louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07015112: Applying a Multidisciplinary Intervention for Drug Adequacy in an Intermediate Care Hospital (AMIDA-ICH)
Official title: Applying a Multidisciplinary Intervention for Drug Adequacy in a Intermediate Care Hospital (AMIDA-ICH)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Poly Pharmacy
Frail Elderly
Keywords: polypharmacy
frailty
adverse drug event
deprescribing
Lead sponsor: Parc Sanitari Pere Virgili
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped-wedge
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if a multi-professional (conducted by geriatricians, clinical pharmacists, nurses) medication revision, centered on patients' goals and characteristics, can improve treatment adequacy in older adults admitted to an intermediate care hospital.

The main question it aims to answer is: does this approach reduce the average number of medications taken per patient?

Researchers will compare this multi-professional patient-centered revision to the usual standard of care (treatment revision conducted by a clinical pharmacist) to see if the patient-centered revision works in improving treatment adequacy.

Participants admitted to an intermediate care hospital will undergo a comprehensive assessment by a geriatrician, and a medication revision (conducted by a multidisciplinary team or a clinical-pharmacist alone). They will also be asked to fulfill some questionnaires on their health status and attitudes. Any possible adverse events to the medications will be recorded at discharge. Participants will be contacted again three months after discharge to check for any readmission or death.


Eligibility criteria: Inclusion Criteria:

* older adults (65+ years)
* ≥ 3 or more chronic conditions requiring medical therapy
* able to speak Spanish
* capacity to provide informed consent or have a surrogate able to consent on their behalf

Exclusion Criteria:

* unable to provide informed consent
* anticipated length of hospital stay \< 72h
* estimated life expectancy \< 3 months
* homeless
* already enrolled in a drug trial

Primary outcomes:
measure: Number of drugs
timeFrame: Baseline and after discharge, an average of 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Parc Sanitari Pere Virgili
Study officials:
References:
Clinical trial NCT02466412: Nicotine Pharmacokinetic Profile of the CHTP 1.1 M
Official title: A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: smoking
nicotine absorption
potential modified risk tobacco product
cigarette
Carbon Heated Tobacco Product
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2015-06-09
Enrollment: 56
Sex: ALL
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile of nicotine (rate and amount of nicotine absorbed) after single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M), a potential Modified Risk Tobacco Product, compared to menthol cigarettes (mCC) in healthy smokers.


Eligibility criteria: Inclusion Criteria:

* Subject is Japanese.
* Subject is at a minimum 23 years of age.
* Smoking, healthy subject as judged by the Investigator.
* Subject has smoked for at least the last 3 years
* Subject smoked at least 10 commercially available mCCs per day over the last 4 weeks.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* Subject has received medication within 14 days or within 5 half-lives of a drug (whichever is longer) which has an impact on CYP2A6 activity.
* Female subject is pregnant or breast feeding.
* Female subject does not agree to use an acceptable method of effective contraception.

Primary outcomes:
measure: Maximum Concentration (Cmax) of Nicotine Following Single Use of CHTP 1.1 M and mCC
timeFrame: Day 3: blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0.
measure: Area Under the Plasma Concentration Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of CHTP 1.1 M and mCC
timeFrame: Day 3: blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0.
Secondary outcomes:
Other outcomes:
Locations:
city: Saitama
country: Japan
facility: Ageo Medical Clinic
Study officials:
affiliation: Philip Morris Products S.A.
name: Christelle Haziza, PhD
role: STUDY_CHAIR
affiliation: Ageo Medical Clinic
name: Fumimasa Nobuoka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05871112: Femoral Rotation and Patellar Positioning After TKA
Official title: Establishing Femoral Component Rotation Using a Dynamic Tensioner Does Not Improve Patellar Position After Total Knee Replacement With Use of Anatomic Implants - Matched-cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Joint Pain
Joint Instability
Patella Disorder
Knee Pain Chronic
Prosthetic Complication
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 125
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive series of patients in age over 60 with 3rd/4th grade of Kellgren - Lawrence osteoarthritis scale.

Brief summary: Analysis of patellar positioning in the trochlear groove after TKA with and without the use of dynamic tensioner.

Detailed description: It appears that by precisely adjusting femoral component rotation and its relation to soft tissues in the area we can achieve better function of the patellofemoral joint and thus reduce the occurrence of anterior knee pain. Achieving proper femoral component rotation is challenging, as the bony landmarks are difficult to identify. This goal may be accomplished by using a dynamic tensioner - a device that intraoperatively measures joint gap stiffness in extension and 90 degrees flexion. This is especially important in knees with high grade arthritis and limb malalignment, where ligaments' and tendons' efficiency is affected.The aim of this study was to analyze patella positioning in the trochlear groove on CT scans of patients undergoing TKR with use of a dynamic tensioner and compare it to the ones undergoing standard measured-resection technique. Secondary outcome was to assess the frequency of anterior knee pain, range of motion and patient-reported outcome 3 and 12 months after the surgery.

Eligibility criteria: Inclusion Criteria:

* age over 60
* BMI \< 40
* ablity to walk for 10meters
* leg length discrepancy \<5mm
* knee flexion \> 90 degrees
* hip extension \< 0 degrees
* hip flexion \> 90 degrees
* III / IV level of osteoarthritis in Kellgren - Lawrence scale

Exclusion Criteria:

* varus/valgus/ fixed flexion deformity \> 15 degrees
* revision TKA
* prior UKA

Primary outcomes:
measure: Patella positioning in the trochlear groove on computed tomography (CT) after TKR
timeFrame: January 2021 - August 2021
Secondary outcomes:
measure: Range of motion after TKR
timeFrame: January 2021 - January 2022
measure: Patient-reported outcome after TKR
timeFrame: January 2021 - January 2022
measure: Prevalence of anterior knee pain after TKR
timeFrame: January 2021 - January 2022
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Othopedics and Rehabilitation, Medical University of Warsaw
state: Mazovian
Study officials:
References:
Clinical trial NCT01295112: Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab for Central Retinal Vein Occlusion
Official title: Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab Therapy for Non-Ischemic Central Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Non-Ischemic Central Retinal Vein Occlusion
Lead sponsor: Texas Retina Associates
Sponsor class: OTHER
First posted: 2011-02-14
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study designed to determine if the addition of Ozurdex® to bevacizumab (Avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.

Detailed description: This is a multicenter clinical study designed to determine if the addition of Ozurdex® injection to bevacizumab (Avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.

Eligibility criteria: Inclusion Criteria:

1. male or female subjects (aged 18 or older);
2. provide written informed consent and sign/date a health information release;
3. women of childbearing potential must be willing to practice effective contraception for the duration of the study.

Exclusion Criteria:

1. any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results;
2. use of systemic steroids within 1 month prior to Baseline Visit (Visit 1) or anticipated use at any time during the study (inhaled and intranasal steroids are allowed);
3. sitting systolic blood pressure equal to or greater than 160 mmHg or diastolic blood pressure equal to or greater than 100 mmHg at the Baseline Visit (Visit 1);
4. use of warfarin, heparin, enoxaparin or similar anticoagulants within 2 weeks prior to Baseline Visit (Visit 1) or anticipated use at any time during the study;
5. known allergy or hypersensitivity to the study medications or their components;
6. previous enrollment in an Ozurdex® clinical trial or previous use of an Ozurdex® implant.

Primary outcomes:
measure: The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
Study officials:
affiliation: Texas Retina Associates
name: Karl Csaky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04926012: Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Cardiovascular Surgery
Official title: Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Cardiovascular Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Death
Keywords: Postoperative death
Cardiovascular surgery
Prediction model
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
name: Henan Provincial People's Hospital
name: Xiangya Hospital
name: Shanxi Bethune Hospital
First posted: 2021-06-14
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients Undergoing Cardiovascular Surgery

Brief summary: The investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after cardiac and vascular surgery.

The investigators identify all patients treated with cardiovascular surgery, between 2000 and 2020, within the Wuhan Union hospital and all collaborators. The surgical patient cohort will be matched with the National Death database to determine the patient's postoperative death data.

60% patients were randomly selected to the development cohort. Logistic regression analysis for prediction of postoperative death adjusted for different covariates. The model was externally validated in the remaining 40% patients.


Eligibility criteria: Inclusion Criteria:

* Patients Undergoing Cardiovascular Surgery

Exclusion Criteria:

* Patients with incomplete electronic medical record information

Primary outcomes:
measure: Postoperative Death
timeFrame: The mortality within 5 years after the cardiovascular surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention
state: Beijing
city: Zhengzhou
country: China
facility: Henan People's Hospital, Henan, China
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital, Hunan, China
state: Hunan
city: Taiyuan
country: China
facility: Shanxi Bethune hospital, Shanxi, China
state: Shanxi
Study officials:
References:
Clinical trial NCT02916212: Quality Improvement - Monitoring Alarm Optimization Study
Official title: Quality Improvement - Monitoring Alarm Optimization Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: No Applicable Condition; Study of Physiologic Monitor Alarms
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-09-27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project aims to reduce the frequency of duplicate, false and clinically insignificant alarms in hospital units, and subsequent alarm fatigue resulting from excessive alarm frequency. The investigators will implement evidence-based guidelines for alarm optimization according to patient-population specific parameters, and evaluate alarm frequency and staff perception of alarm fatigue at baseline and 60 days after implementation of this quality improvement initiative.


Eligibility criteria: Inclusion Criteria:

* Nursing staff at selected units at Duke University Hospital

Exclusion Criteria:

* NA

Primary outcomes:
measure: Change from baseline of frequency of total alarms by hospital unit at 60 days
timeFrame: At baseline and 60 days following implementation
Secondary outcomes:
measure: Change from baseline of number of alarms per bed
timeFrame: At baseline and 60 days following implementation
measure: Change from baseline of number of alarms per day per bed
timeFrame: At baseline and 60 days following implementation
measure: Change from baseline of perceived alarm fatigue, assessed using a questionnaire
timeFrame: At baseline and 60 days following implementation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04693312: Injection of Dorsal Scapular n at Different Levels, Dose it Make Difference?
Official title: Injection of Dorsal Scapular n at Different Levels, Dose it Make Difference?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain, Chronic
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dorsal scapular nerve (DSN) entrapment syndrome is an under-recognized cause of neck and shoulder pain. DSN injuries can be the origin of a well-defined chronic pain syndrome, often referred to as DSN syndrome. DSN syndrome is often characterized by a dull ache along the medial border of the scapula.

Detailed description: Dorsal scapular nerve syndrome typically presents with a weakness of the levator scapulae and the rhomboid muscles, and results in a winged scapula. A winged scapula is where the scapula protrudes from the patient's back and can affect the ability to lift objects or pull and push. The winging of the scapula seen with dorsal scapular nerve syndrome is not as severe as seen as injury or paralysis of the serratus anterior muscle.

Dorsal scapular nerve entrapment is a very under-recognized cause of neck and shoulder pain. The scapular winging may be subtle, and the symptoms are easily mistaken for other problems. A careful history and physical exam, along with a high index of suspicion, are necessary for accurate diagnosis and therefore appropriate treatment. Injection of the dorsal scapular nerve under ultrasound guidance can be diagnostic as well as therapeutic.

Eligibility criteria: Inclusion Criteria:

* scapular pain

Exclusion Criteria:

* cervical radiculopathy

Primary outcomes:
measure: scapular pain
timeFrame: 3 months
Secondary outcomes:
measure: movement pain
timeFrame: 3 months
measure: fatigue
timeFrame: 3 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut governorate
Study officials:
affiliation: assistant professor
name: Manal Hassanien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04347512: EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA
Official title: EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Sars-CoV-2, Community-Acquired Pneumonia,COVID-19
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 0
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: Since end of December, a new coronavirus, close to the 2002 SARS coronavirus, cause serious pneumonias throughout world. There is currently no strong evidence of an efficient specific treatment. Hydroxychloroquine is an old chloroquine-derived drug, prescribed for auto-immune disorders. It has shown efficacy against Sars-CoV-2 in vitro. Some studies showed that Hydroxychloroquine might improve the clinical status of Sars-CoV-2 infected patients. Azithromycin is a macrolide antibiotic, with immunomodulatory properties. Adding Azithromycin to a hydroxychloroquine-based treatment showed an apparent accelerated viral clearance in infected patients. This study wants to evaluate the clinical impact of adding Azithromycin to Hydroxychloroquine in the treatment of Sars-CoV-2 pneumonia


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Positive Sars-CoV-2 RT-PCR on nasopharyngeal swab
* CT scan suggestive of Sars-CoV-2 pneumonia

Exclusion Criteria:

* Negative Sars-CoV-2 RT-PCR on nasopharyngeal swab
* Known hypersensitivity to Hydroxychloroquine, Azithromycin or a macrolide family member
* Long term prescribed treatment contraindicated with azithromycin (colchicine, ergotamine, dihydroergotamine) and/or hydroxychloroquine (citalopram, escitalopram, hydroxyzine, domperidone, piperaquin)
* Retinopathy or maculopathy
* Porphyria
* Severe renal failure (GFR less than 30 mL/min/m²)
* Dyskaliemia, (ie less than 3,5 mmol/L or more than 5,5 mmol/L)
* Hypomagnesiemia, ie less than 0,7 mmol/L
* Severe cholestasis, cirrhosis or severe hepatic failure
* Known cardiac medical history of congestive heart failure or myocardial infarction
* Bradycardia less than 50 beats per minute
* Prolonged corrected QT interval, (ie cQT more than 440 ms in men and 450 ms in women) or medical history of ventricular cardiac rhythm disorders
* Blood disorders with history of hematopoietic stem cells allograft
* Known history of G6PD deficiency
* Pregnancy
* Breastfeeding
* Subject protected by law under guardianship of curatorship
* Inability to take oral medications

Primary outcomes:
measure: Rate of patients reaching a significant hypoxemia, in each arms.
timeFrame: From day 0 to day 7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01908712: Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients
Official title: A Multi-center, Un-controlled, Open-labeled Trial of the Long-term Safety of Lamazym Aftercare Treatment of Subjects With Alpha-Mannosidosis Whom Previously Participated in Lamazym Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alpha-Mannosidosis
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2013-07-26
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall objective of this trial is to provide aftercare treatment with Lamazym and to evaluate the safety of repeated Lamzede i.v. treatment of subjects with alpha-Mannosidosis.

Detailed description: This trial provide aftercare treatment with Lamzede to French patients.

Eligibility criteria: Inclusion Criteria:

* the subject must have participated in previous Lamazym-trials: phase 2b: 2011-004355-40 or phase 3: 2012-000979-17
* Subject or subjects legally authorized guardian(s) must provide signed, informed consent prior to performing any trial-related activities
* The subject and his/her guardian(s) must have the ability to comply with the protocol

Exclusion Criteria:

* Presence of known clinically significant cardiovascular, hepatic, pulmonary, or renal disease or other medical conditions that, in the opinion of the Investigator, would preclude participation in the trial
* Any other medical condition or serious intercurrent illness, or extenuating circumstances that, in the opinion of the Investigator, would preclude participation in the trial
* Pregnancy. Pregnant woman is excluded. Before start fot he treatment the investigators will for women of childbearing potential perform a pregnancy test and decide whether or not there is a need for contraception
* Psychosis; any psychotic disease, also in remission, is an exclusion criteria
* Planned major surgery that, in the opinion of the Investigator, would preclude participation in the trial
* Adult patients who, in the opinion of the Investigator, would be unable to give consent, and who does not have any legal protection or guardianship
* total IgE \> 800 IU/mL
* Known allergy to the IMP or any excipients (Sodium-Phosphate, Glycine, Mannitol)

Primary outcomes:
measure: Change from baseline in Adverse events
timeFrame: 3 year
measure: Change from baseline in Lamazym antibodies
timeFrame: 3 year
Secondary outcomes:
measure: progress from baseline in number of steps climbed in 3 minutes
timeFrame: 1 year, 2 year and 3 year
measure: Progress from baseline in equivalent age
timeFrame: 1 year, 2 year and 3 year
measure: Progress from baseline in Forced Vital Capacity
timeFrame: 1 year, 2 year and 3 year
measure: Progress from baseline in distance walked in 6 minutes
timeFrame: 1 year, 2 year and 3 year
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mére Enfant - CHU de Lyon
Study officials:
References: