louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00212849: Autologous Chondrocyte Implantation in the Patellofemoral Joint
Official title: Autologous Chondrocyte Implantation in the Patellofemoral Joint
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chondrosis
Patellar Articular Cartilage Lesions
Trochlear Articular Cartilage Lesions
Keywords: Articular Cartilage Lesions
Patellar lesions
Trochlear lesions
Patellofemoral joint
Carticel
Autologous Chondrocyte Implantation
Lead sponsor: Orthopaedic Research Foundation
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2005-09-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The purpose of this study is to measure the outcomes of patients who have articular cartilage lesions in the patellofemoral joint and are treated with the Autologous Chondrocyte Implantation.

Detailed description: Cartilage restoration, in general, is a relatively new option for the treatment of articular cartilage lesions primarily of the knee. In the initial autologous cultured chondrocyte transplantation (ACT or, by others implantation, thus ACI) reported by Peterson et. al., the results of femoral lesions were favorable, while 5 of 7 patellofemoral treatments were poor. In the United States, the expedited FDA approval based on these results excluded the patella. As a result, in the United States, it has been difficult to further evaluate use of ACI at the patellofemoral joint in light of the exclusion of "off label" uses by many governmental and private insurance programs. Nevertheless, a growing body of knowledge is accumulating outside the United States that the use of ACI at the patella is a viable option and soon similar findings will be published in the US by Minas et. al. (accepted for publication)

Eligibility criteria: Inclusion Criteria:

* Carticel Implantation of the patella and/or trochlear lesion. Patients who have reached their two-year follow-up date. All patients included in sequential order.

Exclusion Criteria:

* Patients that have had a microfracture in the knee joint at the same time as Carticel Implantation.

Patients that have implantable lesions other than the patella and trochlea.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Orthopaedics Indianapolis
state: Indiana
Study officials:
affiliation: Orthopaedic Research Foundation, Inc.
name: Jack Farr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Minas T, Bryant T. The role of autologous chondrocyte implantation in the patellofemoral joint. Clin Orthop Relat Res. 2005 Jul;(436):30-9. doi: 10.1097/01.blo.0000171916.40245.5d.
Clinical trial NCT05834049: Virtual Parental Presence on Induction of Anesthesia vs Premedication With Midazolam
Official title: Virtual Parental Presence on Induction of Anesthesia Versus Premedication With Midazolam: A Non-Inferiority Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Surgery
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
First posted: 2023-04-28
Enrollment: 322
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This multi-center, prospective, clinical trial targets recruiting children undergoing inhalational induction of anesthesia. The primary objective of this study is to assess the Modified Yale Preoperative Anxiety Scale during induction between children receiving oral midazolam 0.5 mg/kg (max 20 mg) versus virtual parental presence on induction of anesthesia. Patients will be randomized to one of two groups by block randomization.


Eligibility criteria: Inclusion Criteria:

* children from ages 4 years to 8 years old undergoing outpatient surgery
* children identified as needing premedication
* ASA physical status I, II or III
* planned inhalational induction
* children presenting from home prior to surgery (not an inpatient)
* English speaking parents and child

Exclusion Criteria:

* children with developmental delay
* children with psychological / emotional disorders
* children with altered mental status
* children in whom midazolam may be medically contraindicated per the discretion of the anesthesia care team
* children with language barrier
* children who are not accompanied by someone able to consent (ie legal guardian)
* children who are inpatient prior to surgery
* children with expected difficult intubation/airway
* children presenting for emergency surgery
* family history or personal history of malignant hyperthermia / risk of MH
* consent not obtained or withdrawal of consent
* children with past history of violent behaviors during induction of anesthesia
* cancellation of surgery
* patients with a diagnosis of COVID-19 or a patient under investigation for COVID-19, including patients being treated with airborne precautions in the operating room
* receipt of any type of medical sedative prior to induction of anesthesia, including (but not limited to) ketamine, and/or dexmedetomidine.

Primary outcomes:
measure: Change of Anxiety in children
timeFrame: baseline, immediately after the intervention
Secondary outcomes:
measure: Induction compliance
timeFrame: immediately during anesthetic induction
measure: Change of parental anxiety
timeFrame: baseline, immediately after anesthetic induction
Other outcomes:
Locations:
Study officials:
affiliation: Nationwide Children's Hospital
name: Vanessa Olbrecht, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01371149: Patient -Ventilator Interaction in Chronic Respiratory Failure
Official title: A Clinical Trial to Optimise Patient-ventilator Interaction in Patients With Chronic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hypercapnic Respiratory Failure
Obesity Hypoventilation Syndrome
Neuromuscular Disease
Chronic Obstructive Pulmonary Disease
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Royal Brompton & Harefield NHS Foundation Trust
First posted: 2011-06-10
Enrollment: 58
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: To evaluate a novel advanced physiological monitoring system to improve nocturnal non-invasive ventilation (NIV) in Neuromuscular disease (NMD), Chest wall disease (CWD), Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS) patients. By enhancing sleep comfort, adherence to ventilation will increase which, in turn, will improve ventilatory failure, quality of life and reduce length of admission during initiation of therapy. We aim to incorporate this technology into routine clinical practice.


Eligibility criteria: Inclusion Criteria:

1. Patients over the age of 16 years.
2. Patients with confirmed diagnosis of Duchenne Muscular dystrophy or Chronic Obstructive Pulmonary Disease or Obesity Hypoventilation Syndrome.
3. Patients with evidence of nocturnal hypoventilation with an arterial carbon dioxide partial pressure of \>6.0 kPa in the morning.
4. Patients with evidence of hypercapnic respiratory failure with an arterial carbon dioxide partial pressure of \>6.0 kPa during the day.
5. No prior domiciliary ventilation.

Exclusion Criteria:

1. Patients with other co-morbidities e.g. cancer or cardiac failure.
2. Patients with muscular weakness but an unconfirmed diagnosis of Duchenne Muscular Dystrophy, Obesity Hypoventilation Syndrome or Chronic Obstructive Pulmonary Disease.
3. Patients who have had an acute illness within the last 4 weeks prior to starting assessment for ventilation.
4. Patients who have an abnormal bleeding tendency (INR or APTTr \>1.4 or platelets \<100).
5. Patients with a psychological, social or geographical situation that would impair compliance with the project.

Primary outcomes:
measure: Adherence with ventilation
timeFrame: 3 months
Secondary outcomes:
measure: health related quality of life
timeFrame: 3 month
measure: length of hospital stay for initiation of home mechanical ventilation
timeFrame: 3 months
measure: gas exchange
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St. Thomas' NHS Trust
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
References:
Clinical trial NCT05314049: Effects of Sustained Natural Apophyseal Glides in Combination With McKenzie Extension Protocol in the Management of Discogenic Low Back Pain
Official title: Effects of Sustained Natural Apophyseal Glides (SNAGs) in Combination With McKenzie Extension Protocol (Mechanical Diagnostic Therapy) in the Management of Discogenic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Disk Prolapse
Disk Herniated Lumbar
Sciatic Radiculopathy
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition. McKenzie's extension protocol is considered to be the gold standard physical therapy treatment for persons with acute discogenic low back pain, however the evidence is deficient in terms of additive benefits of sustained natural apophyseal glides in the management of discogenic low back pain. Thus, the current study will not only look into the positive effects of McKenzie's extension protocol in the management discogenic low back pain, but will also look into the additive benefits of sustained natural apophyseal glides in combination with McKenzie's extension protocol in the management of discogenic low back pain.


Eligibility criteria: Inclusion Criteria:

* Both male and female participants
* aged 18-50 years old
* low back pain intensity less than 80/100mm on visual analogue scale
* positive centralization phenomenon
* low signal intensity of IV disc on T2 - weighted MRI
* high intensity zone towards the posterior aspect of the disc on MRI

Exclusion Criteria:

Individuals with and any musculoskeletal, metabolic, or neurological disorders that may impair gait, postural stability or sensory integrity will be excluded from the study.

-

Primary outcomes:
measure: Back Pain
timeFrame: 2 weeks
measure: Lumbar Range of Motion
timeFrame: 2 weeks
measure: Postural Stability
timeFrame: 2 weeks
measure: Lumbar Disability
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04493749: Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection
Official title: Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: Withings
Sponsor class: INDUSTRY
First posted: 2020-07-30
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: in and out patients from cardiology services

Brief summary: Withings Move ECG watch is designed to record ECG and detect automatically atrial fibrillation. The aim of this study is to validate the performance of Move ECG watch to detect atrial fibrillation compared to a reference 12-lead ECG.

Detailed description: Patients with atrial fibrillation are included in hospitals. On each patient, ECG with Move ECG and the reference 12-lead ECG are recorded simultaneously. Both records are then reviewed by independent cardiologists to assess

1. The presence or absence of atrial fibrillation
2. if waveforms of ECG recorded with Move ECG compared with the reference.

Eligibility criteria: Inclusion Criteria:

* male or female who are 18 years or older
* Subject who signed the written informed consent form

Exclusion Criteria:

* Vulnerable subject with regard to regulations
* Pregnant, parturient or breastfeeding woman,
* Subject who is deprived of liberty by judicial, medical or administrative decision,
* Underage subject,
* Legally protected subject, or subject who is unable to sign the written informed consent form,
* Subject who is not beneficiary or not affiliated to a social security scheme,
* Subject within several of the above categories,
* Subject who refused to participate in the study,
* Subject in physical incapacity to wear a wrist-worn watch
* Subject with electrical stimulation by pacemaker

Primary outcomes:
measure: Sensitivity and Specificity of the automatic classification in AF by Move ECG single-lead ECG against reference 12-lead ECG
timeFrame: 1 year
Secondary outcomes:
measure: Comparability of ECG waveforms from single strip of Move ECG vs Lead-1 of reference 12-lead ECG
timeFrame: 1 year
measure: Safety of use of Move ECG
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Cœur Paris Centre Turin
state: Ile-de-France
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
state: Ile-de-France
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
state: Ile-de-France
Study officials:
affiliation: Centre Cardiologique du Nord
name: Julien Nahum
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01905449: Ultrasound Biofeedback for Speech Sound Disorders
Official title: Biofeedback and Speech Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Speech Sound Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 35
Sex: ALL
Minimum age (years): 8
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Children with speech sound disorders will receive speech therapy using real-time images of the tongue from ultrasound. These images will be used to cue the child to change the tongue position when producing speech sounds.


Eligibility criteria: Inclusion Criteria:

* Participants must be native English-speaking children with no known hearing or vision deficits. Participants must be within the specified age range and have been identified as having speech production difficulties by a local speech-language therapist.

Exclusion Criteria:

* Participants will be excluded if there is a history of oral structural impairment (e.g., cleft palate), hearing or vision impairment, history of neurological impairment or injury, developmental disabilities such as Down Syndrome or Autism, or intellectual disability.

During initial testing, participants must score below a standard score of 75 on the Goldman-Fristoe Test of Articulation-2 and also score below 20% accurate on a probe list of words assessing accuracy of the /r/ sound

Primary outcomes:
measure: Percent correct for target speech sound
timeFrame: Change in accuracy after 7 one-hour treatment sessions (3.5 weeks), and after 14 one-hour treatment sessions (7 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Haskins Laboratories
state: Connecticut
Study officials:
affiliation: Haskins Laboratories
name: Jonathan Preston, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00979849: AZD8683 Single Ascending Dose Study
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD8683 After Single Ascending Doses in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: safety
tolerability
healthy
inhalation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-09-18
Enrollment: 130
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8683 following single ascending dose administrations in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures
* Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically significant abnormalities at screening examinations
* Use any prescribed or non-prescribed medication

Primary outcomes:
measure: Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
timeFrame: Frequent sampling occasions during study days, before and up to 48 h after dosing, and at a follow-up visit 7-13 days after dosing.
Secondary outcomes:
measure: Pharmacokinetics: Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal rate constant (λz), terminal half-life (t½λz)
timeFrame: Frequent sampling occasions during study days, before and up to 48 h after dosing.
measure: Pharmacokinetics: Area under the plasma concentration-time curve from zero to the time of the last measurable concentration (AUC(0-t)) and from zero to infinity (AUC), apparent plasma clearance (CL/F)
timeFrame: Frequent sampling occasions during study days, before and up to 48 h after dosing.
measure: Pharmacokinetics: Apparent volume of distribution during terminal phase (Vz/F), mean residence time (MRT), amount of drug excreted unchanged (Ae; % dose), and renal clearance (CLR).
timeFrame: Frequent sampling occasions during study days, before and up to 48 h after dosing.
measure: Pharmacodynamics: Lung function by spirometry (forced expiratory volume in the first second [FEV1] and forced vital capacity [FVC]), blood pressure, pulse, QTc, and heart rate.
timeFrame: Frequent sampling occasions during study days, before and up to 48 h after dosing.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: AstraZeneca R&D Lund
name: Gurdrun Schwabe
role: STUDY_DIRECTOR
affiliation: AstraZeneca CPU, Philadelphia
name: Sylvan Hurewitz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04146506: Gender Differences in the Tolerance to Stretch
Official title: The Effect of Stretching on Pain Sensitivity - Potential Gender Differences?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Range of Motion, Articular
Muscle Stretching Exercises
Lead sponsor: University College of Northern Denmark
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy male and female volunteers between the ages of 18 to 45 are eligible for participation.

Brief summary: The effect of stretching on range of motion is believed to rely upon an increased tolerance to stretch. This suggests, that pain modulation has significance in regards to the effect of stretching.

Detailed description: Given that there may be differences in the way men and women perceive a painful stimulus, this suggests that there may be potential gender differences in the tolerance to stretch following stretching.

Eligibility criteria: Inclusion Criteria:

* Absence of any pain or other conditions which might affect the somatosensory system and pain perception

Exclusion Criteria:

* Substance abuse, History of neurological or mental disabilities, Lack of ability to comply with instructions, Delayed onset of muscle soreness

Primary outcomes:
measure: Range of Motion
timeFrame: Passive knee extension range of motion was measured at baseline just prior to Muscle stretching exercises
measure: Range of Motion
timeFrame: Passive knee extension range of motion was measured 30 seconds after Muscle stretching exercises
measure: Pain Thresholds
timeFrame: Pressure pain Thresholds were measured at baseline just prior to muscle stretching exercises
measure: Pain Thresholds
timeFrame: Pressure pain Thresholds were measured 30 seconds after muscle stretching exercises
measure: Torque
timeFrame: Passive resistive torque was measured at baseline just prior to muscle stretching exercises
measure: Torque
timeFrame: Passive resistive torque was measured 30 seconds after muscle stretching exercises
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: University College of Northern Denmark
Study officials:
affiliation: University College of Northern Denmark, Department of Physiotherapy
name: Dorte Drachman, Msc.
role: STUDY_DIRECTOR
References: