scholarly journals Effects of 2% Dorzolamide Hydrochloride and 0.005% Latanoprost Solutions on the Eye Surface of Rabbits

2020 ◽  
Vol 48 ◽  
Author(s):  
Elaine Baptista Barbosa ◽  
Paulo Gabriel Pereira Silva Junior ◽  
Marília Martins Melo
Keyword(s):  
Adverse Effects ◽  
Benzalkonium Chloride ◽  
Pure Water ◽  
Clinical Signs ◽  
Ocular Tissue ◽  
Control Group ◽  
Eye Drops ◽  
Conjunctival Hyperemia ◽  
Group I ◽  
Dorzolamide Hydrochloride

Background: The glaucoma is a progressive optical neuropathy generally associated to the increase of the intraocular pressure (IOP). It is a disease of difficult therapeutic conduct and potential cause of blindness. The dorzolamide at 2% and the latanoprost at 0.005% are topical antiglaucoma drugs that cause significant reduction of the IOP. We decided to evaluate the local adverse effects of the dorzolamide at 2% and of the latanoprost at 0.005% in rabbits treated during 120 days.Materials, Methods & Results: Eighteen adult male rabbits were used in this study. They were randomly distributed into 3 groups (G) [n = 6]. Each animal received topical treatment in both eyes: GI (latanoprost at 0.005%, SID); GII (dorzolamide at 2%, TID) and GIII (ultra-pure water, TID) during 120 days. Ophthalmological evaluation was carried out through daily clinical examination, and at the end of the 120 days of treatment, it was verified clinical-ophthalmological alterations in the eyelids. The measurement of ECC was performed in triplicate, obtaining the lowest value among them as a result. They were carried out at the same time, in the morning between 9 and 10 am in order to avoid the effects of daytime ECC variation related to corneal hydration. In animals from group I, changes were observed in two eyes. Conjunctival hyperemia and ocular secretion, both in mild degree, were evidenced, respectively, in 13.75% and 9.1% of the observations. Conjunctival hyperemia was characterized from the 16th day and lasted until the final time (120 days). The animals from GII, treated with dorzolamide at 2%, presented the highest number of ophthalmological alterations. At the end of the experiment, conjunctival and eyelid changes and presence of ocular secretion, both ranging from mild to moderate, were observed in 60% and 16.32% of eyes, respectively. The animals from control group, GIII, did not present ophthalmological alterations.Discussion: Clinical signs observed in eyes treated with 0.005% latanoprost and 2% dorzolamide hydrochloride demonstrated manifestations of toxicity and / or ocular allergy. The adverse effects described may be related to the preservative of eye drops, benzalkonium chloride, a quaternary ammonia, which demonstrated ocular tissue toxicity, in vivo and in vitro. Benzalkonium chloride present in antiglacomatous drugs can cause conjunctival inflammation affecting the normal immunological functions of the eye. The presence of the preservative mainly justifies the changes found in the group of animals treated with 0.005% latanoprost, considering that the concentration of benzalkonium chloride in this drug is 0.02%, that is, two and a half times greater than of 2% dorzolamide, which is 0.008%. It should be noted that deleterious effects were associated. The other hypothesis associated with the adverse effects observed in the 2% dorzolamide treated group is related to the pH of the drug. This eye drop has a pH of 5.6, while that of 0.005% latanoprost is 6.7. This indicates that 2% dorzolamide may have secondarily induced ocular changes by virtue of its acidic pH. The association of low pH and the presence of benzalkonium chloride in concentration above 0.005% as a preservative of eye drops explains the high percentage of changes observed in this group. When facing the results, one can conclude that the treatment with the latanoprost at 0.005% and dorzolamide at 2% promoted clinical alterations to the eyelids and the conjunctive of rabbits.

↵​Haemato-biochemical and Therapeutic Studies on Ovine Babesiosis in Kashmir

2021 ◽  
Author(s):  
A.U. Haq ◽  
N.A. Tufani ◽  
H.U. Malik ◽  
T.A. Najar
Keyword(s):  
Clinical Signs ◽  
Clinical Manifestations ◽  
Control Group ◽  
Diminazene Aceturate ◽  
Group I ◽  
Blood Smears ◽  
Imidocarb Dipropionate ◽  
Calcium Phosphorus ◽  
Healthy Control ◽  
Therapeutic Study

Background: The clinical study was designed to evaluate the haemato-biochemical changes in sheep affected with babesiosis and therapeutic regimes of various drugs used against babesiosis. Methods: A total of 24 clinically affected sheep with 6 animals in each group were selected for the haemato-biochemical and therapeutic study. The diagnosis was based on clinical manifestations, microscopic examination of blood smears and molecular confirmation of Babesia by PCR technique. For therapeutic study Group I, II, III and IV were treated with imidocarb dipropionate, imidocarb dipropionate+oxytetracycline, diminazene aceturate and diminazene aceturate+oxytetracycline, respectively. Result: The clinical signs recorded were high fever, pale mucous membranes, presence of ticks, inappetence, coffee-coloured urine and diarrhoea. The vectors identified were Haemaphysalis ticks. Hb, PCV, TEC, total protein, albumin, calcium, phosphorus and blood glucose were significantly (P less than 0.05) lower in the diseased group as compared to healthy animals while TLC, globulin and iron levels were significantly (P less than 0.05) higher compared to the healthy control group. The study revealed that the combination of imidocarb dipropionate and oxytetracycline was highly effective for ovine babesiosis.

Taurine ameliorates 5-flourouracil-induced intestinal mucositis, hepatorenal and reproductive organ damage in Wistar rats

2015 ◽  
Vol 35 (1) ◽  
pp. 10-20 ◽  
Author(s):  
AK Al-Asmari ◽  
AM Al-Zahrani ◽  
AQ Khan ◽  
HM Al-Shahrani ◽  
M Ali Al Amri
Keyword(s):  
Adverse Effects ◽  
Anticancer Drugs ◽  
Wistar Rats ◽  
Inflammatory Cells ◽  
Organ Damage ◽  
Reproductive Organ ◽  
Control Group ◽  
Group I ◽  
Intestinal Mucositis ◽  
Cellular Integrity

5-Fluorouracil is one of the most commonly used anticancer drugs for the treatment of various types of cancer but has potential adverse effects such as intestinal mucositis, renal, hepatic, and reproductive organ toxicity. Attention has been given to approaches to reduce the side effects and improve the therapeutic effectiveness of chemotherapeutic drugs. In this study, we have investigated the protective effect of taurine (Tau) on 5-fluorouracil (5-FU) induced adverse effects in Wistar rats. Animals were divided into four groups with six animals ( n = 6) in each group. Group I received vehicle only and served as control group. Groups II, III, and IV animals were given oral gavage of 5-FU at 50 mg/kg body weight for 4 days. Tau was given to the animals of groups III and IV 30 min prior to 5-FU administration. We observed marked elevation in the myeloperoxidase (MPO) activity after 5-FU administration, which was reversed by Tau pretreatment. Histological observation of liver, kidney, intestine, testis, and prostate revealed that 5-FU administration resulted in anomalies like distortion of normal cellular architecture, infiltration of inflammatory cells, and loss of cellular integrity. These histopathological changes were markedly suppressed by Tau treatment. In conclusion, biochemical and histological findings of this study suggest that Tau has strong preventive potential against complications of anticancer drug 5-FU and hence Tau may play an important role in combinational chemotherapy to enhance the therapeutic efficacy of anticancer drugs.

scholarly journals Remifentanil and Propofol Sedation for Retrobulbar Nerve Block

2002 ◽  
Vol 30 (4) ◽  
pp. 433-437 ◽  
Author(s):  
V. Rewari ◽  
R. Madan ◽  
H. L. Kaul ◽  
L. Kumar
Keyword(s):  
Adverse Effects ◽  
Respiratory Depression ◽  
Study Groups ◽  
Group Iv ◽  
Control Group ◽  
Group Iii ◽  
Group I ◽  
Retrobulbar Block ◽  
Significant Movement ◽  
Group Ii

We studied remifentanil and propofol for analgesia and sedation during the placement of an ophthalmic block. Eighty ASA I or II patients undergoing elective cataract surgery under a retrobulbar block in a rural camp setting were included in the study. Patients were randomly divided into four groups and received different drug combinations as follows: Group I—remifentanil 1 μg/kg, Group II—remifentanil 0.5 μg/kg and propofol 0.5 mg/kg, Group III— remifentanil 1 μg/kg with propofol 0.5 mg/kg and Group IV—saline 0.1 ml/kg. Patients were observed for degree of movement, sedation, pain, recall and respiratory depression. No patient in the study groups reported pain or displayed movement whereas most of the patients in the control group had significant pain during the placement of the block. Also, seven (35%) patients in the control group showed significant movement which may have led to failure of block in two patients and retrobulbar haemorrhage in one patient. Incidence of significant respiratory depression was maximum in Group III patients (60%), followed by Group I (20%) and least in Group II (5%). All patients in the study groups remained cooperative and obeyed commands except four patients in group III (OAA/S-4). Postoperatively, other than the control group, recall was maximum in Group I (55%) and least in Group II (5%). Hence, a combination of remifentanil 0.5 μg/kg with propofol 0.5 mg/kg as a bolus was considered to provide excellent relief of pain and anxiety with least adverse effects for the placement of ophthalmic blocks.

TESTOSTERONE DECREASE AND OESTROGEN INCREASE IN MALE PATIENTS WITH OBESITY

1979 ◽  
Vol 91 (3) ◽  
pp. 553-563 ◽  
Author(s):  
H. K. Kley ◽  
H. G. Solbach ◽  
J. C. McKinnan ◽  
H. L. Krüskemper
Keyword(s):  
Body Weight ◽  
Sex Hormones ◽  
Plasma Concentrations ◽  
Clinical Signs ◽  
Free Testosterone ◽  
Control Group ◽  
Obese Patients ◽  
Group Iii ◽  
Group I ◽  
Male Patients

ABSTRACT The concentration of sex hormones and their binding in the plasma were measured in male patients (20–40 years old), who weighed 140–170 % (I), 170–200 % (II) and > 200 % (III) of their ideal weight. Correlated to body weight, there is a reduction in the total concentration of testosterone, which, in the very obese patients, amounts to 41 % (in group I: 85 % in group II: 68 % P < 0.001) of that found in an age-matched healthy control group of subjects of "normal" body weight (90–115 % of the ideal body weight; n: 20). Androstenedione values show only a trend downwards (from 0.94 to 0.72 ng/ml plasma), while the oestrogen values increase significantly; oestrone increases by a factor of 1.09 (I), 1.43 (II; P < 0.001) and 1.69 (III; P < 0.001) and oestradiol by 1.13, 1.43 P < 0.001) and 1.76 (P < 0.001), respectively. Despite the fall in testosterone there are no clinical signs of hypogonadism, as SHBG (from 5.1 ± 0.8 in the controls to 2.4 ± 0.6 ×10−8 Mol/l in the very obese patients of group III) and the protein-bound fraction of testosterone also decrease. As a result the concentration of free testosterone remains constant (120 pg/ml), except in the very obese (93 pg/ml). Because of the different affinity of the binding proteins for testosterone and oestradiol the ratio of free oestradiol: free testosterone shifts less strongly in favour of the feminizing hormone (11.1 × 10−3 in group III as compared to 4.1 × 10−3 in the controls), than is suggested by the total hormone concentrations. A disturbance in the gonadal function of the pituitary gland or the testes is not present, since the concentration of LH is normal and the testicular response to HCG in very obese patients adequate (increase of testosterone by a factor of 3.11 as compared to 2.23 in the controls). The cause of the decrease in testosterone and SHBG is unknown, while the increase of plasma oestrogens is likely to be due to the increased conversion of androgens to oestrogens in the adipose tissue, which clearly plays an important role for plasma concentrations of sex hormones in obese patients.

Use of superphosphate as a phosphorus supplement for lambs – effect of calcination or supplementation with oral cobalt or parenteral vitamin B12

1971 ◽  
Vol 77 (3) ◽  
pp. 467-471 ◽  
Author(s):  
O. N. Agarwala ◽  
K. Nath ◽  
V. Mahadevan
Keyword(s):  
Adverse Effects ◽  
Vitamin B12 ◽  
Fluorine Content ◽  
Control Group ◽  
Common Salt ◽  
Vitamin B ◽  
Mineral Supplement ◽  
Group I ◽  
Group Ii ◽  
Basal Ration

SUMMARYA feeding and balance trial was conducted for 15 weeks on 25 lambs (aged 3–5 months) divided into five groups of 5 animals each on a basal ration consisting of oats, groundnut cake, barley, common salt, green grass and wheat straw. The five groups were fed a mineral supplement as follows:Group I. Basal ration plus ‘Supermindiff’ mineral mixture (control group).Group II. Basal ration plus calcined superphosphate.Group III. Basal ration plus superphosphate.Group IV. Basal ration plus superphosphate plus oral cobalt chloride (3 mg Co/10 kg body weight).Group V. Basal ration plus superphosphate plus parenteral vitamin B12 (50 μg/week/ animal).Calcination of fertilizer-grade superphosphate at 600°C for 2 h reduced the fluorine content from 23350ppm to 1600 ppm. The results show that high fluorine or superphosphate significantly reduced growth rate and retention of calcium and phosphorus and significantly increased blood inorganic phosphorus. Calcination of superphosphate in Group II gave comparable results to the control group (Group I). The oral Co or parenteral vitamin B12 supplementation (Groups IV and V) did not ameliorate the adverse effects of high fluorine in superphosphate.It is concluded that calcination of superphosphate at 600°C for 2 h yields a suitable defluorinated product which can be used as a phosphorus supplement in the feeding of animals. Fertilizer-grade superphosphate is unsuitable due to its high fluorine content, the adverse effects of which are not mitigated by oral Co or parenteral vitamin B12 supplementation.

scholarly journals Efficacy and safety of topical 2% dorzolamide and 0.5% timolol in cases of open angle glaucoma in a tertiary care hospital of East Singhbhum: an observational, prospective and comparative study

2018 ◽  
Vol 7 (7) ◽  
pp. 1303
Author(s):  
Akash Chandra ◽  
Manish Kumar ◽  
Amrendra Narayan Mishra
Keyword(s):  
Adverse Effects ◽  
Open Angle Glaucoma ◽  
Tertiary Care ◽  
P Value ◽  
Care Hospital ◽  
Open Angle ◽  
Group I ◽  
Drug Regimens ◽  
Ocular Pressure ◽  
Dorzolamide Hydrochloride

Background: Present study was undertaken to evaluate and compare the efficacy and side effects of 2% dorzolamide and 0.5% timolol in patients with open angle glaucoma.Methods: There were 60 randomly selected patients were equally divided into Group I (n=30) and Group II (n=30). Further both groups were divided into IA (n=10), IB (n=20), IIA (n=10) and IIB (n=20). 2% Dorzolamide hydrochloride in Group IA and IIA and 0.5% Timolol maleate in Group IB and IIB was administered for 24 weeks. Patients were evaluated for general and ocular examinations on day of enrolment and then at the end of 1st, 4th, 8th and 24th week. Adverse effects of the drug during study period were also noted. Mean±SD, t value, p value and comparison between groups were analysed by graph pad software.Results: At the end of 24 weeks difference in mean reduction of IOP was not significant with 6.2±1.85mm Hg (Right eye) and 5.55±1.68mm Hg (left eye) and 4.72±2.97mm Hg (Right eye) and 5.37±1.24mm Hg (left eye) in Group IA and Group IIA respectively. At the end of 24 weeks difference in mean reduction of IOP was not significant with 5.06±1.62mm Hg (Right eye) and 4.40±1.96mm Hg (left eye) and 4.30±1.41mm Hg (Right eye) and 4.12±2.08mm Hg (left eye) in Group IB and Group IIB respectively. Fall in both systolic and diastolic blood pressure in both the groups were significant. Both drug regimens were well-tolerated, and no serious drug-related adverse effects were reported.Conclusions: Dorzolamide was more efficacious for reduction of intra ocular pressure, well-tolerated, had low allergic response and had a favourable ocular, cardiovascular and respiratory safety profile than Timolol. 

scholarly journals The role of ozonized oil and a combination of tobramycin/dexamethasone eye drops in the treatment of viral conjunctivitis: a randomized clinical trial

2020 ◽  
Vol 40 (12) ◽  
pp. 3209-3215
Author(s):  
C. Cagini ◽  
M. Mariniello ◽  
M. Messina ◽  
A. Muzi ◽  
C. Balducci ◽  
...  
Keyword(s):  
Clinical Signs ◽  
Pcr Analysis ◽  
Control Group ◽  
Study Group ◽  
Eye Drops ◽  
Adenoviral Infection ◽  
Significant Difference ◽  
Corneal Infiltrates ◽  
Punctate Keratitis

Abstract Purpose To determine whether topical tobramycin 0.3%/dexamethasone 0.1% plus ozonized oil eye drops reduces clinical signs and infectious viral titers of presumed viral conjunctivitis more than tobramycin/dexamethasone eye drops alone. Methods Prospective, single-blind, randomized, parallel-groups trial. Eighty patients with a clinical diagnosis of presumed viral conjunctivitis were randomizedly divided into two treatment groups: a study group and a control group, 40 for each group. Patients in the study group received topical tobramycin 0.3%/dexamethasone 0.1% eye drops, plus ozonized oil eye drops, both four times daily; patients in the control group received only topical tobramycin 0.3%/dexamethasone eye drops four times daily. The treatment was for seven days in both groups. Swabs were taken from the conjunctival fornix for adenovirus PCR analysis on the day of recruitment and at seven days follow-up. Clinical signs were also recorded on the day of recruitment and at follow-up examination: the main outcomes were conjunctival injection and conjunctival chemosis, graded on a 4-point clinical scale, presence or absence of superficial punctate keratitis and subepithelial corneal infiltrates. Results No statistically significant difference was reached in adenoviral infection negativization between the two groups, although the study group showed a higher number of PCR negative results at seven days follow-up. PCR real time detected adenoviral infection in 17 of 24 patients on the day of recruitment and it was positive in 4 patients on the seventh day (viral positivity reduction of 76%). In the control group PCR was positive for adenovirus in 18 of 24 patients on the day of recruitment and in 7 patients at seven days follow-up (reduction of 61%). There was statistically significant difference on conjunctival clinical signs between the study and control groups. Significant difference was also found on superficial punctate keratitis resolution between the study and the control group. In the former superficial punctate keratitis was detected in 14 eyes on the first day and in 5 eyes after seven days while in the latter superficial punctate keratitis was found in 124 eyes on the first day and in 6 eyes on the seventh day. No difference was found in subepithelial corneal infiltrates appearance between the two groups. Conclusions The use of ozonized-oil containing eye drops in combination with topical tobramycin 0.3%/dexamethasone 0.1% eye drops four times daily seems to reduce the signs of conjunctivitis, and the duration of viral infection, although it does not affect the subepithelial corneal infiltrates appearance.

scholarly journals Preservative-free Treatment in Glaucoma Is a Sensible and Realistic Aim for the Future

2010 ◽  
Vol 04 (01) ◽  
pp. 23 ◽  
Author(s):  
Marina Hopes ◽  
David Broadway ◽  
◽  
Keyword(s):  
Adverse Effects ◽  
Benzalkonium Chloride ◽  
Adverse Reactions ◽  
Ocular Tissue ◽  
Animal Tissues ◽  
Multiple Components ◽  
Free Treatment ◽  
First Choice ◽  
Choice Option ◽  
Preservative Free

Medical therapy is usually the first-choice option in the management of glaucoma. However, adverse effects of ophthalmic preparations can potentially jeopardise the safety and efficacy of the treatment. Eye-drop bottles contain multiple components, all of which have the potential to cause adverse reactions, although it is the preservatives that are major culprits. The effect of preservatives on the eye has been studied extensively in both human and animal tissues. Benzalkonium chloride (BAC) is a highly effective preservative and the most commonly used in antiglaucoma medications; however, BAC is toxic to ocular tissue, having the potential to cause adverse effects. The use of less toxic preservatives or preservative-free medications has the potential to improve the management of glaucoma.

scholarly journals The effect of dexamethasone and promethazine in combination with buparvaquone in the management of East Coast fever

2004 ◽  
Vol 71 (2) ◽  
Author(s):  
M. Gwamaka ◽  
J.A. Matovelo ◽  
M.M.A. Mtambo ◽  
G.K. Mbassa ◽  
R.M. Maselle ◽  
...  
Keyword(s):  
East Coast ◽  
Morphological Changes ◽  
Clinical Signs ◽  
East Coast Fever ◽  
Control Group ◽  
Febrile Reaction ◽  
Clinical Effects ◽  
Post Mortem ◽  
Post Mortem Examination ◽  
Group I

The effects of dexamethasone and promethazine on the amelioration of pulmonary oedema in East Coast fever were investigated. The clinical effects of these drugs were further investigated when used in conjunction with the antitheilerial drug, buparvaquone. In the first experiment, 15 crossbred (Friesian x Zebu) steers were divided into four groups. With the exception of the animals in group IV, that served as a control group all the others were infected with Theileria parva sporozoites. On the second day of the febrile reaction, the steers in groups I and II were treated with dexamethasone (0.1 mg/kg) and promethazine (1 mg/kg), respectively. Group III steers served as the infected untreated controls. On the fifth day of the febrile reaction the animals in groups I, II and III were infused intravenously with tattoo ink suspension and 1 h later sacrificed for post-mortem examination and tissue sampling. The clinical picture indicated that both drugs significantly mitigated dyspnoea and the post mortem examination revealed a significant reduction in morphological changes. Tattoo ink particle count reflected a significant (P < 0.01) reduction in vascular leakage in the treated animals, with promethazine being significantly (P < 0.05) more effective than dexamethasone in this respect. In the second experiment, 18 steers were infected with T. parva sporozoites, and then were randomly allotted into three groups each of which contained six animals. After the onset of ECF clinical signs, the animals in the first two groups were treated with buparvaquone in combination with either dexamethasone (group I) or promethazine (group II), and the third group was treated with buparvaquone alone. The results indicated that all the animals in groups I, II and III recovered well and no significant differences were observed in clinical disposition between the groups. Two months later, serum samples were collected from the refractory animals and demonstrated the presence of antibodies against T. parva. When the animals were subsequently artificially challenged with T. parva, none of them succumbed to clinical disease. The same T. parva stabilate stock was used in both experiments and it proved to be infective in a separate batch of steers.

scholarly journals Tolerance of torasemide in cats with congestive heart failure: a retrospective study on 21 cases (2016–2019)

2020 ◽  
Vol 16 (1) ◽  
Author(s):  
Camille Poissonnier ◽  
Sarra Ghazal ◽  
Peggy Passavin ◽  
Maria-Paz Alvarado ◽  
Solène Lefort ◽  
...  
Keyword(s):  
Heart Failure ◽  
Congestive Heart Failure ◽  
Retrospective Study ◽  
Adverse Effects ◽  
Survival Time ◽  
Loop Diuretic ◽  
Clinical Signs ◽  
Case Series ◽  
Control Group ◽  
Standard Medical Therapy

Abstract Background In dogs with congestive heart failure (CHF), the efficacy of torasemide, a loop diuretic, has been demonstrated. However, unlike in dogs and humans little has been described about the use of torasemide in the cat with spontaneous CHF. The objectives of this retrospective study were therefore to describe the therapeutic use of oral torasemide in cats with spontaneous CHF, document its potential adverse effects while reporting the clinical course of this feline population following torasemide administration in addition to standard medical therapy. Results Medical records of 21 client-owned cats with CHF (median age = 10.6 years [interquartile range (IQR) = 6.5–11.2]) receiving torasemide were reviewed. Data collected included torasemide dosages, other concurrent medications, physical examination features, echocardiographic data, and potential adverse effects during follow-up. A survival analysis was performed to estimate the time from diagnosis to cardiac death. Dyspnea related to CHF was identified in all cats (pleural effusion [8/21], pulmonary edema [5/21] or both [8/21]), associated with ascites in 4/21 cats. The CHF cause was determined by echocardiography in all cats: hypertrophic (n = 10), restrictive (n = 6), arrhythmogenic right ventricular (n = 3), dilated (n = 1) cardiomyopathies, and aortic valve abnormality (n = 1). At initiation, median torasemide dosage was 0.21 mg/kg [IQR = 0.17–0.23] q24h. Clinical signs declined in most cats (20/21) during the first 2 weeks with no remarkable adverse events. Median survival time after torasemide prescription was 182 days [IQR = 46–330]. A contemporary control group including 54 cats with CHF, receiving furosemide as sole loop diuretic treatment was compared with the study group. Median (IQR) survival time of cats in the control group was not significatively different (p = 0.962) from that of the torasemide group, i.e., 148 days (9–364), although the torasemide group included significantly more cats with recurrent episodes of CHF (52%) that the control group (19%). Conclusions This case series demonstrates that torasemide can be used in cats with spontaneous CHF. This therapeutic interest needs to be confirmed by prospective clinical trials.

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