------
Relation Between Fetal Heart Interventricular Septum Size and Gestational Diabetes Mellitus Control. a Prospective Trial

Conditions
-----------------
Pregnancy, Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consequtive pregnant women with Diabetes Mellitus - Gestational and non Gestational Exclusion Criteria: .No willing to participate. Suspected Heart anomaly

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetes Mellitus in pregnancy<br>Our cohort will include all consequtive women with Diabetes Mellitus atending our clinic | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| width of fetal interventricula heart septum | The investigator will assess the width of the fetal interventricular septum in patients with diabetes. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose control in patients with normal and abnormal interventricular septal width | The investigators will try to show that small interventricular septal width glucose correlates with good glucose control | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Pregnancy
Expression of IRAK1 Gene rs1059703-related Single- Nucleotide Polymorphisms in Egyptian Patient With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis (RA) is known as a long-lasting inflammatory autoimmune disease affecting the diarthrodial joints, which is diagnosed by inflammation and hyperplasia in synovium, generation of RF and anti-citrullinated protein antibody (ACPA), deformity of cartilage and bone, systemic injuries involving cardiovascular, pulmonary, psychological, and skeletal disorders (McInnes and Schett., 2011).

Official Title
-----------------
Expression of IRAK1 Gene rs1059703-related Single- Nucleotide Polymorphisms in Egyptian Patient With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis (RA)

Intervention / Treatment
-----------------
* Genetic: PCR polymorphism


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: approval to sign an informed written consent, patient diagnosed rheumatoid arthritis, patient age range 17-85 year and both sexes are included. Exclusion Criteria: Refusal to sign an informed written consent and patient with other autoimmune disease.

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Normal control | Genetic: PCR polymorphism<br>* PCR polymorphism in Rhomatoid arthritis patients in Egypt<br>|
| Active Comparator: Group 2<br>Diagnosed Rhomatoid arthritis patients | Genetic: PCR polymorphism<br>* PCR polymorphism in Rhomatoid arthritis patients in Egypt<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rs1059703 PCR polymorphism in rhomatoid arthritis patients | PCR polymorphism | 1 year |
Pennington Center Longitudinal Study (PCLS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a cohort of volunteers that can be studied and followed up into the future for changes in health behaviors and development of health problems.

Detailed Description
-----------------
The PCLS represents an effort to utilize the data collected over the last twenty years during the clinical research studies conducted at Pennington Biomedical Research Center. A cohort will be developed and used for cross-sectional analyses, as well as followed prospectively for the development of a variety of health-related outcomes. Several data sources from the PBRC clinical database will be used to establish the PCLS database, including screening, archive and study-specific data. The only protocol specific to the PCLS study is the collection of blood sample for risk factor determination and storage in the PBRC archive bank, only to be invoked in cases where studies do not include a blood draw as part of their protocol.

Official Title
-----------------
Pennington Center Longitudinal (PCLS)

Conditions
-----------------
Health Behaviors, Development of Health Problems

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older volunteer to Participate Exclusion Criteria: younger than 18 years Pregnant

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 |
| --- | --- | --- |
| Cross-sectional analyses database | The only protocol specific to the PCLS study is the collection of blood sample for risk factor determination and storage in the PBRC archive bank, only to be invoked in cases where studies do not include a blood draw as part of their protocol. The PCLS represents an effort to utilize a data collection over the last twenty years during the clinical research studies for cross-sectional analyses, as well as followed prospectively for the development of a variety of health-related outcomes. | twenty-years |
Cyclophosphamide Drug Interaction Study In Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the potential pharmacokinetic interaction between oral GW679769 and IV (intravenous) cyclophosphamide when administered to cancer patients.

Official Title
-----------------
An Open Label, Repeat Dose, Randomized, Two Period Crossover Study to Investigate the Potential Pharmacokinetic Interactions Between Oral GW679769 and Intravenous Cyclophosphamide in Cancer Patients

Conditions
-----------------
Nausea and Vomiting, Chemotherapy-Induced

Intervention / Treatment
-----------------
* Drug: Oral GW679769
* Drug: IV Cyclophosphamide 500-700mg/m2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of cancer. Undergoing chemotherapy with a cyclophosphamide regimen with a cyclophosphamide dose of 500 - 700 mg/m2 and a cycle duration of 14-28 days. Adequate hematologic, renal and hepatic function. Exclusion Criteria: Pregnant or lactating. CNS (central nervous system) metastases. Active systemic infection or any other poorly controlled medical condition. Patients cannot take CYP3A4 inhibitors within 7 days of study treatment or CYP3A4 inducers within 48 days of study treatment.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>cyclophosphamide + dexamethasone + ondansetron | Drug: IV Cyclophosphamide 500-700mg/m2<br>* IV Cyclophosphamide 500-700mg/m2 on day 1 of each cycle<br>* Other names: Oral GW679769;|
| Experimental: Arm B<br>cyclophosphamide + dexamethasone + ondansetron + GW679769 | Drug: Oral GW679769<br>* 150mg oral, once daily on days 1-3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax and AUC of cyclophosphamide and 4-hydroxycyclophosphamideSafety and tolerability parameters including pharmacoeconomics, blood pressure, heart rate, ECG, laboratory tests, clinical observation and adverse event reporting. |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Terminal t1/2, Vd, and Cl of cyclophosphamideTerminal t1/2 of 4-hydroxycyclophosphamideAUC ratio of 4-hydroxycyclophosphamide and cyclophosphamideANC nadir |  | throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cyclophosphamide, CINV, Chemotherapy induced nausea and vomiting