louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01404403: Safety Study of the Rapid System for Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Ischemic Stroke
Lead sponsor: Rapid Medical
Sponsor class: INDUSTRY
First posted: 2011-07-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a safety study of the Rapid System for acute ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* Patients ≥18 to \<85 years old
* Pre stroke modified Rankin Scale (mRS) of ≤2
* A signed informed consent by patient or a legally acceptable representative

Exclusion Criteria:

* Pre-stroke life expectancy of less than 6 months
* Current participation in another investigational drug or device study
* Pregnancy

Primary outcomes:
measure: Percentage of participants with Adverse Device Effects (ADEs) Percentage of participants with Adverse Device Effects (ADEs)Percentage
timeFrame: 12 patients
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Hospital
state: Solna
Study officials:
References:
Clinical trial NCT04559503: Progressive Relaxation Exercises in COPD
Official title: The Effect of Progressive Relaxation Exercises on Dyspnea and Anxiety Levels in Individuals With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Dyspnea
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
Collaborators: name: TC Erciyes University
First posted: 2020-09-23
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: This study aimed to determine the effect of progressive relaxation exercises (PMR) on dyspnea and anxiety level in individuals with COPD Methods: The study was conducted in the pretest-posttest randomized-controlled trial and completed with 44 COPD individuals, 22 interventions and 22 controls. PMR were applied once a day for four weeks in the intervention group in addition to the standard treatments. The control group received standard treatment.

Detailed description: Background: This study aimed to determine the effect of progressive relaxation exercises (PMR) on dyspnea and anxiety level in individuals with COPD Methods: The study was conducted in the pretest-posttest randomized-controlled trial and completed with 44 COPD individuals, 22 interventions and 22 controls. PMR were applied once a day for four weeks in the intervention group in addition to the standard treatments. The control group received standard treatment. For data collection Questionnaire Forms, Patient Follow-Up Schedules, Modified Borg Scale (MBS), Modified British Medical Research Council Dyspnea Scale (mMRC), COPD Assessment Test (CAT), and Beck Anxiety Scale were used.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with COPD,
* Must be able to competence to answer the questionnaire questions,
* Must be able to communicate verbally,
* Over 18 years of age,
* To have 2nd or 3rd grade COPD according to the GOLD Guide Staging System,
* To have 2 or more severe dyspnea according to the mMRC Dyspnea Scale,
* No medication changes have been made in the last three months,
* Not having received pulmonary rehabilitation in the last 6 months,

Exclusion Criteria:

* To have severe psychological disorders,
* To have non-COPD pulmonary diseases,
* To have cancer,
* To have renal failure,
* To have thyroid dysfunction,
* To have liver dysfunction

Primary outcomes:
measure: Modified Borg Scale
timeFrame: change from baseline score at the end of four weeks
measure: Modified British Medical Research Council Dyspnea Scale
timeFrame: change from baseline score at the end of four weeks
measure: COPD Assessment Test
timeFrame: change from baseline score at the end of four weeks
measure: Beck Anxiety Scale
timeFrame: change from baseline score at the end of four weeks
measure: Patient Follow-Up Schedule
timeFrame: change from baseline score at the end of four weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03371303: Analysis of Changes in Medication Prescriptions After Hospitalization for 4 Disciplines: Gerontology, Diabetology, Cardiology and Rheumatology: Medical, Pharmaceutical and Economic Aspects
Official title: Analysis of Changes in Medication Prescriptions After Hospitalization for 4 Disciplines: Gerontology, Diabetology, Cardiology and Rheumatology: Medical, Pharmaceutical and Economic Aspects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Cardiac Disease
Rheumatic Diseases
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients must be hospitalized in one of the services of a university hospital, in the following 4 disciplines: diabetology, geriatrics, cardiology and rheumatology

Brief summary: The modifications of the medicinal treatments secondary to the hospitalizations have multiple reasons: reassessment of the previous treatment (conciliation), new therapeutic necessities, potential risk of iatrogeny or of drug interaction, restrictions of the therapeutic booklet, classification in reserve or hospital prescription ... These modifications are potentially generating extra costs for the Health Insurance and are monitored under the terms of the Contract of Good Use. The aims of this analysis are to define the medical-pharmaceutical rationale of the treatment changes imposed by hospitalization in a university-hospital center, their influence on the security of the medical treatment of patients and their financial implications for healthcare organizations


Eligibility criteria: inclusion criteria

* Patient social insured
* Patient belonging to the general social security scheme
* Patient followed in cardiology, rheumatology, geriatrics or diabetology departments

no exclusion criteria

Primary outcomes:
measure: entry orders before hospitalization
timeFrame: 15 months
measure: exit orders after hospitalization
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
References:
Clinical trial NCT02621203: Patient Journey in Hospital With Acute Heart Failure
Official title: Investigate to Medications, Re-hospitalization and Mortality of Patients With Hospitalized Acute Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital-based registry of patients with acute heart failure (AHF) those whose care was guided by a cardiologist in Turkey.

Brief summary: A multicentre, prospective, observational, hospital-based registry of patients with acute heart failure (AHF) those whose care was guided by a cardiologist in Turkey.

Detailed description: The purpose of this study is to compose a national database of the etiologies, clinical and demographic characteristics, using diagnostic tests, precipitating and risk factors, management of from intensive care unit (ICU) or coronary care unit to hospital discharge, length of stay in the ICU and hospital, in-hospital mortality and discharge medications of hospitalized AHF patients in Turkish population.

The etiologies, precipitating factors, demographics, clinical characteristics, management and outcome of patients admitted in hospital with acute heart failure in Turkish population will be recorded.

Eligibility criteria: Inclusion Criteria:

* Patients \>18 years old
* Clinical diagnosis of acute heart failure
* Admitted to the participating hospitals

Exclusion Criteria:

* Patients \<18 years old
* Patients with acute heart failure who are discharged from the emergency room without admission.
* Failure to obtain informed consent

Primary outcomes:
measure: all cause mortality
timeFrame: 3 months
Secondary outcomes:
measure: Hospitalization
timeFrame: 3 months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Dr. Ahmet ekmekçi
Study officials:
affiliation: mehdi_zoghi@hotmail.com
name: Mehdi Zoghi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05269303: Wearable Monitoring Device in Daily Lives of Community-dwelling Older Adults
Official title: Optimizing the Health-related Functions of a Wearable Monitoring Device in the Daily Life of Community-dwelling Older Adults: A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Device Ineffective
Keywords: community-dwelling older adults
Wearable monitoring device
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 72
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to implement an intervention program to promote the continued use of Wearable Monitoring Devices among older adults through a peer support approach facilitating the incorporation of Wearable Monitoring Devices in daily life.


Eligibility criteria: Inclusion Criteria:

* aged 60 or above
* own a smartphone
* able to communicate in Cantonese or Mandarin
* able to access the Internet at home or elsewhere

Exclusion Criteria:

* have a confirmed diagnosis of cognitive impairment
* bed-bound
* currently own a wearable monitoring device
* have already engaged in other wearable device studies

Primary outcomes:
measure: The change of use intention of wearable monitoring device
timeFrame: Data collection will be conducted at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
Secondary outcomes:
measure: The change of adherence rate of wearing wearable monitoring device
timeFrame: Data collection will be conducted at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
measure: The change in quality of life among baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
timeFrame: baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
measure: The change of health service utilization among baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
timeFrame: baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
measure: Recruitment rate
timeFrame: baseline pre-intervention
measure: Attrition rate
timeFrame: 6-month (T3) time points
measure: Incidence of reports of adverse events
timeFrame: 6-month (T3) time points
measure: Incidence of reports of technical difficulties
timeFrame: 6-month (T3) time points
measure: The change of perceived usability of the wearable monitoring device before and after the program
timeFrame: baseline pre-intervention, 6-month (T3) time points
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Siu Sai Wan
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Arkers Wong, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03675503: Reducing Hospital Falls by Empowering Nurses to Provide Ambulatory Aids
Official title: Reducing Hospital Falls by Empowering Nurses to Provide Ambulatory Aids: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Accidental Falls
Harm Reduction
Keywords: Fall Prevention
Hospital Acquired Conditions
Nurse Education
Assistive Devices
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project proposes to evaluate the potential for nurses to assess if a patient who uses an ambulatory aid at home is fit to use one in the hospital, and the effect that providing ambulatory aids to hospitalized patients will have on reducing hospital falls, with a matched pair cluster-randomized controlled trial.

Hypothesis 1: Of the patients who use an ambulatory aid at home, patients who receive an ambulatory aid in the hospital will have a lower fall rate as compared to patients who do not receive an ambulatory aid in the hospital.

Hypothesis 2: After adequate training, nurses will be able to accurately assess whether or not patients need an ambulatory aid when compared to the gold-standard assessments of physical therapists.

Detailed description: This research project proposes to study the effectiveness of a specific falls prevention intervention in a high risk population by providing ambulatory aids upon admission to the hospital to patients who previously used one at home after a standardized evaluation by a Registered Nurse. This will be a randomized controlled trial within three hospitals in a large academic medical center.

Primary Objectives:

Specific Aim 1: Evaluate the effectiveness in preventing falls by providing an ambulatory aid to patients who use an ambulatory aid at home, and who are deemed fit to use the device in the hospital by their nurse.

Specific Aim 2: Evaluate the nurses' ability to assess the appropriateness of providing an ambulatory aid, such as a cane or walker, to a patient who uses an assistive device at home.

Eligibility criteria: Inclusion Criteria:

* any one determined to be in need of walking aid and
* Can stand up from a seated position independently without assistance
* Can use ambulatory aid at home without assistance/supervision
* Can sit up in bed AND rise to a standing position independently

Exclusion Criteria:

* Not able to give consent
* Not able to use ambulatory aid independently

Primary outcomes:
measure: Change in Number Falls
timeFrame: Baseline and Six months after study
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine Montefiore Medical Center
name: Mary S Ellen Lindros
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03458403: Endoscopist and Endoscope Motions During Digestive Endoscopy
Official title: Endoscopist and Endoscope Motions During Digestive Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scheduled Gastroscopy Under Sedation
Keywords: Digestive endoscopy
Tracking motion
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements in flexible endoscopy.

Detailed description: The increasing development of interventional digestive endoscopy raises the challenge to teach and learn complex endoscopic procedures. Nowadays experts are facing the challenge of explaining precisely an elaborate choreography of movements performed during the procedure, while novices are confronted with a broad range of hand, wrist and shoulder movements each resulting in different endoscope responses. The teaching strategy of endoscopy could benefit from a dedicated motion library that would associate the endoscopist's motion and the consequent endoscope response. A simplified endoscopic language made of individual motions could greatly shorten the learning curve.

The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements in flexible endoscopy.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old
* Patient who are scheduled for a gastroscopy procedure under sedation
* Patient able to understand the study and provide written informed consent
* Patient affiliated to the French social security system.

Exclusion Criteria:

* Patient with an altered upper GI anatomy due to previous surgery
* Patient with a known anomaly of the upper GI anatomy
* Patient carrying an implantable medical device (pacemaker...)
* Patient with a condition preventing its participation to study procedures, according to investigator's judgment
* Pregnancy or breastfeeding
* Patient in custody
* Patient under guardianship

Primary outcomes:
measure: Body motions recording
timeFrame: At time of endoscopy
measure: Endoscope motions recording
timeFrame: At time of endoscopy
measure: Endoscope wheels rotation recording
timeFrame: At time of endoscopy
measure: Endoluminal images recording
timeFrame: At time of endoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Study officials:
affiliation: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
name: Silvana Perretta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kranzfelder M, Wilhelm D, Doundoulakis M, Schneider A, Bauer M, Reiser S, Meining A, Feussner H. A probe-based electromagnetic navigation system to integrate computed tomography during upper gastrointestinal endoscopy. Endoscopy. 2014 Apr;46(4):302-5. doi: 10.1055/s-0033-1358814. Epub 2013 Nov 19.
Clinical trial NCT01881503: Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia
Official title: Expanded Access Protocol for the Treatment Use of HBOC-201
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Anemia
Keywords: life-threatening anemia
blood alternative
HBOC
Lead sponsor: Englewood Hospital and Medical Center
Sponsor class: OTHER
Collaborators: name: HbO2 Therapeutics LLC
First posted: 2013-06-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this expanded access study is to be able to provide treatment with HBOC-201 to patients with life-threatening anemia for whom blood is not an option.

HBOC-201 is not FDA approved for use in the United States, but is approved as an oxygen carrier in South Africa and Russia.

Detailed description: i. Initial Dose

For patients with a hemoglobin level less than 6 mg/dl, an initial dose of 32.5 g (one unit) of HBOC 201 is recommended, to be followed by infusion of additional units as necessary to achieve and maintain a total hemoglobin concentration above 6 g/dl, provided that the patient's circulatory volume is properly controlled and will not impose an inappropriate risk.

ii. Subsequent Doses

The need for additional dose administration should be assessed after each infusion as clinically indicated.

Dosing will be stopped if any one of the following occurs:

* resolution of critical ischemia
* death
* recovery of native Hemoglobin levels to \> 6 g/dL,
* evidence of reticulocytosis

Eligibility criteria: Inclusion Criteria:

1. Patients \> = 18 years of age
2. Patients with hemoglobin \< = 8g/dL with with active bleeding, physiologic evidence of critical ischemia, for example: elevated troponins, altered mental status, acute renal failure, lactic acidosis or central nervous system supply dependency
3. Patients or their Legally Authorized Representatives who are able and willing to provide informed consent

Exclusion Criteria:

1. Patients with known hypersensitivity or allergy to beef products
2. Patients with pre-existing uncontrolled hypertension, heart failure, renal failure, circulatory hypervolemia or systemic mastocytosis (on a case by case and quality of life determination)
3. Patients \> 80 years of age (on a case by case and quality of life determination)
4. Patients who are eligible for blood transfusions

Primary outcomes:
measure: survival
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
Study officials:
affiliation: Englewood Hospital and Medical Center
name: Carmine Gianatiempo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05149703: Efficacy of Postural Reeducation in Elite Gymnasts With Back Pain
Official title: Efficacy of Postural Reeducation in Elite Gymnasts With Back Pain. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Back Strain Lower Back
Athletic Injuries
Keywords: Physiotherapy
Rehabilitation
Treatment
Isostretching
Postural treatment
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Low back pain is a musculoskeletal disorder that is associated with symptoms such as pain, limitation of joint range and postural problems in athletes. Methods: The study design is a randomized controlled clinical trial with a minimum of 35 elite gymnasts with back pain. Two postural treatments will be implemented, Mezieres Method and Isostretching to verify if there is improvement of back pain in gymnasts and to compare both procedures. Discussion: This trial could generate a greater understanding of the importance of posture related to low back pain and its possible treatments.

Detailed description: A randomized controlled clinical trial with two groups (intervention and placebo) will be implemented. The intervention group will have the Mezieres technique as postural treatment while the placebo group will follow a total of 6 isostretching positions.

In total, the two treatments with 30 minutes and duration or with a frequency of 2 weekly sessions will be implemented for a period of 12 weeks. All treatments will be performed by the same certified therapist and with a minimum of 5 years of experience in postural treatments. The measurements will be made immediately after the first session, in 2 weeks, 6 weeks and in the last week of intervention by a blind researcher who did not participate in the treatments, but with experience in this field.

Eligibility criteria: Inclusion Criteria:

* Elite gymnastic athletes with low back pain
* Active participation in the national competition
* Practice at least three times a week for 60 minutes
* Minimum training time of 7 hours a week

Exclusion Criteria:

* Gymnast whom suffer from chronic disease or acute musculoskeletal injury
* Herniated disc
* Spondylolisthesis

Primary outcomes:
measure: Back status
timeFrame: 12 weeks
measure: Back disability
timeFrame: 12 weeks
measure: Range of motion
timeFrame: 12 weeks
measure: Pain intensity
timeFrame: 12 weeks
Secondary outcomes:
measure: Subjetive tension perception
timeFrame: 12 weeks
measure: Spinal curvature evaluation
timeFrame: 12 weeks
measure: Stiffness test
timeFrame: 12 weeks
measure: Posture stability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad Católica de Murcia
Study officials:
affiliation: Universidad Católica San Antonio de Murcia
name: Juan Martínez Fuentes
role: PRINCIPAL_INVESTIGATOR
References: