louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04936412: Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace
Official title: Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Injuries
Knee Injuries
Ankle Injuries
Keywords: Personalized
brace
shoulder
knee
ankle
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is based on human anatomical data and uses computer-aided engineering (CAE) software such as biomedical image processing software, reverse engineering software, CAD software, and finite element analysis software to create a three-dimensional bracing model. With the help of 3D printing technology, we have developed personalized brace, completed the personalized rapid design and optimization of the three series of support equipment products such as the posterior cruciate ligament brace, ankle ankle brace, and shoulder brace.

Detailed description: The traditional brace mainly includes small splints or gypsums. The manufacturing process is rough, and the flexibility is poor. In recent years, with the development of orthopedic surgery, rehabilitation concept, modern polymer materials, and biomechanics, great progress has been made in R\&D, production, and assembly of orthoses. In developed countries, orthoses is not only widely used after orthopedic surgery and the department of rehabilitation, but it has become the main auxiliary device for sports trauma surgery, immobilization, treatment, and rehabilitation training. Leading bracing company such as DJO has developed multi-brand correction devices such as Aircast®, Chattanooga, CMF, COMPEX®, DonJoy®, Empi® and ProCare®. However, these braces are not designed and manufactured based on patients. Individually designed products for anatomical structures still have many problems in clinical applications.

Eligibility criteria: Inclusion Criteria:

* patients accepting arthroscopic surgery of the shoulder, posterior cruciate ligament reconstruction surgery, Achilles tendon rupture repair surgery.

Exclusion Criteria:

* Severe peripheral ligament injury of should, knee and ankle.

Primary outcomes:
measure: appearance score
timeFrame: six weeks after injury
measure: comfort score
timeFrame: two weeks after injury
measure: Convenience score
timeFrame: six weeks after injury
measure: Satisfaction score
timeFrame: six weeks after injury
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Sports Medicine, Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Lin Lin
role: STUDY_DIRECTOR
References:
Clinical trial NCT04642846: Clinical and Laboratory Assessments of Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Caries Among Children and Parental ￼Satisfaction
Official title: Clinical and Laboratory Assessments of Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Caries Among Children and Parental ￼Satisfaction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caries Arrested
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 155
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Globally, it is estimated that 2.4 billion people suffer from caries of permanent teeth and 486 million children suffer from caries of primary teeth . The highest estimate of dental caries prevalence in Saudi Arabia was 95% with maximum DMFT of 7.34 among 3-7 years old children . Also, it was found that 78% of 6-9 years old children in Dammam had caries with an average of 3.66±3.13 DMFT.

The objectives of this study are:

1. To assess the effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries.
2. To assess the antibacterial effect of the Silver Diamine Fluoride (SDF).
3. To assess parents' and children's satisfaction and acceptance.

The aims of our study are to assess the effectiveness of SDF in arresting caries in primary dentition among children visiting Imam Abdulrahman bin Faisal University in Dammam, Saudi Arabia and to assess parental acceptance and satisfaction.

The expected outcome the results of this study will help in understanding the effectiveness SDF in arresting dental caries in this target population especially that it was recently approved for clinical use in Saudi Arabia.


Eligibility criteria: Inclusion Criteria:

* Children between four and six years of age.
* Healthy.
* Have at least two active dentin carious lesions on the primary teeth meeting the International Caries Detection and Assessment System (ICDAS) score 5 or 6.
* Should not have periapical infection, root resorption or widening in the periodontal ligament space.

Exclusion Criteria:

* Participants who have systemic or neurological diseases.
* Tooth abscess, pain on percussion, symptoms of pulpal involvement or mobility,
* Allergic to silver or any dental material to be used.
* Unable to attend follow-up visits.

Primary outcomes:
measure: Effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries.
timeFrame: 2 years
Secondary outcomes:
measure: Clinical changes of dentinal lesion: in the hardness and softness.
timeFrame: 2 years
measure: The antibacterial effect of the Silver Diamine Fluoride (SDF).
timeFrame: 2 years
measure: Parents satisfaction
timeFrame: 2 years
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Imam Abdulrahman Bin Faisal University
state: Eastern Province
Study officials:
References:
Clinical trial NCT05906446: Post-acute Multicomponent Frailty Intervention
Official title: Feasibility of a Multicomponent Frailty Intervention During Post-acute Rehabilitation in Skilled Nursing Facilities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frailty
Lead sponsor: Hebrew SeniorLife
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal is to test feasibility of a frailty intervention, including exercises and nutritional supplementation.

Detailed description: The frailty intervention includes frequent short exercise sessions incorporating balance, resistance training, and walking to accommodate diminished endurance, with synergistic protein and nutritional supplementation, delivered on top of usual care in the post-acute Skilled Nursing Facility (SNF) setting. There is no control group.

Eligibility criteria: Inclusion Criteria:

* Community-dwelling before hospitalization
* Age ≥ 65 years
* Admitted to SNF directly from inpatient hospitalization
* English speaking
* Mild Frailty or worse, as measured by a Clinical Frailty Scale

Exclusion Criteria:

* Discharged from Emergency Department
* Non-community discharge plan on admission (e.g. plan to discharge to hospice)
* Nothing per oral (NPO) dietary status
* Presence of any feeding tube
* Chronic kidney disease stage IV or worse
* Clinician refusal
* Inability or refusal to consume intervention products (e.g. allergies to protein supplement)
* Inability to consent to study procedures

Primary outcomes:
measure: Feasibility of the Intervention
timeFrame: Estimated average <1 month
Secondary outcomes:
measure: Gait Speed
timeFrame: Discharge (on average between 2-3 weeks)
measure: Grip Strength
timeFrame: Discharge (on average at 2-3 weeks)
measure: The Patient Reported Outcomes Measurement Information System (PROMIS Global Health v1.2)
timeFrame: Discharge (on average at 2-3 weeks)
measure: Modified Barthel Index
timeFrame: Discharge (on average at 2-3 weeks)
measure: Adherence to exercise
timeFrame: Entire study period (on average over 2-3 weeks)
measure: Adherence to supplementation
timeFrame: Entire study period (on average over 2-3 weeks)
Other outcomes:
measure: Length of stay
timeFrame: Entire study period (on average over 2-3 weeks)
measure: Hospital readmission
timeFrame: Entire study period (on average over 2-3 weeks)
measure: Community Discharge
timeFrame: Entire study period (on average over 2-3 weeks)
measure: Falls
timeFrame: Entire study period (on average over 2-3 weeks)
Locations:
Study officials:
affiliation: Hebrew SeniorLife
name: Sandra Shi, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00774046: High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for t-MDS/t-AML
Official title: High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for Therapy-Related Myelodysplastic Syndrome/Therapy -Related Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myelodysplastic Syndrome
Acute Myeloid Leukemia
Keywords: Therapy-related myelodysplastic syndrome/ Therapy -related Acute myeloid leukemia
Myelodysplastic syndrome
Acute myeloid leukemia
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2008-10-16
Enrollment: 32
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of a particular combination of drugs used to treat cancer.


Eligibility criteria: Inclusion Criteria:

* Patients must have received cytotoxic chemotherapy,radiation,or a drug known to affect the properties of DNA or cell growth for some condition other than acute myeloid leukemia prior to diagnosis.
* Patients must have t-MDS/t-AML
* To be eligible for allogeneic transplantation, patients must have a suitable donor who is HLA compatible.
* Patients must be over the age of 10.
* Patients must be reviewed and discussed at the Leukemia and Transplant Conferences of the Section of Hematology/Oncology.

Exclusion Criteria:

* Patients must not have any other serious medical condition(e.g.uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection)
* Psychiatric condition which would prevent compliance or possibly be worsened by treatment

Primary outcomes:
measure: Response to Induction Chemotherapy (CR or PR)
timeFrame: Day 28-40
measure: Overall Survival
timeFrame: Up to 2000 days
measure: Relapse-free Survival
timeFrame: Up to 2000 days
Secondary outcomes:
measure: Feasibility of Stem Cell Collection
timeFrame: 1-5 days from initiation of stem cell collection
measure: Numbers of Stem Cells Collected
timeFrame: 1-5 days from initiation of stem cell collection
measure: Overall Survival in Patients Undergoing Autologous Stem Cell Transplant
timeFrame: Up to 817 days
measure: Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant
timeFrame: Up to 883 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Lucy Godley, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05953246: Comparing Designs for Restaurant "Eco-Labels"
Official title: Comparing Designs for Environmental Sustainability "Eco-Labels" for Restaurant Menus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Preferences
Keywords: food labeling
sustainability
diet
food choices
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Harvard Pilgrim Health Care
First posted: 2023-07-20
Enrollment: 2207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare responses to 5 different types of labels for restaurant menus: 1) Control (non-sustainability-label: neutral labels not referencing environmental sustainability); 2) Numeric text-only sustainability label; 3) Endorsement text-only sustainability label; 4) Endorsement icon-only sustainability label; 5) Endorsement text-plus-icon sustainability label. Participants will be randomized to 1 of the 5 labeling arms above. Each participant will view 3 labels (shown in random order) from their randomly assigned labeling arm and respond to survey questions about each label (e.g., attention, perceived effectiveness).

Detailed description: This is an online randomized controlled trial. Investigators will recruit participants through a survey company to complete an online survey. In the study, participants will be randomized to 1 of 5 labeling arms: 1) Control (non-sustainability-label: neutral labels not referencing environmental sustainability); 2) Numeric text-only sustainability label; 3) Endorsement text-only sustainability label; 4) Endorsement icon-only sustainability label; 5) Endorsement text-plus-icon sustainability label. Participants will be randomized to 1 of the 5 labeling arms above. Each participant will view 3 labels (shown in random order) from their randomly assigned labeling arm and respond to survey questions about each label (e.g., attention, perceived effectiveness).

Eligibility criteria: Inclusion Criteria:

* Participants will be US adults
* Ages 18 or older
* With an over-sample of adults (50% of total sample) 18-29 years

Exclusion Criteria:

* Younger than 18
* Non-US

Primary outcomes:
measure: Perceived message effectiveness
timeFrame: The survey will take up to 20 minutes
Secondary outcomes:
measure: Attention
timeFrame: The survey will take up to 20 minutes
measure: Thinking about environmental effects
timeFrame: The survey will take up to 20 minutes
measure: Anticipated social interactions
timeFrame: The survey will take up to 20 minutes
measure: Believability
timeFrame: The survey will take up to 20 minutes
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford School of Medicine
state: California
Study officials:
affiliation: Assistant Professor
name: Anna H Grummon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04263246: Medium-Term Supplementation With Herbal Extract for Exercise Performance and Antioxidant Status
Official title: Does Medium-Term Supplementation With PhytoDyNAmic Affect Exercise Performance and Antioxidant Status in Healthy Men and Women: A Randomized Controlled Trial?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Performance
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: We evaluated here the effects of 6-week intervention with herbal supplement on exercise performance outcomes and serum biomarkers of antioxidant status. In addition, we also assessed the long-term effects (6-month) of the intervention in elderly adults.

Detailed description: Experimental protocol

* Double-blind, randomized, placebo-controlled cross-over trial
* 6-week intervention trial (with additiional follow-up arm after 6 months)
* Experimental intervention (PhytoDyNAmic) = 6 capsules per day
* Placebo (inulin) = 1 g per day b.i.d.
* Administration = 3 capsules with breakfast and 3 capsules with dinner
* Wash-out period = 2 weeks
* No changes in physical activity patterns and diet during the study

Outcomes assessed at baseline and at each follow-up:

* Exercise performance during incremental running-to-exhaustion test
* Serum biomarkers of antioxidant status
* Total antioxidant capacity (TAC)
* Superoxide dismutase (SOD)
* Telomerase activity

Early termination criteria

- Serious subjective side effects of an intervention (e.g. nausea, vomiting, bloating)

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Body mass index 19 - 25 kg/m2
* Free of major chronic diseases or acute disorders

Exclusion Criteria:

* Use of dietary supplements within 4 weeks before study commences
* Unwillingness to return for follow-up analysis

Primary outcomes:
measure: Change in time to exhaustion
timeFrame: Baseline vs. 6 weeks post-intervention
Secondary outcomes:
measure: Change in serum superoxide dismutase
timeFrame: Baseline vs. 6 weeks post-intervention
measure: Change in serum total antioxidant capacity
timeFrame: Baseline vs. 6 weeks post-intervention
measure: Change in serum telomerase activity
timeFrame: Baseline vs. 6 weeks post-intervention
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: Applied Bioenergetics Lab at Faculty of Sport and PE
state: Vojvodina
Study officials:
affiliation: Faculty of Sport and PE
name: Nebojsa Maksimovic, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01707446: Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery
Official title: Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
Keywords: Cardiac surgery
Delirium
Cerebral Oximetry
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 250
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Delirium after cardiac surgery is reported in a range of 3-47% of patients. Delirium is a serious complication that results in prolonged length of stay, increased health care costs and is associated with higher death rates. The exact cause involved in the development of delirium after cardiac surgery is unclear. The latest advancement in near-infrared spectroscopy (NIRS) Oximetry offers real-time management of patients at risk of brain injury. This approved device will monitor cerebral oxygenation during and 24hr after cardiac surgery, recording oxygenation in real time allowing the clinical team the opportunity to intervene early to prevent ischemia and possibly preventing untoward events. Adverse events followed include, but are not limited to, stroke, (transient ischemic attacks), heart attack, (myocardial infarction), clots found in lungs (pulmonary embolism), kidney failure, pneumonia, cause of death for 30-days after surgery (all cause mortality).

Hypothesis: Perioperative restoration of rSO2 desaturation to baseline values results in lower delirium rates after complex cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* age \> 60 years
* combined valve and CABG
* repeat cardiac surgery
* multiple valve replacement or repair
* surgery of ascending aorta and aortic arch
* signed informed consent.

Exclusion Criteria:

* cardiac surgery without the use of cardiopulmonary bypass
* symptomatic cerebrovascular disease,
* history of delirium, or
* schizophrenia

Primary outcomes:
measure: Number of patients who suffer from delirium postoperatively
timeFrame: Delirium we be assessed postoperatively for 7 days or Discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Heatlh Network, Toronto General Hopsital
state: Ontario
Study officials:
References:
Clinical trial NCT03042546: Calcium Sulfate Spacer in Open Tibia Fractures
Official title: Calcium Sulfate Spacer in Open Tibia Fractures With Sub-segmental Bone Loss to Decrease the Need for Secondary Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Open tíbia Fracture With Sub-segmental Bone Loss
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 1
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.


Eligibility criteria: Inclusion Criteria:

* Open tibia shaft fracture treated with an IMN

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Patients With a Nonunion
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Claude Sagi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03298646: Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy
Official title: Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nulliparity
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy. A Randomized Controlled Trial.

Detailed description: 10 ml of 2% lidocaine hydrochloride added on saline infusion media versus 100 mg diclofenac tablet 1 hour before office hysteroscopy , to test their efficacy in reducing pain .

Eligibility criteria: Inclusion Criteria:

* Age: 18-35 years.
* BMI 18.5-30 Kg.
* Nulliparous women assigned for diagnostic hysteroscopy.
* Informed written consent.

Exclusion Criteria:

* Previous cervical surgery.
* Cervical stenosis.
* Known gastritis.
* Recent or active PID.
* Cardiac patients.

Primary outcomes:
measure: Pain reduction using Visual Analogue Scale
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams maternity hospital
Study officials:
References: