louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02652832: Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels
Official title: Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Schizophrenia
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate the effects of non invasive brain stimulation - NIBS - techniques (Electroconvulsivotherapy - ECT, transcranial Direct Current Stimulation - tDCS, repetitive transcranial magnetic stimulation - rTMS) on serum Brain Derived Neurotrophic factor (BDNF) levels in patients with depression and schizophrenia. Four blood samples will be collected in each participants, one before the NIBS sessions, and 3 after the completion of NIBS protocols: one immediately after the end of the NIBS sessions, a second one week after and a last one month after. Two blood samples separated by one month will also be collected in a a group of healthy volunteers.

Detailed description: The hypothesis is that NIBS will modulate BDNF levels and that the modification in serum BDNF levels will be correlated with clinical improvements in the sample of patients.

Eligibility criteria: Inclusion Criteria:

* in the depression group: DSM IV criteria of MDD; HDRS17\> 22; stage 2 of resistance; received rTMS or ECT
* in the schizophrenia group DSM IV criteria of schizophrenia; pharmaco-resistance of symptoms (either negative symptoms or auditory verbal hallucination); received rTMS or tDCS
* in the healthy volunteers group : to not have axis I of DSM IV diagnosis; no siblings with axis I DSM IV diagnosis

Exclusion Criteria:

* less than 18 years old
* pregnancy
* received benzodiazepine

In the depression and schizophrenia group:

* bipolar disorder
* other axis I of DSM IV diagnosis (excluding for Tobacco use disorder)

Primary outcomes:
measure: serum BDNF levels
timeFrame: from baseline to one month
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Le vinatier
Study officials:
affiliation: CH le vinatier
name: jerome brunelin, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06678932: Arm Exercise Capacity, Muscle Strength and Activities of Daily Living in Patients with Fibromyalgia Syndrome
Official title: Comparison of Arm Exercise Capacity, Muscle Strength and Daily Living Activities of Patients with Fibromyalgia Syndrome and Healthy Controls
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fibromyalgia Syndrome
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with fibromyalgia syndrome and healthy individuals will be included in the study.

Brief summary: The aim of this study is to compare the upper extremity exercise capacity, muscle strength and activities of daily living of patients with fibromyalgia syndrome and healthy individuals.


Eligibility criteria: Inclusion Criteria-fibromyalgia syndrome:

* Being diagnosed with fibromyalgia syndrome
* Being aged 18-65
* Stable use of medication for at least 3 months or longer
* Volunteering to participate in the study

Exclusion Criteria-fibromyalgia syndrome:

* Having comorbidities that may affect physical functions
* Failure to cooperate with tests to be performed
* Presence of exercise test contraindication

Inclusion Criteria-healthy control:

* Being aged 18-65
* Volunteering to participate in the study

Exclusion Criteria-healthy control:

* Having a chronic or systemic disease
* Failure to cooperate with tests to be performed

Primary outcomes:
measure: Upper extremity exercise capacity
timeFrame: 1st day
measure: Muscle strength
timeFrame: 1st day
measure: Muscle endurance
timeFrame: 1st day
measure: Activities of daily living
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Kirsehir
country: Turkey
facility: Kirsehir Ahi Evran University
Study officials:
affiliation: Kirsehir Ahi Evran University
name: Basak Kavalci Kol
role: STUDY_CHAIR
affiliation: Kirsehir Ahi Evran University
name: Figen Tuncay
role: STUDY_CHAIR
References:
Clinical trial NCT00423332: Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma
Official title: A Phase II, Randomised, Double-blind, Parallel Group Study to Assess the Efficacy of Cediranib 45mg Versus Placebo Following 12 Weeks of Treatment in Patients With Metastatic or Recurrent Renal Cell Carcinoma Who Have Had no Previous Anti-VEGF Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Keywords: cancer
tumour
advanced cancer
Metastatic renal cell carcinoma
kidney cancer
RECENTIN
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-01-18
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.


Eligibility criteria: Inclusion Criteria:

* Confirmation of metastatic or recurrent renal cell carcinoma

Exclusion Criteria:

* Certain types of previous anti-cancer therapy for Renal Cell Carcinoma
* Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-independent diabetes
* Patients with a history of poorly controlled high blood pressure

Primary outcomes:
measure: Percentage Change From Baseline in Tumour Size at 12 Weeks
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Best Percentage Change From Baseline in Tumour Size During the Study
timeFrame: Treatment period up to Week 12 visit date for last patient in (LPI)
measure: Duration of Response
timeFrame: Treatment period up to 2nd data cut-off of 8th March 2009
measure: Progression Free Survival
timeFrame: Treatment period up to 2nd data cut-off of 8th March 2009.
measure: Objective Tumour Response at 12 Weeks
timeFrame: Response rate at 12 weeks was based on RECIST measurements taken at baseline and at Week 12, or upon progression if this was before Week 12.
measure: Best Objective Tumour Response
timeFrame: Baseline, Week 12 and every 8 weeks thereafter or until progression.
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Research Site
city: Leiden
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Northwood
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Jane Robertson
role: STUDY_DIRECTOR
References:
citation: Mulders P, Hawkins R, Nathan P, de Jong I, Osanto S, Porfiri E, Protheroe A, van Herpen CM, Mookerjee B, Pike L, Jurgensmeier JM, Gore ME. Cediranib monotherapy in patients with advanced renal cell carcinoma: results of a randomised phase II study. Eur J Cancer. 2012 Mar;48(4):527-37. doi: 10.1016/j.ejca.2011.12.022. Epub 2012 Jan 28.
Clinical trial NCT01709552: Brief Intervention for Substance Use and Partner Abuse Among Females in the ER
Official title: A Computer-based Intervention for Women With Substance Use and Intimate Partner Violence in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Related Disorders
Domestic Violence
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to target co-occurring problems of substance use and intimate partner violence (IPV) using a computer-based intervention, B-SAFER (Brief intervention for Substance use and partner Abuse for Females in the Emergency Room). This project will develop and test the computer-based intervention, examining primary outcomes of substance use and utilization of relationship safety resources.


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* English or Spanish language proficiency sufficient to understand and complete study procedures
* moderate drug use in the prior 3 months (by NM-ASSIST)
* IPV victimization in the prior 6 months (by WAST)
* access to a phone

Exclusion Criteria:

Patients who are:

* intoxicated
* medically unstable as determined by ED staff
* suicidal ideation
* psychosis
* combative
* in police custody

Primary outcomes:
measure: Change in past-month drug use days
timeFrame: 1 month, 3 month
measure: Change in use of relationship safety behaviors and referral resources for IPV.
timeFrame: 2 weeks, 1 month, 3 months
Secondary outcomes:
measure: Change in readiness to change drug use.
timeFrame: 2 week, 1 month, 3 months
measure: Change in readiness to change scale for relationship safety behaviors.
timeFrame: 2 weeks, 1 month, 3 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital Department of Emergency Medicine
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Esther K Choo, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05092152: Propofol Versus Esketamine for Rapid Sequence Intubation in Critically Ill Patients
Official title: Propofol Versus Esketamine for Rapid Sequence Intubation in Critically Ill Patients: A Randomized, Multicenter, Unblinded, Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Respiratory Failure
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rapid-sequence intubation is routinely performed in critically ill patients. It is unclear whether different sedative agents may influence short-term outcomes after intubation, specially hemodynamic stability.


Eligibility criteria: Inclusion Criteria:

* Age above 18 years old
* Physician indicated intubation

Exclusion Criteria:

* Pregnancy
* Intubation during cardiac arrest
* Known of suspected intracranial hypertension
* Known allergy to propofol or esketamine
* Bradycardia (heart rate below 50 beats per minute) or atrioventricular block

Primary outcomes:
measure: Lowest mean blood pressure
timeFrame: Ten minutes after induction
Secondary outcomes:
measure: Early death
timeFrame: One hour
measure: Cardiac arrest
timeFrame: One hour
measure: Severe hypotension
timeFrame: One hour
measure: Severe hypoxemia
timeFrame: One hour
measure: Number of intubation attempts
timeFrame: One hour
Other outcomes:
measure: Cumulative vasopressor use
timeFrame: 24 hours after intubation
measure: Maximum heart rate
timeFrame: One hour
measure: Days alive and free of mechanical ventilation
timeFrame: Seven days
measure: Mortality in the Intensive Care Unit
timeFrame: 28 days
measure: Mortality in hospital
timeFrame: 28 days
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Flavia R Machado, MD, PhD
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Raysa Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01090752: Renal and Hormonal Effects of Pioglitazone
Official title: Effects of the PPAR-gamma Agonist Pioglitazone on Renal and Hormonal Responses to Salt in Diabetic and Hypertensive Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Hypertension
Keywords: diabetes
blood pressure
pioglitazone
sodium
insulin resistance, renal function, sodium, pioglitazone
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
First posted: 2010-03-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects.

Detailed description: Aim: Glitazones are powerful insulin sensitizers prescribed for the treatment of type 2 diabetes. Their use is however associated with fluid retention and an increased risk of congestive heart failure. We previously demonstrated that pioglitazone increases proximal sodium reabsorption in healthy volunteers. This study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects.

Methods: In this double-blind, randomized, placebo-controlled, four-way, cross-over study, we examined the effects of pioglitazone (45mg daily during 6 weeks) or placebo on renal, systemic and hormonal responses to changes in sodium intake in 16 individuals, 8 with type 2 diabetic and 8 with hypertension.

Eligibility criteria: Inclusion Criteria:

* Type II Diabetes
* Hypertension

Exclusion Criteria:

* Cardiac or renal diseases
* Anaemia
* Drugs like aspirin, non steroidal anti-inflammatory drugs and hormonal replacement therapy.

Primary outcomes:
measure: Effects of Pioglitazone on Renal Hemodynamics
timeFrame: 2008
measure: Effects of Pioglitazone on Sodium and Lithium Clearances
timeFrame: 2007
measure: Effects of Pioglitazone on 24h Blood Pressure Control
timeFrame: march 2009
Secondary outcomes:
measure: Effects of Pioglitazone on Salt Sensitivity
timeFrame: 2009
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Pechère-Bertschi Antoinette
Study officials:
affiliation: University Hospital, Geneva
name: Antoinette Pechere-Bertschi, MD
role: STUDY_DIRECTOR
References:
citation: Zanchi A, Pechere-Bertschi A, Burnier M, Bonny O. Effects of pioglitazone on renal calcium excretion. J Clin Endocrinol Metab. 2011 Sep;96(9):E1482-5. doi: 10.1210/jc.2011-0373. Epub 2011 Jul 13.
citation: Zanchi A, Maillard M, Jornayvaz FR, Vinciguerra M, Deleaval P, Nussberger J, Burnier M, Pechere-Bertschi A. Effects of the peroxisome proliferator-activated receptor (PPAR)-gamma agonist pioglitazone on renal and hormonal responses to salt in diabetic and hypertensive individuals. Diabetologia. 2010 Aug;53(8):1568-75. doi: 10.1007/s00125-010-1756-2. Epub 2010 Apr 23.
Clinical trial NCT00569452: Comparison of Basal (Fasting) Glycemic Control in Type 1 Diabetic Patients With CSII Achieved by the Circadian Slide Ruler Scale or Flat Basal Rate
Official title: Comparison of Basal (Fasting) Glycemic Control in Type 1 Diabetic Patients With CSII Achieved by the Circadian Slide Ruler Scale or Flat Basal Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 1
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-12-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot trial to establish study procedures that allow comparison of various starting basal rate profiles used in Continuous Subcutaneous Insulin Infusion (CSII). Glycemic control achieved by circadian 'slide ruler scale' basal rate versus that achieved by one constant basal rate (flat profile) will be compared during a composite fasting day as well as therapeutic success after 2 weeks of normal activity.


Eligibility criteria: Inclusion Criteria:

* Adult patients \>= 18 years of age
* Type 1 diabetes
* Diabetic for \>2 years, and treated with CSII for \>= 3 months
* HbA1c \<=8.5%

Exclusion Criteria:

* Excessive fibrosis or lipo-hypertrophy at injection or infusion sites
* Unstable chronic disease other than type 1 diabetes
* Severe hypoglycemic event within last week prior to study start
* Severe diabetic ketoacidosis within last month prior to study start

Primary outcomes:
measure: Pilot trial to establish endpoints such as "time within target range of a composite fasting day"
timeFrame: Study duration
Secondary outcomes:
measure: AUC, MAGE, HbA1c, body weight change
timeFrame: Study duration
Other outcomes:
Locations:
city: Ulm
country: Germany
Study officials:
affiliation: Disetronic Medical Systems AG
name: Andreas Buhr
role: STUDY_DIRECTOR
References:
Clinical trial NCT00371852: Topic Compatibility Dermacyd Wipes - Lactoserum - Hygiene
Official title: Safety Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensibility) of Dermacyd Wipes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-09-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd wipes.


Eligibility criteria: Inclusion Criteria:

* Phototypes: I, II, III and IV;
* Integral skin test in the region;

Exclusion Criteria:

* Lactation or gestation
* Use of Anti-inflammatory and/or immune-suppression drugs
* Personnel history of atopy;
* History of sensibilization or irritation for topic products;
* Active cutaneous disease;
* Use of new drugs and/or cosmetics during the study

Primary outcomes:
measure: Score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG)
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT05644652: Effect of Nordic Walking on Gait-asymmetry Patterns in Children With Hemiparesis
Official title: Effect of Nordic Walking on Gait-asymmetry Patterns in Children With Hemiparesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
gait
spatio-temporal gait parameters
unilateral cerebral palcy
Nordic walking
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nordic walking is a physical activity consisting of walking with poles similar to ski poles. The poles are designed for the purpose of activating the upper body during walking. The poles are equipped with rubber or spike tips and the walking itself resembles.

Detailed description: Compared to normal walking in Nordic walking there is a stronger involvement of the upper body. Furthermore, by using the poles, the muscles in the upper body can be activated, and the length of each step taken is supposedly increased, resulting in a faster gait .

Eligibility criteria: Inclusion Criteria:

* Their age will range from 6-10 years, from both sexes.
* Level I, II and III of gross motor functional classification system (GMFCS) (Jooyeon et al., 2011)
* Grade 1 and 1+ spasticity according to the Modified Ashworth Scale (MAS). (Cloptonetal et al., 2005).

Exclusion Criteria:

* Uncontrolled epilepsy.
* Mental retardation or autistic features.
* Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination),
* Structural or fixed soft tissue deformities of the lower and/or upper extremities.
* Neurological or orthopedic surgery in the past 12 months in the lower and/or upper extremities.
* Botox injection in the lower and/or upper extremities in the past 6 months.

Primary outcomes:
measure: Assessment of gait
timeFrame: after 3 successive months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo university, faculty of physical therapy
name: Emam H El-negamy, Phd
role: STUDY_CHAIR
affiliation: Cairo university, faculty of physical therapy
name: Maricha A Nashed, B.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06723652: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Homozygous Familial Hypercholesterolemia
Lead sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-12-09
Enrollment: 45
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with homozygous familial hypercholesterolemia (HoFH).


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the protocol
2. LDL-C ≥2.6mmol/L at the screening visit
3. Body weight ≥40 kg
4. Receiving stable lipid-lowering therapy for at least 28 days before enrollment.

Exclusion Criteria:

1. Treatment with an ANGPTL3 inhibitor within 24 weeks prior before screening
2. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c \> 8.5%)
3. eGFR \<30ml/min/1.73m2 at the screening visit
4. CK \>5times ULN at the screening visit

Primary outcomes:
measure: Percent change in calculated LDL-C from baseline to week 12
timeFrame: week 12
Secondary outcomes:
measure: Change in calculated LDL-C from baseline to week 12
timeFrame: week 12
measure: Percent change and changer in calculated LDL-C from baseline to week 24
timeFrame: week 24
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University Hospital
state: Hunan
Study officials:
References: