louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01072591: Study to Assess MEDI -578 in Patients With Osteoarthritis (OA) of the Knee
Official title: A Phase I, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess Safety,Tolerability, Pharmacokinetics and Efficacy of MEDI-578, an Anti-NGF Monoclonal Antibody, After Single Ascending Doses in Male and Non-fertile Female Patients With Painful Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Osteoarthritis
Pain
Keywords: anti-NGF
OA
pain
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: MedImmune LLC
First posted: 2010-02-22
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
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 evaluate the safety and tolerability of a single intravenous dose of MEDI-578, a monoclonal antibody, in patients with osteoarthritis of the knee. It will also be evaluated how MEDI-578 is absorbed and distributed through the body.


Eligibility criteria: Inclusion Criteria:

* Patients with painful osteoarthritis of the knee.
* The pain from the knee must exceed pain experienced from any other condition.
* Patients must be willing and able to discontinue all current analgesic treatment.

Exclusion Criteria:

* Any other form of arthritis than osteoarthritis.
* Presence of neuropathic pain, or fibromyalgia, or wide spread chronic pain not related to osteoarthritis.
* Significant abnormalities on the clinical examination that may interfere with the study or present a safety risk to the patient, as judged by the investigator.

Primary outcomes:
measure: Safety variables (adverse events, vital signs, ECG, safety lab)
timeFrame: Assessments performed at (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 2. Thereafter weekly assessments until week 4 when a fortnightly schedule is followed until week 8. A final assessment at week 12.
Secondary outcomes:
measure: To characterize the pharmacokinetics of MEDI-578 in plasma.
timeFrame: Blood sampling performed at (predose, then ranging from every hour to every 24 hour) on Day 1 and 2. Thereafter weekly blood sampling until week 4, when a fortnightly schedule is followed until week 8. A final assessment at week 12.
measure: To assess the immunogenicity of MEDI-578
timeFrame: Blood samples taken fortnightly from Day 1 until week 12.
measure: To evaluate the analgesic efficacy of MEDI-578 during the night and day.
timeFrame: Patients will record their pain intensity every morning and evening during the 13 weeks study period.
Other outcomes:
Locations:
city: London Bridge
country: United Kingdom
facility: Research Site
state: Greater London
Study officials:
affiliation: AstraZeneca RD Södertälje
name: Rolf Karlsten
role: STUDY_DIRECTOR
References:
Clinical trial NCT06290791: Does a Drain Tube Influence the Postoperative Epidural Haematoma for Lumbar Biportal Endoscopic Surgery?
Official title: Does a Drain Tube Influence the Postoperative Epidural Haematoma for Lumbar Biportal Endoscopic Surgery? A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drain Tube Influence the Postoperative Epidural Haematoma
Keywords: Spinal epidural hematoma
Decompression surgery
Lumbar spinal stenosis
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 89
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to evaluate if wound drains could influence postoperative spinal epidural hematoma (POSEH) in biportal endoscopic spinal surgery (BESS) procedures for decompression of lumbar spinal stenosis.

Detailed description: How to reduce the rate of POSEH after lumbar spinal surgery is an obvious concern for spine surgeon. Wound drains were recognized as effective methods and typically used to prevent the development of symptomatic epidural hematomas after spinal surgery. However, whether range prophylactic postoperative drainage after spinal decompression for the prevention of POSEH is still controversial. Although there have been many studies focusing on the potential associations between wound drains and POSEH after lumbar spinal surgery, a prospective study focusing on the role of drains in minimally invasive surgery of BESS for lumbar spinal decompression has been rare. In present study, our team sought to investigate the influence of wound drains for POSEH and provide clinical evidence for the selection of drainage in BESS procedures for the decompression of lumbar spinal stenosis.

Eligibility criteria: Inclusion Criteria:

All patients with two level lumbar stenosis and neurogenic claudication with or without lumbar radiculopathy were eligible for inclusion.

Exclusion Criteria:

Patients were excluded if radiography revealed lumbar instability (motion of \>3mm at the level of listhesis), if they had had previous lumbar spinal surgery, or they had American Society of Anesthesiologists (ASA) class Ⅳ or severe systemic disease.

Primary outcomes:
measure: the cross-sectional area of POSEH
timeFrame: 24 hours after drain withdrawal
Secondary outcomes:
measure: the volume of drain output
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Yiwu
country: China
facility: Zhonglin Zhong
state: Zhejiang
Study officials:
References:
Clinical trial NCT04899791: Positive Effects of Daily Consumption of Bread Enriched With Hydroxytyrosol on the Results of a 12-week Dietary Intervention on Subjects With Type 2 Diabetes Mellitus and Overweight/ Obesity
Official title: Positive Effects of Daily Consumption of Bread Enriched With Hydroxytyrosol on the Results of a 12-week Dietary Intervention on Subjects With Type 2 Diabetes Mellitus and Overweight/ Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Obesity
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
First posted: 2021-05-24
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: TREATMENT

Brief summary: Hydroxytyrosol is a phenolic compound drawn from the olive tree and its leaves as a by-product obtained from the manufacturing of olive oil and has antioxidant and antidiabetic effects. The use of HT extract in food products is a good strategy to improve their nutritional quality. However, this extract has a strong odour and flavour, so it is important to be encapsulated for the odour and flavour to be covered up. The purpose of the study is to investigate the effects of regular consumption of bread enriched with HT on biochemical parameters (blood glucose and cholesterol levels).

Detailed description: Subjects with type 2 diabetes mellitus and overweight/ obesity will participate in the present study. They will follow a 12-week energy-restricted dietary intervention supplemented with a certain amount of bread enriched with hydroxytyrosol. The effects of the dietary intervention on biochemical parameters (blood glucose and cholesterol levels) and body weight reduction will be examined.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus
* bmi : 25-40 kg/ m-2
* normal exercise and dietary habits
* weight stable for at least 3 months before enrollment

Exclusion Criteria:

* HbA1C \> 8.5%
* pregnancy
* chronic medical illness
* regular intense exercise
* alcohol consumption (\> 2 drinks/day)

Primary outcomes:
measure: Change in HbA1C levels
timeFrame: 12 weeks
measure: Change in blood cholesterol levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in body weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens
state: Attiki
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
Study officials:
References:
Clinical trial NCT04544891: TREM-1 Pathway Activation in COVID-19
Official title: Prognostic Significance of the TREM-1 Pathway Activation in COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: University Hospital, Limoges
name: Inotrem
First posted: 2020-09-10
Enrollment: 830
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1000 consecutive COVID-19 patients hospitalized for less than 3 days; among them at least 200 patients hospitalized in ICU (primary admission or secondary transfer from the ward)

Brief summary: Severe Acute Respiratory Syndrome-Corona Virus-2 infection results in a mild infection in most of the patients. However, 15-20% require hospitalization, and among them, 15-20% will develop acute respiratory failure, leading to their admission in Intensive Care Unit. There are no accepted predictive criteria for aggravation. Severe forms of Coronavirus induced disease-19 (COVID-19) are the consequence of endotheliopathy, and hyperinflammatory and pro-coagulant state. The Triggering Receptor Expressed on Myeloid cells-1 (TREM-1) is an immunoreceptor that acts as an amplifier of the inflammatory response. TREM-1 is expressed on myeloid and endothelial cells. Its activation leads to endothelial activation and damage, hyperinflammatory, and pro-coagulant state. TREM-1 activation is associated with poor outcome during septic shock and myocardial infarction.

We here aim at investigating the relationship between TREM-1 pathway activation and clinical degradation and outcome of COVID-19 hospitalized patients.


Eligibility criteria: Inclusion Criteria Consecutive COVID-19 hospitalized patients for less than 3 days

Exclusion Criteria:

No consent Pregnancy protected populations

Primary outcomes:
measure: prognostic value of the TREM-1 pathway activation on clinical worsening
timeFrame: day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHRU Limoges
city: Nancy
country: France
facility: Central hospital
Study officials:
References:
Clinical trial NCT04994691: Effect of Varied Outreach Methods on Appointment Scheduling and Appointment Completion Using MyChart
Official title: Effect of Varied Outreach Methods on Appointment Scheduling and Appointment Completion Using MyChart
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Care Utilization
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 945
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Our objective is to determine the effectiveness of varied outreach methods (e.g. standard versus tailored MyChart messaging) to children age 6-17 years old who are due for a WCC visit and don't have one scheduled in the next 45 days on the outcomes of appointment scheduling and appointment completion.


Eligibility criteria: Inclusion Criteria:

* age 6-17 years
* has not had a well child check in past 365 days
* no future well child check visit scheduled
* parent preferred language = English or Spanish

Exclusion Criteria:

* no active MyChart account

Primary outcomes:
measure: Number of Participants Who Completed Well Child Check Visit
timeFrame: Within 8 weeks of the date of intervention or the date of randomization for the control group
Secondary outcomes:
measure: Number of Participants Who Scheduled an Appointment for a Well Child Check Visit.
timeFrame: Within 8 weeks of the date of intervention or the date of randomization for the control group
measure: Number of Participants Who Received Their First COVID-19 Vaccination
timeFrame: Within 8 weeks of the date of the intervention or the date of randomization for the control group
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Children's
name: William Brinkman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berset AE, Burkhardt MC, Xu Y, Mescher A, Brinkman WB. Effect of Electronic Outreach Using Patient Portal Messages on Well Child Care Visit Completion: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2242853. doi: 10.1001/jamanetworkopen.2022.42853.
Clinical trial NCT03251391: Cardiac Rehabilitation Program in Peripheral Arterial Disease
Official title: To Assess the Safety and Feasibility of a Structured Cardiac Rehabilitation Program in Patients With Peripheral Arterial Disease After Successful Revascularization Procedures: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: revascularization
blocked arteries
leg arteries
leg pain
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main purpose of this study is to see if it is safe and feasible to use cardiac rehabilitation (CR) in patients with peripheral arterial disease (PAD) after successful revascularization. This study will also test if CR improves quality of life and health outcomes in PAD patients.


Eligibility criteria: Inclusion Criteria:

* Patients with PAD post-revascularization (stent, angioplasty, or bypass).
* Patients must have the ability to ambulate safely without assistance and should not have plans for undergoing further staged revascularization procedures.

Exclusion Criteria:

* Below or above the knee amputation.
* Underlying cardiopulmonary or other co-morbidity that would be an exclusion under currently approved standard CR protocols at the University of Kansas Medical Center (KUMC).
* Unfavorable short term prognosis and limited life expectancy (\<2 years)
* Awaiting a planned staged revascularization in same or other leg (patients will be eligible once no further procedures are planned).
* Prior history of having dropped out of CR without completing.
* Unwilling to consent for all aspects of CR or study participation.
* Unable to come for CR (this will exclude patients who live far away or have no means to travel to the CR facility).
* Pregnancy

Primary outcomes:
measure: Change in 6 minute walk test
timeFrame: Change from Baseline to Up to 6 Months
Secondary outcomes:
measure: Short Form Health Survey 36 (SF-36)
timeFrame: Change from Baseline to Up to 6 Months
measure: Short Form Health Survey 36 (SF-36)
timeFrame: Change from Baseline to Week 18
measure: Vascular Quality of Life Questionnaire-6 (VascuQol6)
timeFrame: Change from Baseline to Up to 6 Months
measure: Vascular Quality of Life Questionnaire-6 (VascuQol6)
timeFrame: Change from Baseline to Week 18
measure: Absolute Claudication Distance (ACD)
timeFrame: Change from Baseline to Up to 6 Months
measure: Functional Claudication Distance (FCD)
timeFrame: Change from Baseline to Up to 6 Months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Kamal Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03542591: Supplementation of Critical Nutrients in a Plant-based Diet
Official title: Supplementation of Critical Nutrients in a Plant-based Diet as Assessed by Experts in Nutrition - a Cross-sectional Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deficiency, Vitamin
Vegan's Anemia (Vitamin B12 Deficiency)
Deficiencies Micronutrient
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Participants of the VegMed congress (Berlin, April 2018)
* Expertise of the respondent in the field of nutritional medicine

Brief summary: 500 participants of the vegan/vegetarian congress VegMed are to be included, which should answer once (cross-sectional study) a medicine socio-behaviorist questionnaire on the topic "supplementation of critical nutrients in a plant-based diet" at the VegMed congress on 21/04/2018. The aim of the study is to understand how experts in this field behave and whether actions taken follow official recommendations.


Eligibility criteria: Inclusion Criteria:

* Participants of the VegMed congress (Berlin, April 2018)
* Expertise of the respondent in the field of nutritional medicine
* Presence during the oral education to participate in the survey

Exclusion Criteria:

N/A

Primary outcomes:
measure: Assessment of critical nutrients in vegan diet
timeFrame: 21st April 2018
Secondary outcomes:
measure: Supplementation of critical nutrients in a vegan diet
timeFrame: 21st April 2018
measure: Recommendations for patients by the experts
timeFrame: 21st April 2018
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Study officials:
References:
Clinical trial NCT02253680: The Use of Compression Bandages in Total Knee Replacement Surgery
Official title: A Prospective, Randomised Control Trial Investigating the Use of a Two-layer, Short-stretch Compression Bandage in Elective Total Knee Replacement - Feasibility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Total knee replacement
Enhanced recovery
Compression bandages
Lead sponsor: Northumbria Healthcare NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The use of compression bandages in elective orthopaedic knee surgery is well regarded, however, there is a lack of robust, well-designed evidence to support this.

The aim is to determine the feasibility of conducting a randomised control trial comparing the use of a compression bandage worn post-operatively for 24 hours after elective total knee replacement, compared to standard practice (wool and crepe, non-compressive dressing).


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Able to give written, informed consent
* Primary total knee replacement

Exclusion Criteria:

* Extensive peripheral vascular disease
* Lower limb neurological disorder

Primary outcomes:
measure: Feasibility
timeFrame: 6 months
Secondary outcomes:
measure: Knee range of motion
timeFrame: 6 months
measure: Pain
timeFrame: 6 months
measure: Patient satisfaction
timeFrame: 6 months
Other outcomes:
measure: Knee ROM
timeFrame: 6 months
Locations:
city: Ashington
country: United Kingdom
facility: Wansbeck District General Hospital
state: Northumberland
city: Ashington
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
Study officials:
affiliation: Northumbria NHS Trust
name: Mike Reed, MD FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07003880: Penthrox in Otolaryngology
Official title: Inhaled Methoxyflurane for In-Office Procedures in Otolaryngology
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: All Adult Patients Undergoing an Otolaryngology Procedure With Inhaled Methoxyflurane as an Adjunct to Topical or Local Anesthesia
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients undergoing an otolaryngology proceure in the Otolaryngology clinic of the Jewish General Hospital with inhaled methoxyflurane as an adjunct to topical or local anesthesia

Brief summary: Our objective is to explore the use of methoxyflurane anesthesia as an adjunct analgesic to local anesthesia during in-office otolaryngology procedures in a prospective pilot study. The main outcome of this study will be patient satisfaction with the medication and analgesia. Secondary outcomes will include level of sedation and analgesia, patient-reported post-procedural pain levels, and any reported adverse events.


Eligibility criteria: Inclusion Criteria:

* All adult patients undergoing any of the following procedures with inhaled methoxyflurane as an adjunct to topical or local anesthesia:

  * Skin lesion excision or reconstruction
  * Fine or core needle aspiration biopsy
  * Mucosal biopsy
  * Laryngeal injection or biopsy
  * Myringotomy with or without tympanostomy tube insertion
  * Inferior turbinate reduction
  * Septal button insertion

Exclusion Criteria:

* Patient unable to complete the post-procedure questionnaire (either due to time constraints, neurocognitive impairment, etc.)
* Presence of any contraindications to inhaled methoxyfluorane per product monograph:

  * Patients less than 18 years of age
  * Pregnancy, intended pregnancy, or current breast-feeding
  * Inadequate patient understanding or lack of cooperation
  * Decreased level of consciousness or head injury
  * History of clinically significant renal impairment, e.g., reduced renal output
  * History of liver dysfunction following previous exposure to halogenated anesthetics
  * Current use of tetracycline antibiotics
  * Personal or genetic history of malignant hyperthermia
  * Muscular dystrophy

Primary outcomes:
measure: TSQM-1.4 (Treatment Satisfaction Questionnaire for Medication 1.5)
timeFrame: At first follow-up visit (within 1 month post-procedure)
Secondary outcomes:
measure: Ability to complete intended procedure
timeFrame: At procedure visit
measure: Modified Ramsay Sedation score
timeFrame: At procedure visit
measure: Adverse events
timeFrame: At procedure visit and first follow-up visit (within 1 month post-procedure)
measure: Visual analog pain scale
timeFrame: At procedure visit
Other outcomes:
Locations:
Study officials:
References: