louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03616652: Non-deceptive Application of Placebos in Insomnia
Official title: Non-deceptive Application of Placebos in Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate whether non-deceptive application of a placebo has an impact on subjective or objective sleep parameters in patients with primary insomnia.


Eligibility criteria: Inclusion Criteria:

* age between 18 years to 69 years
* fluent in German language
* provide written informed consent
* ability to understand the explanations and instructions given by the study physician and the investigator

Exclusion Criteria:

* evidence for sleep disorders caused by medical factors (e.g. sleep apnea, restless legs syndrome, narcolepsy, substance-induced insomnia)
* allergies to ingredients of placebo
* patients scoring below 8 or above 21 on the Insomnia Severity Index
* patients suffering from a mental disorder as verified by the SCID
* patients suffering from an acute physical illness
* nicotine consumption \> 10 cigarettes/day
* unwillingness to refrain from alcohol consumption throughout the study
* change in concomitant medication regime during the last 2 weeks prior to visit 1 or after randomization
* intake of psychotropic drugs during the last 3 months prior to visit 1
* currently pregnant (verified by urine pregnancy test) or lactating

Primary outcomes:
measure: Self-reported Total Sleep Time
timeFrame: change from baseline to 1 night after placebo intake
Secondary outcomes:
measure: Objective Sleep Efficiency
timeFrame: change from baseline to 1 night after placebo intake
measure: Objective Total Sleep Time
timeFrame: change from baseline to 1 night after placebo intake
measure: Objective Total Sleep Time
timeFrame: change from baseline to 1 night after placebo intake
measure: Objective Sleep Onset Latency
timeFrame: change from baseline to 1 night after placebo intake
measure: Self-reported Sleep Onset Latency
timeFrame: change from baseline to 1 night after placebo intake
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg
Study officials:
affiliation: Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg
name: Winfried Rief, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03897452: NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study
Official title: NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study. Prestudy to NeoOpioid; No Pain During Infancy by Adapting Off-patent Medicines. EU FP7:HEALTH - 2007-4.2-1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: analgesia
neonates
procedural pain
pain assessment
physiological response
pharmacogenetics
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2019-04-01
Enrollment: 32
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will assess the efficacy of fentanyl using a pharmacokinetic/pharmacodynamic (PK/PD) model where the concentration of the drug is related to effect curve (pain score change in response to standardized procedural pain). Further cortical, physiological and biochemical responses to fentanyl will be assessed, elucidating the feasibility before the main study project (NeoOpioid) start.


Eligibility criteria: Inclusion Criteria:

* Clinical indication for analgesia before any of following procedures;

  1. insertion of peripheral IV-catheter
  2. insertion of arterial cannula
  3. insertion of chest tube
  4. other skin breaking procedure.
* Possibility to obtain blood samle after the procedure (indwelling line)
* Infants all gestational ages.
* Postnatal age 0-28 days
* Informed written parental concent

Exclusion Criteria:

* Concurrent or previous opioid administration (72 h interval required)
* Abdominal surgery
* Major chromosomal anomaly
* Neonatal encephalopathy
* Use of muscle relaxant
* Hypothermia treatment after hypoxic-ischemic insult
* Clinical or biochemical evidence of hepatic failure
* Participation in other intervention trial

Primary outcomes:
measure: Pharmacokinetics; fentanyl clearance
timeFrame: 48 hours
measure: Pharmacokinetics; fentanyl clearance
timeFrame: 6 hours
measure: Pharmacodynamics; Amplitude integrated electroencephalography (aEEG)
timeFrame: 6 hours
measure: Pharmacodynamics; Amplitude integrated electroencephalography (aEEG),
timeFrame: 6 hours
Secondary outcomes:
measure: Pharmacodynamics, change in vital parameters
timeFrame: 6 hours
measure: Pharmacodynamics, change in vital parameters
timeFrame: 6 hours
measure: Pharmacodynamics, change in vital parameters
timeFrame: 6 hours
measure: Pharmacodynamics, behavioural response
timeFrame: 6 hours
measure: Pharmacodynamics, hormonal response
timeFrame: 48 hours
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Neonatal Intensive Care Unit, Skåne University Hospital
Study officials:
affiliation: Dep. of Pediatrics, Lund University, Sweden
name: Vineta Fellman, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02910752: CLAM Chemotherapy With PBSC Support for Relapsed Patients After Allogeneic Stem Cell Transplantation
Official title: Salavge Chemotherapy With Cladribine, Cytarabine and Mitoxantrone Followed by Mobilized Peripheral Stem Cell Infusion From the Original Donor for Relapsed Patients After Allogeneic Stem Cell Transplantation: Phase I/II Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Leukemia
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: For acute leukemia patients with early relapse after allogeneic stem cell transplantation, the overall outcome is poor. In this study, we evaluate the treatment outcome and safety of chemotherapy with Cladribine, cytarabine and mitoxantrone followed by peripheral stem cell support from the original donor.

Detailed description: For acute leukemia patients experienced relapse 6 months or less after allogeneic stem cell transplantation, the overall outcome is poor. In this study, we design a treatment protocol aiming to achieve complete remission for this high-risk group of patients with chemotherapy consisting of Cladribine (5mg/m2), cytarabine (1.5g/m2) and mitoxantrone （10mg/m2）for 5 days followed by infusion of mobilized peripheral stem cell from the original donor. For patients who failed to achieved remission,a second cycles will be given. For patients who achieved remission, the post-remission therapy is open depend on patient's intent: consolidation with one more cycle, second allo-HSCT with different donor or continuous DLI.

Eligibility criteria: Inclusion Criteria:

* patients with acute leukemia relapsed within 6 months after previous allo-HSCT
* no active GVHD
* mobilized PBSC from the original donor available

Exclusion Criteria:

* ECOG \>=3
* liver function/renal function damage (over 2 X upper normal range)
* active infection including CMV and EBV

Primary outcomes:
measure: complete remission (Bone marrow)
timeFrame: 30 days after treatment
Secondary outcomes:
measure: chimerism (bone marrow)
timeFrame: 30 days after treatment
measure: survival
timeFrame: 6 months
measure: relapse (bone marrow)
timeFrame: 6 months
measure: non-relapse mortality
timeFrame: 6 months
measure: GVHD (clinical evaluation and grading)
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Rui Jin Hospital, Department of Hematology
Study officials:
affiliation: Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
name: Jiong HU, M.D.,
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00517452: Platelet Rich Plasma Study in Lower Extremity Bypass Surgery
Official title: Phase 2-3 Observational Wound Care Study Comparing Application of Platelet Rich Plasma With Standard of Care Wound Closure in Vascular Patients Requiring a Groin Incision.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2007-08-17
Enrollment: 81
Sex: ALL
Minimum age (years): 35
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: Vascular surgical patients scheduled for elective lower extremity bypass surgery,aortoiliac revascularizations and endovascular AAA repair requiring a groin incision

Brief summary: The use of platelet rich plasma will decrease wound infection postop.


Eligibility criteria: Inclusion Criteria:

* Vascular surgical patients scheduled for elective lower extremity bypass surgery,aortoiliac revascularizations and endovascular AAA repair requiring a groin incision Exclusion Criteria:Patients requiring emergent procedures, unable to give informed consent

Primary outcomes:
measure: Wound healing
timeFrame: 4- 6 weeks post op
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: London Health Sciences Centre, University of Western Ontario
name: Kirk D Lawlor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05362552: Effects of Urban Afforestation Activity on Mental Health
Official title: The Positive Effects of an Urban Afforestation Activity on the Mental Health of Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Green spaces
Nature-based activities
Urban afforestation
Horticultural therapy
Adults
Mental health
Affect
Vitality
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single-group pretest-posttest clinical trial aims to evaluate the effects of a single-session afforestation activity on affect and vitality levels in a sample of young adults.

Detailed description: The participants will perform an afforestation activity for a single session of 90 minutes. The therapists will direct the participants' attention to the visual, auditory, olfactory, and tactile features of the surrounding environment.

Eligibility criteria: Inclusion Criteria:

* Adults between 18 and 65 years.
* Any sex and gender.

Exclusion Criteria:

* Intake of any psychotropic medication.
* Other severe or medically unstable diseases that may interfere with participation.
* Severe cognitive impairment (Mini-Mental State Examination score \< 17 out of 30 points).
* Severe mental disorders in the acute phase or symptomatic phase.
* Severe intellectual disability.
* Behavioural alterations as this may interfere with their participation.

Primary outcomes:
measure: Affect
timeFrame: Change from baseline affect after 90 minutes.
measure: Subjective Vitality
timeFrame: Change from baseline subjective vitality after 90 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada, Faculty of Health Sciences
Study officials:
affiliation: Associate Professor
name: José Manuel PÉREZ-MÁRMOL, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05591352: Efficacy Testing of Chenopodium Formosanum Extracts on Skin Beauty
Official title: Efficacy Testing of Chenopodium Formosanum Extracts on Skin Beauty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Condition
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-10-24
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess Chenopodium formosanum extracts on skin condition improvement


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, liver, kidney.
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Received facial laser therapy, chemical peeling or UV overexposure (\> 3 hr/week) in the past 4 weeks.
* Constant drug use
* Students who are currently taking courses taught by the principal investigator of this trial.

Primary outcomes:
measure: The change of skin wrinkles
timeFrame: Change from Baseline skin wrinkles at 8 weeks
measure: The change of skin texture
timeFrame: Change from Baseline skin texture at 8 weeks
measure: The change of skin collagen density
timeFrame: Change from Baseline skin collagen density at 8 weeks
measure: The change of skin elasticity
timeFrame: Change from Baseline skin elasticity at 8 weeks
Secondary outcomes:
measure: The change of skin melanin index
timeFrame: Change from Baseline skin melanin index at 8 weeks
measure: The change of skin L* value
timeFrame: Change from Baseline L* value at 8 weeks
measure: The change of skin erythema index
timeFrame: Change from Baseline skin erythema index at 8 weeks
measure: The change of skin moisture
timeFrame: Change from Baseline skin moisture at 8 weeks
measure: The change of transepidermal water loss (TEWL)
timeFrame: Change from Baseline TEWL at 8 weeks
measure: The change of skin pores
timeFrame: Change from Baseline skin pores at 8 weeks
measure: The change of AGEs of blood
timeFrame: Change from Baseline AGEs at 8 weeks
Other outcomes:
measure: The change of liver function biomarkers (AST, ALT) of blood
timeFrame: Change from Baseline liver function biomarkers at 8 weeks
measure: The change of renal function biomarkers (creatinine, BUN) of blood
timeFrame: Change from Baseline renal function biomarkers at 8 weeks
measure: The change of self-assessment skin condition
timeFrame: Change from Baseline skin condition at 8 weeks
Locations:
city: Tainan City
country: Taiwan
facility: Chia Nan University of Pharmacy & Science
Study officials:
affiliation: Chia Nan University of Pharmacy ＆ Science
name: Chia-Hua Liang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01393652: Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679
Official title: A Phase I, Randomized, Placebo-Controlled, Dose Escalating Cross Over Study To Evaluate The Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of PF-05105679 Under Fasted Conditions In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics Safety Tolerability Pharmacodynamics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-07-13
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a two part study. The purpose of the first part (Part A) is the evaluation of the pharmacokinetics, safety and tolerability after single ascending dose of PF-05105679. The second part (Part B) of this study will focus on the exploratory pharmacodynamics of PF-05105679 using pharmacodynamics markers (cold detection) in healthy volunteers. The doses selected in Part B will have been administered previously in the Part A of the study.


Eligibility criteria: Inclusion Criteria:

Healthy Volunteers

Exclusion Criteria:

Standard Healthy Volunteers

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability.
timeFrame: 3 days
measure: Pharmacokinetics of single doses of PF-05105679 as measured by plasma concentrations- Cmax, Tmax, half life, AUC last, AUC(0-24) and MRT
timeFrame: 3 days
Secondary outcomes:
measure: Average AUC2min VAS (cold pressor test) of PF-05105679.
timeFrame: 24 hours
measure: Cold detection threshold (°C) of PF-05105679.
timeFrame: 24 hours
measure: Cold pain threshold (°C) of PF-05105679.
timeFrame: 24 hours
measure: Stimulus-response function to cold stimuli following menthol application.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Winchester WJ, Gore K, Glatt S, Petit W, Gardiner JC, Conlon K, Postlethwaite M, Saintot PP, Roberts S, Gosset JR, Matsuura T, Andrews MD, Glossop PA, Palmer MJ, Clear N, Collins S, Beaumont K, Reynolds DS. Inhibition of TRPM8 channels reduces pain in the cold pressor test in humans. J Pharmacol Exp Ther. 2014 Nov;351(2):259-69. doi: 10.1124/jpet.114.216010. Epub 2014 Aug 14.
Clinical trial NCT00864552: International PMS Study - KOGENATE Bayer
Official title: International PMS Study - KOGENATE Bayer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Keywords: Hemophilia A
Recombinant Factor VIII
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-03-18
Enrollment: 200
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe haemophilia A (\<2% FVIII:C baseline level) treated with Kogenate Bayer as their only source of recombinant FVIII

Brief summary: To evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand.

To evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix between.


Eligibility criteria: Inclusion Criteria:

* Patients with severe haemophilia A (\<2% FVIII baseline plasma levels) treated with KOGENATE Bayer as their only source of recombinant FVIII

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the product information (SmPC)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: Austria
city: Many Locations
country: Belgium
city: Many Locations
country: Denmark
city: Many Locations
country: France
city: Many Locations
country: Greece
city: Many Locations
country: Italy
city: Many Locations
country: Netherlands
city: Many Locations
country: Spain
city: Many Locations
country: Sweden
city: Many Locations
country: Switzerland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04537052: A New Method for Treatment of Deep Venous Insufficiency: Early Results of Vein Restoration Treatment(VRT)
Official title: A New Method for Treatment of Deep Venous Insufficiency: Early Results of Vein Restoration Treatment(VRT) Erdinç EROĞLU
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Varicose Veins
Keywords: Deep venous insufficiency,
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To present the 9. months clinical results of percutaneous Ven Restoration Therapy (VRT), a new method in the treatment of primary femoral vein insufficiency.Twenty four patients diagnosed with isolated primary femoral vein insufficiency between January 2020 and December 2020 were included in the study. Before the procedure, junctional femoral vein diameters and reflux times were measured. CEAP classification and Venous clinical severity scores (VCSS) were recorded. Chronic Venous Insufficiency Questionnaire (CIVIQ-20) were also recorded. Then, VRT was applied percutaneously to the anterior and posterior of the femoral veins of the patients, and the diameter of the femoral vein was narrowed and valve coaptation was achieved. After the procedure, vein diameters and reflux times were measured again. All parameters were reevaluated by calling patients for control at 1.,3., 6. and 9. months.


Eligibility criteria: Inclusion Criteria:

* Patients with isolated deep venous insufficiency, without accompanying superficial venous insufficiency,
* volunteering to take part in the study were included

Exclusion Criteria:

* post-thrombotic or congenital deep venous insufficiency
* Venous reflux disease in the GSV diagnosed by clinical symptoms
* Local or systemic infection

Primary outcomes:
measure: femoral vein diameters
timeFrame: 9 months
measure: reflux times
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05619952: Postprandial Lipemia and Glycemia Following a High-Fat Meal
Official title: Acute Effects of White Button and Shiitake Mushroom Powder Supplementation on Postprandial Lipemia and Glycemia Following a High-Fat Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Postprandial Hyperglycemia
Lipid Disorder
Keywords: mushroom
lipid metabolism
postprandial lipemia
postprandial glycemia
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine the acute effects on postprandial lipemia and glycemia by supplementing a high-fat meal with either white button (WB) or shiitake (SH) mushroom powder in relatively healthy adults, aged 18 to 35.


Eligibility criteria: Inclusion Criteria:

* generally healthy
* non-diabetic
* normal to mildly hypercholesterolemic (Total Cholesterol 200-239 mg/dL and LDL-C 130-159 mg/dL)
* have BMI \<30 or BF% (men \<25%, women \<32%)
* no known disease of the liver or gallbladder
* no documented problems with fat metabolism
* normal lipemic response to a lipid challenge
* No known mushroom allergy

Exclusion Criteria:

* diabetic
* pregnant
* BMI \>30
* liver disease
* gallbladder disease
* mushroom allergy
* lipid disorder

Primary outcomes:
measure: Postprandial Lipemia
timeFrame: Baseline, up to 6 hours postprandial
measure: Postprandial Glycemia
timeFrame: Baseline, up to 6 hours postprandial
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lillian A. Talal, Huipei Wang, Brian T. Wil-liams, Matthew J. Morris, Peter J. Horvath (2023) Acute Effects of White Button and Shiitake Mushroom Powder Supplementa-tion on Postprandial Lipemia and Glycemia Following a High-Fat Meal . International Journal of Nutrition - 7(2):42-56.