PubMed HealthSearch

SEARCH · PubMed Health

Results for “Pilot Projects”

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 37 records · Page 2Linked to original sources

Concurrent use of PGF2 alpha, vibrations to the cervix uteri and amniotomy to induce labor after intrauterine fetal death.

A triad consisting of (a) prostaglandin F2 alpha infusion, (b) dilation of the uterine cervix by low frequency vibrations and (c) early low amniotomy was used to induce labor in ten women after intrauterine fetal death had occurred. Vaginal delivery was successful in all cases, with a mean induction-to-delivery interval of 5.4 +/- 0.8 hours. Vibratory dilation effectively prepares the cervix for the intense prostaglandin-induced uterine contractions and thereby reduces the risk of cervical laceration and fistula. The dilation of the cervical canal also makes an early low amniotomy possible and easy. This study demonstrates a highly effective, safe and relatively nontraumatic method for uterine evacuation after intrauterine fetal death.

Adolescent

Pilot Evaluation of a Digital Pretest Education Platform for Genomic Counseling: Perspectives of Health Care Providers and Patients.

Traditional in-person consultations for genetic services create access barriers. We hypothesized that the Genetics Adviser platform-a web-based digital platform delivering clinical genomic services-could reduce these barriers. Focusing on pretest education and counseling, we tested a pilot version of the platform in medical genetics and pediatric endocrinology group practices. The multimethod design consisted of quantitative patient and caregiver surveys, Google Analytics data, and qualitative healthcare provider interviews. Surveys included validated measures of acceptability and empowerment. Transcribed interviews were thematically coded and analyzed using NVivo. Of the 102 patients and caregivers targeted for this study, 85/102 (83%) accessed the platform, 71/102 (70%) proceeded beyond the landing page, and 60/102 (59%) completed the post-module survey. Users expressed high confidence in genetic understanding and empowerment (Genomics Outcome Scale [GOS]: 77/100), and providers noted potential benefits and highlighted technological and content-related limitations. Further research is needed to validate effectiveness across diverse populations and to evaluate long-term impacts on patient outcomes and healthcare efficiency.

Humans

A randomized pilot study comparing two regimens in the treatment of squamous cell carcinoma.

Thirty-five patients with epithelial carcinomas not considered to be surgically resectable were randomized to receive two different chemotherapy regimens. Regimen 1 was CCNU followed by bleomycin, and Regimen 2 was a combination of CCNU, bleomycin, methotrexate, and vinblastine. Five of 14 patients treated with CCNU-bleomycin had partial responses. Three of 15 patients treated with the four-drug combination had a partial response. The toxicity of the four-drug regimen was significantly greater than that of the two-drug regimen, while the response rate was greater among those patients treated with two drugs. No significant clinical infections occurred despite the fact that leukopenia and thrombocytopenia were more severe and frequent with the four-drug regimen. Most importantly, the two-drug regimen is well tolerated as an outpatient procedure. Two of the two-drug and one of the four-drug recipients were converted from an inoperable to an operable state. In view of the fact that there has not heretofore been an effective chemotherapeutic regimen for Stage III and IV squamous carcinoma, this is a significant observation. It is of note that patients with squamous cell carcinoma of the head and neck were those who responded best to this treatment, although the treatment is worthy of consideration for advanced squamous carcinoma in other areas.

Bleomycin

Effects of Dynamic Neck Sensorimotor Biofeedback Training in Individuals With Mechanical Neck Pain: A Pilot Randomized Controlled Trial.

Mechanical neck pain (MNP) is commonly accompanied by pain-related functional limitations, sensorimotor disturbances, and fear of movement, which together may contribute to persistent disability. This preliminary randomized controlled trial study investigated the short-term effects of dynamic neck sensorimotor-based biofeedback training in individuals with MNP. 20 MNP patients from outpatient clinics were assigned to a biofeedback training group or a control group. The training group underwent dynamic biofeedback exercises twice weekly for 2&#xa0;weeks, whereas the control group performed repeated cervical movements without biofeedback. Outcomes included cervical kinematics as repositioning errors (RPE), movement units (MU), maximal range of motion (ROM), and subjective measures, including pain intensity, Neck Disability Index (NDI), and Fear-Avoidance Beliefs Questionnaire (FABQ). All participants completed post-intervention assessments; adherence in the training group was 100%, with no missing data and no adverse events reported. Within the biofeedback training group, participants receiving biofeedback training demonstrated greater improvements in cervical repositioning accuracy during flexion (51.95%, p&#xa0;=&#xa0;0.04) and extension (46.67%, p&#xa0;=&#xa0;0.02), along with reductions in fear-avoidance beliefs related to physical activity and work (p&#xa0;<&#xa0;0.05); these changes were less apparent in the active control group. Exploratory regression analyses suggested associations between improvements in repositioning accuracy and pain reduction, and between increased cervical range of motion and improvements in fear-avoidance beliefs related to physical activity. These pilot findings suggest that dynamic sensorimotor biofeedback training may improve proprioceptive acuity and fear-avoidance beliefs in individuals with MNP, supporting further evaluation in an adequately powered randomized trial.

Humans

Effects of Transcranial Direct Current Stimulation and Individualized Physical Therapy on Pain and Function in Individuals With Chronic Knee Pain: A Pilot Study.

BACKGROUND AND PURPOSE: Noninvasive brain stimulation is a promising neuromodulatory intervention for chronic pain. This study aimed to determine the impact that transcranial direct current stimulation (tDCS) in combination with individualized physical therapy (PT) has on pain and function in individuals with chronic knee pain. METHODS: This study was a preliminary pragmatic, triple-blinded, randomized, and sham-controlled clinical trial performed in an outpatient orthopedic physical therapy clinic. Participants participated in 5 sessions of active or sham tDCS followed by individualized PT intervention. Pain outcomes included the Numeric Pain Rating Scale, Movement-Evoked Pain, pressure pain thresholds (PPT), and the Central Sensitization Inventory. Functional outcomes included the 2-minute walk test, 5-time sit-to-stand test, quadriceps strength, knee range of motion, Patient Specific Functional Scale, and the Lower Extremity Functional Scale. RESULTS: Thirty participants with chronic knee pain completed the study. There were no significant differences observed for primary patient-centered pain and functional outcomes. For secondary outcomes, the active tDCS group had a significant effect (p&#xa0;<&#xa0;0.05) on percent change in lateral joint line PPT and a significant multivariate effect of group on PPT change scores for 3-site and 5-site clusters (p&#xa0;<&#xa0;0.05). Exploratory responder analyses demonstrated that the active tDCS group was 12.8 times more likely to achieve the minimum detectable change in quadriceps strength improvement compared with the sham tDCS group (p&#xa0;<&#xa0;0.05). DISCUSSION: There were no significant between-group differences for primary pain and functional outcomes. However, the active tDCS group showed improvements in pain sensitivity, as measured by PPT, and quadriceps strength, which were superior to those seen in the sham tDCS group. These preliminary findings provide insight into possible mechanisms of tDCS in addressing pain as opposed to efficacy. Given that there were no clear between-group differences in patient-centered outcomes, there is insufficient evidence for routine tDCS use for chronic knee pain. TRIAL REGISTRATION: NCT06132412.

Humans

Ossification variants of the distal femoral condyle: longitudinal 3&#xa0;T MRI evidence of progression to juvenile osteochondritis dissecans in asymptomatic siblings of patients with JOCD.

OBJECTIVE: Ossification variants (OVs) of the femoral condyles are traditionally regarded as benign developmental findings distinct from juvenile osteochondritis dissecans (JOCD). We aimed to characterize the longitudinal MRI behavior of OVs and JOCD lesions in asymptomatic siblings of JOCD patients. MATERIALS AND METHODS: In this HIPAA-compliant longitudinal pilot study, seven asymptomatic siblings of JOCD patients underwent serial 3&#xa0;T bilateral knee MRI. Two fellowship-trained musculoskeletal radiologists independently assessed 56 studies for bone marrow edema, lesion location, and MRI-defined category (OV or JOCD). RESULTS: OV and MRI-defined JOCD lesions were identified in 21 of 28 condyles (75%, 95% CI: 56.6-87.3%), while 7 condyles (25%, 95% CI: 12.7-43.4%) remained normal throughout follow-up. Six condyles demonstrated MRI-defined JOCD lesions at one or more timepoints. Three OV lesions evolved over time: two progressed to MRI-defined JOCD but remained clinically silent, and one progressed from OV to MRI-defined JOCD and subsequently to clinically manifest JOCD requiring surgery. Using Generalized Linear Mixed model, a statistically significant association was found between bone marrow edema and MRI-defined category (F&#x2009;=&#x2009;31.73, p&#x2009;<&#x2009;0.001). OV lesions showed absent or trace edema, whereas JOCD showed definite edema. Inter-reader agreement using Cohen's Kappa was moderate to substantial between the radiologists (&#x3ba;&#x2009;=&#x2009;0.479-0.739, 95% CI: 0.314-0.633, 0.644-0.845, p&#x2009;<&#x2009;0.001). CONCLUSIONS: In siblings of patients with JOCD, OV lesions are common and may represent dynamic MRI phenotypes along a continuum of epiphyseal ossification abnormalities, with occasional progression to MRI-defined JOCD and rare progression to clinically manifest JOCD.

Humans

Bioabsorbable vs. titanium screws in first metatarsophalangeal joint arthrodesis: a pilot randomized controlled trial with 2-year follow-up.

INTRODUCTION: To assess the feasibility and preliminary clinical outcomes of bioabsorbable screw fixation in first metatarsophalangeal joint arthrodesis compared to conventional titanium screw fixation. METHODS: In this prospective pilot randomized controlled trial, 30 patients were allocated 1:1 to bioabsorbable or titanium cannulated lag screw fixation. Arthrodesis was performed using a cup-and-cone technique at two Finnish hospitals. Full weight-bearing in an orthopaedic shoe was allowed after six weeks. Outcomes included AOFAS and VA-FAS FA-VAS scores, union rates, and complications assessed at 3, 6, 12, and 24 months. RESULTS: Both groups showed significant functional improvement with no between-group differences. At 24 months, mean AOFAS scores were 89.1 (SD 2.7) in the titanium group and 90.0 (SD 0.0) in the bioabsorbable group (p = 0.23). Mean FA-VAS total scores (sum of pain, function, and complaints subscales) were 1948 (SE 59.4) in the titanium group and 1914 (SE 61.4) in the bioabsorbable group (p = 0.655). Union rate was 90% overall; nonunion occurred in one titanium and two bioabsorbable patients, all requiring revision. No implant-related complications or hardware removal surgeries were recorded. Degradation of bioabsorbable screws caused no adverse clinical or radiographic reactions. CONCLUSIONS: Bioabsorbable screws appear safe and feasible in first metatarsophalangeal joint arthrodesis, with preliminary outcomes comparable to titanium fixation. These findings support the conduct of a larger confirmatory trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03133039, registered 28 April 2017. https://clinicaltrials.gov/ct2/show/NCT03133039.

Humans

Smart crutch tipsTM real-time feedback improves adherence to partial weight-bearing protocols following lower extremity fracture surgery: a pilot study.

PURPOSE: To evaluate the effectiveness of Smart Crutch Tips&#x2122; in promoting adherence to prescribed early partial weight-bearing (PWB) protocols and to assess patient experience with real-time weight-bearing feedback during home rehabilitation. METHODS: Twenty patients with lower extremity fractures prescribed partial weight-bearing (PWB) were randomized into two groups utilizing real-time feedback crutch tips (RFC). The Intervention group (n&#x2009;=&#x2009;10) used Smart Crutch Tips&#x2122; (ComeBack Mobility Inc., Kiev, Ukraine), which provided real-time feedback on weight-bearing compliance. The Control group (n&#x2009;=&#x2009;10) also used crutches equipped with Smart Crutch Tips&#x2122;, but notifications were disabled, allowing passive data collection without patient feedback. Weight-bearing compliance was defined as the percentage of steps within &#xb1;&#x2009;10% of the prescribed target. Secondary outcomes included patient satisfaction and device usability assessed using the System Usability Scale (SUS) throughout the home rehabilitation period. RESULTS: The Intervention group demonstrated significantly greater PWB compliance compared with the Control group (73.6% vs. 21.1%, p&#x2009;<&#x2009;0.01). The Intervention group reported a mean SUS score of 84.25, indicating excellent usability. No device-related complications or adverse events were observed. Patient satisfaction, assessed through video interviews, was high, with participants in the Intervention group expressing a strong willingness to recommend the device to others with similar injuries and rating it 10 out of 10. CONCLUSION: Smart Crutch Tips&#x2122; significantly improved adherence to prescribed partial weight-bearing protocols following lower extremity fracture surgery. The RFC device demonstrated high usability, excellent patient satisfaction, and no device-related complications during home rehabilitation throughout the study period.

Humans

Untargeted metabolomics and proteomics reveals cocoa-mediated mitigation of valproic acid-induced dysregulation in a zebrafish model of autism: pilot study.

INTRODUCTION: Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by behavioral impairments and limited therapeutic options. Emerging evidence suggests that plant-derived polyphenols may offer neuroprotective benefits. OBJECTIVES: This pilot study aimed to investigate the therapeutic potential of polyphenol-rich cocoa extract in a valproic acid (VPA)-induced zebrafish model of ASD. METHODS: Zebrafish were exposed to 3&#x202f;&#x3bc;M VPA, cocoa powder providing 2.5 &#x3bc;M (-)-epicatechin, a combination of both, or left untreated. Behavioral phenotyping was conducted using DanioVision and gut morphology was assessed. Untargeted metabolomic and proteomic profiling was performed followed by univariate and multivariate analyses. RESULTS: VPA exposure induced ASD-like behavioral hyperactivity, and severe gastrointestinal abnormalities. Cocoa co-treatment ameliorated both behavioral performance and gut architecture. Metabolomic profiling revealed VPA-associated disruptions in neurotransmission, methylation, mitochondrial function and redox homeostasis. Proteomic profiling showed elevated levels of trafficking protein particle complex subunit 11, proteasomal ubiquitin receptor, betaine-homocysteine S-methyltransferase 1 (BHMT-1), and desmoplakin-A, consistent with genotoxic stress and impaired protein trafficking. Cocoa co-treatment normalized BHMT-1 and desmoplakin-A expression and mitigated broader metabolic dysregulation. CONCLUSION: Collectively, these results suggest that polyphenol-rich cocoa may represent a promising multi-targeted nutraceutical approach for mitigating ASD-related neurodevelopmental and metabolic disturbances.

Animals

EEG power spectral changes secondary to L-DOPA treatment in parkinsonian patients: a pilot study.

Clinical EEG evaluation and power spectral analysis were performed on 12 parkinsonian patients before and during L-DOPA treatment. The EEG evaluation did not disclose any significant effects of L-DOPA treatment. Spectral analysis disclosed normal interlobar and interhemispheric power differences and an increase in delta and slow-theta power in the right temporal as compared to the right occipital lobe before L-DOPA treatment was initiated. L-DOPA treatment significantly increased alpha power in both occipital lobes, decreased theta power in the right temporal lobe, accentuated power differences in the theta and alpha bands between temporal and occipital lobes and attenuated beta power differences in those areas. This work is intended as a pilot study in the quantitative EEG evaluation of Parkinson's disease and L-DOPA treatment.

Electroencephalography

EEG signs of cerebrovascular disorder, using physical exercise as a provocative method.

A group of patients suffering from cerebrovascular insufficiency was submitted to a pilot EEG investigation using physical exercise as a provocative method. Two control groups, one of young (20--30 years) and another of older (more than 50 years) subjects, were also investigated. Quantitative EEG spectral data, determined at rest and during a period after physical exercise, showed that deviations of the frequency distribution of the alpha band were related to cerebrovascular insufficiency.

Adult

Cancellous bone marrow grafts in irradiated dog and monkey mandibles.

A pilot study was conducted to investigate the osteogenic potential of autogenous cancellous marrow grafts placed in irradiated tissue. Five dogs and three monkeys received either 4,100 or 6,520 rads of cobalt-60 irradiation during a 5- or 8-week period. Postirradiation discontinuity mandibular defects were created surgically and restored with autogenous cancellous bone marrow grafts held in position by a titanium mesh basket. Bony union occurred in all the mandibles. Intraoral ulceration was common in the dogs, and extraoral wound dehiscence was found in the monkeys. Hematopoietic marrow was present in the graft sites of both species 6 months to 1 year after surgery.

Animals

Management of adenocarcinoma of prostate with diethylstilbestrol diphosphate and cyclophosphamide.

Eleven patients with terminal metastatic prostatic carcinoma were selected for a pilot study to evaluate how effective diethylstilbestrol diphosphate (Stilphostrol) and cylcophosphamide (Cytoxan) are in this disease. Six of 7 patients had a good response when treated with diethylstilbestrol diphosphate. The mean duration of response was 6.4 months. All 6 patients given cyclophosphamide had marked relief of pain and increased mobility. Of these, 3 died twelve, sixteen, and nineteen weeks, respectively, following initiation of therapy while still benefiting from pain relief. The mean duration of response was 14.8 weeks.

Adenocarcinoma

Development, feasibility, acceptability, and preliminary impact of NutriSOS&#xae;: A behavioral mobile app to promote sustainable diets.

The primary objective of this study was to describe the development of the NutriSOS&#xae; app and to evaluate its feasibility and acceptability for its use in the NutriSOS&#xae; Randomized Controlled Trial (RCT) to promote sustainable diets. A secondary objective was to explore preliminary changes in dietary and physical activity behaviors and environmental impact following app use. The NutriSOS&#xae; app integrates personalized dietary advice, educational content, self-monitoring, and social interaction features. A single-arm, pre-post pilot study was conducted in 37 young Mexican adults over four weeks. Feasibility, acceptability, quality, and usability were assessed using online surveys, alongside exploratory changes in dietary and physical activity behaviors, environmental indicators, and their association with perceived behavioral determinants. Feasibility and acceptability were high overall, with favorable responses reaching up to 100% in key components such as the nutritional guide and learning modules, and above 90% for messaging, registration, and design. Greater variability was observed in some sections, particularly the 24-h recall (41-86%). Reductions in red and processed meat and ultra-processed food consumption were observed (from 3 to 1 times/week, p&#xa0;<&#xa0;0.01), with &#x223c;60% decreases in their related environmental footprints (p&#xa0;<&#xa0;0.01) and favorable self-reported behavioral determinants (p&#xa0;<&#xa0;0.0001). Physical activity type and intensity changed (p&#xa0;<&#xa0;0.05). These findings support NutriSOS&#xae; as a feasible and acceptable tool, while highlighting areas for refinement, particularly those related to the time and effort required for data entry, prior to its implementation in the NutriSOS&#xae; RCT, in which its effectiveness will be formally evaluated.

Humans

Plasma proteomic markers of pain and emotional dysfunction in fibrous dysplasia/McCune-Albright syndrome.

Pain in Fibrous dysplasia/McCune-Albright syndrome (FD/MAS) remains poorly understood and inadequately managed due to uncertainties regarding clinical or biological drivers. This cross-sectional pilot study aimed to use plasma proteomics to identify markers that inform on molecular pathways associated with pain and emotional symptoms in FD/MAS. Seventeen individuals (15 females, 2 males), aged 16 to 63&#xa0;years, with confirmed diagnoses of monostotic FD, polyostotic FD, or MAS participated in a single study visit conducted at Boston Children's Hospital and Massachusetts General Brigham. During the visit, participants completed validated questionnaires assessing neuropathic pain characteristics, pain interference, anxiety symptoms, depression symptoms, and perceived stress, and provided plasma samples. These samples were analyzed for 57 proteins using Olink proximity extension assay. Associations between protein concentrations and symptom scores were evaluated using Spearman's correlations with false discovery rate correction (|r|&#xa0;>&#xa0;0.5, p&#xa0;<&#xa0;0.05). After FDR correction, the concentrations of seven proteins (TNF-&#x3b1;, LTA, CCL19, CSF2, CCL2, CCL4, CCL7) significantly correlated with pain interference, HADS-depression scores, or perceived stress. Four protein concentrations (TNF-&#x3b1;, CCL19, CSF2, CCL7) significantly correlated with multiple clinical measures. This pilot study identified several pain-associated proteins in individuals with FD/MAS, suggesting that proteomic profiling may be a promising approach for discovering pain biomarkers. Larger, longitudinal studies are needed to validate these results and investigate whether targeting immune pathways can alleviate pain and improve emotional health in FD/MAS.

Humans