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PubMed2026

Assessing time to symptomatic progression, a patient-relevant efficacy endpoint, in the MARIPOSA study in non-small cell lung cancer.

INTRODUCTION: In the phase 3 randomized MARIPOSA study, amivantamab and lazertinib combination therapy demonstrated improved progression-free survival (PFS) and overall survival (OS) versus osimertinib in participants with previously untreated, epidermal growth factor receptor-mutated advanced non-small cell lung cancer. Time to symptomatic progression (TTSP) was introduced to assess clinical worsening and complement endpoints that investigate radiographic disease progression and patient-reported outcomes. TTSP provides an easily interpretable measure of disease-specific symptom worsening to further support patient experience. METHODS: In MARIPOSA, TTSP was quantitatively assessed as a secondary efficacy endpoint and defined as the time from randomization until participants experience disease-specific symptom worsening requiring a clinical intervention or treatment change, or death. To evaluate the impact of amivantamab and lazertinib on TTSP considering its established OS benefit against osimertinib, an exploratory analysis censoring death events was performed. RESULTS: At the final protocol-specified OS analysis (median follow up: 37.8 months), median TTSP was 43.6 months with amivantamab and lazertinib versus 29.3 months with osimertinib (hazard ratio [HR]: 0.69; 95% confidence interval [CI]: 0.57-0.83; p&#x202f;<&#x202f;0.0001). Amivantamab and lazertinib reduced deaths following a TTSP event compared to osimertinib. A strong correlation between TTSP and PFS or OS was observed. CONCLUSIONS: Amivantamab and lazertinib significantly delayed TTSP versus osimertinib. TTSP offers a clinician-validated measurement of disease-specific symptom worsening, capturing symptoms perceived by patients that prompt clinical action. TTSP is highly correlated with PFS and OS, providing complementary insights alongside traditional endpoints. TTSP enhances understanding of treatment benefit and supports informed clinical decision-making by integrating patient experience.

Humans↗
PubMed2026

Targeted reflex RNA sequencing for enhanced variant classification on exome and genome sequencing improves patient outcomes.

RNA sequencing (RNA-seq) has been utilized to provide functional evidence regarding the impact of splicing variants. This study explores the utility of targeted reflex RNA-seq to inform classification of predicted splicing variants identified through clinical exome sequencing (ES) and genome sequencing (GS). A retrospective analysis was conducted on consecutive ES/GS cases completed at a single center in which targeted reflex RNA-seq was performed following identification of eligible variants. There were 131 cases (4.1%) that had at least one RNA-seq eligible variant reported, with eight of these cases having two unique eligible variants. Of the 139 eligible variants, 125 were classified as variants of uncertain significance (VUS). Sixty-four cases had targeted reflex RNA-seq completed with 27 cases having at least one variant reclassified (42.2%). After reclassification, 23 cases had positive results, and two cases had a likely diagnosis of an autosomal recessive condition. Clinical outcomes data regarding positive RNA-seq cases showed that 71% (10/14) had clinical management changes and 43% (6/14) had treatment changes. Incorporation of targeted reflex RNA-seq analysis into the diagnostic pipeline of rare diseases enhances variant classification and resolves uncertainty regarding predicted splice variants, leading to an estimated 1.6% increase in diagnostic yield of clinical ES/GS.

Journal Article↗
PubMed1979

Effects of five experimental treatments of stuttering.

Twenty adult stutterers were exposed to each of five experimental treatments: time-out, noise, delayed auditory feedback (DAF), "wrong" and metronome. In each session a subject spoke for 20 minutes without treatment (baserate) followed by 30 minutes in one of the five experimental conditions. Before the five treatment sessions, subjects accomplished three pre-experimental tasks: expectancy, changeability, and adaptation tasks. Percent stuttering decreased significantly in all conditions, and stuttering duration reduced significantly in all but the noise condition. The amount of reduction in percent stuttering from baserate to treatment (change score) in time-out was positively related to the change scores in DAF and metronome. Change scores in metronome were positively related to change scores in time-out and "wrong." Percent stuttering change scores in noise, DAF, and "wrong" were essentially unrelated. Stuttering duration change scores were related only for the time-out and DAF, and metronome and DAF conditions. In general, the pre-experimental expectancy, changeability, and adaptation scores were unrelated to change scores in any of the experimental conditions. Words spoken per minute did not change significantly from baserate to treatment for any experimental condition except time-out.

Adult↗
PubMed1979

Evaluation of acromegaly by radioimmunoassay of somatomedin-C.

We measured serum concentrations of somatomedin-C by radioimmunoassay in 57 acromegalic patients and compared them with various indicators of disease activity. The mean fasting somatomedin-C concentration was 6.8 U per milliliter (range, 2.6 to 21.7) for the acromegalics and 0.67 U per milliliter (range, 0.31 to 1.4) for 48 normal, fasting adults. The somatomedin-C concentration correlated significantly with: heel-pad thickness (r = 0.73), fasting glucose (r = 0.74), and one-hour postprandial glucose (r = 0.77). In contrast, "glucose-suppressed" growth hormone correlated weakly (r = 0.34, 0.36, 0.34) with these clinical indexes of severity. Fasting growth hormone levels showed no correlation (r = 0.14). Five active acromegalics had "normal" growth hormone levels after glucose suppression, but they had elevated somatomedin-C. In 15 patients studied one year after treatment, changes in somatomedin-C concentrations paralleled the degree of clinical improvement. Measurement of somatomedin-C appears to provide a reliable means for confirming the diagnosis of acromegaly and of clinical disease activity than measurement of growth hormone concentrations.

Acromegaly↗
PubMed1975

Differential sub-cellular compartmentalization of thyrotropin releasing hormone (TRH) and gonadotropin releasing hormone (LRH) in hypothalamic tissue.

Homogenates of male rat hypothalami were fractionated by differential centrifugation. Of the total quantity of TRH and LRH in the homogenate, about 50% was in particles sedimenting at 11,500 X g. and 15-20% was in particles sedimenting between 20,000 and 105,000 X g. No LRH or TRH was recovered in the 105,000 X g supernatant fluid. When the 900 X g supernatant fluid was subjected to continuous sucrose density gradient centrifugation, TRH-containing particles distributed as two peaks located at 0.9 and 1.1 M sucrose. On the other hand, LRH-containing particles distributed as only one peak located at 1.2 M sucrose. The 11,500 X g pellet contained those particles comprising the 1.2 M peak of LRH and the 1.1 M peak of TRH. Acid phosphatase activity was found in the gradient fractions containing TRH and LRH, whereas NADPH-cytochrome c reductase and cytochrome c oxidase activities were separated from the peaks of TRH and LRH. Norepinephrine, dopamine, and TRH distributed identically on the gradient. Hypo-osmotic treatment changed the gradient profile of TRH but not that of LRH. Most of the TRH was found near the top of the gradient, but a small amount of TRH was associated with particles which were lighter than those previously noted. The peak of LRH was reduced but its location on the gradient was unchanged. It is concluded that in hypothalamic homogenates TRH and LRH are localized in synaptosome-like particles which have different physical properties.

Animals↗
PubMed2025

Molecular features influencing clinical outcome of advanced HER2-positive gastric cancer receiving trastuzumab plus chemotherapy.

BACKGROUND: Less than half of the human epidermal growth factor receptor 2 (HER2)-positive gastric cancer (GC) patients respond to trastuzumab plus chemotherapy, and the outcomes are unsatisfactory. Understanding the underlying mechanisms remains crucial for identifying patients who are more likely to benefit from treatment. PATIENTS AND METHODS: We performed targeted DNA sequencing on paired pre-treatment and progressive tumour tissues from 22 HER2-positive advanced GC patients undergoing first-line treatment with trastuzumab and chemotherapy. Clinicopathological and genomic characteristics were assessed for the correlation with clinical outcomes. RESULTS: A performance status (PS) of 0-1 was associated with improved progression-free survival (PFS) and overall survival (OS) than a PS of 2. Poorly differentiated tumours exhibited shorter PFS than moderate or moderate-poor ones. Pre-treatment amplification of MYC or TOP2A gene was association with increased PFS, and suggested a potential benefit for OS. Patients with higher tumour mutation burden (TMB) experienced significantly worse PFS, while higher chromosome instability (CIN) appeared to be correlated with longer PFS. Compared to non-responders, responders had a higher CIN but similar TMB and intratumoural heterogeneity (ITH). PS and MYC amplification emerged as independent factors related to PFS according to multivariate survival analysis. Additionally, after treatment, TMB significantly increased in non-responders, while CIN significantly decreased in responders. CONCLUSIONS: Pre-treatment MYC amplification and PS were independently associated with clinical outcomes in HER2-positive advanced GC patients treated with first-line trastuzumab plus chemotherapy. Dynamic post-treatment changes in TMB and CIS provide valuable insights into the relationship between therapeutic response and distinct evolutionary trajectories.

Humans↗
PubMed2026

Relationships among mechanisms in psychosocial treatments for chronic pain: mechanism to mechanism lagged effects and relationships with outcomes.

Results suggest that psychosocial treatments for chronic pain work via several mechanisms, and that they often do so to similar degrees and in similar ways. Extant research, however, has focused on individual and/or independent effects of mechanisms on outcomes. Whether successful outcomes are also partly because of sequential and meaningful relationships among and between mechanisms-mechanism-to-mechanism effects-has not been examined. Secondary analyses were conducted of an RCT that compared cognitive therapy, mindfulness-based stress reduction, and behavior therapy to treatment as usual in a sample (N = 521) of people with chronic low back pain. Results of hierarchical linear modeling revealed that (1) Treatment Condition &#xd7; Mechanism interactions predicting changes in other mechanisms were nonsignificant; (2) lagged prior session mechanism changes predicted next session changes in another mechanism; (3) lagged relationships between pain catastrophizing and pain self-efficacy were reciprocal, whereas links between lagged pain catastrophizing and mindfulness changes and lagged pain catastrophizing changes and behavioral activation changes were unidirectional; and (4) individual differences in the strengths of mechanism-to-mechanism relationships predicted pre- to post-treatment changes in outcomes. Results reveal heretofore hidden therapeutic processes that cognitive therapy, mindfulness-based stress reduction, and behavior therapy may share. Namely, that mechanism-to-mechanism lagged effects do indeed emerge beyond mechanism-to-outcome effects. Findings show not only that mechanisms may change in definable sequences relative to each other but that individual differences in the strengths of mechanism-to-mechanism relationships may themselves be predictive of outcomes.

Humans↗
PubMed1978

Cell proliferation in EMT6 tumors treated with single doses of x-rays or hydroxyurea. I. Experimental results.

EMT6 mouse mammary tumors were treated in vivo with 5 mg/mouse of hydroxyurea (HU) or 300 rads of X-rays. The proliferation of the tumor cells was followed for 28 hr after treatment. Changes in the 3H-TdR labeling index, the mitotic index, the specific activity of the 3H-TdR-labeled DNA, and the proportion of suspended, clonogenic cells in the S phase of the cell cycle were examined and compared. Evidence was found for reassortment of the surviving cells in treated tumors into partially synchronous cohorts. The partial synchrony in the proliferation of the surviving cells was not accurately predicted by the changes in the labeling index and the mitotic index. The changes in DNA specific activity proved unacceptable as an indicator of cell proliferation in solid EMT6 tumors treated with low doses of radiation or HU.

Animals↗
PubMed1978

Changes in the electrolyte content of leucocytes at different clinical stages of cirrhosis.

The intracellular sodium, potassium, and water content of isolated leucocytes was estimated in 47 patients with cirrhosis. The values for sodium showed a wide scatter. In patients without ascites the mean value was significantly increased but in those accumulating ascites it was normal, although often reduced in individual subjects. Reduced values were found in patients with hyponatraemia associated with end-stage cirrhosis and diuretic treatment. Changes in leucocyte water content closely followed those in sodium content. Leucocyte potassium content was normal except in patients accumulating ascites in whom it was significantly reduced, indicating whole body depletion, and this could be corrected by administration of spironolactone.

Adult↗
PubMed1978

Functional and hormonal control of pelvic width in the rat.

Absolute sacral dimensions of the rat are influenced by muscular, ovarian and testicular action, and all affect absolute sacral length more than absolute width. However, relative to trunk-length dimensions are rather stable and drop with a higher level of significance only in castration combined with estrogen or progesterone treatment. Relative pelvic width, as expressed by the transverse interiliac distance, is greatly widened in extreme muscular hypofunction but the sacrum does not participate in this widening. The widening results from a broadening of the proximal part of the ilium, following a genral response of long bones to extreme muscular hypofunction. Pelvic width is reduced in castration and ovariectomy with and without testosterone or estrogen treatment, but not in the combination of castration with progesterone treatment. Changes of sacral width are, however, more often independent from than concomitant with the width changes of the pelvis. The transverse interventral spine distance is dependent on rectus femoris muscle activity and drops drastically in hind-leg removal. It also drops in castration and particularly when castration is combined with estrogen treatment; but progesterone adds little to the effect of castration alone. The effect of ovariectomy alone or combined with testosterone treatment is negligible.

Amputation, Surgical↗
PubMed1978

Tanderil/chloramphenicol eye ointment in the treatment of the "Red Eye" seen in general practice.

An open study is reported in which 35 general practitioners treated 128 patients suffering from 'Red Eye' with a new eye ointment containing 10% Tanderil(oxyphenbutazone) and 1% chloramphenicol. One hundred and seventeen patients completed the seven day treatment period, in which time 99 had completed resolution of the symptoms and were discharged, the remaining 18 patients needed a longer period of treatment. Eleven patients failed to complete the study period, of whom 5 patients were subsequently referred to a specialist and 6 had their treatment changed by the general practitioner. Six patients showed signs of allergy to the ointment, all of whom were being treated for allergic conjunctivitis. Seventeen per cent of patients had some difficulty in applying the eye ointment or complained of subsequent blurring of vision.

Adolescent↗
PubMed1979

The treatment of atrophic vaginal conditions with Ortho-Gynest: a pilot study.

A clinical study was undertaken, in twenty-four patients with atrophic vaginal changes, to assess the efficacy and the acceptability of treatment with Ortho-Gynesi vaginal suppositories, which have as their active constituent the naturally occurring substance oestriol. A regenerative effect on the vaginal epithelium could be objectively demonstrated by an increase in the proportion of superficial cells following treatment. Changes in the vaginal epithelium were accompanied by a diminution in the incidence of infection and inflammation. Subjective complaints such as dyspareunia, pruritus and kraurosis vulvae, which could also be ascribed to a relative oestrogen deficiency, responded well to treatment.

Aged↗
PubMedDate not supplied

[Parenteral hyperalimentation in patients with advanced neoplastic disease (author's transl)].

Two groups of patients suffering from advanced neoplastic disease were fed parenterally for a period ranging from 1 to 16 weeks. The parameters considered were: weight change, serum albumin level, lymphocyte transformation test and serum immunoglobulin level. There were 23 patients in one group and 21 patients in the other. Regimens included for group I: saline solution (1000-1500 ml), glucose (100-150 g) and amino acids (15-30 g) per day; for group 2: 40-50 Cal/kg per day (dextrose about 15 g/kg per day), about 2 g of amino acids/kg/day and about 40-50 ml water/kg/day. In addition, 13 patients underwent both treatments sequentially. All the Group I patients lost weight (1.3 kg/week); while out of 23 patients in Group 2, 15 gained weight, 2 remained unchanged and 6 continued to lose weight, but to a lesser rate than before hyperalimentation (the average weight gain was 1.1 kg/week). Serum albumin levels decreased in 19 out of 25 patients in Group I and increased in 14 out of 26 patients of Group 2. Initial values of the lymphocyte blast transformation test were very low in both groups of patients, and an increase was observed only in patients treated by hyperalimentation. The increase was more evident in patients who were not under antiblastic treatment. Changes in serum immunoglobulin levels were not significant. The authors conclude that malnutrition plays a very important role in neoplastic cachexia and can be improved by parenteral hyperalimentation. Although it is possible that in the near future hyperalimentation and conventional neoplastic therapies will play complementary roles in treatment of advanced neoplastic disease, malnutrition is still the specific indication for intravenous hyperalimentation.

Amino Acids↗
PubMed2026

Comparison of analgesic treatments used for ankle sprains in the emergency department.

BACKGROUND: Ankle sprains (ASs) account for approximately 5% of emergency department visits and 40% of all sports-related injuries, causing significant pain and restriction in the range of motion (ROM). This study aims to observe the clinical outcomes of early administration of intravenously administered paracetamol, ibuprofen, and dexketoprofen, which are frequently used in emergency department practice for ASs. For this purpose, pain monitoring and ROM measurements were performed to demonstrate the effectiveness of early functional analgesia. METHODS: This prospective, randomized, double-blind study was conducted between December 2023 and May 2024 on patients diagnosed with grade 1-2 ASs in the emergency department. Patients were divided into three groups and received intravenous dexketoprofen (Group D, n=52), paracetamol (Group P, n=52), and ibuprofen (Group I, n=51). Pain assessment was performed using the numeric rating scale (NRS) and the Wong-Baker FACES Pain Scale (WBS). ROM was evaluated by measuring dorsiflexion ROM (d-ROM) and plantar flexion ROM (p-ROM) angles using a semicircular goniometer. Pre-treatment and 1-h post-treatment measure-ments were compared. RESULTS: In the post-treatment pain assessment, no significant difference was observed between the groups in terms of NRS scores (p=0.352); however, Group I had the lowest WBS scores (p<0.001). Nevertheless, in all three groups, post-treatment pain scores (NRS and WBS) were significantly lower compared to pre-treatment values (p<0.001). Regarding ROM, pre-treatment d-ROM and p-ROM values were similar among the groups (p=0.196) and p=0.287, respectively). Post-treatment measurements revealed that d-ROM was lower in Group I (p=0.034), whereas p-ROM was higher (p=0.011). However, in all groups, ROM values significantly improved after treatment compared to baseline (p<0.001). When pre- and post-treatment changes (&#x394;) in pain scores and ROM values were compared, no statistically significant differences were found between the groups (&#x394;NRS p=0.264, &#x394;WBS p=0.965, &#x394;d-ROM p=0.099, &#x394;p-ROM p=0.073). CONCLUSION: Paracetamol, ibuprofen, and dexketoprofen demonstrated similar efficacy in reducing pain and improving ankle joint ROM during the acute phase of ASs. These findings suggest that the early initiation of analgesic treatment in ASs contributes to clinical recovery.

Humans↗
PubMed2026

Transcranial Magnetic Stimulation for Patients with Exposure Therapy Resistant Obsessive-Compulsive Disorder (TETRO): Study Protocol for a Multicenter Randomized Controlled Trial.

BACKGROUND: Obsessive-compulsive disorder (OCD) is a disabling mental disorder, characterized by obsessions, compulsions, and substantial morbidity. Approximately 50% of adults with OCD fail to achieve satisfactory outcomes from first-line treatments, such as exposure therapy with response prevention (ERP), with or without medication. This leads to chronic social, educational, and occupational impairment. While invasive procedures such as deep brain stimulation are available for severe, treatment-refractory cases, a need remains for less invasive alternatives. Repetitive transcranial magnetic stimulation (rTMS), a noninvasive intervention, shows promise in reducing OCD symptoms. Unlike in depression, rTMS is not yet reimbursed for OCD in the Dutch healthcare system. OBJECTIVE: This study examines the efficacy and cost-effectiveness of low-frequency (1Hz) rTMS targeting the presupplementary motor area (pre-SMA) compared to sham rTMS as an adjuvant treatment to ERP in adults with OCD with inadequate response to first-line treatment. METHODS: A total of 250 adults with OCD will be enrolled in this multicenter randomized controlled trial. Participants will be randomly assigned to ERP combined with either active or sham 1Hz rTMS over the pre-SMA. Treatment is administered 4 times weekly for at least 5 weeks (20 rTMS-ERP sessions), with optional extension of 1 to 2 weeks, up to 28 rTMS-ERP sessions. Clinical assessments occur at baseline, weekly during treatment, posttreatment, and at 3, 6, and 12 months follow-up. Participants undergo pre- and posttreatment (functional) (MRI) scans, including a symptom provocation task. Blood sampling takes place pre- and posttreatment and at 3-month follow-up. The primary outcome is OCD severity at posttreatment, as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Secondary outcomes include functional improvement, quality of life, and societal costs. Pretreatment symptom profiles, genotype, and brain network topology will be analyzed as predictors of response and relapse risk. Pre-to-post treatment change in blood-based and magnetic resonance (MR)-based neuroplasticity markers will help explore differential mechanisms between ERP alone and combined rTMS-ERP. We expect that the verum rTMS protocol will be cost-effective compared to sham-rTMS. RESULTS: Recruitment started in April 2022, and as of February 2026, 201 participants have been enrolled. Posttreatment assessments are projected to be completed in December 2026, with final one-year follow-up evaluations anticipated by the end of 2027. CONCLUSIONS: To our knowledge, this study is the first adequately powered randomized controlled trial examining efficacy, cost-effectiveness, and mechanism of action of rTMS for OCD as adjuvant therapy to ERP. In case of efficacy and/or cost-effectiveness, it will pave the way for rTMS as insured health care for adults with OCD in the Netherlands, and possibly other European countries. Furthermore, this trial will provide insight into the mechanisms of treatment response to intensive ERP, with and without adjunctive rTMS, as well as potential side effects, individual variability, and long-term outcomes in adults with OCD.

Humans↗
PubMed1979

Effect of Sar1-ala8-angiotensin II on blood pressure and renin in Bartter's syndrome, before and after treatment with prostaglandin synthetase inhibitors.

Three patients suffering from Bartter's syndrome were studied before and after 5 days of treatment with the prostaglandin synthetase inhibitors, aspirin and indomethacin. Saralasin was given by intravenous infusion in increasing doses from 0.6 to 42 micrograms/min.kg/BW. During saralasin infusion a blood pressure reduction was observed in all patients. Aspirin treatment did not affect this response and nor did it affect other manifestations of the syndrome. Indomethacin treatment changed the blood pressure response to saralasin in such a way that the blood pressure was increased in one patient and was unchanged in the other. Indomethacin also tended to normalize other features of Bartter's syndrome, such as the hyperreninaemia and angiotensin unresponsiveness, but did not affect the hypokalaemia. The saralsin effect on blood pressure is thus evidently inversely related to the prevailing activity of the renin-angiotensin system in this condition also, and the patients obviously depended on the renin-angiotensin system to maintain their blood pressure. Our findings, together with data in the literature, indicate that angiotensin unresponsiveness of the vascular bed is not a primary feature in Bartter's syndrome. Chloride loss is currently thought to be the basic abnormality and this may link the Bartter's syndrome with other diseased states characterized by chloride loss, such as the syndrome of habitual vomiting and chronic treatment with loop diuretics.

Adolescent↗
PubMed1975

Destruction of Salmonella on poultry meat with lysozyme, EDTA, x-ray, microwave and chlorine.

Lysozyme, ethylenediaminetetracetic acid, chlorine, x-irradiation and microwaves were used in experimental attempts to eliminate Salmonella senftenberg 775W or Salmonella typhimurium from turkey drumsticks and whole carcasses. Turkey drumsticks or whole carcasses were artificially contaminated with S. senftenberg 775W or S. typhimurium in concentrations ranging between 5 X 10(5) to 8 X 10(5) viable cells per ml. of contaminating fluid. After each treatment, samples were cultured, plated, and tested according to standard methods to determine the susceptibility of Salmonella organisms to the particular treatment. A 0.1 percent solution of lysozyme eliminated the S. senftenberg 775W at 22 degrees C. within three hours. A 0.5 percent solution of ethlenediaminetetracetic acid failed to destroy the test organism under the same conditions. Eighty thousand rads of X-ray eliminated the test organism on turkey drumsticks but failed to remove it from whole turkey carcasses. Microwaves eliminated the S. senftenberg 775W in 150 seconds from turkey drumsticks and ten minutes from broiler chicken carcasses. Aqueous solutions containing 3400 and 2125 p.p.m. chlorine failed to destroy the test organism on turkey drumsticks at 21 degrees C. in 9 and 24 hours. None of the treatments changed the appearance of the skin or meat, except microwaves produced a partially-cooked appearance. Chlorine produced off-color drumsticks.

Animals↗