louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02168634: The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial
Official title: The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Itchiness
Hypertrophic Scar
Botulinum Toxin
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2014-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypertrophic scar, a disfiguring tissue reaction to trauma, occurred in around 20 % of the population. The patients with hypertrophic scar usually seek medical assistance not just for the annoying appearance but mostly due to the intractable itchiness. There have been a variety of effective methods to alter the appearance of the scar. However, the treatments for itching from hypertrophic scar are scarce. In 2009, P.Gazerani used Botox to treat histamine-induced itch with favorable results. In the clinical setting, however, the efficacy of Botox to treat itch from hypertrophic scar was yet to be proven. Therefore, the goal of this study is to conduct a randomized controlled trials about using Botox to treat itch from hypertrophic scar.


Eligibility criteria: Inclusion Criteria:

1. The patients undergoing laparotomy and thoracotomy in Veterans General Hospital in Kaohsiung (VGHKS) during 2003/1/1\~2012/12/31
2. Hypertrophic scars containing more than two itchy sites with itchiness scale \>3
3. Good wound healing condition, no infection sign
4. Age older than 20 year-old

Exclusion Criteria:

1. Allergy to Botulinum toxin
2. Inability to express self-willingness
3. Pregnancy

Primary outcomes:
measure: The degree of itchiness
timeFrame: 6 months
Secondary outcomes:
measure: Pain scale
timeFrame: Within one minue after drug injection
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
References:
citation: Akhtar N, Brooks P. The use of botulinum toxin in the management of burns itching: preliminary results. Burns. 2012 Dec;38(8):1119-23. doi: 10.1016/j.burns.2012.05.014. Epub 2012 Jul 12.
citation: Gazerani P, Pedersen NS, Drewes AM, Arendt-Nielsen L. Botulinum toxin type A reduces histamine-induced itch and vasomotor responses in human skin. Br J Dermatol. 2009 Oct;161(4):737-45. doi: 10.1111/j.1365-2133.2009.09305.x. Epub 2009 May 11.
Clinical trial NCT02754934: Development of a Self-administered Neck Mobility Assessment Tool in Chronic Neck Pain Patients.
Official title: Development of a Self-administered Neck Mobility Assessment Tool in Chronic Neck Pain Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Pain
Keywords: chronic
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
Collaborators: name: Maastricht University
First posted: 2016-04-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Investigators will include 50 participants with chronic neck pain

Brief summary: This study evaluates, if the movement of the cervical spine, assessed via a specific questionnaire by the patient, is a valid and reliable tool and could be used in daily clinical routine.

Detailed description: Cervical range of motion is a frequently used assessment methods in patients with neck pain.

Although it seems to be used frequently, clinicians still prefer hands-on assessment. Furthermore it is interesting, if cervical range of motion,self-assessed by the patient is a valid and reliable tool.

Eligibility criteria: Inclusion Criteria:

* Neck pain \> 90 days
* Able to speak, read and write German

Exclusion Criteria:

* Red Flags e.g. Fracture of the cervical spine

Primary outcomes:
measure: Cervical Spine Mobility
timeFrame: Day one of the study
Secondary outcomes:
measure: Pain Visual Analogue Pain Rating Scale
timeFrame: Day one of the study
measure: Disability on Neck Disability Index
timeFrame: Day one of the study
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: Balgrist University Hospital
name: Jaap Swanenburg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langenfeld A, Bastiaenen C, Sieben J, Swanenburg J. Development and validation of a self-administered neck mobility assessment tool (S-ROM-Neck) in chronic neck pain patients. Musculoskelet Sci Pract. 2018 Oct;37:75-79. doi: 10.1016/j.msksp.2018.04.004. Epub 2018 Apr 10.
Clinical trial NCT05349734: Comparison of Upper Body and Full Underbody Forced Air Blanket in Pediatric Patients
Official title: Comparison of Upper Body and Full Underbody Forced Air Blanket for Maintaining Normothermia in Pediatric Patients Undergoing Cardiovascular Interventions Under General Anesthesia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia; Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 92
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to compare the underbody blanket and overbody blanket for forced air warming to maintain normothermia in pediatric patients undergoing cardiovascular interventions under general anesthesia.


Eligibility criteria: Inclusion Criteria:

* pediatric patients under 15 years of age who are scheduled for cardiovascular interventions in angioroom

Exclusion Criteria:

* anticipated operating time \< 1 hour
* body surface area that exposured by drape \< 30% of total body surface area
* BMI \> 30
* corrected age \< 40 weeks
* preoperative body temperature is higher than 37℃ or less than 35.5℃
* patients with skin disease
* history of malignant hyperthermia
* patients who cannot use esophageal stethoscope

Primary outcomes:
measure: hypothermia
timeFrame: intraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room)
Secondary outcomes:
measure: hyperthermia
timeFrame: intraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room)
measure: thermal comfort scale
timeFrame: 15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit
measure: patient satifisfaction at post-anesthesia care unit
timeFrame: 15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit
measure: shivering score at post-anesthesia care unit
timeFrame: 15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit
measure: clinical outcomes after the surgery
timeFrame: 5 days after the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03183934: A Follow-up Study to Evaluate the Efficacy and Safety of ALLO-ASC-DFU in ALLO-ASC-EB-101 Clinical Trial
Official title: A Follow-up Study to Evaluate the Efficacy and Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 1/2 Clinical Trial of ALLO-ASC-EB-101
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dystrophic Epidermolysis Bullosa
Keywords: Epidermolysis Bullosa
Stem cell
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-12
Enrollment: 2
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subject is enrolled who are treated with ALLO-ASC-DFU sheet in phase 1/2 clinical trial of ALLO-ASC-EB-101

Brief summary: This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1/2 clinical trial(ALLO-ASC-EB-101) for 24 months.

Detailed description: This is an open-label follow up study to evaluate the efficacy and safety for the subjects with ALLO-ASC-DFU treatment in phase 1/2 clinical trial (ALLO-ASC-EB-101) for 24 months.

ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor(VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Dystrophic Epidermolysis Bullosa.

Eligibility criteria: Inclusion Criteria:

1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 1/2 clinical trial of ALLO-ASC-EB-101.
2. A subject who is willing to follow the protocol and provide informed consent on screening, given that the information with respect to the clinical trial is provided.

Exclusion Criteria:

1. Subjects who are considered not suitable for the study by the principal investigator.

Primary outcomes:
measure: Safety assessed by clinically measured abnormality of laboratory tests and adverse events
timeFrame: Every time of visit for follow up to 24 months
Secondary outcomes:
measure: Area of re-epithelization
timeFrame: Every time of visit for follow up to 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severence Hospital
Study officials:
affiliation: Gangnam Severence Hospital
name: Su Chan Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01105234: An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects
Official title: An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Irritation
Keywords: Healthy volunteers
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2010-04-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this trial is to compare the skin irritation potential of eight different formulations of vitamin D analogues after repeated applications on intact skin of healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects having understood and signed an informed consent form.
* Either sex
* Healthy subjects, 18 to 65 years of age
* Subjects with skin types I to IV according to Fitzpatrick Scale
* Subjects without erythema on test areas on the mid back skin (visual irritation score = 0) at baseline (Day 1), before randomisation.

Exclusion Criteria:

* Females who are pregnant, or who wish to become pregnant during the study, or who are breast feeding
* Any topical or systemic corticosteroids or immuno-suppressors within 3 weeks prior to randomisation
* Any other medication which may interfere with the study results, in particular topical drugs applied on the test area within 2 weeks prior to randomisation
* Any other products which may interfere with the study results, in particular emollients, creams, gels, lotions and body powders applied on the test area within 24 hours prior to randomisation
* Any systemic or cutaneous disease that may confound interpretation of the study results (e.g., atopic dermatitis, eczema, psoriasis)
* Scars, moles, sunburn, or other blemishes in the test area which may interfere with grading
* Exposure to excessive or chronic UV radiation (i.e., sunbathing, solarium, phototherapy) within 2 weeks prior to randomisation or is planned during the study period
* Known or suspected hypersensitivity to any component of the investigational products
* Participation in any other interventional clinical trial within 4 weeks prior to randomisation or during the study period, based on interview of the subject

Primary outcomes:
measure: Clinical scoring of the skin reaction.
timeFrame: 10 days
Secondary outcomes:
measure: Transepidermal waterloss measurements
timeFrame: 10 days
Other outcomes:
Locations:
city: Nice
country: France
facility: LEO Pharma site
Study officials:
affiliation: LEO Pharma
name: Patrice Facy, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00036634: A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients
Official title: A Phase 1/2, Randomized, Double-Blind, Active Controlled, Dose Escalation Study of the Safety, Tolerance, Pharmacokinetic,, and Antiviral Activity of GS-7340-02 in Antiretroviral-Naive Patients Who Are Chronically Infected With HIV-1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Keywords: treatment naive
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2002-05-14
Enrollment: 30
Sex: ALL
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: This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).


Eligibility criteria: Inclusion Criteria

* HIV-1 RNA levels greater than or equal to 30,000 copies/mL
* CD4 count greater than or equal to 200 cells/mm3
* Serum creatinine \<1.5 mg/dl
* Hepatic transaminases less than or equal to 2.5 times the upper limit of normal
* Total bilirubin less than or equal to 1.5 mg/dL
* Adequate hematologic function
* Serum amylase less than or equal to 1.5 times the upper limit of normal
* Serum phosphate greater than or equal to 2.2 mg/dL
* Not pregnant

Exclusion Criteria

* Prior treatment with antiretroviral therapy
* Immunization within 30 days of study entry
* A new AIDS defining condition within 30 days of study entry
* Receiving nephrotoxic agents, probenecid, chemotherapeutic agents, corticosteroids, interleukin-2

Primary outcomes:
measure: Time-weighted average change from baseline through Week 2 (DAVG2) for HIV-1 RNA (log10 copies/mL)
timeFrame: Baseline to Week 2
Secondary outcomes:
measure: Change from baseline in HIV-1 RNA (log10 copies/mL)
timeFrame: Baseline to Week 2
measure: Change from baseline in CD4 cell count (cells/mm3)
timeFrame: Baseline to Week 2
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Positive Care Program
state: California
city: Chicago
country: United States
facility: Protocare Trials Chicago Center for Clinical Trials
state: Illinois
city: New York
country: United States
facility: Rockefeller University Hospital
state: New York
Study officials:
References:
Clinical trial NCT06744634: Coping Strategies with Pain Among Older People
Official title: An Analysis of Factors Associated with Chronic Musculoskeletal Pain, Pain Management Preferences, Coping Strategies and Health-related Quality of Life Among Older People: a Comparative Cross-Cultural Study of Turkey, Croatia and Romania
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pain
Keywords: Aged
Coping Strategy
Health-Related Quality of Life
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 336
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Geriatrics

Brief summary: Chronic musculoskeletal pain is common among older adults. This study aimed to identify and describe the characteristics of chronic musculoskeletal pain, pain management and coping strategies among older adults from Turkey, Croatia and Romania. The study also aimed to explore cultural differences in pain experience and management.

Methods:

337 older adults with chronic pain participate 100 from Turkey, 131 from Croatia and 106 from Romania. Semi-structured interviews will explore four main topics, including factors influencing pain, coping strategies, management strategies, and health-related quality of life.

Detailed description: The questionnaire which was prepared by researchers will be performed by older adults. The sociodemographic characteristics are recorded to part A section of questionnaire. The pain assessment section is part B and evaluate pain localization, intensity, type, factors affecting the pain, coping and management strategies of pain. Health related outcomes will be evaluated with CDC (Center of Disease Control and Prevention) Health related Quality of Life-4 Questionnaire

Eligibility criteria: Inclusion Criteria:

* women and men aged between 65-85 years
* living in their own homes or in a nursing home
* older adults with chronic pain for at least 6 months,
* independent in activities of daily living, and independent in walking (with or without assistive walking devices).

Exclusion Criteria:

* Elderly adults with communication problems

Primary outcomes:
measure: A semi-structure questionnaire
timeFrame: 1 week
measure: Visuel analog scale
timeFrame: 1 week
Secondary outcomes:
measure: CDC Health related Quality of Life-4
timeFrame: 1 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
References:
Clinical trial NCT04439734: Effects of Whole-body Electromyostimulation on Golf Performance in Amateur Golfers
Official title: Effects of Whole-body Electromyostimulation on Clubhead Speed and Stability in Ambitious Amateur Golfers - a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athletic Performance
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Golfersworld München
name: Golfclub München-Eichenried
First posted: 2020-06-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with two study groups in parallel: (1) Whole body electromyostimulation (WB-EMS) or 16 weeks (b) non WB-EMS control
Primary purpose: OTHER

Brief summary: Golf is becoming increasingly popular in Germany. However, the biomechanical and motor challenge of golf should not be underestimated. Nevertheless, only very few amateur golfers carry out serious preparation and conditioning as part of a strength/stabilization program. The main argument for this limitation is the aspect of "limited time resources". A solution to this problem could therefore be the time-effective and highly individualizable whole-body electromyostimulation (WB-EMS) technology.

The aim of the present study is to evaluate the effectiveness of 16 weeks of WB-EMS application on trunk stability and clubhead speed in male amateur golfers in a (randomized) controlled setting.


Eligibility criteria: Inclusion Criteria:

* Golfhandicap ≤20,
* members of the Golfclub München-Eichenried

Exclusion Criteria:

* diseases and medication that did not allow WB-EMS training (see contraindications WB-EMS) or enable proper assessment of clubhead speed (in cases of doubt, individual medical decision),
* resistance and/or WB-EMS Training during the last 6 months,
* more than two expected missed WB-EMS sessions

Primary outcomes:
measure: Clubhead speed
timeFrame: At baseline and after16 weeks (i.e. over 16 weeks)
Secondary outcomes:
measure: Trunk stability as determined by
timeFrame: At baseline and after16 weeks (i.e. over 16 weeks)
measure: Clubhead speed
timeFrame: At baseline and after 8 weeks (i.e. over 8 weeks)
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics, Friedrich-Alexanden University Erlangen-Nürnberg
Study officials:
References:
citation: Zink C, Rückel F, von Stengel S, Kemmler W. The Use of Whole Body Electromyostimulation (WB-EMS) as a Golf Warm-Up - A Randomized Controlled Cross-Over Study. Archives of Physical Health and Sports Medicine 2019; 2(1)1: 04-12
Clinical trial NCT05364034: Effects of Urban Afforestation Activity on Pain Mechanisms
Official title: Effects of Urban Afforestation Activity on Thermal and Mechanical Pain Mechanisms: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Green spaces
Nature-based activities
Horticultural therapy
Quantitative sensory testing
Pain mechanisms
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 47
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 pain thresholds.

Detailed description: Participants will perform an afforestation activity for a single session of 90 minutes. The therapist will direct the participants' attention to the visual, auditory, olfactory, and tactile features of the surrounding environment. A battery of quantitative sensory tests pre- and post-intervention.

Eligibility criteria: Inclusion Criteria:

* Free of pain in the hands, cheeks, lower back, wrists and trapezius muscles in the previous 3 months.
* Adults between 18 and 65 years.
* Any sex and gender.

Exclusion Criteria:

* Intake of any analgesic or 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.
* Pregnant or breastfeeding.

Primary outcomes:
measure: Cold pain detection threshold
timeFrame: Change from baseline cold pain detection threshold after 90 minutes.
measure: Cold pain tolerance threshold
timeFrame: Change from baseline cold pain tolerance threshold after 90 minutes.
measure: Cold pain intensity ratings
timeFrame: Change from baseline cold pain intensity ratings after 90 minutes.
measure: Wind-up ratio
timeFrame: Change from baseline wind-up ratio after 90 minutes.
measure: Mechanical pain sensitivity
timeFrame: Change from baseline mechanical pain sensitivity after 90 minutes.
measure: Pressure pain detection thresholds
timeFrame: Change from baseline pressure pain detection threshold after 90 minutes.
measure: Pressure pain intensity ratings
timeFrame: Change from baseline pressure pain intensity ratings after 90 minutes.
measure: Pressure pain tolerance thresholds
timeFrame: Change from baseline pressure pain tolerance threshold 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: