louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06466837: Just-In-Time Adaptive Interventions for Diabetic Patients
Official title: Promoting Self-management Behaviours Among Older Adults With Diabetes Mellitus by Integrating Just-In-Time Adaptive Interventions in Mobile Health Applications: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes
Self-Control
Telemedicine
Keywords: telecare
older adults
diabetes
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 184
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blinded, two-armed, randomized controlled trial.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The addition of proactive nurse consultations was useful to older adults with diabetes mellitus in facilitating their chronic disease self-management. However, the service is time and resource-intensive. With the support of advanced technology, mhealth App seems to be a convenient way to support patients in managing diabetes.

Detailed description: This study examines the effectiveness of mhealth App plus nurse consultations in promoting self-management behaviours for diabetic patients.

Eligibility criteria: Inclusion Criteria:

* With a confirmed DM diagnosis for one year or more than one year
* Using governmental mhealth App
* Living in an area with Internet coverage

Exclusion Criteria:

* Already engaged in other mHealth programmes
* Physical and cognitive limitations

Primary outcomes:
measure: Change in HbA1c
timeFrame: baseline, three-month, and six-month
measure: Diabetic self-management behaviour
timeFrame: baseline, three-month, and six-month
Secondary outcomes:
measure: Change in quality of life
timeFrame: baseline, three-month, and six-month
measure: Change in medication adherence
timeFrame: baseline, three-month, and six-month
measure: Change in health service utilization
timeFrame: baseline, three-month, and six-month
measure: Cost
timeFrame: three-month, and six-month
measure: satisfaction with the JITAIs, as well as usability and technical problems
timeFrame: three-month
Other outcomes:
Locations:
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Arkers Wong, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hong Kong Polytechnic University
name: Arkers NR Wong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06635837: Prospective Evaluation of the Role of MRI in Ovarian Masses During Pregnancy
Official title: Prospective Evaluation of the Role of Magnetic Resonance Imaging in Ovarian Masses During Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with US-indeterminate adnexal masses detected during pregnancy

Brief summary: Ovarian cancer represents 7% of all cancers in pregnant women. Characterizing an ovarian mass during pregnancy is essential to avoid unnecessary treatment and if treatment is required, to plan it accordingly. Ultrasound is the first line modality in these patients and various tools such as IOTA and ADNEX have been validated in non-pregnant patients to accurately categorize ovarian masses according to their malignant potential. A prospective multicentre study, in which Fondazione Policlinico Gemelli is involved, is currently ongoing aiming to validate these tools in pregnant Patients (p-IOTA).

Given the high contrast resolution and the absence of ionizing radiation, Magnetic Resonance Imaging is the preferred second-line modality. It increases the positive predictive value (PPV) of US from 7-50% to 70%, demonstrating a negative predictive value (NV) of 98%. In non-pregnant women, the Ovarian-Adnexal Reporting and Data System-MRI (ORADS-MRI) risk stratification system and the Non-Contrast MRI Score (NCMS) are commonly employed to assess the risk of malignancy in adnexal lesions with accuracies of 92% and 94%, respectively. Recently, both scoring systems have proven effective in retrospectively stratifying benign and malignant adnexal masses in pregnant women.


Eligibility criteria: Inclusion Criteria:

* Pregnant patients \&gt; 18 years old
* Ability to understand and sign informed consent
* Patient with adnexal mass detected during pregnancy with either multilocular morphology or solid component at ultrasound examination
* Availability of MR imaging (1.5T and 3.0T MR scanner)
* Availability of histopathological reports obtained during pregnancy or within 3 months from delivery or at least one US follow-up examination 6-12 months after MRI examination

Exclusion Criteria:

* Patients lacking or with low quality MRI

Primary outcomes:
measure: Evaluation of the accuracy of MRI.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Advanced Radiology Center- Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Camilla Panico
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06563037: The Effect of Hallux Valgus Angle on Dynamic Knee Movement Pattern
Official title: The Effect of Hallux Valgus Angle on Dynamic Knee Movement Pattern
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hallux Valgus
Keywords: Hallux valgus
Injury
Judo
Knee
Weightlifting
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 92
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At leat 3 years of experienced judo and weightlifters

Brief summary: Abstract Background/aim: Little is known about the relationship between hallux valgus and the alignment of proximal joints. Dynamic knee valgus is a movement pattern characterized by excessive knee abduction along with femoral adduction, internal rotation, and relative external tibial rotation. It is more prevalent in females and exacerbates during landing in jumping, predisposing athletes to injuries. The aim of this study is to investigate the effect of hallux valgus deformity on dynamic knee movement pattern and lower extremity injuries in athletes.

Materials and methods: This is a cross-sectional observational study. The study included 92 athletes with at least 3 years of experience in their respective sports.

Detailed description: Athletes without acute injuries that could affect performance tests were included. Demographic data were collected, and the hallux valgus angle was measured using a goniometer. A standard warm-up protocol was then administered. A drop jump test from a 30cm platform was conducted, and images captured during the test were analyzed in 2D using Kistler+Noraxon Measurement Device cameras.

Eligibility criteria: Inclusion Criteria:

* At least 3 years of experience in their respective sports.

Exclusion Criteria:

* Athletes with acute injuries

Primary outcomes:
measure: Drop Jump Test
timeFrame: 30 minutes
Secondary outcomes:
measure: Hallux Valgus Angle Measurement
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences Turkey
Study officials:
References:
citation: Hewett TE, Myer GD, Ford KR, Heidt RS Jr, Colosimo AJ, McLean SG, van den Bogert AJ, Paterno MV, Succop P. Biomechanical measures of neuromuscular control and valgus loading of the knee predict anterior cruciate ligament injury risk in female athletes: a prospective study. Am J Sports Med. 2005 Apr;33(4):492-501. doi: 10.1177/0363546504269591. Epub 2005 Feb 8.
Clinical trial NCT03201237: Comparison of Short- and Long-time Action Observation Training on Upper Limb Function in Children With Cerebral Palsy
Official title: Main Researcher for Action Observation Training (AOT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Spastic
Keywords: Cerebral palsy
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compared short- and long-time action observation training (AOT) in terms of grip strength, the Jebsen Taylor Hand Function Test (JTHF), the Quality of Upper Extremities Skills Test (QUEST), and the ABILHAND-Kids test.


Eligibility criteria: Inclusion Criteria:

* ages between 6 and 15 years
* confirmed diagnosis of spastic CP
* below grade 2 on the modified Ashworth scale
* between grade 4 and 8 on the house functional classification system
* ability to understand the assessor's instructions.

Exclusion Criteria:

* severe spasticity in UL (MAS\>2)
* orthopedic surgery in the UL within 6 months
* absence of sensory

Primary outcomes:
measure: Change of grip strength
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gimhae
country: Korea, Republic of
facility: Inje University
state: Gyeongsangnam-do
Study officials:
affiliation: Inje University
name: Do H Kim, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04503837: Personalized Mobile Phone Video Recording to Improve Inhaler Techniques in Asthma Patients.
Official title: A Randomized Control Trial to Evaluate the Effectiveness of Personalized Mobile Phone Video Recording in Addition to Standard Care Compared to Standard Care Alone in Improving Inhaler Technique Among Patients With Asthma. (RECORD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: inhaler technique
compliance
Lead sponsor: Penang Hospital, Malaysia
Sponsor class: OTHER_GOV
First posted: 2020-08-07
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effectiveness of addition of recording video of the patient performing inhaler techniques using mobile phone for discussion with the patient, to standard care inhaler education compared to standard care inhaler education alone, in improving inhaler technique of asthma patients.

Detailed description: This is a single-centre, randomized, controlled, parallel group, assessor-blinded trial to evaluate the effectiveness of Personalized Mobile Phone Video Recording in addition to standard care, compared to standard care alone, in improving inhaler technique among patients with asthma.

Patients are randomised to either Personalized Video Recording with standard clinical practice group (intervention) or to standard clinical practice group (control) in 1:1 ratio.

Subject's inhaler technique assessment is performed by using a standard checklist of steps according to the type of inhaler used by subject.

All inhaler technique assessment and asthma control questionnaire will be administered before the intervention/control treatment by a blinded assessor. Both intervention and control treatment will be administered by the same investigators.

Eligibility criteria: Inclusion Criteria:

1. 18 years old and above
2. Informed consent
3. Established clinical diagnosis of asthma by patient's treating doctor
4. Prescribed with inhalers (any type) for therapeutic indication for at least 3 months

Exclusion Criteria:

1. Unable to converse/understand Malay or English
2. Not able to perform inhalation on his/her own self
3. Using spacer/valved holding chamber in addition to MDI
4. Not able to comply with study procedures in the opinion of investigators
5. More than two different types of inhaler which require different techniques

Primary outcomes:
measure: Inhaler Technique
timeFrame: 6 months
Secondary outcomes:
measure: Asthma Control
timeFrame: 1, 3 and 6 months
measure: Inhaler Technique
timeFrame: 1 and 3 months
measure: Inhaler Technique Error
timeFrame: 1, 3 and 6 months
Other outcomes:
Locations:
city: George Town
country: Malaysia
facility: Penang General Hospital
state: Penang
Study officials:
References:
Clinical trial NCT03735615: Sprint Interval Training in Patients With Chronic Obstructive Lung Disease
Official title: Sprint Interval Training in Patients With Chronic Obstructive Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Exercise therapy
High-Intensity Interval Training
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 10 patients with stable chronic obstructive lung disease (COPD) stage 3 and 4 according to GOLD guidelines (www.goldcopd.org), recruited from outpatient ward of the Lung Department at St Olav University Hospital. Control group of 10 age-matched but otherwise healthy subjects
Primary purpose: TREATMENT

Brief summary: Exercise therapy is a cornerstone in the management of patients with Chronic Obstructive Pulmonary disease (COPD), and supervised walking exercise three times a week over 12 weeks improves walking ability and quality of life. Despite this, very few patients exercise on a regular basis. The underuse of exercise in COPD patients can partly be explained by discomfort during exercise because it evokes dyspnea, and thereby explain lack of participation in exercise. If the goal is to offer the best medical therapy to these patients, new and effective exercise training methods must be explored and defined since exercise training is an important part of pulmonary rehabilitation.

Intention is to study a new training method called sprint interval training (SIT), which consists of high intensity bouts with very short duration. The idea behind SIT is to avoid the dyspnea associated with traditional endurance training, thus maximizing exercise power without excessive discomfort. The investigators will study training adaptations in patients with COPD and compare the results with age-matched controls.

It is expected that both COPD-patients and healthy elderly will improve exercise cycle time until exhaustion after SIT training, and also that the improvement will be larger in the healthy group due to higher absolute training intensity.


Eligibility criteria: Inclusion Criteria (patients):

* stable CPOD stage 3 and 4 according to GOLD guidelines (www.goldcopd.org)
* post bronchodilator FEV \< 50%

Exclusion Criteria:

* having participated in a pulmonary rehabilitation program during the last 3 months.

Primary outcomes:
measure: exercise cycle time to exhaustion
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs University Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Øystein Risa, phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT03320915: Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing HSCT
Official title: Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hematologic Neoplasms
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University
First posted: 2017-10-25
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Graft-versus-host-disease (GVHD) is common complication of hematopoietic stem cell transplantation. Vitamin D deficiency has been shown to be associated with increased risk of chronic GVHD in previous clinical studies. The purpose of this research is to investigate the effect of vitamin D supplementation in patients undergoing hematopoietic stem cell transplantation

Detailed description: Hematopoietic stem cell transplant candidates are randomized to vitamin D supplementation or usual care. Five milligrams (200,000 IU) of cholecalciferol is injected to intervention group before stem cell transplantation. Additional supplementation of cholecalciferol during follow-up period is determined according to the level of 25(OH)D3. The primary outcome is the incidence of chronic GVHD which is determined according to IBMTR criteria. The secondary outcome consists of the incidence of acute GVHD, incidence and severity of vitamin D deficiency, and serum concentration of 25(OH)D3. Study investigators expect that supplementation of vitamin D may improve the outcome of stem cell transplantation by reducing the incidence of chronic GVHD.

Eligibility criteria: Inclusion Criteria:

* Adults with ≥ 18 years old
* Diagnosed with hematologic maligancies
* Planned to undergo allogeneic stem cell transplantation

Exclusion Criteria:

* Hypercalcemia (ionized serum calcium level \[iCa\] \> 1.3 mmol/L, corrected serum calcium level \> 10.5 mg/dL)
* Impaired renal function (Serum creatinine ≥ 2.4 mg/dL)
* Not in complete remssion (except for myelodysplastic syndrome and myeloproliferative neoplasm)
* Consent withdrawal
* Considered inadequate under investigator's discretion

Primary outcomes:
measure: Chronic GVHD
timeFrame: Up to 1 year
Secondary outcomes:
measure: Acute GVHD
timeFrame: Up to 100 days
measure: Vitamin D deficiency
timeFrame: Up to 1 year
measure: 25(OH)D3
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Youngil Koh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03998215: Diphtheria Vaccination in Adolescents With Inflammatory Bowel Disease
Official title: Immunogenicity of Diphtheria Booster Vaccination in Adolescents With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diphtheria
Inflammatory Bowel Diseases
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Wroclaw Medical University
name: Poznan University of Medical Sciences
name: Medical University of Silesia
First posted: 2019-06-26
Enrollment: 46
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Assessment of the immunogenicity and safety of booster immunization against diphtheria in children with inflammatory bowel disease.


Eligibility criteria: Inclusion Criteria:

* diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic, histologic and radiographic criteria (Porto criteria),
* vaccination, as a part of the basic vaccination course, with five doses of diphtheria, tetanus and whole-cell pertussis vaccine, without booster dose after the age of 6,
* written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age.

Exclusion Criteria:

* serious exacerbation of inflammatory bowel disease defined as Paediatric Ulcerative Colitis Activity Index (PUCAI) \> 65 points for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) \> 40 points for patients with Crohn's disease.

Primary outcomes:
measure: Achieving seroprotective antibody concentration
timeFrame: after 4-8 weeks
Secondary outcomes:
measure: Booster response
timeFrame: after 4-8 weeks
measure: Adverse effects
timeFrame: 3 days
measure: Inflammatory bowel disease exacerbation occurrence.
timeFrame: after 4-8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Warsaw
name: Aleksandra Banaszkiewicz, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Dembinski L, Krzesiek E, Klincewicz B, Grzybowska-Chlebowczyk U, Demkow U, Banaszkiewicz A, Radzikowski A. Immunogenicity of Diphtheria Booster Vaccination in Adolescents With Inflammatory Bowel Disease. Pediatr Infect Dis J. 2020 Mar;39(3):244-246. doi: 10.1097/INF.0000000000002547.
Clinical trial NCT00704015: Smoking Cessation Intervention in Acute Orthopedic Surgery
Official title: Smoking Cessation Intervention in Acute Orthopedic Surgery - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Fracture
Keywords: Smoking cessation
Acute injury
Musculoskeletal
Postoperative complications
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2008-06-24
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to evaluate if an intervention with smoking cessation starting during the acute hospitalization period and continuing during the acute postoperative phase of 6 weeks would reduce the frequency of overall postoperative complications and wound infections in patients with acute musculoskeletal injuries requiring surgical treatment. The secondary aims were to study the short and the long term (1 year) abstinence rate, functional outcome, health related quality of life as well as costs.

Detailed description: Tobacco smoking is a major health problem. The effect of a smoking cessation intervention prior to elective orthopedic surgery has been evaluated previously. However, as far as we know there are no prospective randomized studies investigating the effect of smoking cessation on complication rate in patients with acute musculoskeletal injuries.

Eligibility criteria: Inclusion Criteria:

* daily smoker: more than 2 cigarettes per day for at least one year
* acute fracture of an extremity, in need of surgical treatment
* oral and written consent

Exclusion Criteria:

* pregnancy
* alcohol or drug abuse prohibiting compliance with the study protocol
* living outside the county of Stockholm prohibiting follow-up
* a severe mental illness including dementia
* inability to read and understand Swedish

Primary outcomes:
measure: Postoperative complications including wound related complications
timeFrame: 6-12 weeks
Secondary outcomes:
measure: Abstinence rate and functional outcome including HRQoL
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Sari Ponzer, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: