louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05862246: Gastrocnemius Tightness and Foot Pain in Children
Official title: Is There an Association Between Gastrocnemius Tightness and Foot- and Legpain in Children?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Child Development
Gastrocnemius Equinus
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan Normal University
First posted: 2023-05-17
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children referred to pediatric orthopaedic outpatients clinic from a family doctor

Brief summary: Foot and leg pain among otherwise healthy children is a common reason for referral to our pediatric orthopaedics outpatient clinic. The pain is often intermittent and transient, but for some the pain is more dominating and has an impact on the child and families. Children grown and have normal anatomical variations such as in-toeing, out-toeing, hypermobility, flatfeet, knock knees etc. Assessing such normal variants is a major part of pediatric orthopaedic practice, and a common finding is a positive Silvferskiöld test, indicating gastrocnemius tightness. This is when dorsiflexion of the ankle is limited with extended knee, compared to flexed knee. We do not know if this is a more frequent finding among children with foot and leg pain. There is however evidence that adults with painful foot conditions often have gastrocnemius tightness.

This project will investigate for gastrocnemius tightness in otherwise healthy children referred to our pediatric orthopaedic outpatient clinic with foot and leg pain, and compare results with a similar control group of children without pain. The aim is to investigate if there is an association, and how pain and tightness develops over time. The knowledge from this project will enable us to develop new treatment strategies to this patient group, where current evidence based recommendations are few.


Eligibility criteria: Inclusion Criteria:

* Otherwise healthy children referred to pediatric orthopaedic outpatient clinic with foot and/or leg pain with a normal leg function

Exclusion Criteria:

* Patients with foot conditions, general medical conditions affecting the foot or clinical findings indicating a need for further investigation for a diagnosis. Such as:

Foot deformities (cavo-varus foot, clubfoot) Tarsal coalitions Neuro-orthopedic conditions (CP, MMC) Fracture sequelae Infections and tumour

Primary outcomes:
measure: Silvferskiölds test
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs hospital
Study officials:
affiliation: St. Olavs Hospital
name: Håkon Langvatn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02388646: Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Arthritis
Lead sponsor: Orthopaedic Research Foundation
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to explore the effectiveness of a commercially available, over-the-counter knee brace in the conservative treatment of knee osteoarthritis. Participants will either be fitted with a brace and told to wear it every day during normal activities, fitted with the brace and given instructions on a set of quadriceps strengthening exercises to complete twice daily, every day, or be given the exercise instructions, but not fitted with a brace. Functional and subjective outcomes will be collected preoperatively and at 6 and 12 weeks from baseline, with the goal of informing the effectiveness of bracing alone versus a home exercise program, and whether the combination of those provides the most therapeutic benefit to participants.


Eligibility criteria: Inclusion Criteria:

* Subject is being treated for knee joint pain
* Subject is willing and able to comply with the evaluation schedule

Exclusion Criteria:

* Subject is undergoing surgery during the follow-up window that would limit their ability to comply with the evaluation schedule and/or significantly affect the outcomes measures
* Subject has current alcohol, opioid, or other drug dependence
* Subject is taking prescribed medication for pain other than in the knee joint (e.g. back pain)

Primary outcomes:
measure: Assessment of Pain Using the Visual Analog Scale
timeFrame: Baseline and 3-month Visit
Secondary outcomes:
measure: Change in Quadriceps Force
timeFrame: Baseline and 3-month Visit
Other outcomes:
Locations:
city: Greenwood
country: United States
facility: OrthoIndy
state: Indiana
Study officials:
affiliation: Study Principal Investigator
name: Frank R Kolisek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03857646: The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns
Official title: The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prematurity
Keywords: parenteral nutrition
lipid emulsion
free bilirubin
free fatty acids
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 66
Sex: ALL
Minimum age (years): 0
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this research study is to compare the levels of free fatty acids and free bilirubin between two intravenous lipid emulsion products in premature newborns.


Eligibility criteria: Inclusion Criteria:

* premature newborns (\<32 weeks gestation, stratified \<28 weeks versus \>28 weeks) \<8 days of age
* receiving lipid infusions \<1 g/kg/day at enrollment
* anticipated to be treated with 3 g/kg/day for a minimum of 48 hours.

Exclusion Criteria:

* patients with direct hyperbilirubinemia \>1.5 mg/dl
* with suspected sepsis meeting Systemic inflammatory response syndrome (SIRS) criteria
* undergoing treatment with a continuous infusion of morphine
* with a continuous infusion of pressors (dopamine, dobutamine, epinephrine, etc.)
* positive blood cultures

Primary outcomes:
measure: Free Bilirubin (UB) Serum Levels
timeFrame: first day of infusion at 3 g/kg/day
measure: Free Bilirubin (UB) Serum Levels
timeFrame: second day of infusion at 3 g/kg/day
Secondary outcomes:
measure: Unbound Free Fatty Acid (FFAu) Serum Level
timeFrame: first day of infusion at 3 g/kg/day
measure: Unbound Free Fatty Acid (FFAu) Serum Level
timeFrame: second day of infusion at 3 g/kg/day
measure: Free Fatty Acid (Total) Serum Level
timeFrame: second day of infusion at 3 g/kg/day
measure: Number of Participants With Direct Bilirubin >1.8 Milligrams Per Deciliter (mg/dL)
timeFrame: first and/or second days of infusion at 3 g/kg/day
measure: Number of Participants With Peak Serum Triglyceride Level >350 mg/dl
timeFrame: first or second days of infusion at 3 g/kg/day
measure: Mean Serum Triglyceride Level
timeFrame: first day of infusion at 3 g/kg/day
measure: Mean Serum Triglyceride Level
timeFrame: second day of infusion at 3 g/kg/day
Other outcomes:
Locations:
city: Houston
country: United States
facility: University Texas Houston HSC
state: Texas
Study officials:
affiliation: UT Houston HSC
name: Cody Arnold, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01375946: Pharmacokinetic Study Of AGILE AG200-15 After Weekly Application Under Various Conditions in Healthy Female Volunteers
Official title: A Pharmacokinetic And Wearability Study of the Agile TCDS AG200-15 Following Weekly Application Under Various External Conditions in Healthy Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetic Profile (PK) and Safety
PK analysis of EE and LNG
Lead sponsor: Agile Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A study to evaluate pharmacokinetic profile, wearability and safety of AG200-15, transdermal delivery of levonorgestrel (LNG) and ethinyl estradiol (EE), under normal conditions and external conditions of heat, humidity, cold water and exercise.

Detailed description: Normal conditions - average daily living activities, Dry Sauna - 10 minutes at 168.8 - 179.6 degrees Fahrenheit, Whirlpool - 10 minutes at 102.2 - 105.8 degrees Fahrenheit, Treadmill - 20 - 30 minutes at 60-80% max heart rate, Cold Water - 5 - 15 minutes at 71.6 degrees Fahrenheit.

There will be three treatment periods. Subjects will be randomly assigned to one of the five conditions for the treatment period. The subject will be exposed daily to the condition assigned while wearing the patch. The study patch will be worn for a 7 day treatment period, followed by a 7 day washout period. The total duration of the study is 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Healthy women, ages 18-45
* Body mass index (BMI)of ≥18 and less than or equal to 32, and weight ≥ 110 lbs.
* Willing to use a non-hormonal method of contraception if of childbearing potential, or have already undergone previous bilateral tubal ligation or hysterectomy
* Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior to patch application until completion of each treatment period
* Willing to give informed consent to participate in study

Exclusion Criteria:

* Known or suspected pregnancy
* Breast-feeding or within 1 month after stopping breast-feeding
* Smokers
* Any disease that may worsen with hormonal treatment
* Hypersensitivity to transdermal preparations or sensitivity to surgical/medical tape

Primary outcomes:
measure: Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG)
timeFrame: 6 weeks
measure: AUC(0-168) Profile of Ethinyl Estradiol (EE)
timeFrame: 6 weeks
measure: Steady-state Concentration (Css) (48-168) Profile of LNG
timeFrame: 6 weeks
measure: Css (48-168) Profile of EE
timeFrame: 6 weeks
Secondary outcomes:
measure: Patch Adhesion
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, Inc.
state: Florida
Study officials:
affiliation: Agile Therapeutics
name: Elizabeth Garner, MD, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT04710446: Clinical Characteristics, Treatments, and Outcomes of MI Patients Presenting With Normal ECG
Official title: Clinical Characteristics, Treatments, and Outcomes of MI Patients Presenting With Normal ECG
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-ST Elevated Myocardial Infarction
Electrocardiography
Keywords: Clinical Characteristics
Treatments
Outcomes
normal ECG
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NSTEMI Patients

Brief summary: the investigators aimed to analyzed data for hospitalized MI patients with normal ECG.

Detailed description: The electrocardiogram (ECG) at presentation is a useful tool for risk prediction. Patients with ACS（Acute Coronary Syndromes） and ST-segment depression on ECG have a worse prognosis than patients with a normal ECG. ST-segment depression is not only a qualitative marker, but also a quantitative marker of risk, because the number of leads with ST-segment depression and the magnitude of ST-segment depression (either within a single lead or as sum over all leads) are indicative of the extent of ischaemia and correlate with prognosis.The presence of ST-segment depression \>1 mm in \>_6 leads in conjunction with ST-segment elevation in aVR and/or V1, particularly if the patient presents with haemodynamic compromise, suggests multivessel ischaemia or severe left main coronary artery stenosis. However,in patients presenting without persistent ST-segment elevation,the clinical features, treatments, and outcomes in patients with normal ECG is still unclear.

Eligibility criteria: Inclusion Criteria:all patients hospitalized with a principal diagnosis of non-ST-segment elevation infarction (NSTEMI) according to the current ACC/AHA guidelines.

exclusion criteria: end-stage organic disease, thrombotic hematological disorders, and poor echogenicity

Primary outcomes:
measure: MACE within 2 weeks
timeFrame: within 2 weeks
measure: MACE within 1 year
timeFrame: within 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan province people's hospital
state: Henan
Study officials:
affiliation: Henan Provincial People's Hospital
name: yansheng Huang
role: STUDY_DIRECTOR
References:
Clinical trial NCT01498146: Finding Atrial Fibrillation in Patients With Unexplained Stroke Using Longterm Cardiac Monitoring
Official title: Stroke Prior to Diagnosis of Atrial Fibrillation Using Longterm Observation With Implantable Cardiac Monitoring Apparatus Reveal(SURPRISE) -the SURPRISE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: cryptogenic stroke
atrial fibrillation
longterm monitoring
loop recorder
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the patients are included from the investigators stroke unit and day clinic

Brief summary: The SURPRISE study investigates atrial fibrillation(AFIB) in patients with a previous unexplained stroke. It uses long term monitoring of the heart of up to three years, searching for paroxysmal atrial fibrillation(PAF) otherwise undetected in this population.

Detailed description: The SURPRISE study investigates the patients with cryptogenic stroke or transient ischemic attack (TIA), monitoring them with a cardiac loop recorder for up to three years.

it aims at estimating the amount of paroxysmal atrial fibrillation within our population of cryptogenic stroke patients.

Standard workup for a stroke patient does offer cardiac evaluation, but monitoring is limited to the time admitted, often just a few days.

Eligibility criteria: Inclusion Criteria:

* Computerized Tomography (CT) or Magnetic resonance imaging (MRI) verified cryptogenic stroke or TIA;
* \> 18 years of age,
* the ability to provide a written consent

Exclusion Criteria:

* prior or known AFIB
* AF found during work up including 24 hour telemetric monitoring.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital, University Hospital of Copenhagen, dept of Neurology
Study officials:
affiliation: University of Copenhagen
name: Hanne Christensen, MD, PhD, DMSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biering-Sorensen T, Christensen LM, Krieger DW, Mogelvang R, Jensen JS, Hojberg S, Host N, Karlsen FM, Christensen H. LA emptying fraction improves diagnosis of paroxysmal AF after cryptogenic ischemic stroke: results from the SURPRISE study. JACC Cardiovasc Imaging. 2014 Sep;7(9):962-3. doi: 10.1016/j.jcmg.2014.02.003. Epub 2014 Apr 9. No abstract available.
Clinical trial NCT04884646: Effects of Virtual Reality Versus Motor Imagery Versus Routine Physical Therapy in Patients With Parkinson's Disease.
Official title: Effects of Virtual Reality Versus Motor Imagery Versus Routine Physical Therapy in Patients With Parkinson's Disease: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson
Virtual Reality
Motor Imagery
Routine Physical Therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of VR and MI techniques in addition to routine physical therapy on motor skills, balance and ADL in patients with Parkinson's disease.

Detailed description: Parkinson's disease is one of the most common, insidious neurological disorders with major motor symptoms, including bradykinesia, resting tremors, rigidity, and postural disorders. Virtual reality and motor imagery are among the more innovative techniques for rehabilitation of patients with Parkinson's disease that promote motor learning through both explicit and implicit processes.This study is unique in that it examines the effects of VR versus MI on motor skills, balance, and daily living activities in individuals with Parkinson's disease

Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's disease
* Modified Hoehn and Yahr Scale(H\&Y stages I to III)
* Between the ages of 50 and 80 years of both genders
* Independent in transfers
* A score equal to or greater than 24 on the Mini-Mental State Examination (MMSE), and
* Previous lack of participation in balance or motor training.

Exclusion Criteria:

* History of any neurological conditions such as stroke, multiple sclerosis, epilepsy other than Parkinson's disease,
* History of orthopedic issues such as pain, fracture, or lower limb pathology,
* History of visual abnormalities,
* History of any chronic or cardiovascular pathology that can interfere with the transfer procedure or can affect the training sessions,
* The participants having severe dyskinesia or "on-off" phases,
* Previous history of surgery for PD,
* History of virtual games used for treatment in the past three months, and
* Virtual game phobia.

Primary outcomes:
measure: Unified Parkinson's disease Rating Scale Part II
timeFrame: 3 months
measure: Unified Parkinson's disease Rating Scale Part III
timeFrame: 3 months
measure: Berg Balance Scale (BBS)
timeFrame: 3 months
Secondary outcomes:
measure: Activities-specific Balance Confidence Scale (ABC):
timeFrame: 3 months
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT03797846: Comparison of Fixation Suture Type in Glaucoma Surgery
Official title: Comparison of Effectiveness and Safety of Eye Fixation Types During Combined Glaucoma Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma Eye
Glaucoma
Keywords: ptosis
combined procedures
glaucoma
post-surgery complication
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective randomized trial with a 6 month follow-up period
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the effectiveness and safety of two types of intraoperative eye fixation: for the superior rectus muscle and traction suture in the peripheral cornea.

This is a prospective randomized trial with a 6 month follow-up period, which covers patients with open angle glaucoma qualified for combined glaucoma procedure (phacotrabeculectomy). In I group, the intraoperatively fixation in the peripheral part of the cornea is used, in II group the bridle suture for the superior rectus muscle is performed.

Detailed description: The way of the intraoperatively fixation may have some impact for postoperative results of the level of intraocular pressure (IOP), visual acuity (BCVA) and the incidence of upper eyelid ptosis was determined as a post-operative MRD (margin reflex distance) ≥2mm.

Eligibility criteria: Inclusion Criteria:

* co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale (Lens Opacities Classification System III)
* primary open-angle glaucoma and secondary pseudoexfoliative glaucoma, in which a satisfactory IOP level was not achieved despite maximum tolerable hypotensive treatment, both topical and systemic
* documented progression of loss of field of vision
* significant daily IOP fluctuations
* no cooperation from patient with regard to application of anti-glaucoma treatment, allergy to topical medications

Exclusion Criteria:

* no consent to participation in the study
* prior surgical and laser procedures in the area of the eye
* narrow- or closed-angle glaucoma
* post-inflammatory or post-traumatic secondary glaucoma
* chronic illness of the cornea or optic nerve
* advanced macular degeneration
* active inflammatory process
* pregnancy
* systemic steroid therapy

Primary outcomes:
measure: IOP
timeFrame: baseline and twelve months after surgery
Secondary outcomes:
measure: BCVA
timeFrame: baseline and twelve months after surgery
measure: MRD
timeFrame: baseline and twelve months after surgery
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Medical University
Study officials:
affiliation: Medical University of Bialystok
name: Zofia Mariak, Prof
role: STUDY_CHAIR
References:
citation: Li B, Zhang M, Liu W, Wang J. Comparison of Superior Rectus and Peripheral Lamellar Corneal Traction Suture during Trabeculectomy. Curr Eye Res. 2016;41(2):215-21. doi: 10.3109/02713683.2015.1009635. Epub 2015 Sep 15.