RESEARCH PROJECTS APPROVED BY CMRC
1423-1424 A.H. (2002-2003)
|
S.No. |
Project Title |
Principal |
Date |
|
1) 02-443 |
Investigator Approved.
An open-label, randomized, multicenter, Phase IIIb, parallel group study to compare the efficacy and safety of rosuvastatin and atorvastain in subjects with type IIa and IIb hyperchole sterolemia. |
Dr.M. Arafah
(Medicine) |
19.02.1424
21.04.2003 |
|
2) 03-444 |
Immunopathogenesis of conjunctival remodeling in vernal keratoconjunctivitis. |
Prof. A. Abu El-Asrar
(Ophthalmology) |
30.12.1423
03.03.2003 |
|
3) 03-445 |
Expression of CXCR3- binding chemokines in vernal keratoconjunctivitis. |
Prof. A. Abu El-Asrar
(Ophthalmology) |
30.12.1423
03.03.2003 |
|
4) 03-446 |
Evaluation of nitrous oxide in the gas mixture for anesthesia: a randomized, controlled trial (ENIGMA trial). |
Dr. A.Samarkandi
(Anesthesia) |
28.01.1424
31.03.2003 |
|
5) 03-447 |
Prevalene of human parvovirus B19 in blood donors and patients with chronic hemolytic disorder. |
Dr. Mona Badr
(Pathology) |
25.03.1424
26.05.2003 |
|
6) 03-448 |
Effects of natural honey and amoxicillin against gastric lesions induced by chronic administration of ammonia in rats. |
Prof. A.T.M. Ali
(Pharmacology) |
09.04.1424
09.06.2003 |
|
7) 03-449 |
Bispectral index (BIS) and titration of anesthetics in off pump coronary artery bypass (CAB). |
Dr. A.Samarkandi
(Anesthesia) |
23.04.1424
23.06.2003 |
|
8) 03-454 |
Role of Leptin in non-alcoholic fatty liver disease. |
Prof. I. Al-Mofleh
(Medicine) |
23.04.1424
23.06.2003 |
SUMMARIES OF CMRC-APPROVED PROJECTS
1423 to 1424 (2002-2003)
cmrc research grant no. 02-443
Project Title: An open-label, randomized, multi-center, phase IIIb, parallel group study to compare the efficacy and safety of rosuvastatin and atorvastatin in subjects with type IIa and IIb hypercholesterolemia.
Principal Investigator: Dr. Mohamed Arafah
Department: Medicine
Co-investigators:
Date Approved: 19.02.1424 (21.04.2003)
Project Summary:
This study will be conducted in about 2023 enrolled subjects in order to provide 1362 evaluable subjects. It is planned that each center will enroll a minimum of 9 subjects. The primary objective of the study is to compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS LDL-C target goals after 12 weeks of therapy.
This is a randomized, multi-center, open-label, 2 arm, and parallel group study. Subjects will be selected from primary care physician practices from a primary or secondary prevention subject population, male or female, 18 years or older, with primary hypercholesterolemia and with the following characteristics: (a) subjects switched from start doses of other lipid lowering therapy should have an LDL-C level >3.1 mmol/L (120 mg/dL); (b) naïve subjects should have an LDL-C level >3.5 mmol/L (135 mg/dL); (c) CV risk >20% (as defined in The Joint European Guidelines) or a history of CHD or other established atherosclerotic (Appendix K) disease. Key exclusion criteria: history of SAE with another HMG-CoA reductase inhibitor; active liver disease, severe hepatic or renal impairment, treatment with cyclosporine or any disallowed drug, subjects with unstable angina.
Subjects will be randomized to be treated for 12 weeks with rosuvastatin 10 mg or atorvastatin 10 mg therapy once daily (see figure 1, study flow chart). At the end of the 12 week-study period, subjects may continue on rosuvastatin treatment in an open extension period up to local launch time subject to local regulations. Subjects will be evaluated based on an intention to treat (ITT) population. The ITT population will consist of subjects who have a baseline reading, one week 12 reading and at least one dose of trial medication. If a subject is withdrawn prior to week 12, then the last post baseline assessment taken will be carried forward as the week 12 value.
The analysis will investigate the numbers of subjects reaching and not reaching target on rosuvastatin and atorvastain at week 12. This will be compared using a logistic regression analysis with factors being fitted for treatment, country and subject type (naïve or switched) and treatment-by-patient type interaction and the pre-dose lipid parameter value fitted as a covariate. If the treatment-by-patient type interaction term is found to be significant (p£0.05), the nature of the interaction will be investigated; otherwise the term will be dropped from the final model. The results will be presented as odd ratios, with associated 95% confidence interval and p-value.
The demographic characteristics of height, weight, body mass index, blood pressure and smoking status, along with Coronary Heart Disease (yes/no) and 'actual risk' factors will be summarized by treatment group and will be summarized for all subjects (both treatment groups combined). Data regarding medical history, physical examination findings, concomitant medications will also be recorded.
The incidence of adverse events will be summarized by treatment dose. With regard to laboratory safety data, change from baseline and percentage of values out-of-range will be described over time.
Data from different countries may be pooled in order to perform a similar comparison across a number of countries. Assumptions of the analyses will be explored and, if necessary, appropriate transformations or non-parametric analysis techniques will be used.
cmrc research grant no. 03-444
Project Title: Immunopathogenesis of conjunctival remodeling in vernal keratoconjunc-tivitis.
Principal Investigator: Prof. Ahmed M. Abu El-Asrar
Department: Ophthalmology
Co-investigators: Dr. Samir Al-Mansouri, Prof. K. Geboes
Date Approved: 30.12.1423 (03.03.2003)
Project Summary:
Vernal keratoconjuctivitis (VKC) is an allergic chronic seasonally exacerbated bilateral external ocular inflammation. Chronic conjunctival inflammation in VKC is associated with conjunctival remodeling, in particular epithelial hyperplasia, extensive deposition of extracellular matrix proteins, and possibly angiogenesis. The mechanisms by which chronic conjunctival inflammation in VKC promotes conjunctival remodeling have not been clarified yet. The aims of this study are to investigate the processes involved in mediating conjunctival remodeling in VKC by investigating the expression of: (1) epidermal growth factor receptors (EGFR); (2) vascular endothelial growth factor (VEGF), transforming growth factor-b (TGF-b), basic fibroblast growth factor (bFGF), and platelet derived growth factor (PDGF); (3) the integrin receptors a3, and a6 subunits; and (4) Ki67 antigen which is a marker for cell proliferation. Conjunctival biopsy specimens from 20 subjects with active VKC, and 10 control subjects will be studied by immunohistochemical techniques using a panel of monoclonal and polyclonal antibodies directed against the integrins a3, and a6 subunits, Ki67 antigen, EGFR, VEGF, TGF-b, bFGF, and PDGF. The phenotype of inflammatory cells expressing growth factors will be examined by sequential double immuno-histochemistry.
cmrc research grant no. 03-445
Project Title: Expression of the CXCR3-binding chemokines in vernal keratoconjunc-tivitis.
Principal Investigator: Prof. Ahmed M. Abu El-Asrar
Department: Ophthalmology
Co-investigators: Dr. Soliman Al-Kharashi, Prof. J. Van Damme, Prof. K. Geboes
Date Approved: 30.12.1423 (03.03.2003)
Project Summary:
Vernal keratoconjunctivitis (VKC) is an allergic chronic seasonally exacerbated bilateral external ocular inflammation. Massive infiltration of activated T lymphocytes bearing the chemokine receptor CXCR3 is a hallmark of the lesions of VKC. Several studies demonstrated that CD4+ T lymphocytes in VKC express T helper-2 type cytokines that might play a central role in the pathogenesis of VKC. The mechanisms governing the recruitment of T lymphocytes to the conjunctiva in VKC are not fully understood. The use of chemokine antagonism as a strategy to inhibit leukocyte trafficking into inflammatory sites requires identification of the dominant chemokines mediating recruitment in specific pathologies. The aim of this study is to examine the expression of the 3 interferon-g (IFN-g)-inducible CXCR3-binding chemokines CXCL10/IP-10 (IFN-g-inducible protein of 10 KDa), CXCL9/Mig (monokine induced by IFN-g), and CXCL11/I-TAC (IFN-inducible T-cell a chemoattractant) in the conjunctiva of patients with VKC. These chemokines exhibit potent T lymphocyte chemoattractant activity.
Conjunctival biopsy specimens from 20 patients with active VKC and 10 control subjects will be studied by immunohistochemical techniques using a panel of monoclonal antibodies directed against IP-10, Mig, and I-TAC. The phenotype of inflammatory cells expressing chemokines will be examined by double immunohistochemistry.
cmrc research grant no. 03-446
Project Title: Evaluation of nitrous oxide in the gas mixture for anesthesia: A randomized controlled trial.
Principal Investigator: Dr. Abdulhamid H. Samarkandi
Department: Anesthesia
Co-investigators: Dr. Abdulazeem El-Dawlatly, Dr. Ahmed Turkistani, Dr. Wadha Al-Otaibi
Date Approved: 28.01.1424 (31.03.2003)
Project Summary:
There are some compelling reasons to question the routine use of N2O. It is clear that brief exposure to N2O impairs methionine synthetase, DNA production, red and white blood cell formation. Tissue hypoxia may be more common. These adverse effects are enhanced in sick high risk patients. The extent of wound infection and cardiac morbidity associated with N2O is not known. Large outcome trial data are lacking. Therefore, the present large multicenter randomized controlled study is going to be conducted in collaboration with Prof P. Myles from Alfred Hospital in Australia (principal investigator). Two groups of patients will be studied, Group I, where N2O 70% will be used with the mixture of gases, Group 2 where no N2O will be used. The following measurements will be taken:
Primary endpoint: hospital length of stay; secondary endpoints: wound infection, severe vomiting, quality of recovery, ICU length of stay and 30-day mortality; safety endpoints: myocardial infarction, venous thromboembolism, stroke, awareness, blood transfusion pneumonia or pneumothorax.
Study duration: 3 years. Interim analysis will be performed after enrolment of 800 and 1500 patients; results will be made available to the Data Monitoring & Safety Committee (DMSC) (stopping rule: p-value less than 0.001).
cmrc research grant no. 03-447
Project Title: Prevalence of human parvovirus B19 in blood donors and patients with chronic hemolytic disorders.
Principal Investigator: Dr. Mona A. Badr
Department: Pathology
Co-investigators: Dr. Medhat Shier, Dr. Khadija Kurbaan
Date Approved: 25.03.1424 (26.05.2003)
Project Summary:
Background: Human parvovirus 19 is a non-enveloped, single stranded DNA virus with a predilection for infecting rapidly dividing cell lines such as bone marrow erythroid progenitor cells. Parvovirus B19 effect ranges from asymptomatic infection to life-threatening aplasia, fetal anemia and death in utero.
Project significance: Human parvovirus has been associated with several diseases: erythema, infectiosum, aplastic crisis in chronic hemolytic anemia, arthritis and intrauterine infection with hydrops fetalis. Parvovirus B19's site of replication is the red blood cell precursor in the bone marrow. Infection will cause a temporary shutdown in the red blood cell population. This causes a significant drop of hemoglobin content, especially in patients with chronic hemolytic disorders. Transmission of human parvovirus B19 by blood is well documented. Blood transfusion testing for human parvovirus B19 is particularly important in the risk patient group that needs multiple blood transfusions, like patients with chronic hemolytic disorders.
Project aims: This project will aim to study prevalence of human parvovirus B19 infection of blood donors at KKUH. The study will also determine prevalence of parvovirus B19 infection in a group of patients with chronic hemolytic disorders visiting the outpatient clinic.
Project approach and tools: Blood donors will be tested using specific IgM and IgG antibodies using Enzyme Linked Immunosorbent Assay (ELISA). The patients will be tested for specific IgM and IgG parvovirus B19 antibodies, and parvovirus B19 DNA using real-time PCR. Comparison will also be made between detection of human parvovirus B19 infection using ELISA technique and real-time PCR.
cmrc research grant no. 03-448
Project Title: Effects of natural honey and amoxycillin against gastric lesions induced by chronic administration of ammonia in rats.
Principal Investigator: Prof. A.T. Mobarok-Ali
Department: Medical Pharmacology
Co-investigator: Dr. Mouied Alashari
Date Approved: 09.04.1424 (09.06.2003)
Project Summary:
Background: There is evidence to suggest that the gastrointestinal lesions occur as a result of imbalance between the aggressive and defensive factors. Numerous studies have shown that Helicobacter pylori are associated with chronic gastritis and peptic ulcer diseases. H. pylori have high urease activity resulting in high concentration of ammonia in the stomachs of H. pylori-infected patients. Since ammonia is highly cytotoxic, its production by urease of H. pylori makes it an important aggressive factor in mucosal injury.
Importance: Both honey and amoxycillin have been shown to possess gastric protection effects against different models of experimentally induced gastric lesions. Recently, honey has been shown to afford protection against acute ammonia-induced gastric lesions in rats. Successful completion of this project may provide the scientific support for the use of honey alone or in combination with amoxycillin in the treatment of peptic ulcer diseases associated with H. pylori.
Aim: To investigate the potential gastroprotective effects and the possible mechanisms(s) of action of honey and amoxycillin given orally either alone or in combination on gastric lesions induced in rats by chronic administration of ammonium hydroxide.
Method: Ammonium hydroxide 0.1% or 0.2% in a volume of 1 ml will be given daily orally to the different groups of animals for a period of 4 or 6 weeks. Different doses of honey and amoxycillin either alone or in combination will be given orally twice daily for a period of 4 or 6 weeks. Control groups will receive water. Animals will be killed after 4 or 6 weeks and macroscopic, biochemical, and histopathological evaluation will be performed by using appropriate standard method discussed in the method sections.
cmrc research grant no. 03-449
Project Title: Bispectral index (BIS) and titration of anesthetics in off-pump coronary artery bypass (CAB).
Principal Investigator: Dr. Abdulhamid H. Samarkandi
Department: Anesthesia
Co-investigators: Dr. Waleed Riad, Dr. Mohammad Essam, Dr. Khalid Abdullah
Date Approved: 23.04.1424 (23.06.2003)
Project Summary:
For mainly economic reasons, the recent trend in cardiac surgery has been to extubate patients during the early postoperative period. Awareness after
anesthesia is of concern to patients and anesthesiologists alike especially in cardiac surgery. The BIS can be used intraoperatively to reduce the amount of anesthetics without increase in incidence of awareness.
The aim of this study is to evaluate the bispectral index (BIS) as a newly introduced monitoring tool in cardiac surgery, for assessment of depth of anesthesia and its effects on titration of anesthetic use and incidence of awareness.
This is a controlled, prospective, randomized, and double-blind study. It will include 40 patients of both sexes, ASA II-IV, who requires off-pump coronary artery bypass graft surgery (OPCABG). Patients will be divided randomly into two groups, the BIS and the control groups. BIS group will be managed according to the BIS monitoring with a target value of 50.
Control group will be managed clinically, as usual without the use of BIS monitoring.
Anesthesia is to be induced with sufentanil, midazolam and rocuronium. The rate of infusion and bolus doses of these anesthetic agents to be changed and controlled as necessary as indicated by either the BIS reading value of 50 (in the BIS group), or clinical judgment (in the control group), and if needed sevoflurane may be
added. All patients will be interviewed twice at the end of the first 2 days postoperatively to measure the incidence of awareness.
cmrc research grant no. 03-454
Project Title: Role of leptin in non-alcoholic fatty liver disease (NAFLD).
Principal Investigator: Prof. Ibrahim I. Al-Mofleh
Department: Medicine
Co-investigators: Dr. Reda Al-Badawy, Dr. Eman El-Eteer, Prof. Faleh Al-Faleh, Prof. Hussain Al-Freihi, Dr. Saleh Al-Amro
Date Approved: 23.04.1424 (23.06.2003)
Project Summary:
Non-alcoholic fatty liver disease (NAFLD) is a chronic liver disease characterized by diffuse fatty infiltration and inflammation. It has a worldwide distribution. Patients with NAFLD are more susceptible to develop liver cirrhosis than patients with steatosis. Moreover, liver-related mortality for patients with NAFLD is high. Interestingly, NAFLD recurred in 33% of patients who underwent liver transplantation and 12.5% progressed to cirrhosis within one year of transplant.
The pathogenesis of NAFLD is yet to be clearly elucidated. Leptin, an (Ob-gene) product is now receiving a great attention in liver disease. It is produced from adipose tissue as well as extra-adipose tissues like the stellate cell of the liver. Additionally, sinusoidal endothelial cell and Kupffer cells express functional Obese Receptor (Ob-R), through which leptin increases tissue growth factor b (TGFb mRNA) which is a major candidate of fibrosis. Therefore, it is postulated that leptin is one of the key mediators of progression of hepatic fibrosis in patients with NAFLD.
From the above-mentioned data, we found it interesting to investigate the role of leptin in NAFLD by measuring serum leptin levels and correlating these levels with biochemical markers of liver disease and results of liver biopsy.
For this purpose 100 NAFLD patients will be studied and divided into two groups: (a) HCV NAFLD group, and (b) diabetic and hyperlypidemic NAFLD group. Apparently, 50 healthy volunteers will be considered as control group matched for age and sex.
CMRC ACHIEVEMENTS
RESEARCH PROJECTS APPROVED BY CMRC
1424-1425 A.H. (2003-2004)
|
S.No. |
Project Title |
Principal |
Date |
|
1) 01-420 |
Information disclosure and ethical decision-making in Saudi Arabia. |
Prof. A. Al-Mobeireek
(Medicine) |
12.04.1425
12.04.1425 |
|
2) 03-450 |
Hemoglobin desaturation after off succinylcholine- induced apnea in patients. |
Dr. A. Samarkandi
(Anesthesia) |
13.11.1424
05.01.2004 |
|
3) 03-451 |
Oral megapulse methyl-prednisolone in alopecia universalis, totalis & ophiasis. |
Prof. M.Al-Khawajah
(Dermatology) |
25.12.1424
16.02.2004 |
|
4) 03-452 |
Diabetic complications in Saudi Arabia:a retros-pective study of 1000 diabetic patients. |
Prof. J. Al-Wakeel
(Medicine) |
13.11.1424
05.01.2004 |
|
5) 03-453 |
Impairment of neuro- physiological and cognitive functions in renal failure. |
Prof. J. Al-Wakeel
(Medicine) |
13.11.1424
05.01.2004 |
|
6) 03-456 |
The production of PGE2 and the eosinophil chemokines, eotaxin, and IL-5 in the serum of Asthmatic Saudi patients. |
Dr. M. Alzoghaibi
(Physiology) |
13.11.1424
05.01.2004 |
|
7) 03-457 |
The effect of Ramadan fast on pulmonary function in asthmatic and healthy subjects. |
Dr. H. Mubarak
(Medicine) |
13.11.1424
05.01.2004 |
|
8) 03-458 |
Effects of Islamic fasting during Ramadan on daytime alertness, mood, cognitive function, and chronotype. |
Dr. A. Bahammam
(Medicine) |
13.11.1424
05.01.2004 |
|
9) 03-459 |
Lung function and respi-ratory findings in subjects exposed to crude oil spill in sea water. |
Dr. S. Meo
(Physiology) |
25.12.1424
16.02.2004 |
|
10) 03-460 |
Haemostatic changes in laparoscopic cholecys- tectomy. |
Prof. A.M.A. Gader
|
12.04.1425
31.06.2004 |
|
11) 03-461 |
Use of dexamethasone to reduce postoperative vomiting and pain after paediatric tonsillectomy procedures. |
Dr. A. Samarkandi
(Anesthesia) |
23.01.1425
14.03.2004 |
|
12) 03-462 |
A double-blind, randomized, placebo-controlled, multicenter trial to investigate the efficiency and tolerability of topiramate in prolonged migraine prevention. |
Prof. A. Al-Tahan
(Medicine) |
22.01.1425
13.03.2004 |
|
13) 03-464 |
The dose of succinyl-choline required for excellent intubating conditions. |
Dr. A. Samarkandi
(Anesthesia) |
26.04.1425
14.06.2004 |
|
14) 03-465 |
Efficacy and safety of infliximab in panuveitis |
Prof. A.Abu El-Asrar
(Ophthalmology) |
12.04.1425
31.05.2004 |
|
15) 03-466 |
Serum antioxidant enzymes granulocytes chemotactic protein (GCP-2) levels in comparison to nterleukin-8 in Crohn's Saudi patients. |
Dr. M. Alzoghaibi
(Physiology) |
08.02.1425
29.03.2004 |
|
16) 03-468 |
Randomized prospective study to see the effect
of botulinum – a toxin intravesically as a solo treatment for non-compliant neuropathic bladder. |
Dr. K. Fouda-Neel
|
20.11.1424 |
|
17) 04-471 |
Clinical utility of amlodipine/atorvastatin to improve concomitant cardiovascular risk factors of hypertension and dyslipidemia. |
Prof. J. Al-Wakeel
(Medicine) |
21.03.1425
10.05.2004 |
|
18) 04-472 |
Expression of apoptosis markers in retinas of human subjects with diabetes. |
Prof. A.Abu El-Asrar
(Ophthalmology) |
08.02.1425
29.03.2004 |
|
19) 04-473 |
Hepatitis B genotypes in Saudi Arabia and its effect on clinical progression of hepatitis B. |
Dr. A. Abdo
(Medicine) |
12.04.1425
30.05.2004 |
|
20) 04-474 |
Utility of measuring protein-S level in reptilase time in patients with liver disease. |
Dr. A. Abdo
(Medicine) |
12.04.1425
30.05.2004 |
|
21) 04-475 |
Blood pressure contrl and salt intake in Saudi diabetic hypertensive patients. |
Dr. K. Alsuwaida
(Medicine) |
04.05.1425
22.06.2004 |
SUMMARIES OF CMRC-APPROVED PROJECTS
1424 to 1425 (2003-2004)
cmrc research grant no. 01-420
Project Title: Information disclosure and ethical decision-making in Saudi Arabia.
Principal Investigator: Prof. Abdullah F. Al-Mobeireek
Department: Medicine
Co-investigator: Prof. Feisal Al-Kassimi
Date Approved: 12.04.1425 (31.05.2004)
Project Summary:
Physician-patient relationship is an old subject that has faced new challenges in the past few decades. This is due to the vast development in the 'electronic' information era and diagnostic and therapeutic modalities. The role of the patient, his family, and the doctor in the decision-making process is subject now to controversial positions, which are influenced to a large extent by cultural values and norms. Despite a wealth of studies on this subject in Western countries, studies in Arab countries are very few.
In this study, we propose to study a group of doctors, patients and patient's relatives in different areas of the Kingdom. Our objective is to get insight to their concept of roles of the patient, his relatives and the doctor, and the limits of authority of each party.
We will use a validated instrument (questionnaire) which has been previously used in USA and Japan and, thus, facilitate comparison with our results. This questionnaire contains a number of different clinical scenarios, broadly covering subjects of current importance to the society, such as cancer, human immunodeficiency virus (HIV), physician-assisted suicide (PAS), and ventilation in terminal illnesses.
cmrc research grant no. 03-450
Project Title: Hemoglobin desaturation after of succinylcholine induced apnea in patients.
Principal Investigator: Dr. Abdulhamid H. Samarkandi
Department: Anesthesia
Co-investigators: Dr. Waleed Riad Hussain, Dr. Saleh Al-Harbi
Date Approved: 13.11.1424 (05.01.2004)
Project Summary:
Succinylcholine remains the drug of choice during a rapid-sequence induction of anesthesia. However, it has been demonstrated that spontaneous recovery from 1.0 mg/kg succinylcholine-induced apnea may not occur rapidly enough to prevent hemoglobin desaturation in subjects whose ventilation is not assisted (can't intubate and can't ventilate situation).
The aim of this prospective, randomized study is to investigate whether spontaneous respiration recovers in time to prevent significant hemoglobin desaturation after the administration of smaller doses of succinylcholine in healthy patients.
After preoxygenation with 100% oxygen for 3 min, anesthesia will be induced in 60 patients with 2mg/kg fentanyl and 2mg/kg intravenous propofol. Patients will be randomly allocated to three groups (n=20 each) to receive either 0.56, 1.0 mg/kg succinylcholine or saline (control group). Ventilation will be assisted only if the hemoglobin saturation decreased to 90%. This level of hypoxia is chosen based on the SaO2 tolerated by subjects in studies of pulse oximeter accuracy and hypoxic ventilatory responsiveness.
Throughout the period from loss of consciousness, the investigators will talk gently to patients, reassuring them that all is well and that everything is under control. The duration of apnea and the degree of hemoglobin desaturation will be noted in each group.
cmrc research grant no. 03-451
Project Title: Oral mega pulse methylprednisolone in alopecia universalis, totalis and ophiasis.
Principal Investigator: Prof. Marwan Al-Khawajah
Department: Dermatology
Co-investigator: Dr. Ghada Bin Saif
Date Approved: 25.12.1424 (16.02.2004)
Project Summary:
High dose-intermittent intravenous CS is an alternative method of CS delivery that proved to be safe, well tolerated with a rapid and potent therapeutic efficacy in several diseases including renal transplantation, RA, SLE, multiple sclerosis and pemphigus vulgaris. It has been proven to be effective in the treatment of alopecia areata but not the totalis, universalis or ophiasis types, for which no consistently effective therapy is available. Studies in which IV pulse MP was used in the latter types involved small number of patients and were inconsistent with regard to dosage, frequency or duration of therapy. Most studies used single pulse/cycle or few pulses (2-4) given monthly or at irregular intervals with no or only short follow-up. The dosage of MP ranged from 100mg to 1000mg per day, but lower doses were given more commonly regardless of the weight or age of the patients. The lack of consistency of these studies made it difficult to conclude with certainty on the efficacy of such a valuable and relatively safe, therapeutic modality in the treatment of such sinister subsets of alopecia areata. The need to admit the patient for IV treatment was probably an important deterrent from enrolment of sufficient number of patients. It has been confirmed, however, that oral MP has similar clinical efficacy and range of side effects to that of IV MP, when given in equal doses.
We, therefore, intend to study the short and long-term efficacy including the rate of remission, the time to initial and maximum response and the rate and duration of sustained remission with and without maintenance treatment, as well as the toxicity in alopecia totalis, universalis, and ophiasis on an outpatient basis. The treatment schedule comprises two phases:
1) Induction phase: our aim in this phase is to achieve cosmetically acceptable hair regrowth in at least 90% of the affected scalp areas. By the administration of oral MP sodium succinate as 15 mg/kg/day for 3 consecutive days, bimonthly for a maximum 12 cycles (24 weeks), patients who show less than 90% response will be discharged from the study
2) Maintenance phase: in this phase the re-growing hair will be maintained by the same pulses given at increasingly longer intervals until a relapse-free interval of 24 weeks have been achieved. In case of relapse, however, the treatment intervals will be shortened to that which preceded the one with relapse and the patient will be kept on pulse therapy to maintain hair growth. In either case, patients will be followed up for a minimum of 2 years.
cmrc research grant no. 03-452
Project Title: Diabetic complications in Saudi Arabia: a retrospective study of 1000 diabetic patients.
Principal Investigator: Prof. Jamal S. Al-Wakeel
Department: Medicine
Co-investigators: Prof. Riad Sulimani, Dr. Suleiman Al-Mohaya, Dr. Hani Al-Assad, Dr. Ghulam Malik, Dr. Ali Al-Harbi
Date Approved: 13.11.1424 (05.01.2004)
Project Summary:
This is a retrospective study to determine the complications of diabetes mellitus among Saudi diabetic patients. Hospital files of at least 1000 diabetic patients will be reviewed and important data will be extracted including the demographic characteristics of the patients, age of onset and diagnosis of diabetes, initiation of treatment, modalities used, presence of risk factors, and history of complications. A detailed history of diabetic complications and its pathogenesis will be noted (retinopathy, nephropathy, cardiopathy, hypertension, stroke, amputations) together with interventions done (laser therapy, dialysis, angioplasty, CABG, etc.). This study hopes to present the evolution and prevalence of diabetic complications in Saudi Arabia. Furthermore, we also aim to review the management protocols that have been used together with other factors that may have contributed to the rising incidence of diabetes mellitus among the Saudi population. Currently, there has rarely been an extensive study done on diabetic complications in the Kingdom on or in other centers in Saudi Arabia.
cmrc research grant no. 03-453
Project Title: Impairment of neurophysiological and cognitive functions in renal failure.
Principal Investigator: Prof. Jamal S. Al-Wakeel
Department: Medicine
Co-investigator Dr. Radwan Zaidan, Dr. Nauman Tarif, Dr. Nawaz Memon, Dr. Akram Askrar
Date Approved 13.11.1424 (05.01.2004)
Project Summary:
This is a prospective study to determine the cognitive and electrophysiological impairment in Saudi patients with chronic renal failure and the effect of dialysis in patients with chronic renal failure on the cognitive functions which will run for 15 months. A total of 140 patients (40 patients with moderate renal failure not necessitating dialysis, 80 patients on dialysis, and 20 kidney transplant patients) will undergo cognitive clinical assessment, mini mental status exam (MMS), digit span of Weschler Adult Intelligence Scale (WAIS), electroencephalogram (EEG) and P300. All tests will be done at the Neurophysiology Laboratory of King Khalid University Hospital. Although impairment in cognitive functions in patients with renal failure has been described in previous literatures, there were no studies done in our institution or in other centers in Saudi Arabia.
cmrc research grant no. 03-456
Project Title: The production of PGE2 and the eosinophil chemokines, eotaxin and IL-5 in the serum of asthmatic Saudi patients.
Principal Investigator: Dr. Mohammed Alzoghaibi
Department: Physiology
Co-investigator: Dr. Ahmed BaHammam, Prof. Ali Al-Tuwaijri
Date Approved: 13.11.1424 (05.01.2004)
Project Summary:
Bronchial asthma is a chronic inflammatory disorder characterized by airway inflammation by eosinophils and activated neutrophils (PMNs). The mechanisms that regulate the recruitment of these leucocytes in the inflamed airway are areas of active investigation. Chemokines are a superfamily of 8-10 kd proteins that are potent chemoattractants for leukocytes. The C-C chemokines eotaxin-1, interleukin-5 (IL-5) and the arachidonic acid metabolite, prostaglandin E2 (PGE2) have been implicated in the pathogenesis of asthma. Reactive oxygen species (ROS) have an important role in tissue damage and inflammation. They enhance tissue destruction by damaging the cellular membrane and increase the concentration of the harmful product, lipid peroxide. Superoxide (·O2-) represents the precursor element in the chain production of other ROS. Activated neutrophil is one of the main sources of ·O2- production. The principal objectives of this study are to measure and compare the concentrations of these cytokines with chemoattractant properties for eosinophils in the serum of asthmatic Saudi patients and in normal control subjects using EIA assay and also to measure the levels of superoxide production from its main source, PMNs by chemiluminescence assay. In this study, we will also look at the role of neutrophils in the production of eosinophil chemokines (IL-5, eotaxin-1).
cmrc research grant no. 03-457
Project Title: The effect of Ramadan fast on pulmonary function in asthmatic and healthy subjects.
Principal Investigator: Dr. Hatem F. Al-Mubarak
Department: Medicine
Co-investigator: Dr. Ahmed S. BaHammam
Date Approved: 13.11.1424 (05.01.2004)
Project Summary:
Introduction: The effect of Ramadan fast on human and health has been studied from the biochemical, hormonal, and physiological aspects. It has been our experience that some asthmatics have less control during the month of Ramadan. We hypothesize that Ramadan fasting will cause airway dehydration which will result on changes in pulmonary function and worsening asthma symptoms in mild and moderate asthmatic.
Objectives: (1) To assess the effect of Ramadan fasting on pulmonary function in healthy individuals compared to asthmatic subjects; (2) to assess asthma control during Ramadan month.
Methodology: Thirty male volunteers will be studied; 10 mild to moderate asthmatic Muslims, 10 healthy Muslims and 10 healthy non-Muslims. All volunteers will be evaluated in three occasions. During Shaaban (BL), first week of Ramadan (R1), and third week of Ramadan (R3) to assess the pulmonary function using spirometric testing and to assess asthma control using questionnaire and daily measurements of home peak flow meter.
Utilization: The relationship between Ramadan fasting and asthma control has not been studied before. This study will provide us with a better understanding of such relationship. It will enable us to modify or even renew our approach toward asthma control during the month of Ramadan. This study will also be the basis to explore and study the effect of Ramadan fasting on other obstructive lung disease like emphysema, chronic bronchitis and bronchiectasis.
cmrc research grant no. 03-458
Project Title: Effects of Islamic fasting during Ramadan on daytime alertness, mood, cognitive function, and chronotype.
Principal Investigator: Dr. Ahmed S. BaHammam
Department: Medicine
Co-investigator: Prof. Abdelrahman Al-Tahan
Date Approved: 13.11.1424 (05.01.2004)
Project Summary:
Introduction: During the month of Ramadan many people alter their sleeping habits and stay awake most of the night. Many changes in lifestyle and habit occur during Ramadan like opening stores and shopping malls until late at night. One may assume that the above changes may affect daytime alertness and sleepiness, chronotype and cognitive function of fast performers. Therefore, does Ramadan fasting and its attendant changes in lifestyle affect daytime alertness and circadian pattern?
Objectives: To assess the effect of fasting during Ramadan on chronotype (morningness-eveningness self-assessment questionnaire); to assess the effect of fasting during Ramadan on the cognitive function objectively (event-related evoked potential); to assess the effect of fasting during Ramadan on daytime alertness and mood using the global alertness and mood visual analogue scales (VAS).
Methods: We will study 10 Muslim and 10 non-Muslim male healthy volunteers during Shaban (BL), first week of Ramadan (R1) and third week of Ramadan (R3) to assess cognitive function using event-related evoke potential (200), chronotype using morningness-eveningness questionnaire and alertness and mood using the global alertness and mood visual analogue scales.
Utilization: This project will allow us to assess systematically the potential changes in cognition, chronotype, alertness and mood during Ramadan in Muslims and non-Muslims and to know whether these changes are related to fasting or to the lifestyle changes during Ramadan. Such findings are crucial to refute or accept some conceptions about Ramadan and fasting.
cmrc research grant no. 03-459
Project Title: Lung function and respiratory findings in subjects exposed to crude oil spill in sea waters.
Principal Investigator: Dr. Sultan A. Meo
Department: Physiology
Co-investigator: Dr. Thamir Al-Khalaiwi
Date Approved: 25.12.1424 (16.02.2004)
Project Summary:
In the recent years, the international community has been facing increasingly risks due to major accidents occurring near the marine areas. The Mediterranean zones are most productive and vulnerable areas on the planet but unfortunately their environment is exposed to series of hazards including floods and oil spills in sea water. Oil spill in sea water is one of the most sensitive and highly considerable problem all over the world especially in the oil producing countries. Oil spill in sea water develops many hazardous effects not only to kill the sea life but it also affects the human lives residing in the marine vicinity and whom they are engaged to perform their duties at coastal areas. Recently, the Tasman Spirit, Greek ship was unluckily ran around and got a crack in its center and finally broken into two pieces and oil was spilt into the sea water at marine areas of Karachi, Pakistan. Therefore, the idea is to observe the lung function and respiratory findings in subjects exposed to crude oil spill in sea water.
In this study, a group of 50 apparently healthy volunteer male subjects will be selected from the subjects living in the vicinity and/or performing their duties at the coastal belt areas of Karachi. They will be matched with another group of 50 control healthy male subjects in terms of age, height, weight and socioeconomic status. Both groups will meet with exclusion criter