louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03788135: Localized Muscle Cooling on Balance in Healthy Individuals
Official title: Effect of Localized Muscle Cooling on Balance in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate the effects of localized muscle cooling on static and dynamic stability in healthy adults.

Detailed description: Healthy young adult aged 18-30 years will be recruited from the College of Applied Medical Sciences (CAMS), King Saud University, Riyadh. Subjects will be excluded if they had a history of a hip or knee injury, sensory deficits in the lower extremity, a history of lower-extremity surgery, or a history of a quadriceps or hamstring muscle injury. The protocol was submitted to and approved by the Ethics Sub-Committee of Rehabilitation Research chair (RRC-2018-011). Participants will be requested to sign a written informed consent form approved by the institution ethics committee. A total of 50 participants were randomly assigned to the quadriceps cooling (QC: n = 10), hamstrings cooling (HC: n = 10), calf cooling (CC: n = 10), back muscle cooling (BC: n = 10) or control (no cooling: n = 10) group by a lottery method.A baseline assessment of mean center of gravity (COG), sway velocity (degrees/sec) for the unilateral Stance (US) will be performed. After the baseline assessment, a cold pack (gel pack, temperature -6 degrees to -12 degrees Celsius) will be placed on the target muscle for 20 minutes. One thin dry towel will be kept between the cold pack and the skin to prevent skin damage. Before and after the application of ice application the skin sensibility will be assessed by testing the participant's to a pinprick.

Eligibility criteria: Inclusion Criteria:

* Healthy young adults

Exclusion Criteria:

* history of a hip or knee injury, sensory deficits in the lower extremity and lower back, a history of lower-extremity surgery, spinal surgery, or a history of a quadriceps or hamstring muscle injury.

Primary outcomes:
measure: mean center of gravity (COG) sway velocity (degrees/sec) for the unilateral Stance (US)
timeFrame: up to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: RRC, KSU
Study officials:
affiliation: King Saud University
name: AHMAD H ALGHADIR, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT01493635: Two Step Versus the Standard Three Step Approach of the WHO Analgesic Ladder for Cancer Pain Relief.
Official title: An International, Multicentre, Open Randomised Parallel Group Trial Comparing a Two Step Approach for Cancer Pain Relief With the Standard Three Step Approach of the WHO Analgesic Ladder in Patients With Cancer Pain Requiring Step 2 Analgesia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Pain
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2011-12-16
Enrollment: 152
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 World Health Organization analgesic ladder for cancer pain relief is an internationally used approach to managing cancer pain. Patients generally start on Step 1 of the ladder (paracetamol). As pain increases or is not well controlled on this, they progress to Step 2 which involves a stronger pain killer (weak opioid such as codeine). If pain is still not controlled they progress to Step 3 of the ladder which is a strong opioid (such as morphine). Work to date has suggested that Step 2 may be unnecessary and most patients usually require Step 3 analgesia. The TVT trial aims to examine the standard approach (Step 1-Step2-Step-3) versus a two step approach (Step 1-Step 3).


Eligibility criteria: Inclusion Criteria:

* 18 years of age and over.
* Patient has a cancer diagnosis (based on radiological, histological, cytological, or operative evidence). Those with haematological malignancies are eligible.
* Cancer related pain - which in the opinion of the clinician is caused by the presence of tumour or metastases.
* Average pain score \> 4, on a numerical rating scale from 0-10, requiring step 2 analgesia (weak opioid).
* Patient is able to comply with trial procedures.

Exclusion Criteria:

* Patients who have received radiotherapy in the previous 6 weeks or are planned to receive radiotherapy during the trial period where in either case, it is expected to affect pain during the trial period.
* Pain due to surgery in the preceding 4 weeks.
* Life expectancy less than two months (based on clinical impression).
* Patients with psychotic disorders or cognitive impairment.
* Patients who have received regular doses (scheduled doses - NOT as required dosing) of weak or strong opioids in the preceding two weeks.
* Patients using immediate release opioids \> 2 doses/24 hours, in the previous 24 hours.

Primary outcomes:
measure: Time to achieving stable pain control, where stable pain control is defined as the first day of three consecutive days with average pain score less than or equal to 3 using scores from the Patient Diary and patient assessments.
timeFrame: Up to 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
Study officials:
affiliation: University of Edinburgh
name: Marie Fallon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01127035: Sublingual Immunotherapy In Alternaria-Induced Rhinitis
Official title: STUDIO IN DOPPIO CIECO DISODIOCROMOGLICATO + PLACEBO vs DISODIOCROMOGLICATO + IMMUNOTERAPIA SPECIFICA SUBLINGUALE PER ALTERNARIA IN PAZIENTI CON RINITE ALLERGICA DOVUTA A SENSIBILIZZAZIONE AD ALTERNARIA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis (w/w Asthma) Due to Alternaria Alternata
Keywords: allergic rhinitis
alternaria alternata
symptom score
Lead sponsor: University of Genova
Sponsor class: OTHER
First posted: 2010-05-20
Enrollment: 27
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Respiratory allergy due to Alternaria is a relevant clinical problem, and specific immunotherapy may represent a viable treatment option. Sublingual immunotherapy (SLIT) is safe and effective, but data for Alternaria are lacking. The study is aimed at assessing the efficacy of a standardized SLIT in patients sensitised to Alternaria, in a randomized, double blind, placebo controlled fashion.

Patients with rhinitis with/without intermittent asthma, and ascertained allergy to Alternaria are enrolled. After a baseline season, SLIT or matched placebo are given for 10 months. Symptoms and rescue medication intake are recorded on diary cards from June to October. Skin prick test, specific IgE and IgG4 and precipitins are measured at baseline and at the end of the study. Alternaria spore count is also performed. Primary outcome is the change in symptom score in the active vs placebo group. Secondary outcomes: changes in rescue medication intake, alternaria specific IgE and IgG4, skin prick test reactivity.


Eligibility criteria: Inclusion Criteria:

* Allergic rhinitis
* Symptoms May-October
* Specific IgE to alternaria (skin test/radioallergosorbent \[RAST\] test)
* Age \>14

Exclusion Criteria:

* Sensitization to mites, parietaria, mugwort
* Pregnancy-lactation
* Malignancies
* Chronic systemic steroids
* Previous immunotherapy to alternaria

Primary outcomes:
measure: change in symptom score active versus placebo
Secondary outcomes:
measure: change in rescue medication intake
Other outcomes:
Locations:
city: Rimini
country: Italy
facility: Rimini Hospital
Study officials:
References:
citation: Tabar AI, Lizaso MT, Garcia BE, Gomez B, Echechipia S, Aldunate MT, Madariaga B, Martinez A. Double-blind, placebo-controlled study of Alternaria alternata immunotherapy: clinical efficacy and safety. Pediatr Allergy Immunol. 2008 Feb;19(1):67-75. doi: 10.1111/j.1399-3038.2007.00589.x. Epub 2007 Jul 25.
citation: Cortellini G, Spadolini I, Patella V, Fabbri E, Santucci A, Severino M, Corvetta A, Canonica GW, Passalacqua G. Sublingual immunotherapy for Alternaria-induced allergic rhinitis: a randomized placebo-controlled trial. Ann Allergy Asthma Immunol. 2010 Nov;105(5):382-6. doi: 10.1016/j.anai.2010.08.007. Epub 2010 Sep 26.
Clinical trial NCT07005635: The Effects of Different Time Reminder On Surgical Hand Scrubing
Official title: Comparison of The Effects of Different Time Reminder on Surgical Hand Scrub: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Surgical Site Infection
Keywords: Surgical Hand scrub
skill laboratory
satisfaction
Time reminder
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Music group Alarm group Control group
Primary purpose: OTHER

Brief summary: When surgical hand scrubing is not done properly, it can negatively affect patient outcomes. In addition to the entire surgical team being able to perform surgical hand scrubing properly, every student studying in the health field who will work in operating rooms should also learn and practice surgical hand washing correctly. In this context, this study aims to evaluate the satisfaction and success of different time reminder systems on students' surgical hand scrubing skills.

Detailed description: This randomized controlled study will carry out Sixty-six (music group= 22, alarm group= 22, control group= 22) first year undergraduate operating room services program students. This program places at a Vocational School of Health Services, Operating Room Services Programme in Ankara Turkey.

Eligibility criteria: Inclusion Criteria:

* to be a first-year students of the operating room services program
* to be volunteered

Exclusion Criteria:

* previous experience working in the operating room

Primary outcomes:
measure: Surgical Hand Scrub Time
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Özgü Bakçek
state: Eyalet/Yerleşke
city: Ankara
country: Turkey
facility: Yuksek Ihtisas University
Study officials:
References:
Clinical trial NCT01366235: Clinical Trial for Evaluation of Ethnic Differences in Pharmacokinetics of Chloroquine, an Anti-malarial Drug
Official title: Clinical Trial for Evaluation of Ethnic Differences in Pharmacokinetics of Chloroquine, an Anti-malarial Drug
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2011-06-06
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Chloroquine is an anti-malaria agent. This study is designed to evaluate inter-ethnic differences of therapeutic effect of chloroquine and search the cause of these ethnic differences. For this purpose, chloroquine will be administered to four ethic groups of Korean, Caucasian, African and Southeast Asian and chloroquine concentration in blood will be measured. The result of this study will be helpful in finding more adequate dosing regimen of chloroquine in patients with malaria.


Eligibility criteria: Inclusion Criteria:

* aged 20 - 50 male subjects (6 Koreans, 6 Caucasians, 6 Africans and 6 Southeast Asians)
* Subjects with body weight ≥ 45 kg and within ±20% of the ideal body weight : Ideal body weight = (height \[cm\] - 100)x0.9.

Exclusion Criteria:

* Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
* Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Primary outcomes:
measure: pharmacokinetic evaluation
timeFrame: within 30 days
Secondary outcomes:
measure: pharmacokinetic evaluations
timeFrame: within 30 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT06004635: Reliability of Myotonometry in the Assessment of Mechanical Properties of Thenar Muscles
Official title: Reliability and Sex-Based Variations in Myotonometer Assessment of Thenar Muscle Properties: Implications for Grip Strength
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscular Tone
Keywords: rehabilitation
biomechanics
assessment
skeletal muscle
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults between 18-35 years old

Brief summary: This study aimed to (i) assess the reliability of myotonometer measurements in determining the mechanical properties of thenar muscle in healthy individuals and explore gender-based variations in these properties; (ii) examine the relationship between pinch grip strength and these mechanical properties.

Detailed description: Investigating the mechanical properties of hand muscles using simple applicable methods such as myotonometer can help to evaluate the effectiveness of programs used in hand rehabilitation, optimize the skills of performance-oriented individuals such as athletes and musicians, and create individualized treatment and training programs. In musculoskeletal-related pathologies such as carpal tunnel syndrome, studying the mechanical properties of the thenar muscles may be important to better understand hand grip strength, hand function and mobility. However, the use of myotonometer in the evaluation of the mechanical properties of the thenar muscles requires a reliability study. Accordingly, the aims of our study are: to (i) assess the reliability of myotonometer measurements in determining the mechanical properties of thenar muscle in healthy individuals and explore gender-based variations in these properties; (ii) examine the relationship between pinch grip strength and these mechanical properties.

Eligibility criteria: Inclusion criteria:

* being between 18 and 35 years of age
* having normal upper extremity function
* having a Montreal Cognitive Assessment Test (MoCA) score \> 26 points

Exclusion criteria:

* any neuromuscular or musculoskeletal disease
* history of upper limb injury
* upper limb surgery within the last 6 months
* body mass index (BMI) \> 30 kg/m2.

Primary outcomes:
measure: Muscle tone (Hz)
timeFrame: 30 Minutes
measure: Stiffness (N/m)
timeFrame: 30 Minutes
measure: Elasticity (Logarithmic decrement)
timeFrame: 30 Minutes
Secondary outcomes:
measure: Pinch strength
timeFrame: 30 Minutes
Other outcomes:
Locations:
city: Bitlis
country: Turkey
facility: Bitlis Eren University
Study officials:
References:
Clinical trial NCT05363735: Ultrasound Elastography Application in Cesarean Section Scar Defect
Official title: Ultrasound Elastography Application in the Assessment of Cesarean Section Scar Defect.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cesarean Section; Dehiscence
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women who were diagnosed with CSD

Brief summary: Cesarean Section Scar Defect(CSD) is one of the complications after cesarean section. CSD will cause many long term complications, such as abnormal uterine bleeding, infertility, uterine scar pregnancy and uterine rupture. Transvaginal ultrasound was used to detect uterine scar defects commonly. Ultrasound elastography is a modern imaging technique that has developed rapidly in recent years. Thus, this study intend to investigate the application of Ultrasound Elastography in Cesarean Section Scar Defect.


Eligibility criteria: Inclusion Criteria:

* Clearly diagnosed with CSD
* No serious medical problems (important viscera function in the normal range). uterine fibroids no more than 5cm
* Sign the informed consent.

Exclusion Criteria:

* Indefinite diagnosis.
* Malignant tumors.
* With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
* Pregnant.
* Mental diseases.
* Unwilling to comply with the research plan.

Primary outcomes:
measure: thickness of the remaining muscular layer
timeFrame: 4 weeks before vaginal repair of CSD
measure: thickness of the remaining muscular layer
timeFrame: 12 weeks after vaginal repair of CSD
measure: strain ratio (SR)
timeFrame: 4 weeks before vaginal repair of CSD
measure: strain ratio (SR)
timeFrame: 12 weeks after vaginal repair of CSD
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Wang Xipeng, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT05862935: Influence of Physical Exercise as Adjuvant Treatment in Patients With Alzheimer's Disease
Official title: Influence of Physical Exercise as Adjuvant Treatment in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Dementia
Physical exercise
Locomotion
Lead sponsor: European University Miguel de Cervantes
Sponsor class: OTHER
Collaborators: name: Asociación de Familiares de Alzheimer de Valladolid
First posted: 2023-05-17
Enrollment: 26
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The goal of this non-randomized clinical trial is to assess the effects of strength training in the physical function of Alzheimer's disease (AD) patients. The main question it aims to answer are:

1. Is a basic strength training enough to improve physical function in AD patients?
2. Is an exercise intervention able to delayed the progression of the disease?
3. Is an AMRAP intervention feasible in AD patients?

Participants in the exercise group will perform a 16-weeks program divided in two phases (phase 1: basic strength training; phase 2: AMRAP training). Participants in both (exercise and control) groups will receive their usual care treatments which include occupational therapy, musicotherapy, cognitive stimulation and sensory stimulation.


Eligibility criteria: Inclusion Criteria:

* MMSE (Mini-Metal State Examination) score of ≥15 out of 35 (at screening less than 2 months prior to baseline visit)
* Age ≥60 years old
* Be able to walk with or without aids
* Be able to follow verbal instructions

Exclusion Criteria:

* Surgery in the last 3 months
* Exhibit clear signs of disorientation
* Clinically confirmed signs of aggressiveness

Primary outcomes:
measure: Short Physical Performance Battery
timeFrame: 0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
Secondary outcomes:
measure: Handgrip strength
timeFrame: 0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
measure: Body mass index
timeFrame: 0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
measure: Practicability of AMRAP (As Many Repetitions As Possible) training; it will be analysed by calculating both intra- and inter-subject coefficient variation.
timeFrame: Every session (during 13 sessions)
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Universidad Europea Miguel de Cervantes
Study officials:
References:
Clinical trial NCT04026386: A Center Based Early Intervention Program for Preschoolers with Developmental Disorders
Official title: A Center Based Early Intervention Program for Preschoolers with Developmental Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Development Disorder, Child
Developmental Disability
Development Delay
Autism Spectrum Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: John & Marcia Goldman Foundation
First posted: 2019-07-19
Enrollment: 75
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effectiveness of a 12-week early intervention program that will include 12 weekly hours in an intensive center-based preschool environment or in the home to treat social communication deficits in children with developmental disorders. The study will include children with developmental disorders, such as Autism Spectrum Disorder, neurogenetic disorders, or intellectual disability.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Developmental Disorder, such as Autism Spectrum Disorder, neurogenetic disorder, or intellectual disability, based on clinical interview;
* Boys and girls between 2.0 years and 5.11 years at time of enrollment;
* Ability to participate in the testing procedures to the extent that valid standard scores can be obtained.

Exclusion Criteria:

* Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
* Lack of availability during program hours.

Primary outcomes:
measure: Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.
timeFrame: Baseline, 12 Weeks
Secondary outcomes:
measure: Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.
timeFrame: Baseline, 12 Weeks
measure: Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores During Treatment.
timeFrame: Baseline, 12 Weeks
measure: Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores During Treatment.
timeFrame: Baseline, 12 Weeks
measure: Change From Baseline in Parent Rated Short Sensory Profile Questionnaire (SSPQ) Scores During Treatment.
timeFrame: Baseline, 12 Weeks
measure: Change From Baseline in Parent Rated General Self Efficacy Scale (GSES) Scores During Treatment.
timeFrame: Baseline, 12 Weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Antonio Hardan, MD
role: PRINCIPAL_INVESTIGATOR
References: