Pilot Study: Drug Lowered Autism Behavior Scores

2011 ◽  
Vol 39 (10) ◽  
pp. 20
Author(s):  
DAMIAN McNAMARA
Keyword(s):  
Pilot Study ◽  
Study Drug ◽  
Autism Behavior

Pilot Study: Drug Cut Autism Behavior Scores

2011 ◽  
Vol 45 (8) ◽  
pp. 21
Author(s):  
DAMIAN McNAMARA
Keyword(s):  
Pilot Study ◽  
Study Drug ◽  
Autism Behavior

scholarly journals RheothRx (Poloxamer 188) Injection for the Acute Painful Episode of Sickle Cell Disease: A Pilot Study

Blood ◽  
1997 ◽  
Vol 90 (5) ◽  
pp. 2041-2046 ◽  
Author(s):  
Patricia Adams-Graves ◽  
Amos Kedar ◽  
Mabel Koshy ◽  
Martin Steinberg ◽  
Robert Veith ◽  
...  
Keyword(s):  
Pilot Study ◽  
Sickle Cell Disease ◽  
Pain Intensity ◽  
Sickle Cell ◽  
Study Drug ◽  
Cell Disease ◽  
Drug Infusion ◽  
Double Blind ◽  
Poloxamer 188 ◽  
Painful Episode

Abstract RheothRx (Glaxo Wellcome Inc, Research Triangle Park, NC; poloxamer 188) Injection is a nonionic surfactant with hemorrheologic properties that suggest it may be useful in treating acute painful episodes (vasoocclusive crises) of sickle cell disease (SCD). We conducted a randomized, double-blind, placebo-controlled pilot study to evaluate the safety and efficacy of poloxamer, formulated as RheothRx Injection, in 50 patients with SCD. Patients with moderate to severe painful episodes requiring parenteral analgesics were randomized to receive a 48-hour infusion of either RheothRx or placebo. Pain was assessed every 4 hours. Efficacy endpoints included: (1) painful episode duration, (2) days of hospitalization, (3) quantity of analgesics used, and (4) pain intensity scores. Three subgroups of patients were considered for efficacy analyses based on the actual duration of the study drug infusion and the completeness of pain score data collection. Compared with placebo and depending on the subgroup, RheothRx-treated patients showed a 16% to 45% decrease in duration of painful episodes, a 1- to 2-day reduction in hospital stay, a threefold to fivefold reduction in analgesic requirements, and a 1-point reduction (using a 5-point scale) in average pain intensity scores at 72 hours. RheothRx was well tolerated; no clinically significant differences were observed between treatments with respect to adverse experiences or other safety measures. In addition, there were no differences between treatment groups in the incidence of recurrent painful episodes. In this study, RheothRx significantly reduced total analgesic use and pain intensity and showed trends to shorter duration of painful episodes and total days of hospitalization. In patients with moderate to severe vasoocclusive pain, RheothRx was safe and may offer a therapeutic benefit.

PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT): A Pilot Study.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1784-1784 ◽  
Author(s):  
Ellen McDonald ◽  
Germain Poirier ◽  
Paul Hebert ◽  
Joe Pagliarello ◽  
Graeme Rocker ◽  
...  
Keyword(s):  
Pilot Study ◽  
Creatinine Clearance ◽  
Drug Administration ◽  
Study Drug ◽  
Serotonin Release ◽  
Future Trial ◽  
Study Drug Administration ◽  
Icu Patients ◽  
Icu Discharge ◽  
Surgical Icu

Abstract Rationale: No published randomized trials have compared low molecular weight heparin (LMWH) to unfractionated heparin (UFH) for thromboprophylaxis in medical-surgical ICU patients. Objectives: A) Our Feasibility Objectives were to assess: 1) timely enrollment and complete, blinded study drug administration, 2) LMWH bioaccumulation in renal insufficiency, 3) twice weekly leg ultrasounds, and 4) recruitment rates for a future trial. B) Our Clinical Objectives were to assess 1) the effectiveness of LMWH vs UFH by estimating DVT, and pulmonary embolism (PE) rates, and 2) the safety of LMWH vs UFH regarding bleeding, thrombocytopenia and HIT. Methods: In this prospective randomized stratified concealed blinded multicenter trial, we included patients ≥18 with expected ICU stay ≥72h. We excluded trauma, orthopaedic, cardiac, or neurosurgery, severe hypertension, DVT, PE or hemorrhage within 3 mos, INR >2ULN, PTT >2ULN, platelets <100 x109/L, creatinine clearance <30ml/min, therapeutic anticoagulation, >2 doses of heparin, and palliative care patients. By centralized telephone randomization, we allocated patients to dalteparin 5,000 IU QD SC or UFH 5,000 IU BID SC. All clinicians caring for patients were blinded except the pharmacist. Bilateral leg compression ultrasounds were performed within 48h of ICU admission, twice weekly, on suspicion of DVT, and 7 days post ICU discharge. Results: A) Feasibility Objectives: 1) Timely, complete study drug administration occurred for >99% of scheduled doses; every dose was blinded. 2) No LWMH bioaccumulation was observed as measured by anti-Xa levels when creatinine clearance decreased to <30 ml/min. 3) Ultrasounds were performed without exception. 4) Estimated recruitment for a future trial is 4–5 patients/month/center. B) Clinical Objectives: 1) Effectiveness: Among 128 patients, 11 (8.6 %) had DVT, 2 (1.6 %) had PE. 2) Safety: 6 (4.7 %) had clinically important bleeds, 23 (18 %) had minor bleeds, 4 (3.1%) developed a platelet count <50 x109/L, and 2 (0.8%) had HIT diagnosed by serotonin release assay. Conclusions: DVT rates remain high in medical-surgical ICU patients despite universal heparin thromboprophylaxis. This pilot study suggests that a randomized clinical trial comparing LMWH vs UFH feasible. An adequately powered trial is needed to achieve the clinical objectives.

Levetiracetam for the treatment of hot flashes: A pilot study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9116-9116
Author(s):  
S. L. Thompson ◽  
A. Bardia ◽  
A. Tan ◽  
D. Barton ◽  
L. Kottschade ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Practice ◽  
Pilot Study ◽  
Breast Cancer Survivors ◽  
Hot Flashes ◽  
Estrogen Therapy ◽  
Active Agent ◽  
Study Drug ◽  
Hot Flash ◽  
Increased Risk

9116 Background: Hot flashes affect 75 % to 90 % of women transitioning to menopause and are a major cause of morbidity among breast cancer survivors. Levetiracetam, a popular anticonvulsant, is a centrally active agent that anecdotally appeared to reduce hot flashes in clinical practice. This phase II trial sought to evaluate the efficacy of levetiracetam in reducing hot flashes among women with a history of breast cancer or women who did not wish to take estrogen therapy for fear of an increased risk of breast cancer. Methods: Women who were experiencing bothersome hot flashes (≥ 14 times per week, for ≥ 1 month) were eligible. A single arm pilot study design based on previous work was used with a planned sample size of 30 patients. The patients did not receive any study medication during the first week (baseline week). At the beginning of the second week, patients were started on levetiracetam (500 mg), and were to increase the dose by 500 mg each week to a goal of 1,000 mg twice daily. Hot flash diaries were completed daily. The primary endpoint was hot flash score (frequency times average severity). The change from week 1 (baseline) to week 5, the last treatment week, was analyzed by paired t-test and related Wilcoxon procedures. Results: A total of 30 women were enrolled onto this study in eight months. All patients were eligible. 19 women completed all 4 weeks of the study treatment and provided complete data. After treatment with levetiracetam for 4 weeks, mean hot flash scores were reduced by 57% (95% CI 39%-75%), while mean hot flash frequencies were reduced by 53% (95% CI 38%-68%), reductions being greater than what would be expected with a placebo. There were significant improvements, compared to baseline week data, in sweating, hot flash distress, and satisfaction with hot flash control. Eight subjects stopped the study drug due to treatment related adverse events (grade I/II), with the most frequently reported being somnolence, fatigue and dizziness. Conclusions: While levetiracetam appears to be a promising therapy for the treatment of hot flashes, further study is needed to better substantiate the toxicity and efficacy of this drug before it can be more definitively recommended for use in clinical practice. No significant financial relationships to disclose.

scholarly journals Effect of Navajivana Rasa with Pathyashadangam Kashaya Ghanasatwa in Classical Migraine - An Open Label Single Arm Pilot Study

2021 ◽  
pp. 28-32
Author(s):  
Rohith.M.R ◽  
S.Thara Lakshmi ◽  
Kusumam Joseph
Keyword(s):  
Quality Of Life ◽  
Pilot Study ◽  
Study Drug ◽  
Primary Headache ◽  
Open Label ◽  
Common Cause ◽  
Episodic Headache ◽  
Before And After

Migraine is the second most common cause of primary headache and as per GBD 2015; migraine was ranked third highest cause of disability worldwide. Migraine with aura is an episodic headache associated with certain features such as sensitivity to light, sound or movement; nausea, vomiting and various fully reversible neurological symptoms. The aim of study was to assess the effect of Navajivana rasa with Pathyashadangam kashaya ghanasatwa in Classical Migraine. The formulations were combined and made into a dispensable form of hard gelatin capsules. Selected participants were given with two 500mg capsules twice daily after food for 2 months and were observed during 1 month of follow up. Symptomatic features were assessed before treatment, after 2 months of medication & after follow up. The MIDAS score for the assessment of disability was assessed before and after 3 months of study period. The results showed that, the study drug was effective in relieving the sign & symptoms of classical migraine and in improving the quality of life.

Pilot study on criteria in cavity preparation-facts or artifacts?

1973 ◽  
Vol 37 (11) ◽  
pp. 27-31 ◽  
Author(s):  
G Salvendy ◽  
WM Hinton ◽  
GW Ferguson ◽  
PR Cunningham
Keyword(s):  
Pilot Study ◽  
Cavity Preparation

A Pilot Study of Early Storybook Reading With Babies With Hearing Loss

2019 ◽  
Vol 62 (9) ◽  
pp. 3397-3412
Author(s):  
Michelle I. Brown ◽  
David Trembath ◽  
Marleen F. Westerveld ◽  
Gail T. Gillon
Keyword(s):  
Hearing Loss ◽  
Pilot Study ◽  
Visual Analysis ◽  
Single Case ◽  
Eye Contact ◽  
Preliminary Evidence ◽  
Storybook Reading ◽  
Book Selection ◽  
Turn Taking ◽  
Parent Child

Purpose This pilot study explored the effectiveness of an early storybook reading (ESR) intervention for parents with babies with hearing loss (HL) for improving (a) parents' book selection skills, (b) parent–child eye contact, and (c) parent–child turn-taking. Advancing research into ESR, this study examined whether the benefits from an ESR intervention reported for babies without HL were also observed in babies with HL. Method Four mother–baby dyads participated in a multiple baseline single-case experimental design across behaviors. Treatment effects for parents' book selection skills, parent–child eye contact, and parent–child turn-taking were examined using visual analysis and Tau-U analysis. Results Statistically significant increases, with large to very large effect sizes, were observed for all 4 participants for parent–child eye contact and parent–child turn-taking. Limited improvements with ceiling effects were observed for parents' book selection skills. Conclusion The findings provide preliminary evidence for the effectiveness of an ESR intervention for babies with HL for promoting parent–child interactions through eye contact and turn-taking.

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