Clinical Trial Research Articles

MIGRAINE

Background Migraine is a prevalent neurological disorder characterized by chronic headaches, significantly impacting the global population. This comprehensive review aims to advance the understanding of migraine pathogenesis and treatment, focusing on molecular markers and novel therapeutic strategies. Material Molecular markers such as calcitonin gene-related peptide (CGRP) and their role in migraine development. Traditional medical treatments and emerging therapeutic strategies, including neuromodulation, are analyzed for their effectiveness and limitations. Clinical studies and imaging techniques are leveraged to identify key mechanisms and triggers in migraine pathology. Approximately 95% of people experience a headache at some point, with migraines being a significant contributor. Migraine is recognized by the World Health Organization as one of the top ten causes of disability globally, particularly affecting women. CGRP is identified as a crucial factor in migraine development. Inhibitors targeting CGRP have shown significant effectiveness in managing migraines. Other molecular markers, including proinflammatory cytokines and neurotransmitters, are discussed for their roles in pain transmission and migraine pathophysiology. Traditional treatments, such as triptans and NSAIDs, are evaluated alongside new therapies, including CGRP inhibitors and neuromodulation techniques. Neuromodulation, involving devices like external trigeminal nerve stimulators, shows promise in migraine management. Genetic markers associated with familial hemiplegic migraine (FHM) and common migraine forms are reviewed. Recent genome-wide association studies (GWAS) have identified several genetic variants linked to migraine susceptibility. Conclusion This presentation enhances the understanding of migraine pathogenesis and introduces novel therapeutic possibilities. By focusing on molecular markers like CGRP and exploring advanced treatment options, the study aims to improve migraine management and patient care. The findings underscore the need for continued research and innovation in migraine treatments to reduce the global burden of this debilitating condition.

Loncastuximab in high-risk and heavily pretreated relapsed / refractory diffuse large B-cell lymphoma: a real-world analysis from 21 US centers.

Outcomes in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) are poor. Loncastuximab-teserine (Lonca) is an antibody drug conjugate (ADC) which was FDA approved for R/R DLBCL patients who have received at least 2 prior lines of therapy based on the LOTIS-2 trial. However, there are limited data regarding its efficacy in the real-world setting (RWS). This retrospective study included 21 US centers and evaluated outcomes of patients with R/R DLBCL treated with Lonca. Our analysis includes 187 patients with notably higher risk baseline features compared to LOTIS-2 including a higher proportion of patients with bulky disease (17% vs 0%), high-grade B-cell histology (HGBL) (22% vs 8%), and increased number of prior lines of therapy (median 4 vs 3). The complete response (CR) rate was 14% and overall response rate (ORR) was 32%. Median event free (EFS) and overall survival (OS) were 2.1 and 4.6 months, respectively. Those with bulky disease and HGBL had significantly worse outcomes, and those with non-germinal center cell of origin and CR to most recent line of therapy demonstrated superior outcomes. In summary, in this largest retrospective cohort study of Lonca in the RWS, the response rates, EFS, and OS were lower than those reported in LOTIS-2, which is likely reflective of its use in higher risk and more heavily pre-treated patients within the real world compared to those enrolled on clinical study.

Identifying thresholds for meaningful improvements in NTDT-PRO scores to support conclusions about treatment benefit in clinical studies of patients with non-transfusion-dependent beta-thalassaemia: analysis of pooled data from a phase 2, double-blind, placebo-controlled, randomised trial

ObjectivesTo estimate thresholds for defining meaningful within-patient improvement from baseline to weeks 13–24 and interpreting meaningfulness of between-group difference for the non-transfusion-dependent beta-thalassaemia patient-reported outcome (NTDT-PRO) tiredness/weakness (T/W) and shortness...

Endodontic treatment modifies circulatory inflammatory mediator levels: A systematic review with meta-analysis.

There is limited and conflicting data on the reduction of circulatory inflammatory mediators in patients with apical periodontitis (AP) following endodontic treatment. To answer the following research question: in adult healthy patients with AP [Population (P)], is there a difference before [Comparator (C)] and after various endodontic treatments (nonsurgical, surgical or retreatment) [Intervention (I)] on systemic levels of inflammatory biomarkers [Outcome (O)] in the follow-up period[Time (T)]? An electronic literature search was conducted in the databases Scopus, PubMed, Clarivate Analytics' Web of Science, Cochrane Database of Systematic Reviews and Grey literature from inception to July 2024 with no language restrictions. Observational studies examining changes in serum levels of inflammatory mediators were included. Two independent reviewers selected studies, extracted data and critically appraised the included studies. Qualitative and quantitative (meta-analysis) data synthesis methods were employed. The Newcastle-Ottawa Scale was used to assess the quality of the included studies. Sixteen studies met the inclusion criteria, of which six were included in the meta-analysis. These studies were published between 1992 and 2024, involving a total of 596 patients (54% females) aged between 16 and 75 years. The meta-analysis of pooled data showed a significant decrease in high-sensitive C-reactive protein (hs-CRP) levels in the serum of patients with AP 6 months after treatment [2.26 ± 1.76 versus 1.28 ± 1.06 mg/L, (Z = 2.03, p = .04)] and a decrease in interleukin-1β (IL-1β) levels 12 months after treatment [13.01 ± 5.95 versus 10.86 ± 3.52 pg/mL, (Z = 3.72, p < .01)]. One study was assessed as poor quality, while all others were considered high quality. Despite the differences in methodologies across the included studies, it has been established that effective endodontic treatment leads to a reduction in systemic inflammatory biomarkers in the body. Following effective endodontic treatment in patients with AP, the systemic levels of hs-CRP and IL-1β exhibit a significant reduction at 6 and 12 months, respectively. Further clinical studies should investigate whether effective endodontic treatment and reduced levels of investigated biomarkers may change the clinical presentation of systemic diseases. PROSPERO database (CRD42024559271).

Citrate in autosomal dominant polycystic kidney disease: biomarker or therapeutic agent?

Purpose of review This review highlights the latest findings regarding hypocitraturia in autosomal dominant polycystic kidney disease (ADPKD), from both experimental and clinical studies, exploring the underlying pathophysiology and potential therapeutic approach. Recent findings Experimental studies have shown that the lodging of microcrystals in the tubules can trigger cyst formation and growth in polycystic kidney disease (PKD). ADPKD patients are prone to developing hypocitraturia in early stages, which could predispose to calcium microcrystal formation. Low urinary citrate excretion has been associated with a more rapid decline in eGFR and poorer renal survival in ADPKD patients. Animal studies employing citrate supplementation have shown promising effects on preserving the decline in estimated glomerular filtration rate (eGFR) and cyst growth. Summary Current knowledge suggests that urinary citrate could be incorporated into existing prognostic markers for disease progression and potential adjuvant therapy in ADPKD, but further clinical studies to support such hypothesis must be undertaken.

Prognostic impact of the newly revised IASLC proposed grading system for invasive lung adenocarcinoma: a systematic review and meta-analysis.

This study aimed to evaluate the prognostic value of the newly revised International Association for the Study of Lung Cancer (IASLC) grading system (2020) on the 5-year overall survival (OS) and recurrence-free survival (RFS) in patients with lung adenocarcinoma (LADC). Clinical studies that investigated the prognostic value of revised IASLC staging system in patients with LADC were retrieved from the PubMed, Web of Science, ScienceDirect, and Cochrane Library databases. This study was conducted in accordance to the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and checklists. Based on inclusion and exclusion criteria, we included 12 studies for analysis. The grade of LADC was assessed by revised IASLC system, which included three grades. Compared to Grade 3 LADC, grade 1 (total [95% CI]: 1.38 [1.19, 1.60]) and grade 2 (total [95% CI]: 1.29 [1.15, 1.44]) LADC had higher 5-year OS rates. Similarly, Grade 1 (total [95% CI]: 1.76 [1.42, 2.18]) and Grade 2 (total [95% CI]: 1.51 [1.28, 1.77]) had higher 5-year RFS rates Grade 3 LADC. However, 5-year OS and RFS had no significant difference between Grade 1 and Grade 2 patients. This systematic review and meta-analysis provides evidence that the newly revised IASLC grading system is significantly associated with the prognosis of patients with LADC, where Grade 3 indicated unfavorable prognosis.

INTRAOPERATIVE LOCAL BUPIVACAINE WOUND INFILTRATION VERSUS TRADITIONAL SYSTEMATIC ANALGESIA: A COMPARISON IN TERM OF POST-OPERATIVE PAIN

Effective management of post-operative pain is essential for patient recovery and satisfaction, especially in procedures like appendectomies where pain management can influence overall outcomes. Traditional systemic analgesia, while effective, often comes with side effects and limitations. Local infiltration of anesthetics like bupivacaine may provide a targeted approach to pain control with fewer systemic effects. Objective: To compare the effectiveness of intraoperative local bupivacaine wound infiltration versus traditional systemic analgesia in managing post-operative pain in patients undergoing appendectomies. Methods: This randomized controlled trial was conducted at Lady Reading Hospital, Peshawar, following approval from the hospital's Ethical Committee. A total of 60 patients, who consented and met eligibility criteria, were enrolled. All patients underwent appendectomy under general anesthesia, followed by random allocation into two groups. Group A received 0.5% bupivacaine for local wound infiltration, while Group B did not. Both groups were administered intravenous tramadol on demand, with a maximum dose of 400 mg per 24 hours. Post-operative pain was assessed using a Visual Analog Scale (VAS) at 4, 12, and 24 hours post-surgery. Stratified analysis by age and gender was also performed. Results: The study population (mean age: 41.13 ± 7.96 years) included 34 males (56.7%) and 26 females (43.3%). Group A (bupivacaine group) had a significantly lower mean post-operative pain score (3.33 ± 0.66) compared to Group B (systemic analgesia group) with a score of 5.30 ± 0.95 (p=0.00). Age-based stratification revealed significant differences: among 22-30-year-olds, Group A scored 3.00 versus 6.00 in Group B (p=0.00); for 31-50-year-olds, Group A scored 3.36 compared to 5.33 in Group B (p=0.00); and for those over 50, scores were 3.33 in Group A and 4.50 in Group B (p=0.04). Both male and female patients in Group A experienced significantly lower pain scores compared to Group B (p=0.00 for both). Conclusion: Intraoperative bupivacaine wound infiltration significantly reduces post-operative pain in appendectomy patients compared to traditional systemic analgesia. These findings support its use as an effective pain control method. Further research is recommended to optimize dosing and assess the combined use with other analgesics to enhance pain management across various surgical procedures.

Prevalence and predictors of episiotomy among puerperal women accessing postnatal care in the Kumasi Metropolis.

This study investigated the prevalence and predictors of episiotomy among puerperal women accessing postnatal care in the Kumasi Metropolis. A cross-sectional survey was conducted among 1750 postnatal mothers who had spontaneous vaginal using a questionnaire. Descriptive statistics were conducted to show the rate of episiotomy. Chi-square and binary logistic regression analyses were conducted using Jamovi software version 2.5.3. The prevalence of episiotomy among the study population was 49.7% compared to the 10% of all deliveries recommended by World Health Organisation (WHO). Among those who had an episiotomy, 88.5% gave consent, and 77.6% required repairs. In the bivariate analysis educational status, age, perineal tearing, marital status, household monthly income, spontaneous vaginal deliveries and previous episiotomy had a significant association with episiotomy risk. In the multivariate analysis, married women, lower education levels, moderate household incomes, grand multiparous women, spontaneous vaginal delivery (SVD), instrumental deliveries, longer second stages of labour, and attending more antenatal care (ANC) sessions were all associated with a reduced likelihood of episiotomy. Higher one-minute Apgar scores and anemia also lowered the odds. Conversely, hypertensives, women with four or more previous vaginal deliveries, and those with a history of episiotomy were more likely to undergo the procedure. Episiotomies conducted was high, indicating potential overuse compared to WHO's recommendations. Antenatal attendance and timing should be prioritised to improve maternal preparation and outcomes. Policy interventions to reduce unnecessary episiotomies are needed. Midwifery education must also emphasise the importance of respectful maternity care.

A comparison of the effects of ENTONOX inhalation and spinal anesthesia on labor pain reduction and apgar score in vaginal delivery: a clinical trial study

A comparison of the effects of ENTONOX inhalation and spinal anesthesia on labor pain reduction and apgar score in vaginal delivery: a clinical trial study

Retinal Patterns and the Role of Autofluorescence in Choroideremia

Background: Choroideremia is a monogenic inherited retinal dystrophy that manifests in males with night blindness, progressive loss of peripheral vision, and ultimately profound sight loss, commonly by middle age. It is caused by genetic defects of the CHM gene, which result in a deficiency in Rab-escort protein-1, a key element for intracellular trafficking of vesicles, including those carrying melanin. As choroideremia primarily affects the retinal pigment epithelium, fundus autofluorescence, which focuses on the fluorescent properties of pigments within the retina, is an established imaging modality used for the assessment and monitoring of affected patients. Methods and Results: In this manuscript, we demonstrate the use of both short-wavelength blue and near-infrared autofluorescence and how these imaging modalities reveal distinct disease patterns in choroideremia. In addition, we show how these structural measurements relate to retinal functional measures, namely microperimetry, and discuss the potential role of these retinal imaging modalities in clinical practice and research studies. Moreover, we discuss the mechanisms underlying retinal autofluorescence patterns by imaging with a particular focus on melanin pigment. Conclusions: This could be of particular significance given the current progress in therapeutic options, including gene replacement therapy.

RARE TUMORS OF POSTERIOR CRANIAL FOSSA IN ADULTS

Objectives Tumors arising in the posterior cranial fossa pertain to a special category of neoplasm in the manner that they can cause cerebellar syndrome, obstructive hydrocephalus, brainstem compression – cranial nerve dysfunction – and herniation. In the cerebellopontine angle, the most common tumors are acoustic neuromas followed by meningiomas. Among the petroclival tumors, the most common benign tumors are meningiomas and the most common malign tumors are chordomas and metastases. Among jugular foramen tumors, the common tumors are schwannomas, paragangliomas and meningiomas. We report our unit’s experience with the neurosurgical management of rare posterior cranial fossa tumors as compared to the main literature results, taking into consideration the clinical, radiological aspects and the outcome. Materials and Methods Retrospective analysis of a single unit cohort of patients diagnosed with rare posterior cranial fossa tumors, who underwent surgical treatment in the Neurosurgery I Department of the University Emergency Hospital Bucharest between 2017 and 2024. Relevant literature review was analyzed, as well as serial clinical examinations, imaging studies, and operative records were taken into consideration. Conclusions Depending on the location, size, and pathology of the posterior cranial fossa tumors, there are different treatment options, which include microsurgical resection, observation, stereotactic radiotherapy. These type of lesions still represent a challenge and require electing the most suitable approach whilst preserving the neurologic function of the patient.

Epileptic encephalopathy, autism and cognitive deficit caused by the SYNGAP1 gene mutation

The paper analyzes data from scientific publications and presents a clinical case study of a rare genetic epileptic encephalopathy caused by a mutation in the SYNGAP1 gene. The case study focuses on a 4-year-old girl who has been diagnosed with epileptic encephalopathy due to the mutation. The paper describes the anamnesis of the child’s illness, including family history, neurological, neuropsychological, and speech assessments, as well as the results of genetic testing, electroencephalography, and magnetic resonance imaging (MRI). The findings indicate that the main symptoms of the condition are typically epilepsy, autism spectrum disorder, difficulty with phrasal speech, and mental retardation. Common types of seizures include atypical absence seizures, myoclonic seizures, atonic seizures, and eyelid myoclonia with absences. On the electroencephalogram, there is a slowdown in occipital activity and diffuse, prolonged «peak-polypic-slow-wave» complexes. Pathognomonic neuroimaging changes in the brain are typically absent. Valproic acid, levetiracetam, and ethosuximide have been shown to be the most effective treatments for controlling epileptic seizures. Due to the rarity of this syndrome, the authors have provided a detailed clinical case report from their practice.Conclusion. SYNGAP1-related epileptic encephalopathy has a specific clinical presentation, including characteristic EEG findings and a particular pattern of seizures. The diagnostic approach for children with this condition, autism spectrum disorder, and delayed language development should include video electroencephalography with sleep deprivation, as well as genetic testing if necessary, using next-generation sequencing, to ensure early detection and appropriate treatment planning.

Virtual surgical plan with custom surgical guide for orthognathic surgery: systematic review and meta-analysis.

The shift from traditional two-dimensional (2D) planning to three-dimensional (3D) virtual surgical planning (VSP) has revolutionized orthognathic surgery, offering new levels of precision and control. VSP, combined with computer-aided design/computer-aided manufacturing (CAD/CAM) technology, enables the creation of patient-specific surgical guides and implants that translate preoperative plans into more precise surgical outcomes. This review examines the comparative accuracy and operative efficiency of VSP, especially when used with custom surgical guides, against conventional 2D planning in orthognathic surgery. The study systematically reviewed and analyzed published literature comparing the accuracy and operative time between VSP and conventional planning methods. The meta-analysis included clinical trials, controlled trials, and observational studies on patients undergoing orthognathic surgery, focusing on the degree of alignment between planned and postoperative bone positions and total surgery time. Results indicate that VSP consistently reduces discrepancies between planned and actual surgical outcomes, particularly when integrated with custom surgical guides. Additionally, while VSP demonstrated potential time-saving advantages over conventional planning, these differences were not statistically significant across studies, likely due to high variability among study protocols and designs. VSP with custom surgical guides enhances surgical accuracy in orthognathic procedures, marking a significant advancement over traditional methods. However, the reduction in operative time was not conclusively significant, underscoring the need for further studies to evaluate time efficiency. These findings emphasize VSP's role in improving surgical precision, which holds substantial implications for future orthognathic surgical practices.

Veterans' perspectives on two transdiagnostic group workshops to improve military to civilian reintegration: A comparative thematic analysis.

Veterans deployed in the post-9/11 wars in Iraq and Afghanistan (Operations Enduring Freedom, Iraqi Freedom, and New Dawn) face a multitude of challenges reintegrating into civilian life after military service. There is a need for evidence-based support programs to address the wide-reaching cognitive, psychological, and physical symptoms that can impede civilian reintegration. The present study incorporates quantitative and qualitative methods to assess veterans' experiences with two reintegration treatments (Short-Term Executive Plus-Home [SH] and Present Centered Group Therapy for Reintegration [PCGT-R]) within the context of a larger randomized clinical trial. A total of 131 veterans ages 24-65 years, drawn from the SH (n = 66) and PCGT-R (n = 65) treatment arms, completed quantitative feedback forms and qualitative interviews. Quantitative surveys indicated SH was more highly rated than PCGT-R in terms of program satisfaction (p < .01), helpfulness (p = .03), and connection to other Veterans Affairs (VA) services (ps < .05). Thematic qualitative analysis indicated that both interventions provided beneficial social support and that both groups appreciated online implementation. They also revealed that SH veterans acquired more emotion regulation and impulse control skills and reported greater willingness to engage in further VA treatments, than PCGT-R veterans. Dropout did not differ significantly between groups, and the most highly cited reasons for dropout among both groups were scheduling conflict and dislike of group formats. Findings emphasize the opportunity for group and skills-based interventions focused on reintegration to increase support and access to VA care among veterans. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

The BrEasT cancer afTER-CARE (BETTER-CARE) programme to improve breast cancer follow-up: design and feasibility study results of a cluster-randomised complex intervention trial.

The risk of breast cancer patients for long-term side effects of therapy such as neurotoxicity and cardiotoxicity as well as late effects regarding comorbidities varies from individual to individual. Personalised follow-up care concepts that are tailored to individual needs and the risk of recurrences, side effects and late effects are lacking in routine care in Germany. We describe the methodology of BETTER-CARE, a parallel-arm cluster-randomised controlled trial conducted at 15 intervention and 15 control centres, aiming to recruit 1140 patients, and the results of the pilot phase. The needs- and risk-adapted complex intervention, based on existing development frameworks, includes a multidisciplinary network and digital platforms for symptom and need documentation and just-in-time adaptive interventions. The control group comprises usual care according to clinical guidelines. The primary outcome is health-related quality of life (EORTC QLQ-C30 global health), and secondary outcomes include treatment adherence. The 2-month pilot phase comprising 16 patients in one intervention and one control pilot centre demonstrated the feasibility of the BETTER-CARE approach. BETTER-CARE is a feasible intervention and study concept, investigating individualised needs- and risk-adapted breast cancer follow-up care in Germany. If successful, the approach could be implemented in German routine care. German Clinical Trial Register DRKS00028840. Registered on April 2022.

Effect of an Intensive Nurse Home Visiting Program on Postpartum Contraceptive Use and Birth Spacing

OBJECTIVE: To evaluate the effect of an intensive nurse home visiting program on postpartum contraceptive use and birth spacing among individuals with a first pregnancy who were eligible for Medicaid insurance in South Carolina. METHODS: We conducted a nonblinded, randomized controlled trial of the Nurse-Family Partnership (NFP), an established intensive home visiting program that provides prenatal and postpartum home visits through 2 years after childbirth. The trial included patients who were eligible for Medicaid insurance with a first pregnancy at less than 28 weeks of gestation between April 1, 2016, and March 17, 2020, who were followed up through 2 years after childbirth. Participants were randomized 2:1 to NFP compared with standard of care treatment. The primary outcome was a birth interval of less than 21 months between the index pregnancy and a subsequent birth. The secondary outcomes were birth intervals of less than 15 and 24 months, receipt of a contraceptive implant or intrauterine device (IUD) immediately postpartum, any contraceptive use and receipt of a family planning visit (at both 6 weeks and 1 year postpartum), and IUD receipt at 1 year postpartum. We assessed outcomes using linked birth certificate records and Medicaid claims data. RESULTS: A total of 4,932 trial participants (3,295 in the intervention group and 1,637 in the control group) were included in the study analysis. Within 21 months of the study index birth, 11.0% of individuals in the NFP group and 12.2% of the usual care group had a subsequent birth. The NFP did not have a statistically significant effect on birth intervals of less than 21 months (adjusted coefficient −1.1, 95% CI, −2.9 to 0.8). There were no statistically significant differences between the NFP and control groups for any of the study's eight secondary outcomes related to birth spacing and postpartum contraceptive use. CONCLUSION: Home visits with a registered nurse did not affect postpartum contraceptive use or birth spacing. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03360539.

Toripalimab Plus Chemotherapy as a First-Line Therapy for Extensive-Stage Small Cell Lung Cancer: The Phase 3 EXTENTORCH Randomized Clinical Trial.

Patients with extensive-stage small cell lung cancer (ES-SCLC) have poor prognoses and unmet medical needs. To evaluate the efficacy and safety of toripalimab plus etoposide and platinum-based chemotherapy (EP) vs placebo plus EP as a first-line treatment for patients with ES-SCLC. This multicenter, double-blind, placebo-controlled phase 3 randomized clinical trial (EXTENTORCH study) enrolled patients from September 26, 2019, to May 20, 2021, and was conducted at 49 sites in China. Eligible patients had histologically or cytologically confirmed ES-SCLC without previous systemic antitumor therapy for ES-SCLC. Data were analyzed between May 6, 2023, and June 1, 2024. Patients were randomized (1:1) to receive toripalimab, 240 mg, or placebo plus EP every 3 weeks for up to 4 to 6 cycles, followed by maintenance with toripalimab or placebo until disease progression, intolerable toxic effects, or up to 2 years of treatment. The primary end points were investigator-assessed progression-free survival (PFS) and overall survival (OS). Whole-exome sequencing results identified correlative biomarkers for clinical efficacy. Among 595 screened patients, 442 eligible patients were randomized (median [range] age, 63 [30-77] years; 366 [82.8%] male); 223 patients were randomized to toripalimab plus EP, and 219 to placebo plus EP. By April 20, 2023, the median (range) survival follow-up was 13.7 (0.0-42.7) months. Compared with placebo, toripalimab improved investigator-assessed PFS (hazard ratio [HR], 0.67 [95% CI, 0.54-0.82]; P < .001), and significantly reduced the risk of death (HR, 0.80 [95% CI, 0.65-0.98]; P = .03). The median OS was 14.6 (95% CI, 12.9-16.6) months in the toripalimab group vs 13.3 (95% CI, 11.8-14.4) months in the placebo group. Whole-exome sequencing results from 300 patients identified low intratumor heterogeneity, HLA-A11+ HLA-B62- haplotype, wild-type KMT2D and COL4A4, or sequence variations in CTNNA2 or SCN4A correlated with favorable PFS and OS in the toripalimab group. No new safety signals were observed. Grade 3 or higher treatment-emergent adverse event incidence was similar between the toripalimab and placebo safety set groups (199 of 222 patients [89.6%] vs 193 of 216 patients [89.4%], respectively). In this phase 3 randomized clinical trial, adding toripalimab to first-line chemotherapy demonstrated significant improvements in PFS and OS for patients with ES-SCLC. The treatment exhibited an acceptable safety profile, supporting this combination regimen as a new treatment option for patients with ES-SCLC. ClinicalTrials.gov Identifier: NCT04012606.

CO-CREATION-HF protocol: clinical trial to evaluate the impact of a comprehensive and hybrid cardiac rehabilitation model on patients with heart failure

CO-CREATION-HF protocol: clinical trial to evaluate the impact of a comprehensive and hybrid cardiac rehabilitation model on patients with heart failure

Intra-articular corticosteroid injections versus platelet-rich plasma as a treatment for cervical facetogenic pain: a randomized clinical trial

ObjectiveThe study’s primary objective was to compare the effectiveness of intra-articular platelet-rich plasma injections versus corticosteroid injections for the treatment of cervical facetogenic pain. Secondary aims were to compare self-rated...

Effect of acupuncture on quality of life in atrial fibrillation: study protocol for a randomised controlled trial

IntroductionAtrial fibrillation (AF) is the prevalent cardiac arrhythmia and can significantly impair the quality of life (QoL). Although catheter ablation (CA) is an established treatment for AF,post-procedural complications or perceived...