louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04246541: Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery
Official title: Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meniscus Tear, Tibial
Pain, Postoperative
Postoperative Complications
Ketorolac Adverse Reaction
Opioid Use
Keywords: ketorolac
meniscus tear
analgesics
pain
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The utilization of arthroscopic surgery to treat meniscus injuries has continued to increase in recent years, partly due to a younger, more active population, and improved technology and technique. However, pain management in the post-operative period is critical to the ability to perform this procedure as an outpatient surgery. Traditionally, oral narcotic agents have been the preferred analgesic postoperatively in orthopaedic surgery. However, these agents are associated with several side effects, including nausea/vomiting, constipation, and somnolence. In addition, opioid agents have a significant potential for abuse in comparison to non-narcotic analgesics. In light of the rising opioid epidemic and nationwide initiatives to limit narcotic usage, surgeons must explore alternate pain modalities in the acute postoperative period. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties.1 Multiple prior studies have examined the beneficial effect of oral and intravenous (IV) ketorolac as an analgesic in the postoperative period,1-3 including arthroscopic meniscus surgery. However, the beneficial effects of this agent following arthroscopic meniscus surgery have not been extensively described.


Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 89 years of age
* Patients undergoing primary arthroscopic meniscus surgery

Exclusion Criteria:

* Patients age less than 18 or greater than 89 years
* Illiterate or non-English speaking patients
* Patients with contraindications to ketorolac
* History of drug or alcohol abuse
* Chronic use of analgesic or psychotropic drugs

Primary outcomes:
measure: Pain Levels Recorded With a Visual Analogue Scale
timeFrame: 2 weeks postoperatively
measure: Narcotic Medication Consumed
timeFrame: up to 5 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: UH Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Michael Karns, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01183741: Accuracy of Non-Invasive Blood Pressure Measurement in Adults
Official title: Clinical Evaluation of the Sotera VisiTM System for Measurement of Systolic and Diastolic Blood Pressures in Adults
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypertension
Hypotension
Keywords: Hypertension
Hypotension
Blood pressure
Lead sponsor: Sotera Wireless, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-18
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible subjects are adults of any ethnic background who consent to spot-check blood pressure measurements and in whom paired blood pressure measurements with the ViSi will be feasible during a single visit. Subjects need to be greater than 12 years of age on the date of measurement and need to meet all the other inclusion and exclusion criteria.

Brief summary: The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to auscultation (measurement with a cuff) in determining systolic and diastolic blood pressure (BP) in adult subjects.

Detailed description: This study is a single-center blinded study that will enroll approximately 150 adult subjects. Trained auscultators will perform the standard auscultation BP measurements. They will be blinded to each other's measurements and from the ViSi measurements.

The study population will be randomized into two groups based on the side of the blood pressure measurement: the left arm group (LAG) and the right arm group (RAG).

The randomization ratio of the LAG and RAG will be 1:1. There will be forced stratification in order to ensure that the study subjects meet the required arm circumference and blood pressure distributions as specified in the SP10:2008 and ISO 81060-2:2009(E) standards.

Eligibility criteria: Inclusion Criteria:

* Subject is greater than 12 years of age at the time of screening.
* Subject's upper arm circumference is between 20cm and 55cm.
* Subject is willing to undergo the Informed Consent process prior to enrollment in the study.
* Subject is willing and able to participate for up to 60 minutes.

Exclusion Criteria:

* Subject is participating in another clinical study that may interfere with the results of this study.
* Subject is unable to have a blood pressure measurement taken from either arm for any reason.
* Subject is evaluated by the Investigator and found to be medically unsuitable for participation in this study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Clinic Rancho Bernardo
state: California
Study officials:
affiliation: Scripps Health
name: Margaret Drehobl, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04630041: Social Needs Screenings in ED
Official title: Implementation Barriers to Social Needs Screenings in Routine Emergency Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Determinants of Health
Keywords: Emergencies
Social needs
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2020-11-16
Enrollment: 5081
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will determine whether existing Health Information Technology can be leveraged to 1) implement a universal, patient-centered social needs assessment and referral process during routine Emergency Department care; 2) understand whether linking social needs assessment, community based referral, and health outcomes data may facilitate an understanding of population health; and 3) address the needs and wishes of patients and clinicians.

Hypothesis: Results of this study will provide much needed information to already overburdened hospital systems regarding whether systematically incorporating social needs information and referrals into emergency discharge processes allows for a better understanding of factors placing patients at risk for poor outcomes post-discharge, and whether doing so has potential for enhancing discharge support for a larger patient population seen in emergency departments.


Eligibility criteria: Inclusion Criteria:

* seen in the UHealth University hospital ED
* ability to use touchpad technology
* ability to communicate via telephone for 211 follow-up

Exclusion Criteria:

* Non-English and non-Spanish speaking (English nor Spanish need not be the 1st language)
* unable to communicate verbally
* admitted to an inpatient unit or to a skilled nursing facility (vs discharged to a community-based setting where participants are responsible for their own self-care)

Primary outcomes:
measure: Health Utilization Outcome questionnaire
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
citation: Wallace AS, Luther BL, Sisler SM, Wong B, Guo JW. Integrating social determinants of health screening and referral during routine emergency department care: evaluation of reach and implementation challenges. Implement Sci Commun. 2021 Oct 7;2(1):114. doi: 10.1186/s43058-021-00212-y.
Clinical trial NCT00427141: A Three-Part Study Of GSK580416 In Healthy Subjects
Official title: A Three-part First Time in Human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Food Effect of Single Oral Doses of GSK580416 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Tract Infection
Infections, Bacterial
Keywords: tolerability,
pharmacokinetics,
first time in human,
food effect
safety,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-01-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in animals affected the digestive system and blood cells. Study OPS106400 will be the first administration of GSK580416 in humans. Parts A and B of this study will examine the safety, tolerability, and pharmacokinetics of increasing single doses of GSK580416 with reference to placebo. Part C of the study will assess the effect of food on the safety, tolerability, and pharmacokinetics of a single dose of GSK580416 in healthy subjects.


Eligibility criteria: Inclusion criteria:

* Healthy as determined by a physician
* Healthy male or female of non-child bearing potential between 18 and 55 years of age (inclusive)
* Body weight \> = 50 kg and BMI between 19 and 30 kg/m2 (inclusive)

Exclusion criteria:

* Positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody with 3 months of screening
* Male and female subjects not willing to follow study specified contraceptive methods
* Subjects taking any recreational drugs
* Regular use of tobacco- or nicotine-containing products within 6 months prior to screening
* Has participated in a clinical trial and have not received a drug within 30 days before the dose of study drug
* Has exposed to more than 4 new chemical entities within 12 months before the first dosing day
* Use of prescription or over-the-counter medications within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
* Use of St. John's Wort within 28 days before the first dose of study drug
* Subjects not willing to follow study specified life style restrictions
* Blood donation in excess of 500 mL within a 56 days period

Primary outcomes:
measure: Safety assessments (adverse event, ECG and vital sign) will be performed during the study. Blood samples to determine drug levels in the body will be collected during the study.
timeFrame: during the study
Secondary outcomes:
measure: Blood samples to determine drug levels in the body will be collected during the study.
timeFrame: during the study
Other outcomes:
Locations:
city: Randwick, Sydney
country: Australia
facility: GSK Investigational Site
state: New South Wales
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06994741: Gait Parameters in a Cohort of Patients Fitted With a Canadian Prosthesis: Contribution of Quantified Gait Analysis
Official title: Retrospective Study of Gait Parameters in a Cohort of Patients Fitted With a Canadian Prosthesis: Contribution of Quantified Gait Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Gait, Unsteady
Keywords: Canadian prothesis
Lead sponsor: Institut Robert Merle d'aubigné
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: amputee with canadian prothesis

Brief summary: The goal of this clinical trial is to learn about the biomechanics characterics of amputee with a canadian prothesis during gait. The main question to answer is : what are the main biomechanical characteristics and their statistical description.

Participant had pass through a quantitative movement analysis during their classic reeducaiton and we are going to use these data.


Eligibility criteria: Inclusion Criteria:

* with canadian prothesis
* presence of the gait analysis

Exclusion Criteria:

* major gait disorder due to another pathologie
* major gait disorder due to a wrong adapration of the prothesis

Primary outcomes:
measure: Walking speed
timeFrame: Day 1
Secondary outcomes:
measure: Joint range of motion
timeFrame: Day 1
measure: Force apply to the ground
timeFrame: Day 1
measure: Steplength
timeFrame: During the quantitative movement analysis - retrospective data
Other outcomes:
Locations:
city: Valenton
country: France
facility: Institut Robert Merle d'Aubigné
state: Val-de-Marne
Study officials:
References:
Clinical trial NCT04982341: HFNC and Prone Positioning in Awake Patients With Severe COVID-19
Official title: Effectiveness of High-flow Nasal Cannula and Prone Positioning in Awake Patients With COVID-19 and Severe Acute Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxemic Respiratory Failure
Lead sponsor: Hôpital Universitaire Fattouma Bourguiba
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Covid-19 confirmed by rtPCR, suffering from acute hypoxemic failure requiring oxygenation

Brief summary: The investigators evaluate the effects of High-flow nasal cannula (HFNC) in association with prone in patients with Covid-19 severe ARF.

Detailed description: The investigators evaluate the effects of High-flow nasal cannula (HFNC) in association with prone in patients with Covid-19 severe ARF.

All patients with ARF related to Covid-19 and admitted to the ICU are turned in prone position whenever tolerated, while receiving oxygenation with HFNC.

Outcomes of interest are the rate of success or failure (defined as the need for intubation and mechanical ventilation)

Eligibility criteria: Inclusion Criteria:

* aged ≥18 years, admitted to the medical ICU for confirmed Covid-19 and acute hypoxemic respiratory failure

Exclusion Criteria:

* patients already intubated at admission or those requiring immediate intubation

Primary outcomes:
measure: Number of patients without intubation
timeFrame: through study completion, an average of 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: CHU F.Bourguiba
Study officials:
affiliation: CPPRB
name: Lamia Besbes, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT05670041: Re-hospitalisation After Transcatheter Aortic Valve Implantation
Official title: Re-hospitalisation After Transcatheter Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Disease
Aortic Valve Stenosis
Keywords: Transcatheter Aortic Valve Implantation
Transcatheter Aortic Valve Replacement
Aortic Valve Stenosis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to investigate whether patient-tailored follow-up for patients treated with transcatheter aortic valve implantation (TAVI) can prevent re-hospitalisation and improve quality of life compared with the standard follow-up program.

The rationale of this study is the persistently high rate of re-hospitalisation after TAVI, which increases the risk of mortality and diminishes the patient-evaluated quality of life. Our hypothesis is that patient-tailored follow-up for patients treated with TAVI will reduce the rate of re-hospitalisation after the TAVI-procedure and improve quality of life.

The primary endpoints are the rate of re-hospitalisation within 90 days of the procedure and quality of life adjusted life years at 90-day follow-up.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent technical successful TAVI
* Residing in Denmark
* Provided written informed consent

Exclusion Criteria:

* Index admission mortality
* Index admission conversion to open surgery
* Age \< 18 years
* Women of childbearing potential, pregnant or nursing

Primary outcomes:
measure: The rate of all-cause hospitalisations between discharge from the index procedure and 90 days post-TAVI
timeFrame: 365 days
measure: Quality-of-life adjusted life years at 90 days after the TAVI-procedure
timeFrame: 365 days
Secondary outcomes:
measure: The risk of all-cause mortality
timeFrame: 365 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lars Sondergaard, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02449941: Helicobacter Pylori and Proton Pump Inhibitor
Official title: Distribution of Helicobacter Pylori According to the Use of Proton Pump Inhibitor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Infections
Keywords: Stomach Neoplasms
proton pump inhibitor
endoscopic submucosal dissection
Helicobacter pylori
Gastritis, Atrophic
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sample size will be determined based on the analysis the distribution rate of HP at first 30 patients.

Brief summary: The purpose of this study is to know the distribution of HP in stomach before use of PPI, during use of PPI, and after stop of PPI.

Detailed description: Endoscopy and biopsy will be performed to investigate the distrubition of HP before, during, and after using PPI.

Eligibility criteria: Inclusion Criteria:

1. Patients who are indicated to endoscopic resection due to gastric neoplasm
2. Aged between 19 to 65 years
3. Informed consent

Exclusion Criteria:

1. Previous history of HP eradication
2. Previous history of PPI use within 6 months
3. No HP infection

Primary outcomes:
measure: Analysis the change of Helicobacter pylori distribution according to the use of proton pump inhibitor
timeFrame: Change in the distribution of Helicobacter Pylori(HP) at 4 months.
Secondary outcomes:
measure: Analysis the change of HP distribution according to the use of PPI in atrophic change of stomach
timeFrame: Change in the distribution of Helicobacter Pylori(HP) at 4 months.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: Asan Medical Center
name: Ji Yong Ahn, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gong EJ, Kim DH, Ahn JY, Na HK, Jung KW, Lee JH, Choi KD, Song HJ, Lee GH, Jung HY, Park Y, Kim MJ. Effects of Proton Pump Inhibitor on the Distribution of Helicobacter pylori and Associated Gastritis in Patients with Gastric Atrophy. Digestion. 2020;101(3):279-286. doi: 10.1159/000499424. Epub 2019 May 8.
Clinical trial NCT00327041: Monitoring Response to Antiplatelet Therapy
Official title: Pilot Study Investigating the Use of a Variety of Assays to Detect Individual Response to Antiplatelet Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Stenosis
Coronary Thrombosis
Angioplasty, Balloon
Keywords: Aspirin
Clopidogrel
Balloon Angioplasty
Coronary Thrombosis
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2006-05-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Antiplatelet therapy plays a key role in the prevention of complications related to coronary angioplasty and stenting (PCI) including procedure related myocardial damage. Aspirin and clopidogrel are now universally prescribed in patients undergoing these procedures. However, loading and maintenance doses have not been established and variation in individual response is emerging. New tests to assess the effects of these drugs are being developed but have yet to be incorporated into routine clinical practice. We will assess the effects of aspirin and clopidogrel in a consecutive series of patients undergoing angioplasty using new assays which can be carried out at the bedside. We will compare the results with alternative laboratory based tests and look for an association between the results, peri-procedural myocardial necrosis and subsequent cardiovascular events.


Eligibility criteria: Inclusion Criteria:

Patients aged 18-80 undergoing intended PCI for conventional indications. Informed written consent.

Exclusion Criteria:

Administration of GPIIbIIIa therapy prior to PCI, Oral anticoagulation, ticlopidine, dipyridamole, NSAID therapy, Pregnancy, Troponin I \>0.2mcg/l on day of procedure, Chest pain in the 24 hrs prior to PCI. Anaemia (Hb\<10g/dl). Platelet Count \<150 or \>450 x10\^9/l, Personal or family history of bleeding disorder.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Western Infirmary
state: Scotland
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Keith G Oldroyd, MBChB, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: