louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01405274: Impact of Physiotherapy Intervention for Children With Ankle Sprains
Official title: Exploring the Impact of a Physiotherapy Intervention on the Risk of Re-injury and Recovery in Children and Adolescents With Acute Ankle Sprains: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Therapy
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2011-07-29
Enrollment: 170
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate whether adding a physiotherapy intervention to standard Emergency Department care will lead to improved recovery following an ankle sprain in the pediatric and adolescent population as well as to a decrease recurrence of injuries during the year following the initial ankle sprain. Children will be allocated to standard care or to the added intervention group. The study hypothesis is that recovery will be better while recurrence of injury will be less in those receiving the added physiotherapy intervention.


Eligibility criteria: Inclusion Criteria:

* age 7 to 18
* confirmed diagnosis of ankle sprain
* Ability to Speak French or English

Exclusion Criteria:

* immobilization at the time of ED discharge

Primary outcomes:
measure: recurrence of ankle sprain
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: MUHC-Montreal Children's Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT04005274: Rate of Force Development vs Isometric Strength of Quadriceps
Official title: Is Rate of Force Development (RFD) Superior to Isometric Strength (QS) of the Quadriceps as a Predictor of Functional Performance After Anterior Cruciate Ligament Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post ACL Reconstruction
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 19
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kaiser Permanente patients attending out-patient physical therapy post ACL reconstruction.

Brief summary: Peak isometric strength of quadriceps (QI) has been used to help determine an athletes ability to safely return back to sport following an anterior cruciate ligament (ACL) reconstruction surgery. However, rate of force development (RFD) of the quadriceps, or how fast the quadriceps are able to reach their peak strength, is rarely used as part of this decision despite the role it plays in protecting the knee. This retrospective data only study will look back at the limb symmetry index (LSI) of patients post ACL reconstruction for the Noyes Hop Test, QI, and RFD. The hypothesis is that RFD does not recover at the same rate as Noyes Hop Test and QI.


Eligibility criteria: Inclusion Criteria:

* No pain (at baseline) or edema/effusion
* Full knee range of motion
* Post Op: 20 weeks - 2 years
* Non antalgic gait

Exclusion Criteria:

* History of low back pain or other lower extremity injury within 1 year, skeletal immature, pregnant, concomitant ligament injury

Primary outcomes:
measure: Limb Symmetry (Noyes hop testing, Isokinetic testing-rate of force development, Isokinetic testing-quadriceps index)
timeFrame: March - June 2019
Secondary outcomes:
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: Kaiser Permanente West Los Angeles Medical Center
state: California
Study officials:
References:
Clinical trial NCT06194474: Study on Biomarkers of Postoperative Delirium in Elderly Cardiac Surgery Patients
Official title: Study on Biomarkers of Postoperative Delirium in Elderly Cardiac Surgery Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Delirium
Lead sponsor: Jining First People's Hospital
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To evaluate the relationship between abnormal protein or metabolite expression levels in peripheral blood and postoperative delirium in elderly patients undergoing cardiac surgery.

Brief summary: To evaluate the relationship between abnormal protein or metabolite expression levels in peripheral blood and postoperative delirium in elderly patients undergoing cardiac surgery.


Eligibility criteria: Inclusion Criteria:

1. patients between 55 and 80 years old,
2. American Society of Anesthesiologists (ASA) physical status of II-III and New York Heart Association grade of II-III.
3. The planned cardiac surgery.
4. Hospitalization duration not less than 5 days.
5. The anesthesia time will be no less than 2 hours.All patients had a normal ability to hear, read and cooperate with neuropsychological tests.

Exclusion Criteria:

1. The pre-operative Montreal Cognitive Assessment (MoCA) score was less than 25,
2. Patients with dementia, history of neurological or psychiatric disease, hospital with anxiety depression scale (HADS) over eight points,
3. Currently use sedatives or antidepressants, Patients with substance dependence on drugs or alcohol.
4. Patients with liver and kidney dysfunction, patients with a history of cardiac surgery.
5. Admitted to the ICU for more than two days within the month preceding the current surgery,
6. Unable to cooperate with researcher's investigations.

Primary outcomes:
measure: Proteomics
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jining
country: China
facility: Fuhui Yan
state: Shandong
Study officials:
References:
Clinical trial NCT03447574: Fluid Volume During Fluid Shifts
Official title: Non-invasive Fluid Volume During Fluid Shifts Technique Validation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Development of Non-invasive Protocol
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to answer the question of if several non-invasive methods are comparable to the invasive clinical gold standard of radiolabeled albumin in terms of detecting changes in fluid volume.

It is broken into two studies: Aim 1 Study A is designed as a pilot phase to develop the non-techniques, and Aim 2 Study B is comparing these techniques to the gold standard.


Eligibility criteria: 1. Non-smokers
2. Have a BMI\<30
3. Have no chronic disease
4. Be free of medications with known cardiovascular effects

Primary outcomes:
measure: Validation against Gold Standard
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Bruce D Johnson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01418274: A Study to Evaluate the Effect of Danoprevir/Ritonavir on the Pharmacokinetics of Escitalopram and S-Demethylcitalopram in Healthy Volunteers
Official title: A Study to Investigate the Effect of Multiple Doses of Danoprevir/Ritonavir (DNV/RTV) on the Pharmacokinetics (PK) of Escitalopram (ESC) and S-Demethylcitalopram (S-DCT) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-08-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single-arm, open-label, non-randomized study will evaluate the effect of danoprevir/ritonavir on the pharmacokinetics of escitalopram and S-demethylcitalopram in healthy volunteers. Healthy volunteers will receive oral doses of danoprevir/ritonavir and escitalopram. The anticipated time of the study is 6 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult healthy volunteers, aged 18 to 55 years, inclusive
* Body mass index (BMI) 18.0 to 32.0 kg, inclusive
* Absence of evidence of any active or chronic disease
* Non-smokers

Exclusion Criteria:

* Presence of any active or chronic disease
* Abnormal blood pressure
* Abnormal resting heart rate
* Abnormal ECG values
* History of any clinically significant cardiovascular or cerebrovascular disease

Primary outcomes:
measure: Change in area under the plasma concentration time curve (AUC) of escitalopram
timeFrame: Approximately 4 weeks
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: Approximately 6 weeks
measure: Effect on pharmacokinetics of major escitalopram metabolite: change in AUC of S-demethylcitalopram
timeFrame: Approximately 4 weeks
measure: Effect of co-administration of escitalopram on danoprevir/ritonavir steady-state pharmacokinetics: change in AUC of danoprevir/ritonavir
timeFrame: Approximately 4 weeks
Other outcomes:
Locations:
city: Lenexa
country: United States
state: Kansas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02982174: Evaluation of the Signal to Noise Ratio at Various Retinal Layers
Official title: Evaluation of the Signal to Noise Ratio at Various Retinal Layers in Spectral Domain Optical Coherence Tomography (SD OCT) Compared to Swept Source Optical Coherence Tomography (SS OCT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Eyes
Keywords: no known ocular pathology
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2016-12-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 subjects willing to participate in this study.

Brief summary: Compare the signal to noise ratio of each device at various retinal layers.

Detailed description: Compare the signal to noise ratio of each device (SD OCT and SS OCT) at various retinal layers from the same group of subjects

Eligibility criteria: Inclusion Criteria:

1. Male or female patients \> 18 years old who have full legal capacity to volunteer on the date the informed consent is signed.
2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date.
3. Subjects who agree to participate in the study.

Exclusion Criteria:

1. History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device.
2. Fixation problems which may prevent obtaining good quality images in either eye.

Primary outcomes:
measure: Signal to noise ratio between SD OCT and SS OCT
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Topcon Medical Systems Inc.
state: New Jersey
Study officials:
affiliation: Topcon Medical Systems, Inc.
name: Wei-Chieh Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00683774: Insulin and Polycystic Ovary Syndrome
Official title: Determination if Direct Inhibition of Insulin Release With Diazoxide Decreases Renal Clearance of D-Chiroinositol (DCI) and Increases Circulating DCI in Obese Women With Polycystic Ovary Syndrome (PCOS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PCOS
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2008-05-23
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Increased insulin levels leads to increased secretion of D-chiro inositol(DCI) from the kidneys in women with PCOS, but not in normal women. This leads to a reduction in circulating DCI and insulin stimulated release of DCI-IPG.To determine if decreasing circulating insulin directly by inhibition of islet insulin release with diazoxide in obese women with PCOS 1)decreases the renal clearance of DCI and 2) increases the circulating concentration of DCI.


Eligibility criteria: Inclusion Criteria:

* Obese women with PCOS and normal women aged 18-40,
* PCOS less than 8 periods/year, elevated total or free testosterone, normal thyroid function tests and serum prolactin, exclusion of adrenal hyperplasia
* Normal regular monthly periods, no clinical evidence of androgen excess,
* All Acceptable health on interview, medical history, physical exams and lab tests, signed, witnessed informed consent and ability to comply to study requirements

Exclusion Criteria:

* DM, clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic or malignant disease.

Primary outcomes:
measure: Renal Clearance of D-chiroinositol (DCI) at 12 Days
timeFrame: 12 days
measure: Level of Circulating D-chiro Inositol (DCI)
timeFrame: 12 days
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: General Clinical Research Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: John E. Nestler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00191074: Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature
Official title: Phase III Study of Humatrope in Non-Growth Hormone Deficient Children With Short Stature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 11
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: After approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. In addition, patients who had discontinued early from the core, blinded phase of the study were contacted.

All of these patients were offered the opportunity to enter the unblinded extension phase (if they met eligibility criteria) and continue somatropin treatment (regardless of initial treatment randomization) until they reached final height.


Eligibility criteria: Inclusion Criteria:

Participation in core, blinded phase and ability to be contacted by investigators.

For patients who were on treatment at the time of amendment (g), growth velocity greater than or equal to 1.5 cm/year measured over the prior 12-month period. For patients who had chosen to discontinue treatment in the core, blinded phase, bone age less than or equal to 16 years for boys and less than or equal to 14 years for girls.

Exclusion Criteria:

Diabetes mellitus.

History, evidence or signs of active malignancy within 5 years prior to the start of the extension phase.

Any condition or medication that, in the opinion of the investigators, might significantly increase the risk or decrease the efficacy of growth hormone therapy.

Primary outcomes:
measure: Every 6 months: physical exam, pubertal staging, height, weight, and adverse event collection.
measure: Every year: arm span measurements, head circumference measurements, x-ray for bone age, and
measure: laboratory blood draws.
Secondary outcomes:
measure: Not applicable for Amendment (g).
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Maryland
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05108974: Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study
Official title: Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Fetal Alcohol Spectrum Disorders
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The study is comparing two administration durations (3 months vs. 6 months) of choline. The primary outcome measures are cognitive measures.

Detailed description: This project is the fourth in a series of randomized, double-blind controlled trials of choline bitartrate in children ages 2-5 (under 6) years with prenatal alcohol exposure. Pre-clinical data suggests that choline may attenuate the cognitive deficits caused by prenatal alcohol exposure (especially memory deficits). This study will evaluate the effects of daily choline supplementation in two dosing regimens (3 months choline vs. 6 months choline). Outcome measures include an elicited imitation memory paradigm, IQ measures, and measures of memory and executive functioning, and behavior.

Eligibility criteria: Inclusion Criteria:

* Ages 2.5 years to 5 years old (\<6 years of age) at enrollment
* Prenatal alcohol exposure
* Available parent or legal guardian capable of giving informed consent for participation.

Exclusion Criteria:

* History of a neurological condition (ex. epilepsy, traumatic brain injury)
* History of a medical condition known to affect brain function
* Other neurodevelopmental disorder (ex. autism, Down syndrome)
* History of very low birthweight (\<1500 grams)

Primary outcomes:
measure: Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm)
timeFrame: Change from baseline to 9 months
measure: Stanford-Binet Intelligence Test (SB-5)
timeFrame: Change from baseline to 9 months
measure: Minnesota Executive Function Scale (MEFS)
timeFrame: Change from baseline to 9 months
measure: NIH Toolbox Flanker Test
timeFrame: Change from baseline to 9 months
measure: NIH Toolbox Picture Sequence Memory Test
timeFrame: Change from baseline to 9 months
Secondary outcomes:
measure: Child Behavior Checklist (CBCL)
timeFrame: Change from baseline to 9 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jeffrey R Wozniak, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02398474: Ultrasound TFP (Transversalis Fascia Plane) for Analgesia After Iliac Crest Bone Graft Harvest
Official title: Intérêt du TFP (Transversalis Fascia Plane) Bloc échoguidé Pour l'analgésie du prélèvement Osseux de crête Iliaque
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients Scheduled for Iliac Crest Bone Graft Harvest During Upper or Lower Limb Surgery
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 46
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: Iliac crest bone graft harvest is associated with acute pain that can lead to chronic postoperative pain. Local anesthetic infiltration and regional anesthesia could be of interest to reduce opioid consumption during and after surgery, reduce hyperalgesia and the associated risk of chronic postoperative pain. In this surgery, local anesthetic infiltration of the iliac crest is associated with a pain reduction compare with placebo.

Some studies have shown the benefit of a TAP (transversus abdominal block) for postoperative analgesia after iliac crest bone graft harvest. The TFP block (transversalis fascia plane block) has been recently described. Considering the nerves trajectories, the TFP block is probably anatomically the most appropriate block for analgesia after iliac crest bone graft harvest.

The aim of this study is therefore to assess the benefit of an ultrasound TFP block for analgesia after iliac crest bone graft harvest compare with local anesthetic infiltration Design is prospective, randomized, double blind, controlled study


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Patients scheduled for iliac crest bone graft harvest during upper or lower limb surgery

Exclusion Criteria:

* Allergy to ropivacaine, propofol, paracetamol, remifentanil, morphine, cisatracurium, ketoprofene, nefopam
* Weight \< 50 kg
* Pregnancy
* Severe psychiatric disorder
* Paraplegia or tetraplegia
* Spinal anesthesia
* Contra indication to ketoprofene: age ≥ 75 years, renal insufficiency (creatinine clearance \< 50 ml/min), active gastric ulcer, past of asthma with NSAID
* Contra indication to nefopam: severe cardiac insufficiency, glaucoma, prostate hypertrophy, epilepsy
* Contra indication to paracetamol: severe hepatic insufficiency
* Severe respiratory insufficiency
* Abnormal hemostasis or anticoagulant treatment
* Chronic use of morphine

Primary outcomes:
measure: Morphine consumption 24 hours after the surgery
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References: