louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02937506: Patient Satisfaction With Propofol for Out Patient Colonoscopy
Official title: Patient Satisfaction With Propofol for Out Patient Colonoscopy: A Prospective, Randomized, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colon Cancer
IBS
Polyps
Keywords: propofol
colonoscopy
patient satisfaction
Lead sponsor: Mount Carmel Health System
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary purpose of this study is to determine if patient satisfaction with propofol is better than with non-propofol anesthesia for outpatient colonoscopies.

Detailed description: Outpatient colonoscopies are very common, indicated for various reasons, and are more commonly performed in outpatient surgery or endoscopy centers. There is an increase in the use of propofol for sedation because of the short duration of action and quick turn around time. Propofol has been studied extensively for safety and efficacy but patient satisfaction and preference with use has not been well documented in prospective, randomized setting. In the context of the recent changes in healthcare reimbursement where patient satisfaction is becoming an important metric providing data that could improve patient satisfaction is needed.

Patients who presented for a colonoscopy with the Principal Investigator were approached to participate in the study. After obtaining consent the patients were randomized to anesthesia with propofol or control without propofol per random number tables provided by the statistician. The anesthesiologist or nurse anesthetist were asked to remove the paper with the assignment from the envelope to determine which medications to give the patient. Pre-op, intra-op, and post-op data were collected by registered nurses blinded to the anesthetic. The day one follow-up phone call was made by the resident who was blinded to the anesthetic. Data were collected in the pre-op, intra-op, and post-op areas by the researchers who were blinded to the medications used.

Eligibility criteria: Inclusion Criteria:

- Patients having an outpatient colonoscopy

Exclusion Criteria:

- High risk patients (ASA IV \& V) who are not candidates for colonoscopy in an outpatient center will be excluded.

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Patient satisfaction was assessed the day of the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Mount Carmel Health System
state: Ohio
Study officials:
affiliation: Mount Carmel Health System
name: Anantha Padmanabhan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03854006: Cryoballoon Pulmonary Vein Isolation: Time-to-Isolation Dependent Freeze Protocols Comparison
Official title: Cryoballoon Pulmonary Vein Isolation: Time-to-Isolation Dependent Freeze Protocols Comparison
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will examine long-term efficacy of Cryo-AF using the two proposed dosing algorithms in a nonrandomized fashion.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop and prospectively test two Cryo-AF (atrial fibrillation) dosing protocols guided exclusively by time-to-isolation (TT-I) in patients undergoing a first-time Cryo-AF.

Both protocols guided by TT-I are associated with shorter cryoapplications as compared to conventional approach.

In the first group freeze duration is TTI +120 s. In the second group freeze duration is 240s if TTI is \< 75 s. In case of TTI\>75s a 240s bonus freeze is applied.

The investigators examine long-term efficacy of Cryo-AF using the two proposed dosing algorithms in a nonrandomized fashion.

The study cohort consists of consecutive patients undergoing a first-time Cryo-AF for symptomatic paroxysmal or persistent AF (atrial fibrillation) at Interventional Cadiology and Cardiac Arrhythmias Clinic of Medical University in Łódź. During 12 months investigators are planning to enroll 40 patients Patients are randomly assigned to the groups. All of them will be followed up 3 and 12 months after the procedure. In addition, ambulatory electrocardiographic monitoring will also be performed at 3 and 12 months.

The study is requested for an approval of the university ethics committee.


Eligibility criteria: Inclusion Criteria:

Diagnosis of Paroxysmal or Persistent Atrial Fibrillation on Electrocardiogram

Exclusion Criteria:

Diagnosis of Sinus Rhythm on Electrocardiogram

Primary outcomes:
measure: Atrial Fibrillation Recurrence
timeFrame: 3 months after the procedure
measure: Atrial Fibrillation Recurrence
timeFrame: 12 months after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranów
state: Łódzkie
Study officials:
affiliation: Medical University of Lodz
name: Andrzej Lubinski, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06894706: The Impact of Functional Exercise Training on Postoperative Knee Joint Recovery in Patients with Meniscal Injury
Official title: Lanzhou Anning District People's Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Exercise Training
Knee Meniscus Injury
Knee Joint Function
Keywords: Functional exercise training
knee meniscus injury
knee joint function
Lead sponsor: Lanzhou Anning District People's Hospital
Sponsor class: OTHER_GOV
First posted: 2025-03-25
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: AIM: To investigate the impact of functional exercise training on postoperative functional recovery in patients with knee meniscus injuries.

METHODS:A prospective randomized controlled trial (RCT) was conducted from April 2023 to September 2024, involving 96 patients with knee meniscus injuries who underwent meniscus repair interventions. Participants were randomly assigned to either the Control （CON） group (n=48) or the functional exercise training (FET) group (n=48) using a computer-generated random number table. The CON group received standard rehabilitation, while the FET group underwent functional exercise training. Clinical outcomes were evaluated at baseline, 1 month, and 6 months post-intervention, including the Lysholm score, IKDC score, VAS pain score, range of motion (ROM), serum levels of prostaglandin E2 (PGE2) and serotonin (5-HT), as well as passive 60° position sense and 60° motion sense. Postoperative complications occurring within 1 month were also recorded.


Eligibility criteria: Inclusion Criteria:

* meniscus injury was diagnosed by magnetic resonance imaging; meniscoplasty was performed; No shedding occurred during follow-up.

Exclusion Criteria:

* Patients with joint dislocation and fracture; poor compliance; severe osteoarthritis, rheumatoid arthritis; Combined with metabolic diseases, coagulation disorders and serious organic diseases.

Primary outcomes:
measure: Demographic data comparison
timeFrame: baseline, pre-intervention
Secondary outcomes:
measure: Lysholm Knee Scoring Scale scores
timeFrame: up to 24 weeks
measure: International Society of Knee Injuries and Arthroscopy Score
timeFrame: up to 24 weeks
measure: Range of Motion
timeFrame: up to 24 weeks
measure: Visual Analog Scale
timeFrame: up to 24 weeks
measure: Passive position sense
timeFrame: up to 24 weeks
measure: Kinesthesia test
timeFrame: up to 24 weeks
measure: Prostaglandin E2
timeFrame: up to 24 weeks
measure: 5-hydroxytryptamine
timeFrame: up to 24 weeks
measure: complications
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Lanzhou Anning District People's Hospital
Study officials:
References:
Clinical trial NCT06530706: Effect of Esketamine on Anxiety State in Patients Undergoing Abdominal Tumor Surgery
Official title: Effect of Esketamine on Anxiety State in Patients Undergoing Abdominal Tumor Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety State
Esketamine
Keywords: esketamine
anxiety state
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate whether esketamine can relieve anxiety in patients undergoing abdominal tumor surgery.

Detailed description: Hamilton anxiety Scale was used to screen patients with anxiety. Only patients with score ≥ 8 were enrolled. These patients were randomly assigned to the experimental group and control group.

All patients enrolled were evaluated with Hamilton anxiety Scale, PHQ-8 scale, QoR-15 Scale and Athens Insomnia Scale. After induction, sevoflurane and remifentanil were used to maintain anesthesia. The experimental group had esketamine while the control group had normal saline. Athens Insomnia Scale was used to assess the sleep status 1, 2, 3 days after surgery and 1 month after surgery. Hamilton anxiety Scale was used to evaluate the anxiety state of the patients 3 days after surgery and 1 month after surgery. PHQ-8 scale, QoR-15 Scale were collected 3 days after surgery and 1 month after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing abdominal tumor surgery;
* older than 18 years old and younger than 70 years old;
* ASA grade I-III；
* Hamilton anxiety scale ≥ 8.

Exclusion Criteria:

* Having serious mental illness before surgery or on antipsychotic medication in the two weeks before screening;
* Severe organ function lesions such as heart failure (left ventricular ejection fraction \<30%), myocardial infarction, kidney failure (requiring kidney replacement therapy), liver function impairment (Child-Pugh grade C), etc.
* Patients arranged to receive general anesthesia combined with epidural anesthesia patients;
* Patients who cannot communicate, read or write due to visual, auditory, language or other reasons;
* Patients allergic to ketamine;
* Patients refused to use postoperative self-controlled intravenous analgesia pump;
* Patients refused to participate in the study.

Primary outcomes:
measure: Whether esketamine can reduce anxiety status in patients with anxiety
timeFrame: 1 day before surgery, 3 days after surgery, 1 month after surgery
Secondary outcomes:
measure: To explore whether esketamine can improve sleep status
timeFrame: 1 day before surgery, 1,2 and 3 days after surgery, 1 month after surgery
measure: To explore whether esketamine can improve life quality
timeFrame: 1 day before surgery, 3 days after surgery, 1 month after surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang cancer hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT03304106: Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
Official title: Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensorineural Hearing Loss, Bilateral
Cochlear Implant
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2017-10-06
Enrollment: 102
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.


Eligibility criteria: Inclusion Criteria:

Newly implanted and existing recipient Groups (Groups 1 and 2):

* Age 12 and older
* Monosyllabic word score administered at 60dBA (2 lists) with an appropriately fit hearing aid in the ear to be implanted who are receiving a cochlear implant as standard of care
* Group 2: 3 months or greater combined experience with commercially available sound processors
* Fluent spoken English skills

Exclusion Criteria:

* Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations
* Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the Investigational team
* Unwillingness or inability of the subject to comply with all investigational requirements
* Use of an acoustic component in the implanted ear
* Less than 18 active electrodes
* Hybrid L Cochlear Implant

Primary outcomes:
measure: Change in Monosyllabic Word Recognition Scores (CNC) in Quiet
timeFrame: Pre-operative/Visit A; Group 1: 6 months; Group 2: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Rocky Mountain Ear Center
state: Colorado
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Kansas City
country: United States
facility: Midwest Ear Institute
state: Missouri
city: New York
country: United States
facility: New York University
state: New York
city: Oklahoma City
country: United States
facility: Hearts for Hearing
state: Oklahoma
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Cochlear Hearing Center Houston
state: Texas
city: Provo
country: United States
facility: Peak ENT Associates
state: Utah
Study officials:
References:
citation: Zwolan TA, Presley R, Chenier L, Buck B. Investigation of an Outcomes-Driven, Computer-Assisted Approach to CI Fitting in Newly Implanted Patients. Ear Hear. 2021 May/Jun;42(3):558-564. doi: 10.1097/AUD.0000000000000957.
Clinical trial NCT03510806: Nutritional Supplements for Exercise Recovery
Official title: Evaluation of Nutritional Supplements for Exercise Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-exercise Muscle Soreness
Lead sponsor: Beachbody
Sponsor class: INDUSTRY
First posted: 2018-04-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study will examine the effects of nutritional supplement on post-exercise muscle soreness as well as recovery of muscle strength and function.


Eligibility criteria: Inclusion Criteria:

* Ability to consume supplement
* Willing to adhere to the study intervention regimen
* Willing to abstain from analgesics for duration of the study
* Agreement to adhere to Lifestyle Considerations

Exclusion Criteria:

* Current use of NSAIDs
* Use of other nutritional or herbal supplements (e.g., protein powders, tart cherry juice, BCAAs, Vitamin D, probiotics, etc.) that have been shown to effect primary or secondary outcomes
* Presence of chronic diseases, including, but not limited to, cancer, HIV, hepatitis, cardiovascular, metabolic, and orthopedic conditions
* Weight \> 350 pounds
* Pregnancy or lactation
* Known food allergies or sensitivities or dietary restrictions
* Habitual consumption of \> 2 alcoholic drinks per day
* Febrile illness or antibiotic use within 1 month prior to baseline testing
* Treatment with another investigational drug or other intervention within 1 month
* Current smoker or tobacco use within 1 month
* Any condition(s) or diagnosis, both physical or psychological, that, in the opinion of the principal investigator or study physician, precludes participation and/or ability to consent
* Any other factor that, in the opinion of the principal investigator or study physician, would cause harm or increased risk to the participant or close contacts, or preclude the participant's full adherence with or completion of the study

Primary outcomes:
measure: post-exercise muscle soreness
timeFrame: 7 days
Secondary outcomes:
measure: post-exercise muscle strength
timeFrame: 7 days
measure: post-exercise muscle function
timeFrame: 7 days
measure: satiety
timeFrame: 4-5 hours
measure: sleep quality
timeFrame: 15 days
Other outcomes:
Locations:
city: El Segundo
country: United States
facility: Beachbody
state: California
Study officials:
affiliation: Beachbody, LLC
name: Catherine R Mikus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00449306: Physical,Histological,and Genetic Analyses of Lipid-rich Atherosclerotic Plaques
Official title: Physical,Histological,and Genetic Analyses of Lipid-rich Atherosclerotic Plaques
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerosis
Aortic Aneurysm
Peripheral Vascular Diseases
Keywords: Atherosclerosis
Carotid plaque
Abdominal aortic aneurysm
Vulnerable plaque
Angiogenesis
Intraplaque hemorrhage
Carotid artery atherosclerosis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital Goettingen
name: Carmel Medical Center
name: CVPath Institute Inc.
First posted: 2007-03-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic patients

Brief summary: Lipid-rich atherosclerotic plaques, or "vulnerable plaques" are prone to rupture, causing local intravascular thrombosis, with subsequent grave clinical consequences. Atherosclerotic plaques normally removed during surgery, and peripheral blood samples will be studied to achieve the following objectives:

"1" Define histological features of the vulnerable plaque, analyze its physical characteristics, and investigate selected gene expression.

"2" Study biomarkers of inflammation in conjunction with the presence of vulnerable plaques.

"3" Explore the potential role of infection in atherogenesis.


Eligibility criteria: Inclusion Criteria:

* Evidence of symptomatic carotid stenosis exceeding 60%(TIAs or stroke within the last 6 months), and asymptomatic carotid artery stenosis (presenting with progressive carotid stenosis, exceeding 70%)
* Abdominal aortic aneurysm, and aortic occlusive disease
* Peripheral occlusive or aneurysmal disease

Exclusion Criteria:

* Non-compliant patients, incapable of granting approval by informed consent

Primary outcomes:
measure: To uncover mechanisms of cardiovascular diseases
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center, Tel Hashomer
Study officials:
affiliation: Department of Vascular Surgery, Sheba Medical Center, Tel Hashomer
name: Jacob Schneiderman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ben-Zvi D, Savion N, Kolodgie F, Simon A, Fisch S, Schafer K, Bachner-Hinenzon N, Cao X, Gertler A, Solomon G, Kachel E, Raanani E, Lavee J, Kotev Emeth S, Virmani R, Schoen FJ, Schneiderman J. Local Application of Leptin Antagonist Attenuates Angiotensin II-Induced Ascending Aortic Aneurysm and Cardiac Remodeling. J Am Heart Assoc. 2016 May 3;5(5):e003474. doi: 10.1161/JAHA.116.003474.
citation: Schneiderman J, Schaefer K, Kolodgie FD, Savion N, Kotev-Emeth S, Dardik R, Simon AJ, Halak M, Pariente C, Engelberg I, Konstantinides S, Virmani R. Leptin locally synthesized in carotid atherosclerotic plaques could be associated with lesion instability and cerebral emboli. J Am Heart Assoc. 2012 Oct;1(5):e001727. doi: 10.1161/JAHA.112.001727. Epub 2012 Oct 25.
Clinical trial NCT00440206: Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes
Official title: Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
Immune Markers
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Ontario HIV Treatment Network
First posted: 2007-02-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Purpose is to identify whether immune markerscan predict success of salvage anti-retroviral therapy.

Detailed description: Over the last several years two markers of disease have been utilized to determine if antiretroviral therapy has been successful, one is a CD4 cell count (reflects the immunocompetence of an infected individual) and a HIV viral load (a blood test used to determine the amount of HIV in the infected individual). However in patients who fail their first line of therapythe likelihood of extended resuppressing viral replication with subsequent therapies may be as low as 25-50%. This information may take several months to determine the new therapies possible continuing success. It would be preferable to have additional markers that respond to therapies in the first several weeks to such therapies, therfore possibly offering patients alternate treatment earlier without potentiatinglong term side effects and possible further drug resistance.

Eligibility criteria: Inclusion Criteria:

* Patient must be HIV infected
* must be \&#8805;18 years old
* must have been taking the same combination ARV regimen (\&#8805;3 drugs) for at least 3 months.
* Must be experiencing virologic failure (viral load \&#8805;50 copies/mL on two occasions at least 2 weeks apart).
* must be changed to a salvage antiretroviral regimen
* Patient has to have signed and dated a full infomred consent.

Exclusion Criteria:

* Patient with any of the following abnormal laboratory test results in the previous 3 months:
* Hemaglobin \&lt;100 g/L
* Platelet count \&lt;20,000 cells/L
* INR \&#8805;3.5 IU
* PTT \&#8805;60 IU
* Patient with other significant underlying disease (non-HIV) that might impact immune markers ( eg. advanced liver disease, malignancy).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Health Science Center
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Maple Leaf Clinic
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: J Angel, MD
role: PRINCIPAL_INVESTIGATOR
References: