louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05050708: Riskfactors of Post-operative Pain and Nausea After Ambulatory Gynaecological Laparocopy.
Official title: Risikofaktorer for Postoperativ Smerte og Kvalme Etter Dagkirurgisk Gynekologisk Laparoskopi
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pain
Postoperative Nausea
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult females

Brief summary: Patient due for elective, ambulatory gynaecological laparoscopy will be screened peri-operatively for known and potential risk factors of postoperative pain and nausea/vomiting.

The actual incidence and severity of pain and nausea/vomiting will be recorded during th 0-24 hr intervall after end of surgery, as well as the doses of all drugs, given for either prophylaxis or treatment


Eligibility criteria: Inclusion Criteria:

* Elective adult patients due for planned ambulatory gynaecological laparoscopy
* Must be able to speak and write in Norwegian language

Exclusion Criteria:

* Patients who, for some reason, is transferred to non-ambulatory (same day discharge) care.
* Patients who, for some reason, have a change in surgical procedure from laparoscopy

Primary outcomes:
measure: postoperative pain
timeFrame: 0-24 hours
measure: postoperative nausea
timeFrame: 0-24 hours
Secondary outcomes:
measure: Peri-operative nausea risk score
timeFrame: preop, 0-24 hours post-operatively
measure: Peri-operative pain risk score
timeFrame: preop, 0-24 hours
measure: Post-op fatigue
timeFrame: 0-24 hrs
measure: Post-op function
timeFrame: 0-24hr
measure: Post-op analgesia consumption
timeFrame: 0-24hr
measure: Post-op anti-emetic drug consumption
timeFrame: 0-24hr
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
Clinical trial NCT04468308: VRQOL in Cataract Patients During the COVID-19 Pandemic
Official title: Assessment of Vision-related Quality of Life (VRQOL) in Cataract Patients During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Senile Cataract
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 116
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with senile cataract with indication for for unilateral or bilateral cataract surgery.

Brief summary: The aim of this questionnaire survey is to evaluate the improvement in vision-related quality of life before and after cataract surgery using the National Eye Institute Visual Function Questionnaire 25 and the delay of improvement in the COVID-19 pandemic.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 50 years
* Senile cataract
* Indication for unilateral or bilateral cataract surgery
* Postponed cataract surgery due to the COVID-19 pandemic
* Signed and dated declaration of consent

Exclusion Criteria:

* Complex form of cataract (traumatic cataract, secondary cataract after intraocular inflammation)
* Amblyopia on the eye that is to be operated on
* Severe, visually impairing eye disease on the eye that is to operated on
* Known dementia or memory problems

Primary outcomes:
measure: Improvement Vision-related quality of life
timeFrame: 3 months
Secondary outcomes:
measure: Delay of Vision-related quality of life
timeFrame: 3 months
measure: Visual acuity
timeFrame: 1 month
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tyrol
Study officials:
References:
Clinical trial NCT01341808: Immunogenicity of Hepatitis A Vaccine in Inflammatory Bowel Disease (IBD) Patients
Official title: Immunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Hepatitis A
Keywords: Crohn's disease
Ulcerative colitis
Hepatitis A
vaccine
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2011-04-26
Enrollment: 493
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to measure the immune response in 18-40 year old IBD patients after receiving the hepatitis A vaccine.

Detailed description: The spread of hepatitis A has prompted the need for vaccination against this virus. It is uncertain that IBD patients can achieve a truly protective response after vaccination. The efficacy and safety of hepatitis A vaccination have not been evaluated in this population of patients. We would like to estimate the efficacy and safety of vaccination against hepatitis A in patients with IBD.

Eligibility criteria: Inclusion Criteria:

1. Patients suffering from inflammatory bowel disease: Crohn's disease/Ulcerative colitis
2. Age 18-40
3. Willing to provide informed consent

Exclusion Criteria:

1. Have history of vaccination to hepatitis A
2. Have other autoimmune disease
3. Have any malignancy
4. Have acute infectious disease
5. Unwilling to provide consent

Primary outcomes:
measure: antibody titer to hepatitis A vaccine
timeFrame: Month 7
Secondary outcomes:
measure: vaccine-associated adverse events and side effects
timeFrame: within the first 30 days after first vaccination
measure: vaccine-associated adverse events and side effects
timeFrame: within the first 30 days after second vaccination
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Suk-Kyun Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: D'Acremont V, Herzog C, Genton B. Immunogenicity and safety of a virosomal hepatitis A vaccine (Epaxal) in the elderly. J Travel Med. 2006 Mar-Apr;13(2):78-83. doi: 10.1111/j.1708-8305.2006.00001.x.
citation: Hou JK, Velayos F, Terrault N, Mahadevan U. Viral hepatitis and inflammatory bowel disease. Inflamm Bowel Dis. 2010 Jun;16(6):925-32. doi: 10.1002/ibd.21284.
citation: Park SH, Yang SK, Park SK, Kim JW, Yang DH, Jung KW, Kim KJ, Ye BD, Byeon JS, Myung SJ, Kim JH. Efficacy of hepatitis A vaccination and factors impacting on seroconversion in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2014 Jan;20(1):69-74. doi: 10.1097/01.MIB.0000437736.91712.a1.
Clinical trial NCT02115308: Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging
Official title: Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Aspire Foundation
Sponsor class: OTHER
Collaborators: name: Saint Luke's Health System
name: Saint Luke's Cardiovascular Consultants
First posted: 2014-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to measure the changes in cardiac function during a Lexiscan pharmacologic stress test using cardiac magnetic resonance imaging test.


Eligibility criteria: Inclusion Criteria:

* Myocardial rest/regadenoson stress perfusion PET study within 60 days
* Normal rest LVEF (greater than or equal to 50%)
* No change in symptoms or treatment between the PET and the MRI study
* Willing to consent to the study
* Male or female who is either post-menopausal, surgically sterile, or if has a childbearing potential, a negative pregnancy test within 2 days prior to the MRI study.

Exclusion Criteria:

* Renal dysfunction (estimated glomerular filtration rate \< 60 mL/min/1.73m2) within 6 months
* Metallic implants, pacemaker, blood vessel clip (contra-indicated for MRI)
* Patient size exceeds MRI bore/table limits: (Max body diameter \> 60 cm, weight \> 136 kg)
* History of gadolinium contrast allergy or intolerance
* Second or third degree AV block
* Sinus node dysfunction
* Acute myocardial infarction (past 3 months)
* Actively wheezing or with acute asthma or bronchospastic attacks requiring changes in therapy within the past 30 days
* Patients that have experienced a previous hypersensitivity reaction thought to be related to regadenoson

Primary outcomes:
measure: RADIAL STRAIN
timeFrame: Day 1
measure: CIRCUMFERENTIAL STRAIN
timeFrame: Day 1
Secondary outcomes:
measure: Late Gadolinium Enhancement (LGE) and RADIAL Myocardial Strain
timeFrame: Day 1
measure: Adverse Events
timeFrame: Day 1
measure: Late Gadolinium Enhancement and CIRCUMFERENTIAL Myocardial Strain
timeFrame: Day 1
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Health System
state: Missouri
Study officials:
affiliation: Aspire Foundation
name: Timothy M Bateman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00134108: Clinical Benefit of Cognitive Behaviour Therapy (CBT) for Insomnia in Cancer Patients
Official title: Randomised Controlled Clinical Effectiveness Trial of Cognitive Behaviour Therapy (CBT) Versus Treatment as Usual (TAU) for Insomnia in Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Cancer
Lead sponsor: NHS Greater Clyde and Glasgow
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
First posted: 2005-08-24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct a formal controlled evaluation of the potential benefits of CBT for insomnia in cancer patients.


Eligibility criteria: Inclusion Criteria:

* Meets clinical criteria for insomnia.
* Diagnosis of breast, prostate, colorectal or gynaecological cancer.
* In follow-up phase with no further anti-cancer therapy planned.

Exclusion Criteria:

* Anti-cancer chemotherapy or radiotherapy within 4 weeks of trial entry.
* Evidence of sleep apnoea or other sleep disorder.
* Evidence of untreated major depressive disorder.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow and Aberdeen
country: United Kingdom
facility: North Glasgow and Grampian Trusts
Study officials:
affiliation: University of Glasgow
name: Colin Espie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05001308: Infectious Mediastinitis Among the Strasbourg Universitary Hospital
Official title: Infectious Mediastinitis Among the Strasbourg Universitary Hospital, a Retrospective Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mediastinitis
Keywords: Mediastinitis
Sternitis
Deep Sternal Wound Infection
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject diagnosed with mediastinitis between 01/01/2010 and 31/12/2020

Brief summary: Mediastinitis are rare but serious infections, with mortality rates varying from 6 to 30% according to the literature. They are essentially linked to surgical management (cardio-thoracic in particular), but some forms can be spontaneous, after extension of an ENT infectious focus, for example.

Despite their seriousness, there is no strong recommendations to define their management, especially concerning antibiotic therapy and its duration.

The aim of this research is to make a descriptive analysis of the cases of mediastinitis at HUS in recent years, and to study the therapeutic strategy used


Eligibility criteria: Inclusion Criteria:

* Major subject (≥18 years old)
* Subject diagnosed with mediastinitis between 01/01/2010 and 31/12/2020
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion Criteria:

* Subject having expressed opposition to participate in the study
* Subject under guardianship, curatorship or safeguard of justice

Primary outcomes:
measure: Analysis of the cases of mediastinitis and the therapeutic strategy used in recent years at University Hospitals of Strasbourg
timeFrame: Files analysed retrospectively from January 01, 2010 to December 31, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg
name: Yvon RUCH, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05582408: Evaluation of Novel Noise Reduction Principles in Hearing Instruments
Official title: Evaluation of Novel Noise Reduction Principles in Hearing Instruments to Determine Their Applicability.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2022-10-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In the study, the speech intelligibility in noise (Outcome) between a novel noise reduction algorithm (Intervention) versus the standard noise reduction (Comparator) will be tested in adults with a N3-N4 hearing loss (Population) using streamed signals via hearing aids.


Eligibility criteria: Inclusion Criteria:

* Minimum age for men: 18 years, minimum age for wom-en: 64 years, hearing aid users,
* Written and spoken German,
* Hearing loss range: N3-N4 Hearing loss (sensorineural)
* Healthy outer ear,
* Ability to understand and follow the instruction of the in-vestigator
* Informed consent as documented by signature.

Exclusion Criteria:

* Clinical contraindications 1) hearing loss is not within the fitting range of the hearing aid, 2) acute tinnitus, 3) de-formity of the ear (closed ear canal or absence of pinna), and 4) neural hearing loss i.e., retro-cochlear pathologies such as absent / non-viable auditory nerve
* Pregnant or breastfeeding women
* Age \>85 years
* known hypersensitivity or allergy,
* limited mobility and not able to attend the appointments

Primary outcomes:
measure: Difference in speech reception thresholds (SRTs) in noise between novel noise reduction algorithm (NR2) and the standard noise reduction (NR1; Comparator)
timeFrame: 4 weeks
Secondary outcomes:
measure: Evaluation whether the novel noise reduction algorithm (NR3) provides different SRTs in noisy situation with speech from front compared to the current implemented "standard noise reduction" (NR1; Comparator)
timeFrame: 4 weeks
measure: Evaluation of subjectively different sound quality attributes/dimensions of the novel noise reduction algorithms versus standard noise reduction (Comparator)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Oldenburg
country: Germany
facility: Hörzentrum Oldenburg gGmbH
state: Niedersachsen
Study officials:
affiliation: Sonova AG
name: Marlene Zippel
role: STUDY_DIRECTOR
References:
Clinical trial NCT00197808: Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines
Official title: Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumococcal Infections
Meningococcal Infections
Keywords: Streptococcus pneumoniae
Neisseria meningitidis
Lead sponsor: Public Health England
Sponsor class: OTHER_GOV
First posted: 2005-09-20
Enrollment: 392
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the immune responses of UK infants after one or two doses of pneumococcal conjugate vaccine or one or two doses of three different types of meningococcal conjugate vaccine given at either two and three or two and four months of age.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained from parent or legal guardian of infant
* Age 7-11 weeks at first dose

Exclusion Criteria:

* Any contraindications to vaccination as specified in the UK Handbook "Immunisation Against Infectious Disease" (Ed 1996)
* \< 7 weeks or \> 11 weeks at first dose

Primary outcomes:
measure: Immunogenicity
timeFrame: 3 months after last sample
Secondary outcomes:
Other outcomes:
Locations:
city: Welwyn Garden City
country: United Kingdom
facility: Hertfordshire Primary Care Trusts
state: Hertfordshire
city: Gloucester
country: United Kingdom
facility: Gloucestershire Primary Care Trusts
Study officials:
affiliation: Public Health England
name: Elizabeth Coates, PhD
role: STUDY_CHAIR
References:
citation: Goldblatt D, Southern J, Ashton L, Richmond P, Burbidge P, Tasevska J, Crowley-Luke A, Andrews N, Morris R, Borrow R, Cartwright K, Miller E. Immunogenicity and boosting after a reduced number of doses of a pneumococcal conjugate vaccine in infants and toddlers. Pediatr Infect Dis J. 2006 Apr;25(4):312-9. doi: 10.1097/01.inf.0000207483.60267.e7.
citation: Goldblatt D, Southern J, Ashton L, Andrews N, Woodgate S, Burbidge P, Waight P, Miller E. Immunogenicity of a reduced schedule of pneumococcal conjugate vaccine in healthy infants and correlates of protection for serotype 6B in the United Kingdom. Pediatr Infect Dis J. 2010 May;29(5):401-5. doi: 10.1097/INF.0b013e3181c67f04.
Clinical trial NCT04845308: Radiographic Evaluation of Secondary Alveolar Bone Grafting in Patients With Alveolar Cleft
Official title: 3D Radiographic Evaluation of the Long Terms Results of Secondary Alveolar Bone Grafting in Patients With Alveolar Cleft: Comparison of Early Versus Late Secondary Grafting SABG : Secondary Alveolar Bone Grafting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alveolar Cleft
Keywords: Secondary alveolar bone grafting
3D score
Navigation system
3D-reconstruction
Bone loss
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 49
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated with an alveolar bone grafting (taken from the anterior iliac crest ) for a single or bilateral labio-alveolar cleft in the pediatric plastic surgery department of the University Hospital of Montpellier between 1999 and 2021.

Brief summary: Study about the comparison of post-operative results of secondary alveolar grafts according to two age groups: early secondary (4 to 7 years) versus late secondary (8 to 11 years) using a recently proposed score based on post-operative 3D CT analysis.

Comparison of the initial results of the graft in the two groups, with a reference 2D score and evaluation of the concordance between the results found with this score and those of the 3D score.

Finally, comparison of graft bone densities and nasal floor level (using 3D visualization) on post-operative TDMs in the 2 groups.

The aim of this study is to determine the optimal age for grafting using three-dimensional CT assessment.


Eligibility criteria: Inclusion criteria:

- Patients operated with an alveolar bone grafting for a single or bilateral labio-alveolar cleft in the pediatric plastic surgery department of the University Hospital of Montpellier between 1999 and 2021 and having had 3D imageries defined as:

* Group 1:

  o Patients operated with an early secondary alveolar grafting between the ages of 4 to 7 years with a 3D imaging (CT, CBCT or scan) performed between the ages of 8 to 11 years.
* Group 2:

  * Patients operated with a late secondary alveolar graft between the ages of 8 to 11 years with a 3D imaging (CT, CBCT or scan) performed at least 1 year after the operation.

Exclusion criteria:

* Patients operated with an alveolar bone grafting before 4 years or after 11 years
* Patients without post-operative CT

Primary outcomes:
measure: Kamperos's score
timeFrame: Day 1
Secondary outcomes:
measure: Bergland's score
timeFrame: day 1
measure: Post-operative average bone density of the grafted area in axial slice
timeFrame: day 1
measure: Nasal floor level of the grafted side compared to the non grafted side using 3D visualization by volume rendering
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Guillaume CAPTIER, MD.PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02998008: Effects of Acute High Intensity Exercise Training on Cardiac Function in Type II Diabetes
Official title: Effects of Acute High Intensity Exercise Training on Cardiac Function in Type II Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Exercise Therapy
Heart Function Tests
Heart/physiology
Echocardiography
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Helse Nord-Trøndelag HF
First posted: 2016-12-20
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is known from research that long-term exercise exposure in type 2 diabetes had positive effects. However, the effect of acute exercise in a patient group with already reduced cardiac function is not known.

In this study, the impact of acute exhaustive high intensity interval training on cardiac function will be investigated in type 2 diabetes patients.

One single session of exhaustive high intensity interval exercise training is expected to lead to a greater cardiac stress in diabetics than in non-diabetics, and in addition the right ventricle of the heart is expected to be more affected than the left ventricle.


Eligibility criteria: Inclusion Criteria:

* Type II diabetes

Exclusion Criteria:

-

Primary outcomes:
measure: echocardiography
timeFrame: 30 minutes each measurement per subject
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Circulation and Medical Imaging, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Øystein Risa, phd
role: STUDY_DIRECTOR
References:
citation: Ness HO, Ljones K, Gjelsvik RH, Tjonna AE, Malmo V, Nilsen HO, Hollekim-Strand SM, Dalen H, Hoydal MA. Acute effects of high intensity training on cardiac function: a pilot study comparing subjects with type 2 diabetes to healthy controls. Sci Rep. 2022 May 17;12(1):8239. doi: 10.1038/s41598-022-12375-2.