A pilot study to compare compliance against side effects, drugs and attitude

1996 ◽  
Vol 11 ◽  
pp. 400s
Author(s):  
N. Woodhead ◽  
V.M. Mathew
Keyword(s):  
Pilot Study ◽  
Side Effects

scholarly journals Pilot Study: Quantitative Photoacoustic Evaluation of Peripheral Vascular Dynamics Induced by Carfilzomib In Vivo

Sensors ◽  
2021 ◽  
Vol 21 (3) ◽  
pp. 836
Author(s):  
Thi Thao Mai ◽  
Manh-Cuong Vo ◽  
Tan-Huy Chu ◽  
Jin Young Kim ◽  
Chulhong Kim ◽  
...  
Keyword(s):  
Pilot Study ◽  
Side Effects ◽  
Cardiovascular Events ◽  
Evaluation Method ◽  
Vascular System ◽  
Maximum Amplitude ◽  
Peripheral Vascular ◽  
Peripheral Vasculature ◽  
Mouse Ear

Carfilzomib is mainly used to treat multiple myeloma. Several side effects have been reported in patients treated with carfilzomib, especially those associated with cardiovascular events, such as hypertension, congestive heart failure, and coronary artery disease. However, the side effects, especially the manifestation of cardiovascular events through capillaries, have not been fully investigated. Here, we performed a pilot experiment to monitor peripheral vascular dynamics in a mouse ear under the effects of carfilzomib using a quantitative photoacoustic vascular evaluation method. Before and after injecting the carfilzomib, bortezomib, and PBS solutions, we acquired high-resolution three-dimensional PAM data of the peripheral vasculature of the mouse ear during each experiment for 10 h. Then, the PAM maximum amplitude projection (MAP) images and five quantitative vascular parameters, i.e., photoacoustic (PA) signal, diameter, density, length fraction, and fractal dimension, were estimated. Quantitative results showed that carfilzomib induces a strong effect on the peripheral vascular system through a significant increase in all vascular parameters up to 50%, especially during the first 30 min after injection. Meanwhile, bortezomib and PBS do not have much impact on the peripheral vascular system. This pilot study verified PAM as a comprehensive method to investigate peripheral vasculature, along with the effects of carfilzomib. Therefore, we expect that PAM may be useful to predict cardiovascular events caused by carfilzomib.

Treatment of Aggressive Behavior in Dementia With the Anticonvulsant Topiramate: A Retrospective Pilot Study

2003 ◽  
Vol 15 (3) ◽  
pp. 307-309 ◽  
Author(s):  
Benny Fhager ◽  
Inga-Maj Meiri ◽  
Magnus Sjögren ◽  
Åke Edman
Keyword(s):  
Quality Of Life ◽  
Pilot Study ◽  
Side Effects ◽  
Aggressive Behavior ◽  
Extrapyramidal Side Effects ◽  
Treatment Resistant ◽  
Careful Treatment ◽  
And Training ◽  
Low Dosage

Aggressive behavior in dementia often has a severe impact on the quality of life of the patient and the caregivers, and is therefore important to handle. The strategy of treatment should be broad. Nonpharmacological interventions, including environmental adjustments and supporting and training the caregivers, should always be considered. Pharmacological treatment of aggressive behavior in patients with dementia often includes the use of neuroleptics. The atypical compounds clozapine, risperidone, and olanzapine have been shown to have an effect on aggressive behavior at low dosage with limited extrapyramidal side effects. The anticonvulsants carbamazepine and sodium valproate are further alternatives. In treatment-resistant cases, buspirone or lithium may be tried, although the effect of these substances on aggressive behavior in dementia has not been well established. In the end, however, a considerable degree of aggressive behavior sometimes remains after careful treatment trials, particularly in patients with severe aggressive behavior. In addition, treatment is sometimes limited by side effects.

Post-ECT increases in MRI regional T2 relaxation times and their relationship to cognitive side effects: A pilot study

1994 ◽  
Vol 54 (2) ◽  
pp. 177-184 ◽  
Author(s):  
David J. Diehl ◽  
Matcheri S. Keshavan ◽  
Emanuel Kanal ◽  
Robert D. Nebes ◽  
Thomas E. Nichols ◽  
...  
Keyword(s):  
Pilot Study ◽  
Side Effects ◽  
Relaxation Times ◽  
T2 Relaxation ◽  
Cognitive Side Effects

A pilot study on the sexual side effects of finasteride as related to hand preference for men undergoing treatment of male pattern baldness

2012 ◽  
Vol 111 (4b) ◽  
pp. E221-E226 ◽  
Author(s):  
Ion G. Motofei ◽  
David L. Rowland ◽  
Simona R. Georgescu ◽  
Daniela L. Baconi ◽  
Nicoleta P. Dimcevici ◽  
...  
Keyword(s):  
Pilot Study ◽  
Side Effects ◽  
Hand Preference ◽  
Male Pattern Baldness ◽  
Sexual Side Effects ◽  
Male Pattern

Metoclopramide Treatment in Patients with Diamond-Blackfan Anemia: Preliminary Results of a French Prospective Trial.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2843-2843
Author(s):  
Thierry Leblanc ◽  
Isabelle Marie ◽  
Marianne Debre ◽  
Lydie Da Costa ◽  
Pierre Bordigoni ◽  
...  
Keyword(s):  
Pilot Study ◽  
Side Effects ◽  
Low Cost ◽  
Accurate Determination ◽  
Prospective Trial ◽  
Drug Efficacy ◽  
Complete Response ◽  
High Dose ◽  
Diamond Blackfan Anemia ◽  
Nervous Breakdown

Abstract Metoclopramide has been shown to be a potential new therapeutic approach for Diamond-Blackfan anemia (DBA) affected individuals and has been hypothetized to stimulate erythropoiesisis through the induction of prolactin release. Among 15 transfusion-dependent patients enrolled in a previous pilot study, 9 completed 16 weeks of treatment, 3 of whom reaching a complete and sustained response (Abkowitz et al, Blood 2002). In order to further assess the drug efficacy we performed a prospective study in patients included in the French DBA registry. Patients over 2 years of age and dependent on regular transfusions were randomized at inclusion either to be treated immediately after a transfusion (Arm B), or 6 weeks later (Arm A), the comparison of these 2 groups aiming to provide a more accurate determination in the delay of response. All patients were prescribed metoclopramide for 16 or 22 weeks: 10 mg x 3/d in adults and 0.2 mg/kg x 3/d in children (weight < 50 kg). Packed Red Blood Cell transfusions were prescribed for hemoglobin values < 80g/L. The definition of response relied on Hb levels, reticulocyte counts, and the intervals between transfusions. Prolactin as well as other hormones levels were assessed. The study was initiated in October 2003. 7 adults and 22 children have been included so far (13F, 16M): 17 in A and 16 in B arms, respectively; 4 additional pts are planned to be included within a month. The treatment had to be prematurely discontinued in 2 pts because of severe side effects: nervous breakdown (8w of treatment) and anaphylaxis (14w of treatment). Other side effects were mild. Most patients complained of asthenia and drowsiness which both decreased after the 1st weeks of treatment; amenorrhoea (2 pts) and bulimia (3 pts) were also observed. No increase in transfusion need occurred. An update of the trial was performed on August 1st: at that time 21 pts had completed at least 16w of treatment. None of them experienced a complete response, as defined by a transfusion independence. In two a partial response, as defined by an increase in the transfusion interval was obtained: In one patient it evolved from 3–4 to 8 w, and in the other from 6–8 to 10–11w. Both are still on treatment. Lastly, it has to be emphasized that the 2 French responder patients previously included in the pilot study are still transfusion independent more than 5 yr after the initiation of metoclopramide treatment. CONCLUSION: metoclopramide may be of interest in some DBA affected individuals, even though we only obtained a low rate of partial responses in the present ongoing trial. We believe that this non toxic, and low cost treatment warrants to be tested in all patients with regular transfusion need or requiring high dose steroids. The duration of response and long term tolerance remain to be determined. Acknowledgments: Maria Daniela Arturi Foundation, DBA foundation and Assistance Publique-Hôpitaux de Paris (DRRC)

Pilot study on outcome and antitumor efficacy of an autologous cancer cell vaccine applied in patients with advanced solid tumors.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 3000-3000 ◽  
Author(s):  
Eglys Gonzalez Marcano ◽  
Leona Kröhle ◽  
Joachim Ahlers ◽  
Joachim Drevs
Keyword(s):  
Pilot Study ◽  
Side Effects ◽  
Tumor Marker ◽  
Solid Tumors ◽  
Tumor Cells ◽  
Cell Vaccine ◽  
Advanced Solid Tumors ◽  
Tumor Cell Death ◽  
Informed Consent Form

3000 Background: In the last decade cancer immunotherapy has emerged as the most promising anti-tumor approach. The most commonly used immunotherapies are vaccines and checkpoint inhibitors. An autologous cell vaccine is made with the patient's own tumor cells processed in vitro, which may elicit a cytotoxic T-lymphocytic immune response against tumor cells antigens, resulting in tumor cell death. We performed a pilot study to evaluate the clinical relevance and general outcome of an autologous vaccine as a treatment in different types of cancer. Methods: A total of 31 patients (n=31) with advanced solid tumors and the lack of standard treatments were treated with an immunotherapy protocol consisting of 6 intradermal doses of the vaccine, given the first two doses at day 1 and 2, and the rest every two weeks. All patients signed an informed consent form. Response evaluation was assessed by PET/CT identified as metric (iRECIST) response and in some cases tumor markers where available. Results: Out of 31 patients treated, 2 patients suffered from pancreatic cancer, 2 from sarcoma, 1 from lung cancer, 13 from breast cancer, 2 from ovarian cancer, 1 from prostate cancer, 1 from cholangiocarcinoma, 4 from colorectal cancer, 1 from non-Hodgkin lymphoma, 1 from gastric cancer, 1 from laryngeal and hypopharyngeal cancer, 1 from fallopian tube cancer, 1 from peritoneal cancer. Side effects related to the therapy were rare including light redness in the area of injection and in one case inflammation of the tumor area. 26 patients were evaluated for metric response and 5 for tumor marker response assessment. For tumor marker follow up 9.6 % had a SD of > 3 month and 6.5 % a PD. For metric follow up 12.9 % had a CR, 6.5 % a PR, 25.8 % a SD of > 3 month and 38.7 % a PD. Conclusions: This study have confirmed an anti-tumor response in the majority of patients treated, with none to very low side effects and a good quality of life during the treatment. To obtain more detailed and significant data on the efficacy of this therapy, a further controlled clinical phase study should be performed.

High-Dose Riboflavin as a Prophylactic Treatment of Migraine: Results of an Open Pilot Study

Cephalalgia ◽  
1994 ◽  
Vol 14 (5) ◽  
pp. 328-329 ◽  
Author(s):  
J Schoenen ◽  
M Lenaerts ◽  
E Bastings
Keyword(s):  
Pilot Study ◽  
Side Effects ◽  
Prophylactic Treatment ◽  
Low Cost ◽  
Controlled Trial ◽  
High Dose ◽  
Short Term ◽  
Global Improvement ◽  
The Brain ◽  
Open Pilot

If the brain of migraineurs is characterized between attacks by a reduction of mitochondrial phosphorylation potential, riboflavin, which has the potential of increasing mitochondrial energy efficiency, might have prophylactic effects in migraine. In this preliminary open pilot study, 49 patients suffering from migraine (45 without aura, 4 with aura) were treated with 400 mg of riboflavin as a single oral dose for at least 3 months. Twenty-three patients received in addition 75 mg of aspirin. Mean global improvement after therapy was 68.2% and there was no difference between the two groups of patients. With the exception of one patient in the riboflavin plus aspirin group who withdrew because of gastric intolerance, no drug-related side effects were reported. High-dose riboflavin could thus be an effective, low-cost prophylactic treatment of migraine devoid of short-term side effects. A placebo-controlled trial of its efficacy seems worthwhile.

scholarly journals Virtual Reality Support for Joint Attention Using the Floreo Joint Attention Module: Usability and Feasibility Pilot Study (Preprint)

2019 ◽  
Author(s):  
Vijay Ravindran ◽  
Monica Osgood ◽  
Vibha Sazawal ◽  
Rita Solorzano ◽  
Sinan Turnacioglu
Keyword(s):  
Virtual Reality ◽  
Pilot Study ◽  
Side Effects ◽  
Joint Attention ◽  
Autism Spectrum ◽  
Primary Objective ◽  
School Aged Children ◽  
Attention Skills ◽  
Study Results ◽  
Target Skills

BACKGROUND Advances in virtual reality (VR) technology offer new opportunities to design supports for the core behaviors associated with autism spectrum disorder (ASD) that promote progress toward optimal outcomes. Floreo has developed a novel mobile VR platform that pairs a user receiving instruction on target skills with an adult monitor. OBJECTIVE The primary objective of this pilot study was to explore the feasibility of using Floreo’s Joint Attention Module in school-aged children with autism in a special education setting. A secondary objective was to explore a novel joint attention measure designed for use with school-aged children and to observe whether there was a suggestion of change in joint attention skills from preintervention to postintervention. METHODS A total of 12 participants (age range: 9 to 16 years) received training with the Joint Attention Module for 14 sessions over 5 weeks. RESULTS No serious side effects were reported, and no participants dropped out of the study because of undesirable side effects. On the basis of monitor data, 95.4% (126/132) of the time participants tolerated the headset, 95.4% (126/132) of the time participants seemed to enjoy using Floreo’s platform, and 95.5% (128/134) of the time the VR experience was reported as valuable. In addition, scoring of the joint attention measure suggested a positive change in participant skills related to the total number of interactions, use of eye contact, and initiation of interactions. CONCLUSIONS The study results suggest that Floreo’s Joint Attention Module is safe and well tolerated by students with ASD, and preliminary data also suggest that its use is related to improvements in fundamental joint attention skills.

scholarly journals Virtual Reality Support for Joint Attention Using the Floreo Joint Attention Module: Usability and Feasibility Pilot Study

10.2196/14429 ◽  
2019 ◽  
Vol 2 (2) ◽  
pp. e14429 ◽  
Author(s):  
Vijay Ravindran ◽  
Monica Osgood ◽  
Vibha Sazawal ◽  
Rita Solorzano ◽  
Sinan Turnacioglu
Keyword(s):  
Virtual Reality ◽  
Pilot Study ◽  
Side Effects ◽  
Joint Attention ◽  
Autism Spectrum ◽  
Primary Objective ◽  
School Aged Children ◽  
Attention Skills ◽  
Study Results ◽  
Target Skills

Background Advances in virtual reality (VR) technology offer new opportunities to design supports for the core behaviors associated with autism spectrum disorder (ASD) that promote progress toward optimal outcomes. Floreo has developed a novel mobile VR platform that pairs a user receiving instruction on target skills with an adult monitor. Objective The primary objective of this pilot study was to explore the feasibility of using Floreo’s Joint Attention Module in school-aged children with autism in a special education setting. A secondary objective was to explore a novel joint attention measure designed for use with school-aged children and to observe whether there was a suggestion of change in joint attention skills from preintervention to postintervention. Methods A total of 12 participants (age range: 9 to 16 years) received training with the Joint Attention Module for 14 sessions over 5 weeks. Results No serious side effects were reported, and no participants dropped out of the study because of undesirable side effects. On the basis of monitor data, 95.4% (126/132) of the time participants tolerated the headset, 95.4% (126/132) of the time participants seemed to enjoy using Floreo’s platform, and 95.5% (128/134) of the time the VR experience was reported as valuable. In addition, scoring of the joint attention measure suggested a positive change in participant skills related to the total number of interactions, use of eye contact, and initiation of interactions. Conclusions The study results suggest that Floreo’s Joint Attention Module is safe and well tolerated by students with ASD, and preliminary data also suggest that its use is related to improvements in fundamental joint attention skills.

Sign in / Sign up

Export Citation Format

Share Document