louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01609764: Physical Activity, Sleep and Age
Official title: Physical Activity and Movement Efficiency and Quality Sleep With Increasing Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Movement Efficiency
Sleep
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Ageing is associated with a reduction of physical activity, movement efficiency, and quality of sleep. This leads to reduced health and well being in elderly subjects. Exercise training can increase movement efficiency and quality of sleep.

Objectives:

1. Laboratory validation test of body acceleration based indexes for movement efficiency and quality of sleep;
2. Cross-sectional analysis to assess relations between these indexes and age;
3. Intervention study to assess the effect of exercise training on daily life movement efficiency and quality of sleep in ageing subjects

45 healthy human volunteers, age 50-83 yr, BMI 20-30 kg/m2 are divided in control or intervention group. Subjects that will have practiced fitness activities in the previous year, as well as pregnant or lactating women, will be excluded.


Eligibility criteria: Inclusion Criteria:

* Men and women
* Age between 50-85 years
* No fitness activity in the previous year, to amplify training effects on movement efficiency and quality of sleep.
* Body mass index between 20 and 30 kg/m2, obesity limits the training capacity of subjects.

Signed informed consent by the participants

Exclusion Criteria:

* Age below 50 or above 85 years;
* body mass index below 20 kg/m2 or above 30 kg/m2;
* neurologic, cardiologic or invalidating orthopaedic disease;
* pregnancy or lactation.

Primary outcomes:
measure: Changes in movement efficiency
timeFrame: At baseline and after 1 year
Secondary outcomes:
measure: Changes in quality sleep
timeFrame: At baseline and after 1 year
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
affiliation: Maastricht University, NUTRIM, Human biology
name: Klaas R Westerterp, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valenti G, Bonomi AG, Westerterp KR. Walking as a Contributor to Physical Activity in Healthy Older Adults: 2 Week Longitudinal Study Using Accelerometry and the Doubly Labeled Water Method. JMIR Mhealth Uhealth. 2016 Jun 7;4(2):e56. doi: 10.2196/mhealth.5445.
Clinical trial NCT04663464: Study to Evaluate and Compare the PK Profiles of Abaloparatide-SC and Abaloparatide-sMTS in a Cohort of Healthy Men and Healthy Women.
Official title: An Open-Label, Randomized, 2-Cohort, 2-Period Crossover Pharmacokinetic Study of Abaloparatide-SC and Abaloparatide-sMTS in Healthy Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: osteoporosis
transdermal delivery
solid microstructured transdermal system
abaloparatide
TYMLOS®
abaloparatide-SC
abaloparatide-sMTS
PK
Lead sponsor: Radius Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2020-12-11
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In each of 2 study periods, subjects received receive either a transdermal patch containing 300 μg abaloparatide for 5 minutes or an injection of abaloparatide SC 80 μg.
Primary purpose: TREATMENT

Brief summary: A study to evaluate and compare the PK profiles of abaloparatide-SC 80 μg and abaloparatide-sMTS 300 μg in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women

Detailed description: This study aims to evaluate and compare the pharmacokinetic (PK) profiles of abaloparatide-SC 80 μg injected subcutaneously into the periumbilical region of the abdomen, and abaloparatide-sMTS 300 μg applied to the thigh for 5 minutes in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women.

Eligibility criteria: Inclusion Criteria

* Male and female subjects aged 40 to 65 years old, inclusive, at Screening;
* Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index between 18 and 32 kg/m\^2;
* Laboratory test results within the normal range
* Serum 25-hydroxyvitamin D values must be \> 20 ng/mL.

Exclusion Criteria:

* Presence or history of any disorder that may prevent the successful completion of the study;
* Diagnosed with osteoporosis, Paget's disease, or other metabolic bone diseases (eg, vitamin D deficiency or osteomalacia), or had a non-traumatic fracture within 1 year prior to the initial screening;
* History of any cancer within the past 5 years other than squamous or basal cell carcinoma;
* History of allergy to abaloparatide or drugs in a similar pharmacological class;.

Primary outcomes:
measure: PK Cmax
timeFrame: Time frame for collection of PK data after each single-dose administration, separated by 48 hours
measure: PK AUC1
timeFrame: Time frame for collection of PK data after each single-dose administration, separated by 48 hours
measure: PK AUC2
timeFrame: Time frame for collection of PK data after each single-dose administration, separated by 48 hours
Secondary outcomes:
measure: Subjects with AEs and SAEs
timeFrame: 10 Days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Medpace Clinical Pharmacology
state: Ohio
Study officials:
References:
Clinical trial NCT05426564: Exploratory Assessment of the Quantra® System in Adult ECMO Patients
Official title: Exploratory Assessment of the Quantra® System With the QPlus® and QStat® Cartridges in Adult ECMO Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Loss
Thrombosis
Extracorporeal Circulation; Complications
Keywords: Quantra
ECMO
QPlus
Viscoelastic testing
Coagulation
Lead sponsor: HemoSonics LLC
Sponsor class: INDUSTRY
Collaborators: name: University of California, Irvine
First posted: 2022-06-22
Enrollment: 10
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: Patients undergoing arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure. Both COVID-19 and non-COVID-19 related ECMO patients will be enrolled

Brief summary: This is a prospective, observational exploratory study of the performance of the Quantra System in adult patients that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure.

Detailed description: Patients 18 years or older that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure will be enrolled in this prospective, observational exploratory study. From each enrolled subject, blood samples will be collected at multiple time points for analysis on the Quantra QPlus or QStat Cartridge in parallel with other assessments performed as standard of care.

Eligibility criteria: Inclusion Criteria:

* Subject is \> 18 years.
* Subject is scheduled to undergo either VA or VV ECMO procedure or has been placed on VA or VV ECMO within 24 hours.
* Subject or subject's legally authorized representative (LAR) is willing to provide informed consent, either prospectively or by deferred consent.

Exclusion Criteria:

* Subject is younger than 18 years of age.
* Subject is pregnant.
* Subject is incarcerated at the time of the study.
* Subject, or subject's legally authorized representative is unable or unwilling to provide informed consent.
* Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks.

Primary outcomes:
measure: Comparison of Quantra Clot Time results to standard coagulation test results.
timeFrame: At the start of ECMO (considered the Baseline timepoint)
measure: Comparison of Quantra Clot Stiffness results to standard coagulation test results.
timeFrame: At the start of ECMO (considered the Baseline timepoint)
measure: Comparison of Quantra Clot Time results to standard coagulation test results.
timeFrame: 6 hours after the previous measurment
measure: Comparison of Quantra Clot Stiffness results to standard coagulation test results.
timeFrame: 6 hours after the previous measurment
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
Study officials:
References:
Clinical trial NCT00795964: Influence of Tidal Volume on Postoperative Pulmonary Function
Official title: Influence of Tidal Volume on Postoperative Pulmonary Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Function
Keywords: tidal volume
predicted body weight
lung function
respiratory outcome
Respiratory Function Tests
surgery
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 101
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Lung function impairment is common after abdominal surgery. Few preventive strategies exist against postoperative lung function impairment. A new potential preventive strategy against postoperative lung function impairment comes from research on critically ill patients with severe respiratory failure. In this field research has long focused on influence of breathing volume (= tidal volume) during mechanical ventilation on outcome. It has been shown, that low tidal volumes improve patients outcomes as compared to (conventional) high tidal volumes. Therefore, we propose a patient and investigator blinded randomised trial to test the hypotheses that intraoperative mechanical ventilation with low tidal volumes as compared to high tidal volumes reduces postoperative lung function impairment in high risk patients.


Eligibility criteria: Inclusion Criteria:

* written informed consent
* age ≥ 50 years and ASA classification ≥ II
* elective upper abdominal surgery of at least 3 hours duration
* general anaesthesia plus epidural anaesthesia.

Exclusion Criteria:

* \< 18 years of age
* impaired mental state
* unwillingness to participate
* pregnancy
* duration of surgery \< 3 hours
* ASA physical status ≥ IV
* increased intracranial pressure
* neuromuscular disease that impairs spontaneous breathing

Primary outcomes:
measure: Lung function as assessed by spirometry
timeFrame: 1 year
Secondary outcomes:
measure: lung function as assessed by blood gas analysis
timeFrame: 1 year
measure: time till hospital discharge
timeFrame: 1 year
measure: postoperative organ dysfunction
timeFrame: 1 year
measure: postoperative chest x-rays
timeFrame: 1 year
measure: time till mobilisation
timeFrame: 1 year
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Department of Anesthesiology
Study officials:
affiliation: Department of Anesthesiology at Duesseldorf University Hospital
name: Tanja A Meyer-Treschan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00846664: Short Arc Multifidus Study
Official title: Increase in Multifidus Size By Short Arc Banding on the ATM Machine as Measure by Diagnostic Ultrasound
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Multifidus Disuse Atrophy
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients will be performing Logan short arc banding protocols to see the effect on multifidus size

Detailed description: The subjects will initially be scanned by diagnostic ultrasound by to assess the cross sectional area of their lumbar multifidi. Then they will perform 3 sets of 30 second periods of Logan Short Arc Banding on the ATM machine twice a week for 4 weeks and then they will be scanned again using diagnostic ultrasound to assess the effects of the rehabilitation exercise.

Eligibility criteria: Inclusion Criteria:

* Male or Female ages 18-54

Exclusion Criteria:

* Asymptomatic of: Low Back Pain, previous spinal injury, surgery or other condition affecting the spine, local infection, injury or malignancy; pregnancy or any condition affecting muscle reaction time.

Primary outcomes:
measure: Multifidus cross sectional area
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan College of Chiropractic
state: Missouri
Study officials:
References:
Clinical trial NCT03067064: Prevelance of Molar Incisor Hypomineralization Among a Group of Egyptian Children
Official title: Prevelance of Molar Incisors Hypomineralization Among a Group of Egyptian Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Development Disorder
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 610
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Group of Egyptian children attending in paediatric dentistry and dental public health department in the faculty of oral and dental medicine,Cairo university

Brief summary: The purpose of this study is to find out the prevalence of molar incisor hypomineralization among a group of Egyptian children

Detailed description: Molar incisor hypomineralization is frequent in many population throughout the world and a wide variation of molar incisior hypomineralization 2.4_40% has been reported.To the best of our knowledge,there is no Sufficient information regarding the prevalence of molar incisor hypomineralization in Egyptian children therefore the aim of this study is to assess the prevalence of molar incisor hypomineralization among a group of Egyptian children.

Eligibility criteria: Inclusion Criteria:

- Patient seeks dental care in paediatric dentistry and dental public health department in Cairo university

* positive patient acceptance for participation in the study
* children with at least one of four permanent molars erupted or partially erupted

Exclusion Criteria:

* uncooperative children

  * children with appliance
  * children with systemic diseases

Primary outcomes:
measure: Presence of Molar incisor hypomineralization
timeFrame: 10min
Secondary outcomes:
measure: Severity of Molar incisor hypomineralization
timeFrame: 15min
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Reem Zaki Youssef
city: Cairo
country: Egypt
facility: Reem Zaki Youssef
Study officials:
affiliation: Cairo University
name: Reem Za Youssef, Bechlor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05157464: Losartan Use to Mitigate Arthrofibrosis Following Total Join Arthroplasty
Official title: Losartan Use to Mitigate Arthrofibrosis Following Total Join Arthroplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Arthrofibrosis
Keywords: Total Knee Arthroplasty (TKA)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomized, controlled, open label, parallel two-arm design, single-center study to compare the use of losartan in the prevention of stiffness following total knee arthroplasty.
Primary purpose: TREATMENT

Brief summary: Recent research has focused on methods to mitigate scar tissue formation and arthrofibrosis following surgery in hopes that patients may attain maximal range of motion goals, avoid manipulation and secondary surgery (i.e. revision arthroplasty), and improve their function. The synovial fluid milieu has also highlighted the role of local biochemical markers that may be implicated in the development of arthrofibrosis. Losartan is an angiotensin receptor blocker with inhibitory effects on transforming growth factor beta (TGF-b), largely implicated in tissue repair and fibrosis by way of SMAD protein signaling suppression, and has been used in orthopaedic sports medicine to prevent stiffness following hip arthroscopy. To date, this has not commonly been used at NYU Langone in orthopedic surgery. The purpose of this study is to evaluate the efficacy of losartan use pre- and post-operatively on range of motion and the incidence of manipulation under anesthesia following total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

1. Patients are candidates for elective primary total knee arthroplasty for a diagnosis of osteoarthritis or inflammatory arthritis.
2. Patients ≥18 years of age
3. Patients have been medically cleared and scheduled for surgery
4. Patients' primary care physician has verified that the patient can safely take the described dose of Losartan for the duration of the study period.

Exclusion Criteria:

1. Any contraindications to Losartan
2. Revision surgery
3. Surgery for fracture, infection, or malignancy
4. Patients with a diagnosis of post-traumatic arthritis
5. Bilateral, simultaneous surgery
6. Patients already taking an ACE-inhibitor or Angiotensin receptor blocker for hypertension

Primary outcomes:
measure: Post-Operative Range of Motion (ROM)
timeFrame: 90 days post-surgery
measure: Post-Operative Rate of Manipulation under Anesthesia (MUA)
timeFrame: 90 days post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Joshua Rozell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213902: Clonidine and Left Ventricular Dysfunction
Official title: Evaluation of Effects of Central Sympathetic Inhibition in Elderly With Left Ventricular Diastolic Dysfunction and Preserved Ejection Fraction: A Proof-of-Concept Trial With Clonidine
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ventricular Dysfunction
Keywords: Heart failure
Diastolic
functionClonidine
Left ventricular diastolic dysfunction with preserved ejection fraction
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The objectives of this study are:

1. To evaluate the effect of clonidine, a sympathetic modulator, to reverse cardiac remodeling and to improve hemodynamics in diastolic heart failure (DHF).
2. To evaluate the effect of clonidine on neurohormones and quality of life in patients with DHF.

The study is a double-blind, placebo-controlled study evaluating the effects of clonidine compared to placebo in patients with DHF. A total of 70 patients with DHF will be randomized in a 1:1 ratio to:

1. placebo (n=35) or to
2. clonidine (n=35) in a dose of 0.075 mg twice a day for the first 6 weeks followed by uptitration to 0.150 mg twice a day for 6 months.

The primary outcome is the reversion of cardiac remodeling and hemodynamic parameters evaluated by magnetic resonance imaging (MRI) and echocardiography.


Eligibility criteria: Inclusion Criteria:

* Age: 60 and greater
* Gender: Both
* Patients with heart failure New York Heart Association (NYHA) II and ejection fraction over 45%

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hopitaux Universitaires de Strasbourg
name: Pascal Bousquet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00821002: A Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug Delivery System (L-PPDS)
Official title: An Open-Label, Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Lead sponsor: Mati Therapeutics Inc.
Sponsor class: INDUSTRY
Collaborators: name: QLT Inc.
First posted: 2009-01-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study objective is to compare IOP and safety outcomes based on plug placement (upper or lower puncta).


Eligibility criteria: Inclusion Criteria:

* Over 18 years
* Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension

Exclusion Criteria:

* Uncontrolled medical conditions
* Subjects who wear contact lenses
* Subjects requiring chronic topical artificial tears, lubricants, and /or requiring any other chronic topical medications

Primary outcomes:
measure: Intraocular pressure change from baseline (mmHg)
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Menlo Park
country: United States
state: California
Study officials:
affiliation: QLT Inc.
name: Oscar Cuzanni, MD, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT02297802: A Single Patient IND for PD-0325901
Official title: A Phase I Single Patient IND for PD-0325901
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Prior Treatment With PD-0325901 With Ongoing Clinical Response
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
First posted: 2014-11-21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to provide access for a single patient to PD-0325901 who was previously enrolled in a phase I clinical trial.


Eligibility criteria: Inclusion Criteria:

* Prior treatment with PD-0325901 with ongoing response

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Healthcare
state: California
Study officials:
References: