louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03831568: Mechanical Cough Augmentation in Children With NMD
Official title: Prevalence and Use of Mechanical Cough Augmentation in Children With Neuromuscular Disorders in Norway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Diseases
Children, Only
Airway Clearance Impairment
Cough
Keywords: Airway management
Cough
Neuromuscular diseases
Pediatrics
Mechanical insufflation-exsufflation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital of North Norway
name: St. Olavs Hospital
name: Haukeland University Hospital
name: Helse Stavanger HF
name: Sorlandet Hospital HF
First posted: 2019-02-06
Enrollment: 72
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with neuromuscular disorder bellow 18 years that has received a machine for MI-E.

Brief summary: The study investigates the prevalence and use of mechanical insufflation - exsufflation (MI-E) in children with Neuromuscular disorders (NMD) in Norway. The NMD related prevalence of MIE use in Norway will be described and possible regional differences regarding use will be assessed.

Detailed description: Neuromuscular diseases (NMD) in children are severe, possibly life-threatening orphan conditions. Respiratory tract infections and lung complications are the main causes of increased morbidity and mortality.

The use of mechanical cough augmentation with insufflation-exsufflation (MIE) is a strategy to treat and prevent. Possible major benefits are described, but optimal settings for best efficacy and comfort in children are not established.

The main objective is to determine the prevalence and use of MIE among children with NMD in Norway. All children with NMD \< 18 years which has received a machine for MI-E will be invited to participate in the study.

The participants will be asked to complete two questionnaires. In addition will information from the data card in the MI-E machines give information about use. The information will be linked to the National register for Long term mechanical ventilation.

Eligibility criteria: Inclusion Criteria: ,

* Received a MI-E device
* Neuromuscular disease
* \< 18 years

Exclusion Criteria:

- None

Primary outcomes:
measure: Residency
timeFrame: At one point (1 day)
measure: Indication for use
timeFrame: At one point (1 day)
measure: Diagnosis
timeFrame: 01.01.2018
Secondary outcomes:
measure: Health related quality of life
timeFrame: One time at completion of questionaire
measure: Settings in use
timeFrame: One time at completion of questionaire
measure: Opinion on treatment
timeFrame: One time at completion of questionaire
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo university hospital
Study officials:
affiliation: MD
name: Vegard Hovland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05054868: Ketorolac vs Oxycodone for Great Toe Arthrodesis
Official title: Effect of Ketorolac Administration on Post-operative Narcotic Utilization and Union Rates in Great Toe Arthrodesis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Arthrodesis
Keywords: big toe arthrodesis
big toe
joint fusion
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery.

Detailed description: This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery.

Eligibility criteria: Inclusion Criteria:

* Age 18 - 75 years.
* Women of childbearing potential must have a negative serum or urine pregnancy test results within 24 hours before the first dose of ketorolac.
* Primary elective great toe MTP arthrodesis (CPT 28750). Other forefoot procedures often performed in conjunction with toe fusion will be included (CPT codes 28308, 28285, 28270).

Exclusion Criteria:

* Chronic pain syndrome, CRPS or fibromyalgia
* Revision procedures
* Use of allograft bone at the fusion site
* Tobacco use
* Diabetes
* Narcotic abuse or IV drug abuse
* Any CPT codes involving the midfoot, hindfoot, and/or ankle
* Unable to take NSAIDs secondary to medical comorbidities such as kidney disease (impaired renal function with CrCl ≤ 50 ml/min) or gastric ulcers
* Weight \< 50 kg
* Does not speak or read English
* If pregnant or planning to become pregnant or breastfeeding
* Non-independent dweller (prisoner)

Primary outcomes:
measure: Pain scores - collected at baseline (standard of care) and for the study using a study survey on days 3, 7, and 14 after surgery.
timeFrame: From baseline to 14 days after the surgery
measure: Quantitative pain management - measured using a study survey.
timeFrame: 14 days after the surgery
Secondary outcomes:
Other outcomes:
measure: Bone fusion - doctor will review the 3 month postop x-ray to see if the bones have fused at the site of surgery
timeFrame: Approximately 90 days after surgery (or until 3-month post-op visit is completed)
Locations:
city: Baltimore
country: United States
facility: Amy Loveland
state: Maryland
Study officials:
References:
Clinical trial NCT05221268: Effect of Downhill Training on Ankle Joint
Official title: Effect of Repeated Downhill Walking Bouts on Ankle Isokinetic Parameters in Children With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Taif University
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 32
Sex: MALE
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Downhill training help to improve musculoskeletal condition. Applying downhill training could help obese children by improving their muscular strength.

Detailed description: the current study aimed to find the effect of downhill training on the ankle isokinetic parameters of obese children. There were two experimental groups, the first received level walking while the second received downhill training. The ankle isokinetic parameters were assessed pre and post-intervention for 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Body mass index percentile 95% or more
* age ranged from 8-12 year
* student in one of Taif's elementary schools

Exclusion Criteria:

* suffering from any musculoskeletal problem or chronic disease.
* engaged in regular sports activities during the last 6 months

Primary outcomes:
measure: Isokinetic eccentric plantarflexion tourque
timeFrame: 6 weeks
measure: Isokimetic Concentric plantarflexion tourque
timeFrame: 6 weeks
measure: Isokinetic Eccentric dorsiflexion tourque
timeFrame: 6 weeks
measure: Isokinetic Concentric dorsiflexion tourque
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taif
country: Saudi Arabia
facility: College of applied medical sciences
state: Mecca
Study officials:
References:
Clinical trial NCT05070169: Early Surgical Fixation of Low-Velocity Hip Fractures in Patients With Direct Oral Anticoagulation
Official title: Early Surgical Fixation of Low-Velocity Hip Fractures in Patients With Direct Oral Anticoagulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Fractures
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-10-07
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 140 patients with intertrochanteric fractures with DOAC therapy undergoing surgical fixation: 70 patients will be included prospectively starting with October 2021, 70 patients with a delayed surgical fixation will be included retrospectively within the time frame January 2014- December 2018.

Brief summary: Prospective cohort study on patients with intertrochanteric fractures under direct oral anticoagulation (DOAC) therapy undergoing early surgical fixation (within 24 hours). The primary aim of this study is to evaluate the reduction of the peri operative blood loss. The secondary aim is to assess the influence of early surgical fixation of intertrochanteric fractures in patients with DOAC therapy on the 30-day and 1-year mortality. Moreover, the prospective cohort group of patients will be compared with a retrospectively analyzed age-, gender- and fracture-type-matched control group of patients who underwent delayed surgical fixation from January 2014 to December 2018 (≥ 48 hours).


Eligibility criteria: Inclusion Criteria:

Prospective cohort study:

Patients with intertrochanteric fractures that need a surgical fixation and under treatment with a DOAC medication

Control group:

Patients with intertrochanteric fractures under DOAC medication with a delayed surgical fixation from January 2014 to December 2018 (≥ 48 hours after the trauma)

Exclusion Criteria:

Prospective cohort group:

* patients with multiple fractures
* acute heart failure, kidney and lung failure and
* other concomitant diseases which prevent prompt fixation

Retrospective cohort group:

Patients with delayed surgical fixation due to other causes than DOAC medication (e.g. multimorbidity, acute myocardial infarction, acute heart, lung or kidney failure)

Primary outcomes:
measure: Evaluation of the perioperative blood loss
timeFrame: 3 days
measure: Evaluation of the perioperative need for transfusions
timeFrame: 3 days
Secondary outcomes:
measure: Coagulation parameters
timeFrame: 3 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Traumatology
Study officials:
References:
Clinical trial NCT02803268: A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vasomotor Symptoms
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2016-06-16
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms


Eligibility criteria: Inclusion Criteria:

* Subjects must meet one of the following criteria:Woman aged ≥18 years with histologically proven non-metastatic breast cancer (Stages I, II or III) and without evidence of disease / Woman aged ≥40 years who are post-menopausal / Woman aged ≥40 years who are peri-menopausal
* Subjects who have ≥7 Vasomotor Symptoms per day on average
* A body weight of ≥45 kg

Exclusion Criteria:

* Participation in more than three clinical studies involving administration of an unlicensed Investigational Medicinal Product in the previous year, or any study within 12 weeks
* Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder
* Clinically relevant abnormal medical history, physical findings or laboratory values

Primary outcomes:
measure: Safety and Tolerability as measured by vital signs
timeFrame: Up to Day 21
measure: Safety and Tolerability as measured by number of participants with adverse events
timeFrame: Up to Day 21
Secondary outcomes:
measure: Plasma concentration of MT-8554 after dosing
timeFrame: Up to Day 15
measure: Change from baseline in core body temperature
timeFrame: Up to Day 14
measure: Frequency of Vasomotor Symptoms
timeFrame: Up to Day 15
Other outcomes:
Locations:
city: City name
country: Germany
facility: Investigational center
Study officials:
References:
Clinical trial NCT00731068: Platelet Rich Plasma (PRP) as a Treatment for ACHILLES Tendon Tears
Official title: PRP as a Treatment for ACHILLES Tendon Tears - Randomized-Double-Blind-Placebo Control Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Achilles Tendon Tear
Keywords: Achilles tendon
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2008-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To review the influence of patient derived PRGF on the healing process of Achilles tendon after a surgical correction of a complete tear.

Detailed description: Autologous platelet-rich matrices may aid in post surgical patients by promoting and accelerating tissue healing because of the release of growth factors including transforming growth factor (TGF)-beta1 and platelet-derived growth factor (PDGF) from platelet alpha-granules.

Eligibility criteria: Inclusion Criteria:

* A complete tear of Achilles tendon
* Age 18-50 years old

Exclusion Criteria:

* under 18 year of age
* pregnancy
* physical or mental disabilities

Primary outcomes:
measure: improvement of symptoms / disease progress
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Meir Medical Center
name: Omer Mei Dan, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06724068: Diabetes, Insulin Resistance and Body Composition
Official title: The Correlation Between Diabetes, Insulin Resistance and Body Composition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin Resistance, Diabetes
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes adult patients aged 18 years and older who were diagnosed with type 2 diabetes mellitus. The population consists of individuals with documented medical records, including diabetes duration, glycemic control data (HbA1c levels), and body composition measurements such as muscle mass assessments. The study also includes a control group of non-diabetic individuals matched by age and sex to enable comparative analysis.

Brief summary: The goal of this retrospective study is to learn about the correlation between diabetes, insulin resistance and body compositions.

The main question\[s\] it aims to answer are:

* \[The difference of body composition between the individuals of insulin resistance and diabetes\]
* \[The effect of diabetes on body composition\]


Eligibility criteria: Inclusion Criteria:

1. Adults aged 18 years and older.
2. Diagnosed with type 2 diabetes mellitus according to recognized diagnostic criteria.
3. Availability of complete body composition data (e.g., DXA measurements).
4. Documented HbA1c levels and other glycemic control data.
5. Continuous medical records available during the study period

Exclusion Criteria:

1. Presence of other severe metabolic diseases, such as liver failure or kidney failure.
2. Use of medications affecting muscle mass (e.g., glucocorticoids) for more than three months.
3. History of malignancy or ongoing treatment for cancer.
4. Missing critical research data (e.g., diabetes duration or HbA1c levels).
5. History of surgeries causing significant body composition changes (e.g., bariatric surgery).

Primary outcomes:
measure: Prevalence of Sarcopenia in Diabetic Patients
timeFrame: Retrospective analysis of data collected between2019 and 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Shandong First Medical University
name: Song Xuan, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02437968: Disseminating Evidence-based Practice to the Schools: CBT for Child Anxiety
Official title: Disseminating Evidence-based Practice to the Schools: CBT for Child Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study aims to test the implementation and sustainability of (a) a Computer-Assisted Cognitive-Behavioral Treatment (CACBT) for youth anxiety and (b) the BASC-2 TRS to identify anxious youth in the school setting using a cohort-sequential design (i.e., three years at 20 schools over the span of five years).

'Camp Cope-A-Lot (Computer-assisted CBT program)'

Detailed description: The present study will test the implementation and sustainability of (a) a Computer-Assisted Cognitive-Behavioral Treatment (CACBT) for youth anxiety and (b) the BASC-2 TRS to identify anxious youth in the school setting using a cohort-sequential design (i.e., three years at 20 schools over the span of five years). There are 3 phases: Phase I (baseline): Gather data on prevalence and services provided via screening measures and treatment trackers: Phase II (implementation): Train school staff in the identification of anxious youth (i.e. BASC-2 TRS) and the provision of the intervention (i.e., CACBT), modifying assessment and treatment procedures so as to best fit each individual school. Identify barriers and facilitators of implementation by gathering the qualitative experience of school staff: Phase II (sustainability): Discontinue training and supervision. Assess sustainability of the assessment and intervention. Identify barriers and facilitators of implementation by gathering the qualitative experience of school staff.

'Camp Cope-A-Lot (Computer-assisted CBT program)"

Eligibility criteria: Inclusion Criteria:

* All mental health workers (e.g., guidance, social work, school psychologists) in the schools will be eligible to be trained.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Change in the number of children identified as anxious.
timeFrame: Baseline, end of year 1, end of year 2, end of year 3
measure: Change in the number of children treated for anxiety.
timeFrame: Baseline, end of year 1, end of year 2, end of year 3
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00581568: Cutaneous Effects of Cryogen Spray Cooling
Official title: Cutaneous Effects of Cryogen Spray Cooling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: Skin cooling during laser treatment
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2007-12-27
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cryogen Spray Cooling spurt is applied to the skin surface immediately before laser exposure. As liquid cryogen rapidly evaporates, the superficial skin temperature is reduced as a result of supplying the latent heat of vaporization. Tetrafluoroethane, an environmentally compatible, non-toxic, non-flammable freon substitute, has been demonstrated in multiple studies to be a safe and effective cooling agent and is the only cryogenic compound currently approved for dermatologic use by the Food and Drug Administration.

Detailed description: The researcher can use laser treatment in combination with Cryogen Spray Cooling. The specific aim of this study is to characterize the clinical cutaneous effects of varying spurt durations and spurt delivery patterns that spurt durations of 100 ms or less will result in a very low incidence (less than 2%) of clinical skin effects (redness, blistering, local skin allergic reaction or skin discoloration) in any skin type.

Researchers can use Cryogen Spray Cooling to protect the skin epidermis during laser therapy to decrease treatment pain, allow safe treatment of darker skin types, and safe use of high laser fluences. Cryogen Spray Cooling with Tetrafluoroethane has been incorporated into many Food and Drug Administration approved, commercially available laser devices currently used for treatment of vascular lesions, hair removal and non-ablative skin rejuvenation.

Eligibility criteria: Inclusion Criteria:

* Adult 18 years and older

Exclusion Criteria:

* Age \<18
* History of cold sensitivity
* Inflammatory rash on the test site

Primary outcomes:
measure: Skin cooling during laser treatment
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical and Surgical clinic
state: California
Study officials:
affiliation: Beckman Laser Institute
name: John S Nelson, M.D.,Ph.D
role: STUDY_CHAIR
affiliation: Beckman Laser Institute
name: Wangcun Jia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01313468: Interval Training and Resting Metabolism
Official title: Effect of Aerobic Interval Training on NEAT in Sedentary Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: NEAT
maximal oxygen uptake
stroke volume
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2011-03-11
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It has been reported that obese individuals are seated 2 ½ hour more than lean individuals and that non exercise thermo genesis (NEAT) may vary with as much as 2000 Kcal/day between equal size people due to different occupational and leisure time activities. The primary aim of the study is to investigate if 10 weeks of exercise training increase NEAT in sedentary men.

Subject will be randomized to three different training intervention, with 3 exercise session each week for 10 weeks. NEAT will be measured using an activity sensor and recorded over a 7 day period both before and after training.


Eligibility criteria: Inclusion Criteria:

* Male gender
* Age 18-50
* BMI 25-30 kg x m2
* No significant comorbidities
* Abel to exercise
* Not partaking in organized physical activity

Exclusion Criteria:

* Inability to exercise due to musculoskeletal conditions
* Known ischemic cardiovascular disease
* High daily physical and occupational activity levels

Primary outcomes:
measure: nonexercise activity thermogenesis
timeFrame: Baseline and 10 weeks
Secondary outcomes:
measure: Cardiopulmonary maximal oxygen uptake
timeFrame: Baseline and 10 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: NTNU
Study officials:
affiliation: National Taiwan Normal University
name: Trine Karlsen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zisko N, Stensvold D, Hordnes-Slagsvold K, Rognmo O, Nauman J, Wisloff U, Karlsen T. Effect of Change in VO2max on Daily Total Energy Expenditure in a Cohort of Norwegian Men: A Randomized Pilot Study. Open Cardiovasc Med J. 2015 Apr 30;9:50-7. doi: 10.2174/1874192401509010050. eCollection 2015.