PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Clinical Trials, Phase II as Topic”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 217 records · Page 12Linked to original sources
PubMed1992

Evaluation of new anti-infective drugs for the treatment of genital infections due to herpes simplex virus. Infectious Diseases Society of America and the Food and Drug Administration.

This guideline addresses clinical trials of new therapies for genital infections due to herpes simplex virus (HSV). Of the two types of virus, HSV-2 is the more common pathogen. Both HSV-1 and HSV-2 become latent in sacral nerve root ganglia and intermittently reactivate. Patients who have frequent recurrences (more than four per year) may be candidates for long-term suppressive therapy. In both first-episode and recurrent genital HSV infections, lesions should be cultured for HSV. Testing for human immunodeficiency virus is encouraged but not required. Serum antibodies to HSV-1 and HSV-2 should be quantitated at enrollment and 3-5 weeks thereafter. Randomized, double-blind, active-control comparative studies are generally recommended. Placebo-controlled trials may be appropriate for recurrent genital herpes or for suppression of recurrences. Final evaluation should generally take place 10-15 days after the completion of therapy.

Anti-Infective Agents↗
PubMed1994

Role of antiprogestational therapy for meningiomas.

Epidemiological evidence, including the greater incidence of female patients, a positive association with pregnancy, and a positive association with breast cancer suggested a role for female sex hormones (and hormonal modulation) in regulating the growth of meningioma. The detection of hormone receptors on meningioma specimens provided a mechanism for this effect. However, unlike breast cancer, progesterone receptors (not oestrogen receptors) predominate in meningioma. Clinical trials with anti-oestrogens have shown little effect while trials with progesterone agonists have shown no effect or possible stimulation of meningioma growth. Three trials have now indicated an inhibitory activity of the antiprogestational agent mifepristone. In the largest of these trials, 28 patients received daily oral mifepristone for up to 62 months with a suggestion of response in eight patients. Long-term therapy has been well tolerated. Adverse events include fatigue, hot flushes, gynaecomastia/breast tenderness, skin rash, cessation of menses and decrease in libido. Increases in cortisol and thyroid-stimulating hormone are the most striking endocrine changes. A randomized double-blind placebo-controlled phase III trial is underway to confirm the activity of mifepristone in unresectable meningioma.

Buserelin↗
PubMed1993

Clinical safety and tolerance of azithromycin in children.

An analysis of the safety data emanating from several clinical trials of the use of azithromycin in children has been undertaken. The studies compared azithromycin with standard regimens of various comparator agents: co-amoxiclav, amoxycillin, penicillin V, erythromycin, dicloxacillin and flucloxacillin, in the treatment of otitis media, pharyngitis and skin infections. Side-effects, based on the investigators' assessments of the severity and possible relationship to the study drugs, were measured within 35 days of the start of therapy. The total number of side-effects reported was significantly lower in the azithromycin-treated patients (46/606; 7.6%) than in the comparator-treated patients (72/523; 13.8%; P = 0.001). Two (0.3%) and five (1.0%) patients, respectively, withdrew from treatment in each group. The most frequently reported side-effects were gastrointestinal with an incidence of 5.6% (34 patients) in the azithromycin group and 11.7% (61 patients) in the comparator group (P < 0.001). The only other organ system with more than 0.5% of subjects reporting side-effects was the skin, with nine (1.5%) patients in the azithromycin and 11 (2.1%) patients in the comparator group complaining of dermatological reactions. Azithromycin was equally well tolerated in children of all ages. Inspection of individual studies showed no significant differences in laboratory test abnormalities between treatment groups. Overall, the most frequently (> or = 1% incidence) reported treatment-related laboratory test abnormalities were changes in neutrophil count (3.2%), lactate dehydrogenase (1.5%), blood urea (1.3%) and potassium (1.2%) in the azithromycin group; and in neutrophil (3.2%) and eosinophil count (2.1%) in the comparator group.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed2003

Chemoprevention of cancer--focusing on clinical trials.

Chemoprevention of cancer is reviewed from the viewpoints of action mechanisms and methodology of clinical trials in order to introduce promising agents discovered by in vitro and/or in vivo studies to applications in humans. The clinical trial procedure essentially follows the phase study which has been employed for chemotherapeutic drugs. Chemoprevention of bladder cancer, prostate cancer, gastric cancer, hepatocellular carcinoma, breast cancer, head and neck cancer, colorectal cancer and lung cancer is reviewed, mainly focusing on clinical trials. Previous clinical trials have shown the effectiveness of the following: polyprenoic acid (acyclic retinoid) for hepatocellular carcinoma; tamoxifen for breast cancer; retinoic acids for head and neck tumor; and aspirin, a COX-2 inhibitor, for colorectal cancer. Despite the advantageous effects of some of these agents, their toxic effects must also be of concern at the same time. For example, in a chemoprevention trial of lung cancer, beta-carotene was unexpectedly found to increase the risk of lung cancer among high-risk groups. It is also noted that large-scale clinical trials demand large research grants, which may not be affordable in Japan. Chemoprevention is still an emerging field of oncology where researchers in both basic and clinical sciences face great challenges.

Animals↗
PubMed1995

An overview of clinical cancer chemoprevention studies with emphasis on positive phase III studies.

Cancer prevention aims to halt or reverse the development and progression of precancerous cells through the use of noncytotoxic nutrients and/or pharmacologic agents during the lengthy time period between tumor initiation and frank malignancy. This paper reviews cancer chemoprevention studies and focuses on Phase III trials, which are large, randomized, placebo-controlled studies that usually last several years. Studies may include multiple agents and dose levels, long-term toxicity evaluations or the modulation of surrogate endpoint biomarkers. Sample sizes of individual studies vary depending on statistical concerns and the demographics of the subject population. Recent Phase III trials include several promising agents: retinol; the retinoids 13-cis retinoic acid, all-trans-retinoic acid and 4-hydroxyphenyl retinamide; beta-carotene; finasteride and tamoxifen. Because one of the many actions of retinoids is the induction of epidermal differentiation, clinical trials with this class of agents have largely been conducted in epithelial or squamous cell tumor types. Several Phase III studies that have targeted the reversal of premalignant lesions or the prevention of second primary tumors have shown promising positive results. In contrast, some studies have shown that chemopreventive agents may have limited activity against the recurrence or progression of cells that have already undergone malignant transformation. Thus, the role of chemoprevention appears to lie in reversal of the premalignant process rather than suppression of malignant growth.

Antineoplastic Agents↗
PubMed1997

Safety of long-term administration of granulocyte colony-stimulating factor for severe chronic neutropenia.

When a new product with huge clinical potential explodes on the scene, the hope is that the benefits far outweigh the risks in long-term administration. After 10 years of clinical use, granulocyte colony-stimulating factor (G-CSF) has lived up to that promise so far. In the context of severe chronic neutropenia, more than 90% of patients have reaped big benefits in terms of improved quality of life and less infection, inflammation, antibiotic use, and hospitalization as well as oropharyngeal ulcers. With long-term use, toxic and adverse events have been catalogued but in general are not clinically troublesome and, aside from occasional adjustment of scheduling and dosing, seldom necessitate stopping therapy. Currently, the topic of intense focus is the phenomenon of malignant myeloid transformation in patients with congenital neutropenia who are receiving G-CSF. Data from the Severe Chronic Neutropenia International Registry have identified 23 of 249 patients with congenital neutropenia who have developed myelodysplasia or acute myelogenous leukemia (MDS/AML) giving a crude rate of about 9% with an average follow-up of 4.5 years. No cases of MDS/AML have occurred in 257 patients with cyclic or idiopathic neutropenia. A critical analysis of the incidence of transformation year by year showed a fairly uniform hazard rate of less than 2% per year, and the risk of MDS/AML after 5 to 6 years of therapy did not appear to be greater than during the first year of therapy. The transformation risk in the congenital cohort must also be viewed in the context of published reports of spontaneous myelodysplasia or acute myelogenous leukemia occurring in these patients in the pre-G-CSF era. Thus, the role of G-CSF in malignant conversion is still not clear and requires long-term vigilance and research. G-CSF is still deemed specific therapy for severe chronic neutropenia with a high margin of safety and should be the initial treatment for this family of disorders.

Chronic Disease↗
PubMed2004

Challenges to conducting HIV preventative vaccine trials with adolescents.

It is estimated that 10.3 million people aged 15-24 are living with HIV infection/AIDS worldwide, with 7000 new infections occurring each day. Many of these infections occur during the adolescent years. These rates of infection make adolescents an important target for research in primary prevention. Currently, preparations are under way by the National Institutes of Health-supported HIV networks--the Adolescent Trials Network, the Pediatric AIDS Clinical Trials Group, and the HIV Vaccines Trials Network--for phase 1/2 HIV vaccine trials involving adolescents in the United States. Identifying the challenges to conducting HIV vaccine trials with this population is a crucial component of these preparations. Challenges to HIV vaccine trials with adolescents were identified by reviewing previous vaccine research for adolescents and HIV infection in adolescents and speaking with experts in HIV/AIDS and adolescent medicine. Adolescents (typically those younger than 18 years of age) are minors and fall under ethical and regulatory safeguards for their participation in clinical research including parental permission. Adolescents may not appropriately perceive personal risk, posing challenges for informed consent as well as prevention counseling during a trial. Safety and immunogenicity studies of adolescents are likely to be required by the US Food and Drug Administration before vaccine approval for this population. Early identification and subsequent follow-up of high-risk adolescents are problematic. Vaccine-induced seropositivity may present potential barriers to military service, employment, marriage, and acquiring health insurance. The age at optimal immunization, particularly for girls in some countries, may be during preadolescence. The successful completion of HIV vaccine trials with adolescents must address these challenges both in the United States and internationally. This report addresses relevant background information, identifies the issues surrounding HIV vaccine trials with adolescents, discusses what progress has been made, and addresses plans and implications for the implementation of these trials.

AIDS Vaccines↗
PubMed1995

Design of field trials for the evaluation of antibacterial products for therapy of bovine clinical mastitis.

In this paper, the design and statistical analysis of field trials for the evaluation of the efficacy of clinical mastitis therapeutics is covered. First, general issues underlying the design of clinical trials are reviewed. These include bias and confounding; randomization and blocking; and study objectives and choice of the corresponding hypothesis. Specific issues in the design of clinical mastitis trials are also discussed. Selection of subjects is discussed with regard to choice of experimental units, identification of reference population and study population, inclusion and exclusion criteria, and sample size calculation. Next, a section on treatment administration and evaluation of cure reviews treatment, blinding, choice of response measure, as well as compliance, withdrawal, and early termination. The statistical analysis section addresses possible statistical models, treatment of confounding, and fixed vs. random effects. In conclusion, well-conducted clinical mastitis trials represent an invaluable, albeit difficult and expensive, effort to evaluate efficacy and tolerance under usual circumstances of use.

Animals↗
PubMed2004

Imatinib mesylate (Gleevec/Glivec) a molecular-targeted therapy for chronic myeloid leukaemia and other malignancies.

Imatinib mesylate (Gleevec/Glivec, Novartis, Basel, Switzerland), formerly called STI571, is a specific and potent inhibitor of the BCR-ABL tyrosine kinase, the molecular hallmark of chronic myeloid leukaemia. Several clinical trials have demonstrated the efficacy of imatinib in different phases of this disease. On the other hand, imatinib is also active against other tyrosine kinases, such as ABL, the stem cell factor receptor (c-kit) and the platelet-derived growth factor receptor, whose inhibition might have potential implications for the treatment of several malignancies. In this regard, imatinib has already shown a remarkable activity in patients with hypereosinophilic syndrome and gastrointestinal stromal tumours. Imatinib is an example of how a better understanding of the pathogenetic mechanisms of a neoplastic disease can lead to the development of a molecular-targeted therapy.

Antineoplastic Agents↗
PubMed2004

Recurrent and de novo disease after renal transplantation: a report from the Renal Allograft Disease Registry.

Recurrent and de novo disease is an increasing problem and is known to negatively impact transplant graft survival. Immunosuppressive medications have not had an impact on the prevalence of recurrent and de novo disease. Renal Allograft Disease Registry (RADR) was established to study the prevalence, impact and risk factors for the development of recurrent and de novo disease. Retrospective and prospective study on recurrent disease is discussed in this manuscript.

Clinical Trials, Phase I as Topic↗
PubMed1994

Clinical development outlook of oxcarbazepine.

Oxcarbazepine (OCBZ) has been accepted for registration as a first-line antiepileptic drug (AED) in several countries. However, because of changing regulations, further studies confirming statistically significant proof of efficacy are necessary in accordance with new standards. Therefore, Ciba has initiated a worldwide clinical development program to achieve registration. Four different types of design to demonstrate statistically significant proof of efficacy in partial seizures will be initiated. These studies are a "classical" polytherapy add-on study, a monotherapy substitution trial, a high-dose/low-dose active-control monotherapy study, and a study in presurgical patients.

Aged↗