louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02938689: Efficacy Comparison of the Exercises Based on the Lumbar Extension and Flexion in Chronic Low Back Pain
Official title: Efficacy Comparison of the Exercises Based on the Lumbar Extension and Flexion in Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to compare the efficacy of exercises based on the lumbar extension and flexion on the pain relief and the prevention of pain recurrence in chronic low back pain patients.

Detailed description: 68 people that meet the inclusion criteria on screening test are assigned to one of two groups by randomization. Each of the group learns one of the exercises based on the lumbar extension or flexion for four weeks. The main outcome variables are measured and compared respectively in baseline, immediately after the education, 3, 6, 12 months after the enrollment. Finally lumbar extension exercise is verified whether it is more effective than the lumbar flexion exercise on the pain relief and the prevention of pain recurrence in chronic low back pain patients.

Eligibility criteria: Inclusion Criteria:

* chronic low back pain (\>6 months, VAS score of 5 or above)
* presence of discogenic or axial pain
* duration of \>6 months

Exclusion Criteria:

* Spondylolisthesis or retrolisthesis on radiograph
* Hx of spine surgery
* Hx of any spine intervention within 3 months
* other neurological, inflammatory, or poor medical conditions
* who cannot understand or conduct the protocol of the study

Primary outcomes:
measure: Average Back pain VAS score (0~10) at 12 month
timeFrame: Baseline, Month 1, Month 3, Month 6, Month 12
Secondary outcomes:
measure: brief pain inventory (right now pain, worst pain, least pain, pain interference)
timeFrame: Baseline, Month 1, Month 3, Month 6, Month 12
measure: Oswestry Disability Questionnaire
timeFrame: Baseline, Month 1, Month 3, Month 6, Month 12
measure: EQ-5D
timeFrame: Baseline, Month 1, Month 3, Month 6, Month 12
measure: PASE
timeFrame: Baseline, Month 1, Month 3, Month 6, Month 12
measure: How often did the subject conduct exercise in the past a month? (5 levels)
timeFrame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department of Rehabilitation Medicine, Seoul National University Hospital
name: Sun Gun Chung, MD. PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01636089: Bicarbonates Versus Saline for Contrast Induced Acute Kidney Injury Prevention in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contrast Induced Acute Kidney Injury
Keywords: intensive care unit
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2012-07-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare bicarbonates versus saline for prevention of contrast induced acute kidney injury in critically ill patients.


Eligibility criteria: Inclusion Criteria:

* patient \> 18 years old
* in intensive care unit since 24h and for up to 48 hours
* with contrast medium injection

Exclusion Criteria:

* patient under renal replacement therapy
* rise in creatinine \> 26µmol/L within 48hours
* anuria within 12 hours
* cardiogenic pulmonary oedema
* pH \> 7.50 or kaliemia \< 3mmol/L
* pregnancy

Primary outcomes:
measure: contrast induced acute kidney injury
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Medical Intensive Care Unit
city: Caen
country: France
facility: Surgical Intensive Care Unit
city: Saint Lô
country: France
facility: Intensive care unit
Study officials:
References:
Clinical trial NCT04044989: Photobiomodulation and Root Resorption
Official title: Placebo-Controlled, Randomized, Double Blind Trial of Effect of Photobiomodulation Therapies On The Root Resorption Associated With Orthodontic Forces: A Pilot Study Using Micro Computed Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Pathological Resorption of External Root
Orthodontic Appliance Complication
Orthodontic Tooth Movement
Keywords: photobiomodulation
laser
LED
resorption
micro-CT
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: The aim of this study is to investigate the effect of photobiomodulation therapies on root resorption compared with the placebo group. Materials and Methods: 30 patients, who were admitted to the ............. University Faculty of Dentistry Orthodontics Department for treatment, with an indication of upper right 1st premolar tooth extraction was included. Before the individuals' orthodontic treatment, 0.022 slot MBT brackets and tubes were placed on the maxillary 1st premolar and molar. A 150g buccal tipping force was applied to the 1st premolar. Individuals were then randomly divided into 3 groups. For the first group; laser application was performed with a 810 nm GaAlAs laser device at 0,3,7,14,21 and 28 days to 8 J/cm2. Second group; an LED application according to the manufacturer's instructions with a 850 nm wavelength and 20 mW/cm2 output power for 10 minutes per day during the experiment. Third group; a placebo therapy was completed whereby a laser device that did not make active pulses was used. At the end of four weeks, the amount of root surface resorption was compared using micro-CT imaging after the extraction of the teeth.


Eligibility criteria: Inclusion Criteria:

* No history of orthodontic treatment
* No systemic disease or craniofacial anomaly
* No dental trauma and tooth with root resorption
* Having good oral hygiene
* No periodontal disease (no more than 3mm pocket)
* No restored or endodontically untreated upper right 1st premolar teeth
* Having the maxillary right 1st premolar tooth extraction indication of orthodontic treatment

Exclusion Criteria:

* Problems in patient compliance
* Inadequate oral hygiene
* Development of any medical problem making orthodontic treatment contraindicated during the study period

Primary outcomes:
measure: Root Resorption
timeFrame: through study completion, an average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep University
Study officials:
affiliation: Gaziantep University Orthodontics Department
name: Aysegul Gulec, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziantep University Orthodontics Department
name: Merve Goymen, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02507089: Tailored Approach to Sleep Health Education: A Community Engaged Approach
Official title: Tailored Approach to Sleep Health Education: A Community Engaged Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthcare Disparities
Minority Health
Sleep
Sleep Disorders
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-07-23
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to develop educational tools and platforms to promote the transfer of sleep health information to blacks to foster adoption of healthful sleep practices.


Eligibility criteria: Inclusion Criteria:

* self-reported race/ethnicity as African American, African, Caribbean American or black men and women; ages ≥18 years;
* accessible by telephone; no plans to move away from the region within the year following enrollment;
* consent to participate, which includes permission to release medical record information;
* documented OSA risk based on scores received from the Apnea Risk Evaluation System questionnaire

Exclusion Criteria:

* progressive medical illness in which disability or death is expected within one year;
* impaired cognitive or functional ability which would preclude meaningful participation in the study;
* sleep apnea diagnosis;
* stated intention to move within the same year of enrollment.

Primary outcomes:
measure: Sleep Hygiene Index
timeFrame: 6 months
measure: Apnea Knowledge/Apnea Belief Scale
timeFrame: 6 months
measure: Self-Efficacy Scale
timeFrame: 6 months
measure: Change Assessment Scale
timeFrame: 6 months
Secondary outcomes:
measure: 7-Day Physical Activity Recall
timeFrame: 6 months
measure: By-Meal Fruit/Vegetable Intake Screener
timeFrame: 6 months
measure: Rapid Estimate of Adult Literacy in Medicine
timeFrame: 6 months
measure: Medical Outcomes Study Short Form 36
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Girardin Jean-Louis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jean-Louis G, Robbins R, Williams NJ, Allegrante JP, Rapoport DM, Cohall A, Ogedegbe G. Tailored Approach to Sleep Health Education (TASHE): a randomized controlled trial of a web-based application. J Clin Sleep Med. 2020 Aug 15;16(8):1331-1341. doi: 10.5664/jcsm.8510.
citation: Williams NJ, Robbins R, Rapoport D, Allegrante JP, Cohall A, Ogedgebe G, Jean-Louis G. Tailored approach to sleep health education (TASHE): study protocol for a web-based randomized controlled trial. Trials. 2016 Dec 8;17(1):585. doi: 10.1186/s13063-016-1701-x.
Clinical trial NCT01331889: Effect of Rapid Transfusion With Fluid Management System (FMS) on Plasma Potassium in Liver Transplantation Recipients
Official title: Potassium Change in the Fluid Management System (FMS) Reservoir and Its Effect on the Plasma Potassium Concentration During Liver Transplantation Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Condition Requiring Rapid Transfusion During Liver Transplantation Surgery
Keywords: transfusion
liver transplantation
potassium
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University
First posted: 2011-04-08
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult liver transplantation recipients

Brief summary: Rapid infusion of red blood cells is known to result in hyperkalemia in the body. However, potassium concentration in the blood mixture (usually made of RBC, FFP and normal saline) in the reservoir of rapid infusion system and its effect on the plasma potassium change during rapid transfusion are unknown. This study is designed to investigate these changes while massive transfusion is performed during liver transplantation surgery.


Eligibility criteria: Inclusion Criteria:

* preoperative anemia (hemoglobin \< 10 g/dl)
* preoperative coagulopathy

Exclusion Criteria:

* children under age 18
* low risk of intraoperative bleeding

Primary outcomes:
measure: potassium concentration in the Fluid Management System (FMS) reservoir
timeFrame: after transfusion of 150 ml of blood mixture
Secondary outcomes:
measure: plasma potassium of the patient
timeFrame: before and after transfuison of 300 ml of blood mixture
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chul-Woo Jung, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03998189: Metabolic and Microbial Profiling of Lung Cancer
Official title: Pilot Study: Metabolic and Microbial Profiling of Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nonsmall Cell Lung Cancer
Nonsmall Cell Lung Cancer Stage
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-06-26
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 45 female/ 45 male participants
Primary purpose: DIAGNOSTIC

Brief summary: This pilot study will establish non-invasive sample collections, including breath, saliva, blood and urine pre-surgery and at the participant's one-month post-surgery follow-up visit. Participants with suspected non-small cell lung cancer (NSCLC) stage I-III will be recruited.

Detailed description: Primary Objective

* To evaluate the feasibility of adding non-invasive sample collections in the pre-surgical setting and at the post-surgery follow-up visit.
* To identify and assess metabolic and microbial signatures collected at pre- and post-surgery and determine which are indicative of lung cancer.

Secondary Objective

* To identify signatures which are associated with lung cancer stage.
* To identify signatures which are impacted by patient's pulmonary function status.

Eligibility criteria: Inclusion Criteria:

* Male and female patients age \>18 years, of all racial and ethnic origins, with suspected nonsmall cell lung cancer stages I, II, and III, as evident through radiographic evidence and felt acceptable to undergo surgical resection.
* Patients who have the ability to understand and the willingness to sign a written consent form.

Exclusion Criteria:

* Patients who are have taken antibiotics within two weeks.
* Patients who are on continuous supplemental oxygen.
* Patients currently undergoing active treatment for other malignancies.
* Subjects who are unable or unwilling to provide consent.

Primary outcomes:
measure: Number of Participants Needed for Feasibility
timeFrame: One month
measure: Pre-Surgery and Post-Surgery Metabolic Signatures
timeFrame: One month post surgery
measure: Pre-Surgery and Post-Surgery Microbial Signatures
timeFrame: One month post surgery
Secondary outcomes:
measure: Identification of Lung Cancer Stage Specific Signatures
timeFrame: One month post surgery
measure: Identification of Signatures Associated With Pulmonary Function
timeFrame: One month post surgery
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Andrew Bishop, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06877689: EAP of Apitegromab for Patients With Spinal Muscular Atrophy
Official title: Expanded Access Protocol of Apitegromab for Patients With Spinal Muscular Atrophy
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: SMA
Keywords: Expanded Access
Pre-Approval Access
Compassionate Use
Lead sponsor: Scholar Rock, Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-14
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this expanded access program (EAP) is to provide access to apitegromab for eligible patients with spinal muscular atrophy (SMA) prior to approval by the local regulatory agency . A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria: Inclusion Criteria:

1. ≥2 years of age.
2. Documented diagnosis of 5q SMA.

Exclusion Criteria:

1. Previous history of a hypersensitivity reaction to a monoclonal antibody or recombinant protein bearing an Fc domain (eg, a soluble receptor-Fc fusion protein), apitegromab, or excipients of apitegromab.
2. Enrolled in a clinical study for any investigational drug.
3. Pregnant or breastfeeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00434889: A Study of Why People With Early Memory Problems Fall or Almost Fall
Official title: Factors Associated With Falls and Near-Falls in Community Dwelling Older Adults With Early-Stage Dementia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dementia
Falls
Near-Falls
Keywords: dementia
falls
risk factors
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Saskatchewan Health Research Foundation
First posted: 2007-02-14
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The purpose of this study is to identify the factors that are associated with falls and near falls in community-dwelling older adults with early-stage dementia.

Detailed description: The specific objectives of this six month study are to: characterize falls and near-falls in community dwelling older adults with early-stage dementia; determine which potentially modifiable physical fall risk factors contribute to falls and near-falls in older adults with early-stage dementia; examine the relationship between dementia sub-type, medical and neuropsychological factors, balance and gait, and falls and near-falls in community dwelling older adults with early-stage dementia.

Eligibility criteria: Inclusion Criteria:

* males or females over the age of 50 with early-stage dementia as described by Global Deterioration Scale levels 2,3,4 or 5.

Exclusion Criteria:

* subjects who have a medical condition that significantly predispose them to falls (Meneire's disease or Parkinson's disease)
* subjects without a caregiver/spouse to assist with the completion of a Fall Diary
* subjects unable to stand independently or safely walk a short distance either unaided or with the support of an assistive device
* subjects unable to safely complete the balance and gait evaluations.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: School of Physical Therapy, University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Vanina Dal Bello-Haas, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02718989: Modulation of H-reflex After Application of Electric Currents in Healthy People
Official title: Modulation of H-reflex After Application of Electric Currents in Healthy People. Effects on Myotonometer Properties.A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spasticity
Keywords: H-reflex
TENS
Tone
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determinate whether the application of electric currents produce changes in the excitability of alpha moto neurone. Moreover evidence whether the effect of the electric currents can change the tone of the muscle under stimulation in healthy volunteers

Detailed description: In the last years several experimental studies have evidenced that the transcutaneous electric nerve stimulation (TENS) in peripheric application can cause a decrease of spasticity and modulation of H-reflexes.

But if the application is in the central nervous system the results are different. So the purpose of this study is quantify the modulation of the excitability of alpha moto neurone when the application of the current is in the central nervous system compared with a sham group.

Eligibility criteria: Inclusion Criteria:

* Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years.

Exclusion Criteria:

* Neuromuscular disease
* Epilepsy
* Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area
* Osteosynthesis material in the upper limb
* Diabetes
* Cancer
* Cardiovascular disease
* Pacemaker or other implanted electrical device
* Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
* Presence of tattoos or other external agent introduced into the treatment or assessment area.
* Pregnancy
* Sensitivity disturbance in lower limb

Primary outcomes:
measure: Baseline H reflex
timeFrame: baseline at 0 min.
measure: During treatment H reflex
timeFrame: During treatment at 33min.
measure: Post treatment H reflex
timeFrame: Immediately after treatment at 40 min.
Secondary outcomes:
measure: Baseline muscle tone
timeFrame: Baseline at 0 min.
measure: Muscle tone during treatment
timeFrame: During treatment at 35 min.
measure: Muscle tone post-treatment
timeFrame: Post-treatment at 42min
Other outcomes:
Locations:
city: Talavera de la reina
country: Spain
facility: Diego Serrano-Muñoz
state: Castilla-La Mancha
Study officials:
affiliation: Hospital Nacional de Parapléjicos de Toledo
name: Diego Serrano-Muñoz, MsC
role: PRINCIPAL_INVESTIGATOR
References: