louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06181097: Routine Use of Negative Pressure Wound Therapy THR TKR RCT
Official title: Routine Use of Negative Pressure Wound Therapy in Primary Hip and Knee Arthroplasties; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Arthropathy
Hip Arthropathy
Negative Pressure Wound Therapy
Keywords: Knee Arthropathy
Hip Arthropathy
TKR
THR
Wound therapy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 82
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be recruited and randomized to either NPWT and standard dressing.
Primary purpose: TREATMENT

Brief summary: Negative pressure wound therapy (NPWT) for post total joint arthroplasty incisions has demonstrated benefits in reducing wound complications. A prospective randomized trial will be conducted including 40 patients who will undergo total knee and total hip arthroplasty. The number of wound complications within 21 days will be recorded. As well, the aesthetic appearance and quality of scarring of the scar will be assessed.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing total knee or total hip arthroplasty at Prince of Wales Hospital, Hong Kong.

Exclusion Criteria:

* Patients using steroid, or other immune modulators that is known to affect wound healing, prior surgery to the knee or hip, skin condition such as eczema that would result in poor healing or widen scars, patients with a known significant history of hypertrophic scarring or keloid.

Primary outcomes:
measure: Wound-related complications
timeFrame: 21 days after surgery
Secondary outcomes:
measure: Patient Scale and Observer Scale (POSAS)
timeFrame: 21 days after surgery
measure: Multi-category visual analogue scale
timeFrame: 21 days after surgery
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT00838097: European Union Registry in Paediatric Chronic Kidney Disease Patients Looking at Safety and Usage Patterns of Darbepoetin Alfa
Official title: A Prospective Registry Study Observing the Safety and Patterns of Use of Darbepoetin Alfa in EU Paediatric Chronic Kidney Disease Patients Receiving or Not Receiving Dialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: CKD
Paediatric
Darbepoetin Alfa
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2009-02-06
Enrollment: 321
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Specialist Centres

Brief summary: This European study observes paediatric patients with Chronic Kidney Disease using Darbepoetin Alfa to assess the drug's long term safety and profile the patterns of its use within this population.


Eligibility criteria: Inclusion Criteria:

* Anaemia attributed to Chronic Kidney Disease (CKD)
* Sixteen years of age or under
* Documented CKD as demonstrated by estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m² (Schwartz equation) for ≥3 months if not on dialysis, or: Receiving dialysis
* Treatment with darbepoetin alfa
* Documented informed consent by a parent or authorised individual, if required, and assent by the patient if appropriate

Exclusion Criteria:

* Active malignancy or current chemotherapy or radiation therapy
* Investigator unlikely to be able to obtain adequate follow-up information, or participant will not be available for follow-up assessment
* Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study; subject receiving other investigational agents

Primary outcomes:
measure: Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs)
timeFrame: 2 years
Secondary outcomes:
measure: Hemoglobin Concentration by Three Monthly Intervals
timeFrame: Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24
measure: Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
timeFrame: Baseline and Months 1 to 24
measure: Parathyroid Hormone Level by Three Monthly Intervals
timeFrame: Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24
measure: Number of Participants With Non-serious Adverse Drug Reactions (ADRs)
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03084497: Effects of Infant Massage on Development of Down Syndrome Babies
Official title: Effects and Effectiveness of Infant Massage in Motor, Cognitive, Language and Social Developmental in Babies With Syndrome of Down Aged Between 4 and 8 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Keywords: Massage
Development
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of ths study is to know the effects of infant massage in the maturation of the baby with Down syndrome. Scale Psychomotor Development Early Childhood Brunet-Lézine-Revised will be used to measure the maturational development of the baby with Down syndrome . Investigators will analyze two groups of intervention, the experimental group, in which parents will participate and will apply the knowledge learned in the course of Infant Massage and control, which does not receive the Infant Massage course during the study. Babies in both groups will be evaluated twice, at the beginning of the intervention (pretest) and end it after five weeks (posttest). The study population consists of 32 babies with Down syndrome between 4 and 8 months old.

Detailed description: In this study, the investigators will compare the maturational development of the experimental group Down syndrome babies (will receive infant massage in the period between the two measurements) with the maturational development of the control group Down syndrome babies (will receive infant massage after two measurements). Assess both the development partial motor, cognitive, language and social, and also the maturational development global. Finally, measure also the ratio of development, both in the pretest as on the posttest. The test that will use to measure the development of them babies is the scale of development psychomotor of her first childhood Brunet-Lezine-R. The babies of the study may hay between 4 and 8 months old.

Eligibility criteria: Inclusion Criteria:

* Babies with Down Syndrome that received Early Attention.

Exclusion Criteria:

Babies with Down syndrome:

* With associated pathology.
* Adopted.
* Have received infant massage course.

Primary outcomes:
measure: Change from Developmental Age
timeFrame: At the start of the study (before the first session of Infant Massage and before the asignation of a group) and after the last session of Infant Massage Course (5 weeks)
Secondary outcomes:
measure: Change from Developmental coefficient
timeFrame: At the start of the study (before the first session of Infat Massage and before the asignation of the group) and after the last session of Infat Massage Course (5 weeks)
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: University of Seville
Study officials:
affiliation: University of Sevilla
name: PIÑERO PINTO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00351897: The Efficacy of Pulsed Dye Laser in Dermatophytosis
Official title: The Efficacy of Pulsed Dye Laser in Dermatophytosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cutaneous Dermatophytosis
Pulsed Dye Laser
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-07-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Pulsed Dye Laser therapy are effective in the treatment of Cutaneous Dermatophytosis.

Detailed description: This study was conducted to determine the efficacy of Pulse Dye Laser in skin fungal infection, if this study showed that Laser could be effective, this would be introduced as a new treatment modality.

Eligibility criteria: Inclusion Criteria:

* Patients with Positive KOH Smear skin plaques

Exclusion Criteria:

* Tinea Capitis,Onychomycosis
* Pregnancy and feeding

Primary outcomes:
measure: smear & culture of skin scrap
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Skin Research Center, Shaheed Beheshti Medical University
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Nima Ostovari, M.D.
role: STUDY_DIRECTOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Parviz Toossi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01432197: Occupational Therapy for Cancer Patients: a Randomised, Controlled Study
Official title: Occupational Therapy for Cancer Patients: A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: HRQOL (Health Related Quality of Life)
Keywords: HRQOL
Occupational therapy
ADL intervention
Cancer patients
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Naestved Hospital
First posted: 2011-09-12
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to investigate the effect of occupational therapy, in shape of activities of daily living, for cancer patients.

Detailed description: Background

Cancer patients often experience serious dysfunctions leading to problems with activities of daily living (ADL) and reduced quality of life. Occupational therapy is believed to be effective in handling many of the problems with ADL experienced by patients with cancer, but the evidence is sparse.

Aim

The purpose of this study is to analyse the effects of an occupational therapy intervention targeting cancer patients.

Outcome measures are the patients self-reported quality of life and the patients ability to perform ADL.

Methods

Randomised controlled trial with 288 patients with cancer treated at Naestved hospital in Denmark. Occupational therapy intervention programme for the intervention group (N=144) and standard treatment and care for the controls (N=144).

A systematic review including studies of ADL intervention for cancer patients will be carried out. Feasibility of the recruitment and the intervention will be analysed and published.

The patients need for occupational therapy will be analysed using baseline information from the randomised controlled trial.

The effects of the intervention will be analysed using patient validated questionnaires including EORTC QLQ-C30 and the ADL taxonomy questionnaire.

Eligibility criteria: Inclusion Criteria:

* Cancer patients
* Disability comparable with a performance status of 10 to 70 on Karnofsky Performance Status Scale
* Able to read and understand Danish

Exclusion Criteria:

* Referred to occupational therapy before study start

Primary outcomes:
measure: Health related quality of life
timeFrame: 15 months
Secondary outcomes:
measure: Ability to perform activities of daily living
timeFrame: 15 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Research Unit of General Practice, IST, University of Southern Denmark
Study officials:
affiliation: Research Unit of General Practice, IST, University of Southern Denmark
name: Dorte Gilsaa Hansen, Ph.D, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Health, Man and Society, IST, University of Southern Denmark
name: Karen la Cour, Ph.D, OT, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04650997: The Mechanical,Physiological and Therapeutic Effects of Eccentric Exercise Combined With Extracorporeal Shockwave Therapy in Athletes With Patellar Tendinopathy
Official title: The Mechanical,Physiological and Therapeutic Effects of Eccentric Exercise Combined With Extracorporeal Shockwave Therapy in Athletes With Patellar Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellar Tendinopathy
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patellar tendinopathy is one of the most common injuries in jumping athletes. Changes in mechanical and physiological properties of tendon are the two proposed forms of pathogenesis. The efficacy of eccentric exercise when applied alone and combined with extrocoporeal shockwave therapy had been reported; however, the underlying treatment mechanisms of pain and dysfunction are not clear. This project aimed to explore the mechanical, physiological and therapeutic effects of eccentric exercise when applied as a single treatment and as an adjunct to extracorporeal shockwave therapy.


Eligibility criteria: Inclusion Criteria:

* Competitive athletes
* Pain at the inferior pole of the patella with training for at least 3 months
* Tenderness at the inferior pole of the patella on palpation

Exclusion Criteria:

* Patellofemoral pain syndrome, fat pad irritations, meniscus injury, osteoarthritis, rheumatoid arthritis or infections
* History of fracture over lower limbs and inflammatory myopathies
* Cortisone injuection and other interventions within 3 months
* Contraindication to extracorporeal shockwave therapy

Primary outcomes:
measure: Tendon stress in pascals at baseline
timeFrame: Before intervention
measure: Change of tendon stress in pascals at 12 weeks
timeFrame: 12 weeks
measure: Change of tendon stress in pascals at 16 weeks
timeFrame: 16 weeks
measure: Tendon vascularity index as percentage at baseline
timeFrame: Before intervention
measure: Change of tendon vascularity index as percentage at 12 weeks
timeFrame: 12 weeks
measure: Change of tendon vascularity index as percentage at 16 weeks
timeFrame: 16 weeks
Secondary outcomes:
measure: Tendon related pain on visual analogy scale at baseline
timeFrame: Before intervention
measure: Change of tendon related pain on visual analogy scale at 12 weeks
timeFrame: 12 weeks
measure: Change of tendon related pain on visual analogy scale at 16 weeks
timeFrame: 16 weeks
measure: Tendon related dysfunction by questionnaire at baseline
timeFrame: Before intervention
measure: Change of tendon related dysfunction by questionnaire at 12 weeks
timeFrame: 12 weeks
measure: Change of tendon related dysfunction by questionnaire at 16 weeks
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00092105: Study of MK0476 (Montelukast Sodium) and Effects on Asthma and Nasal Symptoms Upon Exposure to Cats (0476-256)
Official title: A Multicenter, Double-Blind, Randomized, Crossover Study Investigating the Clinical Effect of Montelukast in Patients With Concomitant Asthma and Allergic Rhinitis Upon Controlled Exposure to Cat Allergen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma, Bronchial
Rhinitis, Allergic, Perennial
Keywords: Rhinitis, Allergic
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-24
Enrollment: 58
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the protective effect of an approved medication on asthma and allergic rhinitis (inflammation of the mucous membrane of the nose) upon exposure to cats.

Detailed description: The duration of treatment is 2 weeks.

Eligibility criteria: Inclusion Criteria:

* Increased sensitivity to cat allergen proven by positive allergy testing, and by decreased lung function and increased symptoms of allergic rhinitis (runny nose) upon exposure to cats.

Exclusion Criteria:

* Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.

Primary outcomes:
measure: Co-Primary endpoints: (1) Area Under the Curve (AUC) for the percent fall from prechallenge FEV1 during allergen challenge; (2) Area Under the Curve for the increase from prechallenge Nasal Symptoms score during allergen challenge
Secondary outcomes:
measure: (1) Maximum percent fall from prechallenge FEV1; (2) AUC for the increase from prechallenge Chest Symptoms score (3) AUC for the increase from prechallenge Nasal Symptoms score collected over 60 minutes after terminating the challenge.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Perry TT, Corren J, Philip G, Kim EH, Conover-Walker MK, Malice MP, Massaad R, Dass SB, Reiss TF, Wood RA. Protective effect of montelukast on lower and upper respiratory tract responses to short-term cat allergen exposure. Ann Allergy Asthma Immunol. 2004 Nov;93(5):431-8. doi: 10.1016/S1081-1206(10)61409-3.
Clinical trial NCT03685305: Weight Loss and Cognitive Function in Adults
Official title: Weight Loss and Cognitive Function in Middle-Aged and Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Weight loss
Cognitive function
Weight maintenance
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 33
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: More than two-thirds of middle-aged and older adults are overweight, which places them at greater risk of disability and higher medical expenses. Lifestyle interventions which promote weight loss for this population are needed. However, it is not known how different weight loss approaches impact brain (cognitive) functions, such as memory and attention. The investigator's investigation aims to improve adherence to a hypocaloric diet prescription through improved attention and inhibitory control, reduced hunger, and increased satiety.

The objectives of this pilot study are to: 1) determine the feasibility and establish proof-of-concept; 2) establish proficiency and feasibility of the proposed cognitive function assessments; and 3) obtain preliminary data for effect size generation.


Eligibility criteria: Inclusion Criteria:

* Overweight or obese, BMI 25-40 kg/m\^2
* Able to use a computer, keyboard, and mouse

Exclusion Criteria:

* Uncontrolled hypertension
* Orthopedic injury
* Other conditions that preclude participation in a walking program
* Previous participation in psychology research which involved computerized cognitive testing
* Diabetes which requires insulin

Primary outcomes:
measure: Cognitive function changes - attention
timeFrame: 30-min measurement per session
measure: Cognitive function changes - inhibitory control
timeFrame: 30-min measurement per session
measure: Weight change
timeFrame: 5-min measurement per session
Secondary outcomes:
measure: Perceived hunger
timeFrame: 15-minute measurement per session
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: Virginia Tech
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Brenda Davy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00505505: Intensive Insulin Therapy for Strict Glycemic Control in Neurosurgical Patients: Safety and Efficacy
Official title: Effects of Intensive Insulin Therapy on Mortality, Morbidity and Long Term Neurologic Outcome in Neurosurgical Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Subarachnoid Hemorrhage
Traumatic Brain Injury
Intracranial Hemorrhage
Keywords: Neurointensive care
Intensive insulin infusion
Hypoglycemia
Postoperative Mortality
Postoperative Morbidity
Neurologic outcome
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2007-07-23
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Strict glycemic control improves mortality and morbidity of patients admitted to the postoperative intensive care unit (ICU). The investigators would like to know if this therapy could improve the long term neurologic and cognitive outcomes of patients treated for acute subarachnoid hemorrhage with either a surgical or intravascular approach.

Detailed description: Intensive Insulin Therapy and Strict Glycemic Control (80-120 mg/dL) Versus Standard Insulin Therapy in Neurosurgical Intensive Care Patients (Subarachnoid Hemorrhage, Traumatic Brain Injury, Intracranial Expanding Lesion): Safety, and Efficacy (Mortality, Morbidity, Long Term Neurologic Outcome).

Eligibility criteria: Inclusion Criteria:

* Subarachnoid hemorrhage
* Traumatic brain injury
* Intracranial hemorrhage

Primary outcomes:
measure: Episodes of hypoglycemia
Secondary outcomes:
measure: Infection rate
timeFrame: during the study
measure: Vasospasm rate
timeFrame: during the study
measure: Mortality
timeFrame: 6 months follow up
measure: Neurologic status
timeFrame: 6 months follow up
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University of Rome La Sapienza
Study officials:
affiliation: Department of Anesthesiology, Critical Care and Pain Medicine
name: Federico Bilotta, MD, PhD
role: STUDY_CHAIR
References: