louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04932733: Isometric Exercises in Healthy Elderly Individuals
Official title: Effects of a Single Session of Knee Isometric Exercises on Blood Pressure in Healthy Elderly: A Clinical Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Blood pressure
Isometric exercise
Lead sponsor: Isra University, Jordan
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A total of 58 participants were selected and divided into two groups equally, namely, elderly, and young groups with the age groups of 60-80 years and 20-30 years, respectively. The Heart Rate (HR), Respiratory Rate (RR), Blood Pressure (BP), Oxygen Saturation (SaO2), and Mean Arterial Pressure (MAP) for each participant were assessed before and after the treatment session.

Detailed description: The elderly participants in the experimental group and the young participants in the control group underwent a single session of 5-minute quadriceps isometric exercise. The participant was asked to take rest of 10 minutes before performing the exercise. After that, the exercise was performed from a long-sitting position.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were normotensive males and females in the above age groups.

Exclusion Criteria:

* Participants with a chronic history of alcohol, smoking, resting tachycardia (\>100 beats per min), hypertension, history of any other cardiovascular disorders, any peripheral vascular disease, those on a regular exercise program, and uncooperative participants.

Primary outcomes:
measure: Blood Pressure (BP)
timeFrame: Change from baseline blood pressure at 1 day
Secondary outcomes:
measure: Respiratory Rate (RR)
timeFrame: Change from baseline respiratory rate at 1 day
measure: Oxygen Saturation (SaO2)
timeFrame: Change from baseline oxygen saturation at 1 day
measure: Heart Rate (HR)
timeFrame: Change from baseline heart rate at 1 day
measure: Mean Arterial Pressure (MAP)
timeFrame: Change from baseline mean arterial pressure at 1 day
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Isra University
Study officials:
affiliation: Isra University
name: Salameh Aldaja, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01299233: Reproducibility of RNFL Circle Scans With ART-Function of Heidelberg Spectralis SD-OCT Software Version 5.3
Official title: Reproducibility of RNFL Circle Scans With ART-Function of Heidelberg Spectralis SD-OCT Software Version 5.3
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma Patients and Healthy Controls
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients and controls are selected out of our primary care clinic

Brief summary: To assess the improvement in reproducibility of 100 vs. 16 averaged images by Automatic Real Time (ART) using Spectralis™ Spectral Domain-Optical Coherence Tomography (SD-OCT, Heidelberg Engineering GmbH, Heidelberg, Germany) in retinal nerve fiber layer thickness (RNFL) circle scan-measurements.

* Trial with medical device


Eligibility criteria: Inclusion criteria:

for both groups (glaucoma study group and control group): men and women of at least 50 years of age

for the glaucoma study group: diagnosis of primary open angle glaucoma (POAG)

Exclusion criteria:

for both groups (glaucoma study group and control group):

* less then 18 years of age
* any pathology of the central retina
* any optic nerve disorder other then glaucoma
* retinal vascular disorder

for the glaucoma study group: other glaucoma diagnosis then primary open angle glaucoma

for the control group: any diagnosis of glaucoma

Primary outcomes:
measure: COV
timeFrame: T0
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Ophthalmic Clinic
state: ZH
Study officials:
affiliation: University Hospital Zurich, Ophtalmic Clinic
name: Jens Funk, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01890733: InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.
Official title: A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Efficacy and Safety of InSpace™ Device in Comparison to Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV
Keywords: Massive Rotator Cuff Tear, Sub-acromial spacer, Best repair of rotator cuff,
Lead sponsor: OrthoSpace Ltd.
Sponsor class: INDUSTRY
First posted: 2013-07-02
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .

The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily living(ADL) and improvement of range of motion (ROM).


Eligibility criteria: Main Inclusion Criteria:

* Age 40 or older.
* Positive diagnostic imaging (CT arthrogram or MRI)\* of the affected shoulder indicating full thickness Massive RCT of at least 5cm in diameter (according to Cofield classification) or long - narrow tears of at least 4cm2 (W\>2cm and L\>2cm) including fatty infiltration grade III or IV (according to classification of Goutallier) involving more than one tendon. - Persistent pain and functional disability of the affected shoulder for at least 3 months.

Main Exclusion Criteria :

* Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).
* Evidence of significant osteoarthritis or cartilage damage in the shoulder
* Evidence of gleno-humeral instability
* Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
* Evidence of major joint trauma, infection, or necrosis in the shoulder
* Partial-thickness tears of the rotator cuff

Primary outcomes:
measure: Comparison of respose rate at each treatment arm
timeFrame: 6m
Secondary outcomes:
measure: subjects requiring re-operation of the repaired tear at the end of the follow-up period.
timeFrame: 24 m post implantation
measure: change of total questionnaires scores from baseline to each follow-up visit.
timeFrame: 6W, 3m, 6m , 12m ,24m
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Policlinico
Study officials:
affiliation: Policlinico de Milano
name: Luigi Solimeno, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02098733: Long-term Use of Sonias Combination Tablets in Patients With Type 2 Diabetes Mellitus
Official title: Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey on Long-term Use for in Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-03-28
Enrollment: 1168
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes

Brief summary: The purpose of this study is to evaluate the safety and efficacy of long-term use of Sonias Combination Tablets in patients with type 2 diabetes mellitus in the routine clinical setting.

Detailed description: This a special drug use surveillance on long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets) designed to investigate the frequency of adverse drug reactions in patients with type 2 diabetes mellitus in the routine clinical setting.

The usual adult dosage is one tablet of Sonias administered orally once daily before or after breakfast (15 mg/1 mg or 30 mg/3 mg of pioglitazone/glimepiride).

Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus for whom a physician has concluded that combination therapy with pioglitazone hydrochloride and glimepiride is appropriate and for whom long-term treatment with Sonias Combination Tablets is considered necessary

Exclusion Criteria:

* (1) Patients with cardiac failure or a history of cardiac failure (2) Patients with serious hepatic or renal impairment (3) Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (4) Patients with severe infection, severe trauma, or pre- and post-operative patients (5) Patients with gastrointestinal disorders such as diarrhea and vomiting (6) Pregnant or potentially pregnant women (7) Patients with a history of hypersensitivity to the ingredients in Sonias Combination Tablets or sulfonamides

Primary outcomes:
measure: Number of Participants With Adverse Drug Reactions
timeFrame: For 12 months
Secondary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, and Months 3, 6, 9, 12 and at Final Assessment
measure: Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, and Months 3, 6, 9, 12 and at Final Assessment
measure: Change From Baseline in Fasting Blood Glucose Level
timeFrame: Baseline, Months 3, 6, 9, 12 and at Final Assessment
measure: Fasting Blood Glucose Level
timeFrame: Baseline, Months 3, 6, 9, 12 and at Final Assessment
measure: Change From Baseline in Fasting Insulin Level
timeFrame: Baseline, Months 3, 6, 9, 12 and at Final Assessment
measure: Fasting Insulin Level
timeFrame: Baseline, Months 3, 6, 9, 12 and at Final Assessment
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Postmarketing Group Manager
role: STUDY_CHAIR
References:
Clinical trial NCT02851433: Evaluate the Protective Effect of Conditioning With Sevoflurane on the Myocardium
Official title: Evaluate the Protective Effect of Conditioning With Sevoflurane Versus Propofol on the Myocardium in Scheduled Aortic Valve Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Surgery
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 82
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Heart surgery is a considerable source of stress for the myocardium that must be minimized.

Troponin Ic is a reliable marker to determine the level of this myocardial stress.

Studies have shown that post-conditioning with AVH has a protective effect on the myocardium, if the treatment is initiated at the start of the ischemia.

The aim of this study is to evaluate the protective effect on the myocardium (by measuring troponin levels) of the association of pre-conditioning and post-conditioning with Sevoflurane (AVH) sedation administered during and after scheduled surgery for valve replacement, via sternotomy or thoracotomy compared with total intravenous anaesthesia with Propofol.


Eligibility criteria: Inclusion Criteria:

* Patients who have provided informed written consent.
* Aortic valve replacement via sternotomy or thoracotomy, under Cardiopulmonary bypass (CPB).
* Anterograde cardioplegia with cold blood

Exclusion Criteria:

* Adults under guardianship.
* Patients without national health insurance cover.
* Epileptics.
* Heart grafted patients.
* Patients under 18 years and pregnant or beast-feeding women.
* Aortic dissections and vascular surgery.
* Contra-indications to treatment with Sevoflurane: hypersensitivity to halogen-based anaesthetic agents, myopathy, personal or family history of malignant hyperthermia, hyper-eosinophilia, liver disease, icterus or unexplained fever after anaesthesia with a halogen-based anaesthetic agent
* Contra-indications to treatment with Propofol: known hypersensitivity to propofol or one of the constituents of the specific form used, hypersensitivity to peanuts or soja.
* pre-operative LVEF\<35%.
* Coronary artery bypass graft alone or associated.
* Mitral valve replacements.
* Warm cardioplegia.

Primary outcomes:
measure: Levels of troponin
timeFrame: Change at Hour 6, Hour 12, Hour 24, Hour 48 compared with baseline level
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT00984633: Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 (Study P05976)(COMPLETED)
Official title: Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 Following a Single Intubating Dose in Adult Subjects Undergoing Operation Under Sevoflurane or Propofol Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Muscle Relaxation
Keywords: Neuromuscular Blocking Agents
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, pharmacokinetics, and safety of Org 9426 in maintenance of muscle relaxation in adult subjects undergoing general elective surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects at least 20 but under 65 years of age.
* Subjects of asa class 1, 2 or 3 for general elective surgery.
* Subjects who are not considered to be pregnant.
* Subjects scheduled for elective surgery under sevoflurane or propofol anesthesia, with anticipated duration of surgery of about 1.5-3 hours.
* Subjects with normal laboratory values for serum electrolytes (Na+, K+, Cl-), BUN, creatinine, total bilirubin, ALP, ALAT and ASAT as judged by the investigator or the sub-investigator.
* Subjects who received an explanation of the trial and agreed informed consent in writing to participate in the trial in advance.

Exclusion Criteria:

* Subjects with renal dysfunction as a complication or in the history.
* Subjects with serum creatinine level greater than 1.6 mg/dL.
* Subjects with severe hepatic dysfunction as a complication or in the history.
* Subjects with known significant metabolic or neuromuscular disorders.
* Subjects with showing dyspnea, airway obstruction or bronchial asthma.
* Subjects with a history of hypersensitivity to pancuronium bromide, vecuronium bromide or bromine.
* Subjects with atopic diseases.
* Subjects who have developed any systemic allergic symptoms.
* Subjects receiving antihistamines and antiallergic agents for 1 month or more.
* Subjects receiving any of the following drugs known to affect on the action of neuromuscular blocking agents on surgery day: calcium antagonists; anticonvulsants; aminoglycoside antibiotics; polypeptide antibiotics; or metronidazole.
* Subjects under hypothermic anesthesia.
* Subjects who participated as research subjects in another trial within the last 6 months or is now participating in other trials.
* Other subjects judged to be ineligible as subjects in this trial by the discretion of the investigator or the sub-investigator.

Primary outcomes:
measure: Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation
timeFrame: Time from intubating dose to bolus maintenance dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05959733: Maximal Repair Versus Bridging Reconstruction with BioBrace®
Official title: Maximal Repair Versus Bridging Reconstruction with BioBrace® for the Treatment of Chronic, Massive Rotator Cuff Tears: Clinical, Radiographic, and In-vivo Biomechanical Analysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Tears
Bioinductive Implant
Keywords: shoulder
rotator cuff
clinical outcomes
radiographic outcomes
biomechanics
bridging reconstruction
rotator cuff repair
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: CONMED Corporation
First posted: 2023-07-25
Enrollment: 60
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: The purpose of this study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Specifically, the researchers will be comparing the re-tear rate, patient reported outcomes, shoulder strength, range of motion, muscle activation, in-vivo biomechanics, and other radiographic outcomes using x-ray and MRI.


Eligibility criteria: Inclusion Criteria:

* magnetic resonance imaging (MRI) proven diagnosis of a large or massive (\> 3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff
* over 18 years of age

Exclusion Criteria:

* glenohumeral osteoarthritis
* Western Ontario rotator cuff score \>60
* uncontrolled diabetes (Hgb A1C \>7%)
* pregnant
* local or systemic infection
* inability to cooperate with and/or comprehend post-operative instructions
* MRI proven non-vascular sites
* poor nutritional state (Alb \<30 g/L)
* cancer
* paralysis of the shoulder
* contracture of the shoulder
* patients unable to provide informed consent for the study

Primary outcomes:
measure: Radiographic or clinical failure
timeFrame: 2 years
Secondary outcomes:
measure: Acromiohumeral Distance
timeFrame: 2 year
measure: Muscle Atrophy
timeFrame: 2 year
measure: Fatty Infiltration
timeFrame: 2 year
measure: Healing Rate
timeFrame: 2 year
measure: Western Ontario Rotator Cuff Index (WORC)
timeFrame: Baseline, 6-month, 1-year, 2-years
measure: American Shoulder and Elbow Surgeon survey
timeFrame: Baseline, 6-month, 1-year, 2-years
measure: EQ-5D-5L
timeFrame: Baseline, 6-month, 1-year, 2-years
measure: Range of motion
timeFrame: Baseline, 6-month, 1-year, 2-years
measure: Shoulder strength
timeFrame: Baseline, 6-month, 1-year, 2-years
measure: Biomechanics and Muscle Activity
timeFrame: Baseline and 2 years
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority, Orthopaedic Surgeon
name: Ivan Wong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00621933: Surveillance of Ocular Surface Flora (SURFACE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 399
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cataract Surgery Patients

Brief summary: Topical fluoroquinolones (FQs) have achieved widespread use in ophthalmology for both the treatment and prophylaxis of ocular infections. The present study is set to determine the bacteria present on the ocular surface in patients at the time of cataract surgery and to assess the rate of resistance of ocular isolates to commonly used topical antibiotics.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo cataract surgery
* Able to provide written informed consent

Exclusion Criteria:

* NSAID in the eye to be swabbed within the past 30 days
* Topical anesthetic, topical antibiotic or antiseptic, or dilating drops in the eye to the swabbed within the past 7 days
* Over-the-counter artificial tear drops or astringent /redness reliever drops (e.g., Visine®, Clear eyes® in the eye to be swabbed on the day of trial
* History of conjunctivitis or any ocular infection within the past 3 months

Primary outcomes:
measure: Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid
timeFrame: Baseline
measure: Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva
timeFrame: Baseline
Secondary outcomes:
measure: Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid
timeFrame: Baseline
measure: Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva
timeFrame: Baseline
Other outcomes:
Locations:
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Olson R, Donnenfeld E, Bucci FA Jr, Price FW Jr, Raizman M, Solomon K, Devgan U, Trattler W, Dell S, Wallace RB, Callegan M, Brown H, McDonnell PJ, Conway T, Schiffman RM, Hollander DA. Methicillin resistance of Staphylococcus species among health care and nonhealth care workers undergoing cataract surgery. Clin Ophthalmol. 2010 Dec 10;4:1505-14. doi: 10.2147/OPTH.S14333.
Clinical trial NCT06010433: CERAMENT G Device Registry
Official title: CERAMENT G Device Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Osteomyelitis
Fracture Related Infection
Diabetic Foot Osteomyelitis
Lead sponsor: BONESUPPORT AB
Sponsor class: INDUSTRY
First posted: 2023-08-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The racial, gender and ethnic characteristics of the individuals approached for participation in this Observational Registry Study shall reflect the demographics of patients that would ordinarily receive CERAMENT\|G for the treatment of their condition at the designated investigative centres. No individuals shall be excluded from participation in the Observational Registry Study based on race, nationality, ethnicity, gender, or sexuality

Brief summary: This is an Observational Device Registry Study of CERAMENT\|G in normal use in accordance with the IFU. It will run for a period of three years from enrolment of the first patient into the Study at each Site, before being subject to review. A Device Registry is a form of observational study that concerns the performance of a device in normal use. It is intended to collect data that is reflective of 'real world' device performance.


Eligibility criteria: Inclusion Criteria:

* 18 years and over (on the day of surgery)
* receive CERAMENT\|G as a component of their treatment at a participating, contracted centre or healthcare provider, in accordance with the IFU for the implanted product
* In receipt of patient information leaflet and have signed appropriately designed informed consent form.

Exclusion Criteria:

* Any exclusion criteria as per IFU for CERAMENT\|G
* Any off-label use

Primary outcomes:
measure: Primary Outcomes
timeFrame: 12 months
Secondary outcomes:
measure: Secondary Outcome
timeFrame: 12 months
measure: Secondary Outcome
timeFrame: 6 and 12 months
measure: Secondary Outcome
timeFrame: 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
References: