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114 Diseases |  |
361 Trials |
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361 Trials |  |
7200 News |  |
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- | Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date, PD(L)-1 Biomarker, Metastases: Pembrolizumab and Doxorubicin Hydrochloride or Anti-Estrogen Therapy in Treating Patients With Triple-Negative or Hormone Receptor-Positive Metastatic Breast Cancer (clinicaltrials.gov) - Nov 15, 2019
P2, N=56, Recruiting, Sponsor: City of Hope Medical Center
Trial completion date: Oct 2019 --> Oct 2021 | Trial primary completion date: Oct 2019 --> Oct 2021
- ||| Ibrance (palbociclib) / Pfizer, Kadcyla (ado-trastuzumab emtansine) / Roche
Enrollment change, Metastases: Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer (clinicaltrials.gov) - Nov 15, 2019
P1/2, N=4, Recruiting, Sponsor: University of Kansas Medical Center
Trial completion date: Oct 2019 --> Oct 2021 | Trial primary completion date: Oct 2019 --> Oct 2021 N=62 --> 4
- || temozolomide / Generic Mfg.
PK/PD data, Preclinical, Journal: Plasma and brain pharmacokinetics of letrozole and drug interaction studies with temozolomide in NOD-scid gamma mice and sprague dawley rats. (Pubmed Central) - Nov 14, 2019
N=62 --> 4 These results will guide the optimization of dosing regimen for further development of letrozole for HGG treatment.
- | letrozole / generics
Clinical, Journal: Clinical effect of letrozole in treatment of idiopathic short stature in adolescent boys (Pubmed Central) - Nov 14, 2019
These results will guide the optimization of dosing regimen for further development of letrozole for HGG treatment. In adolescent boys with ISS and a high bone age, rhGH combined with letrozole can safely and effectively delay the increase in bone age and improve PAH and final adult height, with little adverse effect.
- | letrozole / Generic mfg.
New P4 trial: The Outcomes of ICSI Cycles With and Without Letrozole (clinicaltrials.gov) - Nov 14, 2019
P4, N=224, Recruiting, Sponsor: Mansoura University
- | Verzenio (abemaciclib) / Eli Lilly
New P3 trial, Metastases: AMBRE: Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer (clinicaltrials.gov) - Nov 14, 2019
P3, N=378, Not yet recruiting, Sponsor: UNICANCER
- || metformin / generics
Review, Journal: Medical and Surgical Treatment of Reproductive Outcomes in Polycystic Ovary Syndrome: An Overview of Systematic Reviews. (Pubmed Central) - Nov 14, 2019
LOD results in lower multiple pregnancy rates. However, due to the heterogeneous nature of the included populations of women with PCOS, further larger scale trials are needed with more precise assessment of treatments according to heterogeneous variants of PCOS.
- | letrozole / Generic mfg., carboplatin / Generic mfg., paclitaxel / Generic mfg.
Trial completion date, Monotherapy: NRG-GY019: Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Nov 13, 2019
P3, N=450, Recruiting, Sponsor: NRG Oncology
However, due to the heterogeneous nature of the included populations of women with PCOS, further larger scale trials are needed with more precise assessment of treatments according to heterogeneous variants of PCOS. Trial completion date: Feb 2028 --> Feb 2027
- | letrozole / generics, triptorelin / generics
Preclinical, Journal: The regulation of the follicular synchronization and sensitivity of rats with PCOS by AMH during prolonged pituitary downregulation. (Pubmed Central) - Nov 10, 2019
Rats in the GnRH-a group were given triptorelin for 11 days, whereas those in blank group were given an equal volume of 0.9% NaCl...The results of immunohistochemistry showed that follicular AMH, AMHRII, and FSHR significantly decreased in the GnRH-a group. Prolonged GnRH-a protocol can improve synchronization and sensitivity of follicular development by balancing the expressions of AMH, AMHRII, and FSHR among follicles at all levels, thereby achieving better therapeutic effect.
- | letrozole / generics
Journal, IO Biomarker: The influencing mechanism of mTOR signal pathway mediated by mitofusin-2 in development of follicle. (Pubmed Central) - Nov 8, 2019
Prolonged GnRH-a protocol can improve synchronization and sensitivity of follicular development by balancing the expressions of AMH, AMHRII, and FSHR among follicles at all levels, thereby achieving better therapeutic effect. Downregulated expression of Mfn2 may affect the regular development of follicle through the mediation of mTOR signal pathway.
- | Ibrance (palbociclib) / Pfizer
New P4 trial: Palbociclib + Letrozole Versus Epirubicin + Cyclophosphamide and Sequential Docetaxel as Neoadjuvant Chemotherapy (clinicaltrials.gov) - Nov 8, 2019
P4, N=152, Not yet recruiting, Sponsor: Shengjing Hospital
- || Ibrance (palbociclib) / Pfizer
Trial completion date, Trial primary completion date, Metastases: Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer (clinicaltrials.gov) - Nov 7, 2019
P2, N=55, Recruiting, Sponsor: Washington University School of Medicine
Downregulated expression of Mfn2 may affect the regular development of follicle through the mediation of mTOR signal pathway. Trial completion date: Feb 2021 --> Jul 2021 | Trial primary completion date: Aug 2019 --> Jan 2021
- || Itovebi (inavolisib) / Roche
Enrollment change, Trial completion date, Trial primary completion date: GO39374: To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer (clinicaltrials.gov) - Nov 7, 2019
P1, N=104, Recruiting, Sponsor: Genentech, Inc.
Trial completion date: Feb 2021 --> Jul 2021 | Trial primary completion date: Aug 2019 --> Jan 2021 N=236 --> 104 | Trial completion date: Dec 2021 --> Dec 2020 | Trial primary completion date: Dec 2021 --> Dec 2020
- | letrozole / Generic mfg., everolimus / Generic mfg.
Trial completion date, Trial primary completion date, Metastases: PerELISA: Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients (clinicaltrials.gov) - Nov 6, 2019
P1, N=42, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
N=236 --> 104 | Trial completion date: Dec 2021 --> Dec 2020 | Trial primary completion date: Dec 2021 --> Dec 2020 Trial completion date: Jul 2019 --> Jul 2021 | Trial primary completion date: Jul 2019 --> Jul 2021
- || Verzenio (abemaciclib) / Eli Lilly
Trial completion date, Trial primary completion date: A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread (clinicaltrials.gov) - Nov 6, 2019
P1b, N=198, Recruiting, Sponsor: Eli Lilly and Company
Trial completion date: Jul 2019 --> Jul 2021 | Trial primary completion date: Jul 2019 --> Jul 2021 Trial completion date: Dec 2021 --> Oct 2022 | Trial primary completion date: Mar 2020 --> Apr 2021
- | Ibrance (palbociclib) / Pfizer
Enrollment closed, Trial primary completion date, Combination therapy, Metastases: PALEO: Trial of Letrozole + Palbociclib/Placebo in Metastatic Endometrial Cancer (clinicaltrials.gov) - Nov 3, 2019
P2, N=78, Active, not recruiting, Sponsor: Nordic Society for Gynaecologic Oncology
Trial completion date: Dec 2021 --> Oct 2022 | Trial primary completion date: Mar 2020 --> Apr 2021 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2020 --> Dec 2018
- | letrozole / generics
Clinical, Journal: Impact of letrozole supplementation during ovarian stimulation for fertility preservation in breast cancer patients. (Pubmed Central) - Nov 3, 2019
As a result, the number of mature oocyte vitrified was lower in COSTLES group (7.8 ± 5.3 vs. 10.3 ± 8.5 oocytes, p < 0.001 respectively). Despite similar response to exogenous FSH, BC patients having undergone COSTLES show reduced oocyte maturation rates in comparison with those having received standard stimulation regimen.
- | dasatinib / Generic mfg.
Clinical, P2 data, Journal: Randomized phase-II evaluation of letrozole plus dasatinib in hormone receptor positive metastatic breast cancer patients. (Pubmed Central) - Nov 1, 2019
Letrozole plus dasatinib was well tolerated, although 26% of patients required dasatinib dose reductions. In this non-comparative phase-II trial, the CBR of 71% and the median PFS of 20.1 months with letrozole + dasatinib are encouraging and suggest that dasatinib may inhibit the emergence of acquired resistance to AI therapy.
- |||| Afinitor (everolimus) / Novartis
Clinical: Everolimus, letrozole, and metformin in women with advanced or recurrent endometrioid endometrial cancer: A multi-center, single arm, phase II study @rcoledude @PamSolimanMD https://t.co/1HDvh2e7ju (Twitter) - Oct 31, 2019
- | cyclophosphamide oral / Generic Mfg.
Clinical, P2 data, Journal: A multicenter phase II trial of neoadjuvant letrozole plus low-dose cyclophosphamide in postmenopausal patients with estrogen receptor-positive breast cancer (JBCRG-07): therapeutic efficacy and clinical implications of circulating endothelial cells. (Pubmed Central) - Oct 31, 2019
CEC quantification is a promising tool for treatment monitoring and prognostic stratification for metronomic therapy following validation of our results in larger studies. UMIN000001331 Phase II study of neoadjuvant letrozole combined with low-dose metronomic cyclophosphamide for postmenopausal women with endocrine-responsive breast cancer (JBCRG-07).
- | Ibrance (palbociclib) / Pfizer
Clinical, P2 data, Journal: Randomized Phase II Study Evaluating Palbociclib in Addition to Letrozole as Neoadjuvant Therapy in Estrogen Receptor-Positive Early Breast Cancer: PALLET Trial. (Pubmed Central) - Oct 31, 2019
UMIN000001331 Phase II study of neoadjuvant letrozole combined with low-dose metronomic cyclophosphamide for postmenopausal women with endocrine-responsive breast cancer (JBCRG-07). Adding palbociclib to letrozole significantly enhanced the suppression of malignant cell proliferation (Ki-67) in primary ER-positive BC, but did not increase the clinical response rate over 14 weeks, which was possibly related to a concurrent reduction in apoptosis.
- |||| Ibrance (palbociclib) / Pfizer
Trial completion date, Trial primary completion date: PATINA: Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (clinicaltrials.gov) - Oct 30, 2019
P3, N=496, Recruiting, Sponsor: Alliance Foundation Trials, LLC.
Adding palbociclib to letrozole significantly enhanced the suppression of malignant cell proliferation (Ki-67) in primary ER-positive BC, but did not increase the clinical response rate over 14 weeks, which was possibly related to a concurrent reduction in apoptosis. Trial completion date: Aug 2024 --> Dec 2025 | Trial primary completion date: Oct 2020 --> May 2021
- | Arimidex (anastrozole) / AstraZeneca, Remedica, Tamoxis (tamoxifen) / Bioprofarma
Journal: The Impact of Perioperative Hormonal Therapy for Breast Cancer on Transverse Rectus Abdominis Myocutaneous Flap Abdominal Complications. (Pubmed Central) - Oct 30, 2019
Trial completion date: Aug 2024 --> Dec 2025 | Trial primary completion date: Oct 2020 --> May 2021 Hormonal therapy is a useful adjunct for chemoprevention in breast cancer; however, use of letrozole in patients undergoing reconstruction with pedicled TRAM can lead to increase in certain complication rates.
- | letrozole / Generic mfg.
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: Study of Letrozole in Recurrent Gliomas (clinicaltrials.gov) - Oct 29, 2019
P1, N=42, Recruiting, Sponsor: University of Cincinnati
Hormonal therapy is a useful adjunct for chemoprevention in breast cancer; however, use of letrozole in patients undergoing reconstruction with pedicled TRAM can lead to increase in certain complication rates. N=12 --> 42 | Trial completion date: Jun 2019 --> Jun 2022 | Trial primary completion date: Apr 2019 --> Jun 2021
- || xentuzumab (BI-836845) / Boehringer Ingelheim
Trial completion date, Trial primary completion date, Combination therapy, Metastases: This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer (clinicaltrials.gov) - Oct 29, 2019
P1, N=148, Recruiting, Sponsor: Boehringer Ingelheim
N=12 --> 42 | Trial completion date: Jun 2019 --> Jun 2022 | Trial primary completion date: Apr 2019 --> Jun 2021 Trial completion date: Nov 2021 --> Apr 2022 | Trial primary completion date: Apr 2020 --> Nov 2021
- | letrozole / generics
Clinical, Journal: GnRH agonist and letrozole in women with recurrent implantation failure. (Pubmed Central) - Oct 29, 2019
Trial completion date: Nov 2021 --> Apr 2022 | Trial primary completion date: Apr 2020 --> Nov 2021 No abstract available
- | Arimidex (anastrozole) / AstraZeneca, Remedica
Retrospective data, Journal: Comparison of Changes in the Lipid Profiles of Eastern Chinese Postmenopausal Women With Early-Stage Breast Cancer Treated With Different Aromatase Inhibitors: A Retrospective Study. (Pubmed Central) - Oct 29, 2019
As a small-size retrospective study, our data do not support a judgment about whether one AI or another carries more or less risk in terms of lipid disorders in eastern Chinese breast cancer patients. The exact effects need further randomized, controlled trials to investigate.
- ||| Herceptin (trastuzumab) / Roche, Kisqali (ribociclib) / Novartis, Perjeta (pertuzumab) / Roche
Trial completion date: Detect V / CHEVENDO (Chemo vs. Endo) (clinicaltrials.gov) - Oct 27, 2019
P3, N=270, Recruiting, Sponsor: Prof. W. Janni
The exact effects need further randomized, controlled trials to investigate. Trial completion date: Sep 2021 --> Jun 2023
- | Tamoxis (tamoxifen) / Bioprofarma
Clinical, Journal: Adjuvant Letrozole and Tamoxifen Alone or Sequentially for Postmenopausal Women With Hormone Receptor-Positive Breast Cancer: Long-Term Follow-Up of the BIG 1-98 Trial. (Pubmed Central) - Oct 27, 2019
Letrozole reduced contralateral breast cancer frequency in the first 10 years, but this reversed beyond 10 years. This study illustrates the value of extended follow-up in trials of luminal breast cancer.
- | letrozole / generics
Clinical, Journal: Letrozole as co-treatment agent in ovarian stimulation antagonist protocol in poor responders: A double-blind randomized clinical trial. (Pubmed Central) - Oct 26, 2019
The number of patients with no oocyte, in the control group, was higher than the LZ-treated group, and the clinical pregnancy rate in LA-treated group (25%) was higher than the control group (18%); however, the differences were not significant statistically. Adding 5 mg of LZ to rFSH/hMG antagonist protocol may improve the in vitro fertilization/intracytoplasmic sperm injectioncycle outcome in POR patients.
- ||| Afinitor (everolimus) / Novartis
Exciting work from @MDAndersonNews #GYNOnc team of combining metformin with everolimus and letrozole in #Endometrial cancer. A trial born out of YEARS of preclinical and translational work from an outstanding team- @PamSolimanMD @karenluMD @ShannonWestin @rcoledude (Twitter) - Oct 26, 2019
- || metformin / generics, letrozole / generics
#deft approach was used to investigate interactions (within-trial interaction alone): - treatment effect of letrozole vs CC: influenced by baseline total testosterone levels - treatment effect of CC+metformin vs CC: affected by baseline insulin levels (Twitter) - Oct 25, 2019
- ||| metformin / generics, letrozole / generics
Clinical: Compared to #CC, #letrozole ⬆️live birth, ⬆️clinical pregnancy, ⬇️time-to-pregnancy CC+metformin may ⬆️clinical pregnancy ⬇️reduce time-to-pregnancy, insufficient evidence of a difference on live birth (Twitter) - Oct 25, 2019
- | estradiol valerate / Generic Mfg.
Clinical, Journal: ANDRO-IVF: a novel protocol for poor responders to IVF controlled ovarian stimulation. (Pubmed Central) - Oct 24, 2019
This protocol apparently improved clinical outcomes of poor responders in parameters such as number of oocytes retrieved and clinical pregnancy rates. Further randomized controlled trials are needed to confirm these findings.
- | letrozole / generics, exemestane / generics
Clinical, Journal, IO Biomarker: Growth inhibitory efficacy and anti-aromatase activity of Tabebuia avellanedae in a model for post-menopausal Luminal A breast cancer. (Pubmed Central) - Oct 22, 2019
Inhibition of aromatase activity, based on the NFD content of TNM was superior to the clinical AIs Letrozole and Exemestane. These data demonstrated the potential efficacy of TNM as a nutritional alternative for current therapy of aromatase positive, post-menopausal breast cancer.
- || Zolgensma (onasemnogene abeparvovec-xxxx) / Novartis, Avastin (bevacizumab) / Roche, Lucentis (ranibizumab) / Roche, Novartis
Na #stockbreuk van #Femara met een geurtje, miljoenenprijs voor #Zolgensma voor baby Pia en geheime deal rond oogmedicijnen #Lucentis en #Avastin; nu het "prachtresultaat" voor @Novartis dit kwartaal: winst stijgt naar 3,3 miljard (+15%). #grootgraaiers https://t.co/MrJ09zFCCW (Twitter) - Oct 22, 2019
- | Ibrance (palbociclib) / Pfizer
Trial completion date: NeoPAL: Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women (clinicaltrials.gov) - Oct 21, 2019
P2, N=125, Active, not recruiting, Sponsor: UNICANCER
These data demonstrated the potential efficacy of TNM as a nutritional alternative for current therapy of aromatase positive, post-menopausal breast cancer. Trial completion date: Apr 2019 --> Sep 2020
- | New P2/3 trial, HEOR: EUROPA: ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ?70 Years Early Stage Breast Cancer (clinicaltrials.gov) - Oct 21, 2019
P2/3, N=600, Not yet recruiting, Sponsor: Azienda Ospedaliero-Universitaria Careggi
- | Ibrance (palbociclib) / Pfizer
New P1 trial, Combination therapy: PROMETEO II: Palbociclib Plus Letrozole in Hormone Receptor Positive Residual Disease After Neoadjuvant Chemotherapy (clinicaltrials.gov) - Oct 16, 2019
P1, N=20, Not yet recruiting, Sponsor: SOLTI Breast Cancer Research Group
- Mekinist (trametinib) / Novartis
Exceptional response with combined anti-hormone and MEK inhibitor therapy in a patient with hormone receptor-positive ovarian cancer and isolated KRAS alteration. Implications for a precision medicine strategy () - Oct 16, 2019 - Abstract #ESGO2019ESGO_1571;
P=N/A
The patient was subsequently started on monotherapy with letrozole; however, after 3 months of treatment, the tumor progressed...Conclusion We report a patient with recurrent ovarian cancer with KRAS alteration and positive ER expression who demonstrated a remarkable response to combination therapy with a MEK inhibitor and aromatase inhibitor after failing treatment with the same MEK inhibitor in combination with a SERM. The current case suggests that different hormone modulators may have divergent effects and that selection of specific combination therapies for potentially pharmacologically tractable alterations can be effective.
- Tamoxis (tamoxifen) / Bioprofarma
Morbidity outcomes of cytoreductive surgery in advanced low grade serous and sex chord stromal tumor () - Oct 16, 2019 - Abstract #ESGO2019ESGO_1565;
This may be attributable to younger age and good performance status of such patients. However the cost of surgery needs to be addressed in mid-income countries.
- letrozole / generics
fertility preservation in breast cancer: the protective role of letrozole () - Oct 16, 2019 - Abstract #ESGO2019ESGO_1250;
The estradiol level on the day of ovulation triggering was significantly lower 479±323 pg/ml in the breast cancer group versus 1701±682 pg/ml (p=0.02) The number of CCOs obtained in the breast cancer group was 10.76±8.39 compared with 9.11±6.81 (p=1.83). Conclusion Letrozole as a hormonotherapy in breast cancer, would also allow an efficient ovarian stimulation in women with breast cancer, and safer with a lower estradiol levels.
- Tamoxis (tamoxifen) / Bioprofarma
Breast-conserving surgery (BCS) in the management of carcinoma ductal in situ (DCIS): reoperation rates and safety margins () - Oct 16, 2019 - Abstract #ESGO2019ESGO_819;
Conclusion Re-excision must be individualized according to: life expectancy, DCIS extension, margin’ proximity, residual calcifications or cosmetic impact, given the good long-term rates of local control compare to the consequences: increase in surgical complications, stress, cosmetic compromise or greater risk of mastectomy. We must become more aware of the possible overtreatment of entities with a good prognosis, such as the DCIS, without forgetting the importance of a precise pre-surgical diagnosis.
- | Soltamox (tamoxifen citrate) / Jazz
New P2 trial: The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer (clinicaltrials.gov) - Oct 15, 2019
P2, N=30, Recruiting, Sponsor: Johns Hopkins University
- | Ibrance (palbociclib) / Pfizer
Enrollment open, Metastases: Palbociclib Combined With an Aromatase Inhibitor in Breast Cancer (clinicaltrials.gov) - Oct 15, 2019
P3, N=420, Recruiting, Sponsor: Shengjing Hospital
We must become more aware of the possible overtreatment of entities with a good prognosis, such as the DCIS, without forgetting the importance of a precise pre-surgical diagnosis. Not yet recruiting --> Recruiting
- ||||| buparlisib (BKM120) / Novartis, Adlai Nortye
Clinical: PIK3CA and MAP3K1 Are Associated With Clinical Benefit From Buparlisib + Letrozole in ER+ MBC | comment: @DrReshmaMahtani - https://t.co/wwQhhPGEE8 #bcsm (Twitter) - Oct 15, 2019
- || letrozole / generics
Letrozole much better outcomes for #PCOS than clomid #ASRM2019 (Twitter) - Oct 14, 2019
- | Ibrance (palbociclib) / Pfizer
Trial completion date, Metastases: A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2) (clinicaltrials.gov) - Oct 14, 2019
P3, N=666, Active, not recruiting, Sponsor: Pfizer
Not yet recruiting --> Recruiting Trial completion date: Jun 2020 --> Aug 2023
- | Trial completion date, Trial primary completion date, Metastases: Analysis of Tumor Tissue and Circulating Genetic Material in the Blood to Obtain Further Insight in the Effectiveness of Everolimus When Combined With Exemestane (clinicaltrials.gov) - Oct 14, 2019
P=N/A, N=175, Active, not recruiting, Sponsor: VU University Medical Center
Trial completion date: Jun 2020 --> Aug 2023 Trial completion date: Jan 2019 --> Jan 2021 | Trial primary completion date: Jan 2019 --> Jan 2021
- | letrozole / generics
Clinical, Journal: Is ovulation induction with letrozole in breast cancer patients still safe even if it could increase progesterone levels? (Pubmed Central) - Oct 12, 2019
If the progesterone increase will be confirmed, epidemiological and experimental data do not seem to indicate a detrimental effect or they could even be protective. As this possible rise of levels is a very short event in the very long lasting and multifactorial breast carcinogenesis, it is unlikely that it will significantly influence breast cancer prognosis.