louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04644640: Telerehabilitation Following Meniscectomy
Official title: Telerehabilitation Following Meniscectomy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniscectomy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Telerehabilitation is a form of tele-treatment in which rehabilitation services are dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information. Since telerehabilitation was found to be equally effective as conventional therapy, it was being practiced even before the COVID times, however it was truly valuable during the lockdown. The advantages of telerehabilitation include reducing unnecessary travel to the hospital and person to person contact while maintaining social distancing. While some of the patients are truly staying at remote areas, others are unable to manage travel in the lockdown period. Telemedicine offers the opportunity to deliver rehabilitative services in the patients' home, closing geographic, physical, and motivational gaps. Punctuality on either side is also assured since the travel times are saved on both the ends.

The purpose of the proposed study is to evaluate telerehabilitation vs in-person rehabilitation following Meniscectomy.


Eligibility criteria: Inclusion Criteria:

* Scheduled for meniscectomy
* Age 18-75
* Ability to comply with a standardized postoperative protocol
* Willing and able to provide consent

Exclusion Criteria:

* Pregnant patient
* Age \>75 years, or \< 18
* Previous knee surgery
* Unable to speak English or perform informed consent

Primary outcomes:
measure: Visual Analogue Scale (VAS) Score
timeFrame: up to 1 year post-op
measure: International Knee Documentation Committee (IKDC) Score
timeFrame: up to 1 year post-op
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: Kirk Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01510340: Evaluation of a Tailored Virtual Intervention to Empower Persons Living With HIV for Therapy Self-management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
Keywords: adherence
HIV
antiretroviral therapy
tailored web intervention
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
First posted: 2012-01-16
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the efficacy of an online virtual intervention in optimizing adherence to antiretroviral medication intake among Persons Living with HIV (PLHIV).


Eligibility criteria: Inclusion Criteria:

* have to be under ART for at least six months¸
* have internet access

Exclusion Criteria:

* be pregnant
* active IV drug user
* actual diagnosis of psychiatric health problem

Primary outcomes:
measure: Adherence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: José Côté
state: Quebec
Study officials:
affiliation: CRCHUM, Université de Montréal
name: José Côté, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Gaston Godin, Ph.D.
role: STUDY_CHAIR
affiliation: Polytechnique
name: Yann-Gael Guéhéneuc, Ph.D.
role: STUDY_CHAIR
affiliation: CRCHUM
name: Cécile Tremblay, MD,Ph.D.
role: STUDY_CHAIR
affiliation: Université du Québec a Montréal
name: Joanne Otis, Ph.D.
role: STUDY_CHAIR
References:
citation: Cote J, Rouleau G, Ramirez-Garcia MP, Auger P, Thomas R, Leblanc J. Effectiveness of a Web-Based Intervention to Support Medication Adherence Among People Living With HIV: Web-Based Randomized Controlled Trial. JMIR Public Health Surveill. 2020 Apr 20;6(2):e17733. doi: 10.2196/17733.
citation: Cote J, Godin G, Gueheneuc YG, Rouleau G, Ramirez-Garcia P, Otis J, Tremblay C, Fadel G. Evaluation of a real-time virtual intervention to empower persons living with HIV to use therapy self-management: study protocol for an online randomized controlled trial. Trials. 2012 Oct 5;13:187. doi: 10.1186/1745-6215-13-187.
Clinical trial NCT02364440: Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand
Official title: Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkles
Keywords: skin laxity
Ultherapy™ System
rhytids
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
First posted: 2015-02-18
Enrollment: 7
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Enrolled subjects will receive Ultherapy™ System treatment on the back of their both hands. Follow-up visits will occur at 90 days post-treatment. Study photos will be obtained pre-treatment and at 90 days post-treatment

Detailed description: Before Treatment:

The subject's eligibility (inclusion/exclusion criteria) will be assessed, and the 5-point Hand Grading Scale wil be evaluated by the Investigator in charge of assessment.

Treatment:

The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with 20 lines of 1.5 and 3.0 probe respectively to the back of the left and right hand .

Post-Treatment:

All subjects will visit the Institution at12 weeks from the day of procedure, and will take photos of the back of the hands. Efficacy evaluation will performed by the Photographic Evaluator.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 30 to 65 years.
* Score of 1 to 3 on The 5-point Hand Grading Scale
* Subjects who understand the study contents and signed the informed consent

Exclusion Criteria:

* Presence of an active systemic infectious disease
* Significant scarring in the hand to be treated
* Previous episode of surgery in the hand to be treated
* Subjects who have aesthetic addiction, drug abuse, alcohol abuse

Primary outcomes:
measure: Investigator's evaluation of 5-point Hand grading scale
timeFrame: 12 weeks post-treatment
Secondary outcomes:
measure: Subject Assessment of Improvement at 12 weeks post-treatment
timeFrame: 12 weeks post-treatment
measure: Investigator Assessment of Improvement at 12 weeks post-treatment
timeFrame: 12 weeks post-treatment
measure: Subjects' Assessment of Pain during treatment
timeFrame: Subjects were assessed for the duration of study treatment
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: ChangSik Pak, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02238340: Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery
Official title: Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgery
Keywords: Postoperatory pain
Oxycodone
Lead sponsor: Hospital Central Dr. Luis Ortega
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inadequate control of acute postoperative pain (DAPO) brings deleterious consequences for the patient, including significant cardiovascular and respiratory complications. Apart from the human suffering that is undeniable pain. Schemes oral analgesia with opioids for the treatment of DAPO, have shown to be as or more effective than intravenous or epidural regimes, and less expensive. Comparing the effectiveness of 10 to 20 mgs of oxycodone sustained release for 12 hours before surgery, into two groups of 20 patients (O-10, O-20) undergoing orthopedic surgery, in a scheme involving multimodal ketoprofen, dipyrone metoclopramide and dexamethasone. Values were recorded visual analog scale (VAS)for pain at rest and effort, requirement for rescue intravenous morphine and incidence of side effects to the entry and exit of the PACU (T0, TE) and at 6 and 18 hours postoperatively (T6, T18),and patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* ASA I and II patients between 18 and 60 years old, both sexes, undergoing elective orthopedic surgery.

Exclusion Criteria:

* Use of psychotropic medication or illicit drug use
* Pregnancy
* Liver disease
* Opioid use
* History of postoperative nausea and vomiting
* Ileus
* Allergy or intolerance to any of the study drugs
* Physical or mental inability to use the pain scale, or any surgical complications.

Primary outcomes:
measure: Percents of patients with EVA < 4 to the alt of UCPA, and 6 , 18 postoperatory hours
timeFrame: 24 hours
Secondary outcomes:
measure: Percents of patients with adverse events because of treatment
timeFrame: 24 hours
Other outcomes:
Locations:
city: Porlamar
country: Venezuela
facility: Servicio de Aestesiologia.Hospital "Dr Luis Ortega"
state: Nueva Esparta
Study officials:
affiliation: Sociedad Venezolana de Anestesiologia
name: Beatriz S Arismendi Gomez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01070940: L-NMMA Dose-response Study in Healthy Subjects
Official title: L-NMMA's Effect on Renal and Cardiovascular Variables in Healthy Subjects. A Randomized, Placebo-controlled Crossover Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: L-NMMA
blood pressure
arterial stiffness
pulse wave velocity
augmentation index
dose-response
healthy subjects
GFR
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2010-02-18
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to investigate the effect of different levels of nitric oxide inhibition on blood pressure and arterial stiffness in healthy subjects. L-NMMA, an inhibitor of the nitric oxide synthase, is administered as bolus injection followed by continuous infusion, and is expected to raise blood pressure and arterial stiffness according to L-NMMA dose.


Eligibility criteria: Inclusion Criteria:

* Healthy males
* Age 18-35 years
* BMI 18.5-30.0

Exclusion Criteria:

* Tobacco or illicit drug use
* Current use of any prescription or non-prescription drugs
* Alcohol abuse
* History of heart failure, lever failure, chronic kidney disease or cerebral insult
* Diabetes
* Clinical or paraclinical signs of infection
* Pathologic ECG
* Ambulatory blood pressure \>140/90 mmHg
* Abnormal blood or urin screening tests

Primary outcomes:
measure: Systolic blood pressure
timeFrame: 6 hours
Secondary outcomes:
measure: GFR
timeFrame: 6 hours
measure: Arterial Stiffness
timeFrame: 6 hours
measure: Fractional excretion of sodium
timeFrame: 6 hours
measure: Fractional excretion of potassium
timeFrame: 6 hours
measure: Plasma renin concentration
timeFrame: 6 hour
measure: Plasma angiotensin II
timeFrame: 6 hours
measure: Plasma aldosterone
timeFrame: 6 hour
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Departments of Medical Research
Study officials:
affiliation: Departments of Medical Research, Holstebro Hospital
name: Thomas Larsen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Departments of Medical Research, Holstebro Hospital
name: Frank H Christensen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Departments of Medical Research, Holstebro Hospital
name: Erling B Pedersen, Dr.med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Departments of Medical Research, Holstebro Hospital
name: Jesper N Bech, Ph.d.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05945940: Preoperative Nutritional Status and Postoperative Acute Kidney Injury
Official title: Prognostic Significance of Preoperative Nutritional Status for Postoperative Acute Kidney Injury in Elderly Patients Undergoing Major Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Acute Kidney Injury
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 2977
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients (aged ≥ 65 years) who underwent a major abdominal surgery under general anesthesia at Tongji Hospital between July 2018 and December 2021 were included in our study.

Brief summary: There is a high prevalence of postoperative acute kidney injury (AKI) in patients who undergo intra-abdominal surgery, and it is particularly common in the elderly. Identifying high-risk patients for postoperative AKI early can facilitate the development of preventive and therapeutic management strategies.

The goal of this retrospective study is to investigate the predictive value of preoperative nutritional status, as measured by three scoring systems - the geriatric nutritional risk index (GNRI), prognostic nutritional index (PNI), and controlling nutritional status (CONUT) score - on postoperative AKI in elderly patients undergoing major abdominal surgery.


Eligibility criteria: Inclusion Criteria:

1. aged ≥ 65 years
2. intra-abdominal procedures including gastric, colorectal, pancreatic, prostate, and urinary bladder surgeries, as well as abdominal exploration.
3. surgery duration lasting longer than 2 hours.

Exclusion Criteria:

1. patients with an American Society of Anesthesiologists (ASA) physical status V.
2. those with concurrent cardiac or renal surgeries.
3. those with end-stage renal disease (i.e. a glomerular filtration rate of 15 mL/min/1.73 m2 or receiving haemodialysis).
4. those did not have sufficient data required for nutritional evaluation or AKI evaluation.

Primary outcomes:
measure: Postoperative acute kidney injury
timeFrame: Within 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Rao Sun
Study officials:
affiliation: Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
name: Rao Sun, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01912040: Study Of the Safety of Locally Manufactured 123I-metaiodobenzylguanidine(MIBG) in Routine Clinical Use
Official title: A Prospective, Open Label, Single Arm Cohort Study to Assess the Frequency of Adverse Reactions of Locally Manufactured 123I-metaiodobenzylguanidine in Routine Clinical Use
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Adrenergic Pathology
Keywords: Safety profile
locally produced 123 Iodine MIBG
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those patients referred for MIBG assessment.

Brief summary: Assessing 123 Iodine MIBG produced locally for safety while being used in clinical practice to help in patient management decisions.

Detailed description: We will be assessing for adverse reactions of patients injected with locally manufactured 123 Iodine MIBG. With monitoring of blood pressure and heart rate following injection and any potential immediate side effects.

Eligibility criteria: Inclusion Criteria:

* Patients with potential Adrenergic pathology

Exclusion Criteria:

* Pregnant or breast feeding females
* Hypersensitivity to MIBG

Primary outcomes:
measure: Safety profile of the 123Iodine MIBG
timeFrame: BP and Heart rate for 24 hours after injection.
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Capital District Health Authority
state: Nova Scotia
Study officials:
affiliation: Division Head, Nuclear Medicine
name: Andrew Ross, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01593540: Clinical Examination of Metal Free Interdental Brushes
Official title: Clinical Efficacy and Patient Acceptance of Metal and Metal-Free Interdental Brushes: A Controlled Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingivitis
Periodontitis
Lead sponsor: University of Freiburg
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study was to evaluate the clinical efficacy (Eastman Interdental Bleeding Index, Quigley and Hein) of a novel metal-free interdentalbrush compared to a classig metal-core interdental brush.

Detailed description: Self-performed interdental cleaning is a crucial element in preventing gingival or periodontal diseases. Interdental cleaning is most efficiently performed through usage of interdental brushes. Commonly used metal-core interdental brushes can harbour the risk of hard tissue damage when used inappropriately.The aim of the study was to evaluate the clinical efficacy and patient satisfaction of a novel metal-free interdental brush. This was tested on healthy participants. The control group performed interdental cleaning with a commonly used metal-core interdental brush.

Eligibility criteria: Inclusion Criteria:

* minimum age: 18 years

Exclusion Criteria:

* allergy against one or more parts of the interdental brushes
* non-treated periodontitis
* soft-tissue changes of the mucosa
* orthodontic treatment
* removable prosthesis
* pregnancy
* anticoagulants
* drugs causing gingivahyperplasia
* indications for antibiotics

Primary outcomes:
measure: Analysis of the differences between both groups. Measurements in form of Plaque-Index (Quigley und Hein, Tureskey Mod. 1970)
timeFrame: Beginning and after four weeks of use
Secondary outcomes:
measure: Eastman Interdental Bleeding Index, questionnaire of patient acceptance
timeFrame: Beginning and after four weeks of use
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Freiburg Medical Center , Dept of Operative Dentistry and Periodontology
Study officials:
affiliation: University of Freiburg
name: Johan P Woelber, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00935740: Tissue Factor Expression in Stage C Heart Failure
Official title: Tissue Factor Expression in Stage C Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: thromboembolic disease
thromboplastin
hypercoagulability
congestive heart failure
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2009-07-09
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Heart failure

Brief summary: Monocyte tissue factor (TF) was characterized in Class C heart failure (HF) vs. 25 age-matched volunteers. TF was 2.9 fold higher (p \< 0.001) in HF patients vs. controls. HF patients showed increased clinical events (RR=1.29, p=0.04) when comparing procoagulant activity above/below median. HF is associated with increased TF expression.

Detailed description: Monocyte tissue factor (TF) was characterized in Class C heart failure (HF) vs. 25 age-matched volunteers. TF was 2.9 fold higher (p \< 0.001) in HF patients vs. controls. HF patients showed increased clinical events (RR=1.29, p=0.04) when comparing procoagulant activity above/below median. HF is associated with increased TF expression.

Previous studies suggest that markers of coagulation are elevated in heart failure (HF). Tissue factor (TF) plays the cardinal role in initiating the coagulation cascade. This study determines TF expression in HF and its association with disease progression.

Methods: Monocytes were obtained from 50 NYHA function class II-IV HF patients and 25 age-matched disease-free volunteers. TF protein, TF procoagulant activity, and tissue factor pathway inhibitor (TFPI) were determined.

Eligibility criteria: Inclusion Criteria:

* Heart failure subjects with symptomatic heart failure (New York Heart Association \[NYHA\] functional class II to IV) due to either idiopathic dilated cardiomyopathy or ischemic cardiomyopathy and had a left ventricular ejection fraction \< 0.35.

Primary outcomes:
measure: This study determines TF expression in HF and its association with disease progression.
timeFrame: Hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Utah
name: Mark A Munger, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: