louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04330794: the NMFACT Caries Index
Official title: the NMFACT Anew Caries Index
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: the NMFACT is a new caries index to overcome the drawbacks of DMF cries index the ''N'' is for non carious lesion, the ''M''for missed teeth,the ''F''for filled teeth,the''C''for carious teeth,the ''A''for alignment and the ''T''for dental trauma.

each problem will be scored from 0(normal).

Detailed description: the new caries index will be used to record the dental problem . the validation will be recorded against the gold standard DMF index

Eligibility criteria: Inclusion Criteria:

* any patient suffering form dental problem

Exclusion Criteria:

* edentulous patient children adolescents

Primary outcomes:
measure: the accuracy of NMFACT index in describe the oral health condition
timeFrame: 3months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01634594: The Effect of Deliberate Hypotension on QTc, Tp-e Intervals and Heart Rate Variability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mandibular Prognathism
Mandibular Retrognathism
Keywords: Deliberate hypotension, QTc, Tp-e, heart rate variability
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-07-06
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Deliberate hypotension is defined as lowering the systolic blood pressure to 80-90mmHg, or the mean blood pressure to 50-65mmHg. This technique is usually employed for operations that have a high risk of intraoperative hemorrhage, such as orthognathic surgery. Several different regimens are used to lower the patient's blood pressure, such as vasodilators, autonomic nervous system inhibitors, opioids and inhalation anesthetics. However, the effects that these agents have on the QTc and Tp-e intervals during deliberate hypotension is not known. Virtually every kind of anesthetic is reported to have some effect on the QTc and Tp-e intervals. Because orthognathic surgery usually takes 3-4 hours to complete, the amount of anesthetics and drugs used to maintain low blood pressure is not small. Therefore, the effect that these agents may have on the QTc and Tp-e intervals may not be negligible. The investigators of the present study found that the high dose of commonly used hypotensive agents tend to prolong these variabilities to some extent. This study will be able to provide insight as to which hypotensive anesthesia regimen has the least effect on the QTc and Tp-e intervals, and therefore will be helpful in minimizing cardiovascular risks of deliberate hypotensive anesthesia.


Eligibility criteria: Inclusion Criteria:

1. ASA class 1
2. Adults over the age of 20
3. Patients requiring deliberate hypotensive anesthesia for orthognathic surgery

Exclusion Criteria:

1. Patient refusal
2. Patients with arrhythmia
3. Patients with cardiac anomalies or past history of cardiac surgery
4. Patients with abnormal electrolyte levels
5. Patients taking medications that are known to prolong QT intervals
6. Patients with QTc intervals greater than 440ms
7. Illiterate patients

Primary outcomes:
measure: Changes in QTc, Tp-e interval during deliberate hypotension
timeFrame: Before induction of anesthesia (T1), 10 minutes after induction of anesthesia (T2), 30 minutes after target blood pressure is reached (T3), every 60 minutes after from the end of surgery
Secondary outcomes:
measure: Changes in Tp-e interval during deliberate hypotension
timeFrame: Before induction of anesthesia (T1), 10 minutes after induction of anesthesia (T2), 30 minutes after target blood pressure is reached (T3), every 60 minutes after from the end of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Young Jun Oh
Study officials:
References:
Clinical trial NCT01513694: Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease
Official title: Clinical Trial Phase I / II Prospective, Open, Non-randomized for Treatment of Lumbar Intervertebral Degenerative Disc Disease With Posterolateral Instrumented and Autologous Mesenchymal Stem Cells.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Intervertebral Disc Disease
Keywords: Mesenchymal Stem Cells
Stem Cells
Intervertebral disc disease
Lead sponsor: Red de Terapia Celular
Sponsor class: INDUSTRY
Collaborators: name: Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
name: Spanish National Health System
First posted: 2012-01-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to test the effectiveness of the use of a new therapeutic strategy in treating patients with degenerative disc disease lumbar intervertebral fusion with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium phosphate ceramic (Conduit TM).


Eligibility criteria: Inclusion Criteria:

Clinical

* Box symptomatic (back pain and / or root) of lumbar degenerative disc disease monosegmental.
* Discopathy refractory to conservative treatment (drugs, physical therapy.)
* Evolution greater than or equal to 6 months. Radiological
* Discopathy radiation. Disc space narrowing, osteophytes, abnormal mobility, etc
* NMR: grades IV and V of Pfirman.

Exclusion Criteria:

* Rejection of surgical treatment.
* Systemic inflammatory disease (spondylitis, rheumatoid arthritis etc), tumor or infection.
* Immunosuppressive treatment.
* Congenital or acquired anatomical abnormality that prevents the surgical procedure.
* Neuropsychiatric pathology, drug addiction, psychosis, severe personality disorder.
* High surgical risk (ASA\> IV), or contraindication to anesthesia.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Trauma Service. Hospital Universitario de Salamanca
state: Castilla-León
Study officials:
References:
citation: Blanco JF, Villaron EM, Pescador D, da Casa C, Gomez V, Redondo AM, Lopez-Villar O, Lopez-Parra M, Muntion S, Sanchez-Guijo F. Autologous mesenchymal stromal cells embedded in tricalcium phosphate for posterolateral spinal fusion: results of a prospective phase I/II clinical trial with long-term follow-up. Stem Cell Res Ther. 2019 Feb 22;10(1):63. doi: 10.1186/s13287-019-1166-4.
Clinical trial NCT00781794: Study Evaluating The Effects Of Single Oral Doses Of NSA-789 On Auditory P50 Suppression In Schizophrenic Patients
Official title: A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effects of Single Oral Doses of NSA-789 on Auditory P50 Suppression in Nonsmoking Patients With Stabilized Schizophrenia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-10-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the effect of single doses of NSA-789 on the P50 component of the auditory evoked potentials and to assess the safety, tolerability and the concentration of NSA-789 in the blood, in nonsmoking patients with schizophrenia.


Eligibility criteria: Inclusion criteria:

* Women of nonchildbearing potential, or men, aged 18 to 55 years inclusive on study day 1. Women of nonchildbearing potential may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for â‰¥1 year (with a follicle-stimulating hormone \[FSH\] level of â‰¥38 mIU/mL). Women who are surgically sterile must provide documentation of the procedure by an operative report or ultrasound scan. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after test article administration.
* Body mass index in the range of 18 to 32 kg/m2 and body weight â‰¥50 kg.
* Hemoglobin no lower than 0.4 g/dL, less than the lower limit of the normal range, and white blood cell count no lower than 0.5 103/mm3, less than the lower limit of the of the normal range at screening and day -1. Hematocrit and absolute neutrophil count within normal range at screening and on day -1.

Exclusion criteria:

* Women of childbearing potential.
* Presence or history of any disorder that may prevent the successful completion of the study.
* Any unstable psychiatric condition, which may prevent the successful and safe completion of the study in the opinion of the investigator.

Primary outcomes:
measure: electroencephalogram
timeFrame: 8 weeks
Secondary outcomes:
measure: blood sample
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
city: Rouffach
country: France
city: Toul
country: France
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02517294: , "Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"
Official title: "Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epistaxis
Keywords: Nasotracheal intubation
adenoid size
epistaxis
nasopharyngeal mucosal injury
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 73
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison is made between standard nasotracheal tubes and a specially designed nasotracheal tube during nasotracheal intubation in children undergoing general anesthesia for dental surgery.

Detailed description: The Parker flex-tip, midline-beveled nasotracheal tube theoretically slides past obstruction in the nasopharynx causing less mucosal damage than standard nasotracheal tubes.

The investigators aim to test whether mucosal injury during nasotracheal intubation in children undergoing general anesthesia for dental procedures can thus be minimized taking into consideration adenoid size, and differences in nasopharyngeal diameter.

Eligibility criteria: Inclusion Criteria:

* children between the ages of 3-11, ASA 1-3, presenting to Wolfson Children's Hospital (WCH) for dental procedures requiring general anesthesia with nasotracheal intubation.

Exclusion Criteria:

* ASA \>3
* known bleeding disorders
* recent or ongoing treatment with blood-thinning medicines
* frequent epistaxis
* active URI/congestion/rhinorrhea
* craniofacial abnormalities prohibiting NTI
* known difficult airway
* prior nasal surgery/trauma
* allergies to any of the medicines used in this study.

Primary outcomes:
measure: Number of Participants With Epistaxis
timeFrame: within approximately 4hrs of surgery (day of surgery)
Secondary outcomes:
measure: Number of Participants With Nasotracheal Tube Impingement
timeFrame: perioperative, immediate during intervention - expected 2hrs (day of surgery)
measure: Number of Participants With Postoperative Epistaxis
timeFrame: Participants will be followed for the duration of the hospital stay, an expected average of 6 hours
measure: Number of Participants With Postoperative Croup
timeFrame: end of surgery until time of discharge, approximately 4hrs
measure: Time to Discharge in Minutes
timeFrame: emergence from anesthesia to meeting discharge criteria, approximately 4hrs
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Wolfson Children's Hospital
state: Florida
Study officials:
affiliation: Nemours Children's Clinic, Jacksonville, FL
name: Robert B Bryskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00517894: Dose-Dense Therapy in Aggressive Lymphoma
Official title: Phase 3 Study of Dose-Dense Therapy Versus CHOP in Aggressive Non-Hodgkin's Lymphoma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Lymphoma
Keywords: lymphoma
aggressive
chemotherapy
dose-dense
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
First posted: 2007-08-17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT

Brief summary: To investigate if a dose-dense chemotherapy with weekly chemotherapy compared to standard treatment every 3 weeks results in better survival in aggressive non-Hodgkin's lymphoma.

Detailed description: Patients are randomized to receive dose-dense CEOP/IMVP-Dexa chemotherapy or standard 3-weekly CHOP.

Eligibility criteria: Inclusion Criteria:

* 18 and 70 years of age
* Centrally reviewed, histologically proven diffuse large B-cell, anaplastic large-cell, or peripheral T-cell unspecified
* Measurable disease
* All stages

Exclusion Criteria:

* Lymphoblastic or Burkitt histology
* CNS-disease
* HIV-positive
* pregnant or lactating women
* Pretreatment
* Other malignancy
* Concomitant diseases that forbid chemotherapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Fridrik MA, Hausmaninger H, Lang A, Drach J, Krieger O, Geissler D, Michlmayr G, Ulsperger E, Chott A, Oberaigner W, Greil R. Dose-dense therapy improves survival in aggressive non-Hodgkin's lymphoma. Ann Hematol. 2010 Mar;89(3):273-82. doi: 10.1007/s00277-009-0811-x. Epub 2009 Aug 20.
Clinical trial NCT02952794: Endoscopic Submucosal Dissection (ESD) and Endoscopic Mucosal Band Ligation (EMBL) for Early Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Cancer
Keywords: endoscopic submucosal dissection (ESD)
endoscopic mucosal band ligation (EMBL)
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer

Brief summary: To compare the treatment methods of endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer.


Eligibility criteria: Inclusion Criteria:

* Patients with early neoplasm in the gastrointestinal tract

Exclusion Criteria:

* Patients who can not meet the surgery

Primary outcomes:
measure: 5-year overall survival
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Endoscopy Center, Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Endoscopy Center, Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT03734094: Custom-made Ceramic Barrier vs Titanium Mesh
Official title: Comparative Study Between Custom-made Ceramic Barrier and Titanium Mesh for Augmentation of Atrophic Posterior Mandible
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a comparative study between custom-made ceramic barrier and titanium mesh for augmentation of atrophic posterior mandible.


Eligibility criteria: Inclusion Criteria:

* Patients with atrophic posterior mandible
* Both sexes
* No intraoral soft and hard tissue pathology
* No systemic condition that contraindicate implant placement

Exclusion Criteria:

* Untreated gingivitis
* Periodontitis
* Insufficient oral hygiene
* Previous radiation therapy
* Head and neck neoplasia
* Systemic disorders
* Heavy smokers
* Bone pathology
* Psychiatric problems
* Emotional instability
* Unrealistic aesthetic demands

Primary outcomes:
measure: Bone height
timeFrame: 6 months
measure: Bone width
timeFrame: 6 months
Secondary outcomes:
measure: Histomorphometric - bone area percent
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT02740894: Can Epidermal Growth Factor Receptor Improve the Postoperative Survivorship for Inoperable Non-small Cell Lung Cancer With Spinal Metastasis ?
Official title: Can Epidermal Growth Factor Receptor - Tyrosine Kinase Inhibitor Improve the Postoperative Survivorship for Inoperable Non-small Cell Lung Cancer With Spinal Metastasis of the Thoracic and Lumbar Spine?- A Retrospective Comparison With Platinum-based Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Is Targeted Therapy Increasing Survival Inoperable Nonsmall Cell Lung Cancer With Spinal Metastasis ?
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2016-04-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NSCLC with spinal metastasis

Brief summary: Not significantly increased survival in T/T


Eligibility criteria: Inclusion Criteria:

* NSCLC with spinal metastasis

Exclusion Criteria:

* brain metastasis and expected survival \< 3 months

Primary outcomes:
measure: Survival and neurologic outcome of 60 participants receiving targeted therapy for nonsmall cell lung cancer with spinal metastaasis. Neurological outcome by Frankel grading and ambulation status.
timeFrame: postoperation to mortality, up to 2 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03644394: Implantable MyoElectric Sensors (IMES) for Prosthetic Control in Transhumeral Amputees
Official title: Implantable MyoElectric Sensors (IMES) for Prosthetic Control in Transhumeral Amputees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 3
Sex: MALE
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The Implantable Myoelectric Sensors (IMES) system is an investigational device intended to improve signal quality and consistency of myoelectric signals for prosthetic control in individuals suffering from an above elbow (transhumeral) amputation. The sensors pick up myoelectric signals intramuscularly and therefore signal quality is not affected from electrode replacement, perspiration, or artefacts.

Detailed description: Implantable Myoelectric Sensors (IMES), the surgical tools implantation, and the external equipment used to control an electromechanical prosthetic device, together comprise the IMES System (investigational product, medical device).

Each IMES acts as an independent differential amplifier consisting of custom electronics housed within a biocompatible, hermetically sealed ceramic cylinder with metal end caps. The end caps serve as electrodes for picking up EMG activity during muscle contraction. Reverse telemetry (via a coil around the arm) is used to transfer data from the implanted sensor, and forward telemetry is used to transmit power and configuration settings to the sensors. The coil and associated electronics are housed within the frame of a prosthesis. A control system that sends data associated with muscle contraction to the motors of the prosthetic joints is housed in a belt-worn, battery-powered device. A cable attaches the control unit to the prosthetic frame.

An IMES is implanted into each targeted muscle that will be used to control a function of the prosthetic arm. Two IMES devices are needed for each DOF. For example, one device would control fingers opening and another device would control fingers closing.

Eligibility criteria: Inclusion Criteria:

* unilateral transhumeral amputation
* can speak and comprehend German
* undergone amputee rehabilitation, including being trained to wear and use a conventional myoelectric prosthesis
* residual upper limb meets the criterions for TMR surgery

Exclusion Criteria:

* Known genetic neuromuscular disorder
* bleeding or clotting disorder
* active implant
* any metal fragments or metal implants located within the residual upper limb stump
* Female patients if pregnant or breast-feeding

Primary outcomes:
measure: Change in hand function over time
timeFrame: at 3, 6, 9 and 12 months after final prosthetic fitting
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Otto Bock
name: Christian Hofer, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04615494: Internal Carotid Artery Blood Flow in Robot-Assisted Laparoscopic Prostatectomy
Official title: Change of Internal Carotid Artery Blood Flow During Pneumoperitoneum With Steep Trendelenburg Position in Robot-Assisted Laparoscopic Prostatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone robot-assisted laparoscopic prostatectomy with prostate cancer

Brief summary: The purpose of this study is to evaluate the change of the internal carotid artery blood flow according to the steep trendelenburg position and pneumoperitoneum in patients undergoing robot-assisted laparoscopic prostatectomy.


Eligibility criteria: Inclusion Criteria:

* Patients who have undergone robot-assisted laparoscopic prostatectomy with prostate cancer and who are 20 years or older and under 80 years
* Patients who agree to voluntarily participate in this study
* Patients with ASA class 1-2

Exclusion Criteria:

* History of diagnosis of cerebrovascular disease
* Patients who refused to participate in clinical studies

Primary outcomes:
measure: Difference in internal carotid artery blood flow
timeFrame: At 10 minutes after pneumoperitoneum with steep Trendelenburg position
Secondary outcomes:
measure: Internal carotid artery blood flow
timeFrame: Baseline (Before anesthetic induction)
measure: Internal carotid artery blood flow
timeFrame: At 10 minutes after anesthetic induction
measure: Internal carotid artery blood flow
timeFrame: At 10 minutes after pneumoperitoneum and Trendelenburg position
measure: Internal carotid artery blood flow
timeFrame: At 30 minutes after pneumoperitoneum and Trendelenburg position
measure: Internal carotid artery blood flow
timeFrame: Procedure (At skin closure)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical Center
Study officials:
affiliation: Asan Medical Center
name: Young-Kug Kim, Professor
role: STUDY_CHAIR
References: