louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03289689: Whole-body Vibration and Manual Ability
Official title: The Acute Effects of Whole-Body Vibration on Manual Ability Performance: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Vibration
Motor Activity
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: To evaluate the short-term effects of whole-body vibration (WBV), using reciprocating plate technique, on manual ability performance in healthy younger.

Material and methods: 38 healthy young volunteers were randomized to WBV group (N=19; 6 men, 13 women; mean age 21, 3.8yrs) or control group (N=19; 6 men, 13 women; mean age 20.5, 3.5yrs). The subjects in the WBV group performed one series of five consecutive repetitions of 60 sec unsynchronised WBV (Zeptoring, Scisen GmbH, Germany; 4 Hz, amplitude 3mm) with a 1-min pause between administrations, three times a week. The controls did not receive any training. Both groups were evaluated at baseline and after intervention, in the Rey Juan Carlos University´s Gait Analysis Laboratory. Four outcome measures of Purdue Pegboard test (PPT): preferred hand (PH), non-preferred hand (NPH), both hands (BH) and assembly (A) was performed baseline and 5 min after intervention.


Eligibility criteria: Inclusion criteria:

- Healthy subjects aged between 18 and 30 years.

Exclusion criteria:

* Contraindication for WBV: pregnancy, recent fractures, malignancies, kidney stones, cardiac pacemaker, infectious disease or recent thromboembolic.
* Subjects with any musculoskeletal o neurological disorders that affected their hands.
* Individuals already treated with WBV were excluded.

Primary outcomes:
measure: Purdue Pegboard test (change)
timeFrame: Baseline, immediately after intervention and one month after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
References:
Clinical trial NCT01507389: Safety of Liraglutide in Subjects With Liver Impairment and in Subjects With Normal Liver Function
Official title: A Single-centre, Open-label Trial Investigating the Pharmacokinetics and the Safety Profile After a Single Dose of Liraglutide in Subjects With Hepatic Impairment and in Subjects With Normal Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate liraglutide in subjects with mild, moderate and severe degrees of hepatic impairment compared with subjects with normal hepatic function.


Eligibility criteria: Inclusion Criteria:

* Subjects with normal hepatic function and liver parameters within normal range
* Subjects with stable hepatic impairment classified as Child-Pugh grade A, B or C
* Body Mass Index between 18.5-40.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Known or suspected allergy to trial product or related products
* Liver transplanted subjects
* Cardiac problems
* Uncontrolled treated/untreated hypertension
* Signs of acute liver insufficiency
* Positive HIV (human immunodeficiency virus) 1+2 antibodies
* Cancer or any clinically significant disease or disorder except for conditions associated with the hepatic impairment
* Impaired renal function
* Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator

Primary outcomes:
measure: Area under the Curve (0-infinity)
Secondary outcomes:
measure: Area under the Curve (0-t)
measure: Cmax, maximum concentration
measure: tmax, time to maximum concentration
measure: t½, terminal half-life
measure: Adverse events
Other outcomes:
Locations:
city: Warszawa
country: Poland
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05109689: A Randomized Controlled Trial of ACT-P Versus T4C for Community Reentry
Official title: A Randomized Controlled Trial of ACT-P Versus T4C for Community Reentry: Differential Efficacy and Mechanisms of Change
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Criminal Behavior
Violence
Keywords: Cognitive behavior therapy
Community reentry
Recidivism
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into either ACT-P or T4C, two group programs that will run simultaneously.
Primary purpose: TREATMENT

Brief summary: The purpose of the proposed study is to determine the efficacy of Acceptance and Commitment Therapy for prisons (ACT-P) and Thinking for a Change (T4C) as reentry programs in a randomized controlled trial (RCT).

Detailed description: The proposed study will focus on medium to high risk adult males, currently institutionalized and approaching release, who will be randomized to Acceptance and Commitment Therapy for prisons (ACT-P) or the Thinking for a Change (T4C) program. ACT-P is a cognitive behavioral treatment that targets acceptance and mindfulness processes to reduce criminal behavior, and has been adapted for the prison setting. T4C is a widely used and well-established traditional cognitive behavioral program that targets changing criminal thinking.

The first aim of the study is to test the relative efficacy of the ACT-P intervention, compared to T4C, on recidivism. Recidivism will be measured in 3 ways: rearrests, reconvictions, and reincarceration during the 3 years post-release. A secondary aim is to test the theory of change and the proposed mechanisms of ACT-P and T4C. By focusing on the mechanisms that account for program success, it will provide insight into the theory of change underlying each program. Based on the theories underlying each treatment, we hypothesize differences in mechanisms of action between the two treatments. Given the emphasis in T4C on cognitive change, we predict stronger mediation effects in T4C for reductions in antisocial/criminal thinking. In contrast, we hypothesize that increases in psychological flexibility would be stronger mediators for ACT-P than for T4C.

Eligibility criteria: Inclusion Criteria:

* deemed medium or high risk according to the Iowa Risk Revised
* eligible and appropriate for cognitive programming as determined by normal operating procedures

Exclusion Criteria:

* court-mandated to either program

Primary outcomes:
measure: Rearrests, convictions, and reincarcerations
timeFrame: 3 years post-release
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Dodge
country: United States
facility: Fort Dodge Correctional Facility
state: Iowa
Study officials:
References:
Clinical trial NCT04247789: The Associated Factors With Fatigue in Older Adults Living in a Rest Home
Official title: The Fatigue in Older Adults Living in a Rest Home: Prevalence and Associated Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatigue
Older People--Abuse of
Keywords: fatigue
physical function
strength
older adults
nursing homes
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 92
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The older adults living in a rest home

Brief summary: Fatigue is an important and prevalent problem in older adults. The ratio of fatigue may rise in older adults who live in nursing homes/rest homes. In the literature, a few studies investigated the prevalence of fatigue, and there is no study explaining the associated factors. The aim of the present study is to investigate the prevalence of fatigue in rest home residents and to determine the associated variables with fatigue.


Eligibility criteria: Inclusion Criteria:

* age older than 65 years
* able to walk with/without walking device
* living at a rest home for at least 12 months
* being voluntary for all assessments

Exclusion Criteria:

* had a cognitive problem (MMSE\<24 scores)
* had a neurologic disorder
* had a cancer history
* had uncontrolled cardiopulmonary dysfunction

Primary outcomes:
measure: Fall Severity Scale (FSS)
timeFrame: 5 minutes
Secondary outcomes:
measure: Strength assessment
timeFrame: 5 minutes
measure: Functional Capacity
timeFrame: 6-10 minutes
measure: Physical Function
timeFrame: 5 minutes
measure: Boddy mass index
timeFrame: 2 minutes
measure: Physical activity habits
timeFrame: 1 minutes
measure: Body mass
timeFrame: 30 seconds.
measure: Body Height
timeFrame: 30 seconds
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Sevim ACARÖZ CANDAN
state: Altinordu
Study officials:
References:
Clinical trial NCT01675089: Zoledronic Acid to Prevent Bone Loss After Kidney Transplantation
Official title: A Prospective and Randomized Trial of Zoledronic Acid to Prevent Bone Loss in the First Year After Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Osteodystrophy
Keywords: bone disease
kidney transplantation
bisphosphonates
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2012-08-29
Enrollment: 34
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: The purpose of this study is to determine whether zolendronic acid, a third generation bisphosphonate, is effective in preventing bone loss in the first year after kidney transplantation.

Detailed description: For the treatment of osteoporosis in the general population, a number of drugs reduce BMD (bone mineral density) loss and the rate of incident fractures. For instance, bisphosphonates improve BMD, reduce hip fracture rates and decrease mortality in post-menopausal women. Because of lack of data on safety and an increased risk of adverse effects, the use of these drugs is controversial in patients with chronic kidney disease (CKD) and abnormalities of PTH or vitamin D, an estimated glomerular filtration rate (GFR) less than 30 ml/min/1.73m² (CKD stages 4 and 5) and after transplantation. The efficacy of short and long term bisphosphonate treatment after kidney transplantation has been examined; however, histomorphometric and fracture rate reduction data are lacking.

The purpose of this study is to determine whether zolendronic acid, a third generation bisphosphonate, is effective in preventing bone loss in the first year after kidney transplantation.

Eligibility criteria: Inclusion Criteria:

* All adult kidney transplant recipients who were stable perioperative and able to return for regular follow-up

Exclusion Criteria:

* Glomerular filtration rate \< 30 ml/min/1.73m² one week after transplantation
* Previous parathyroidectomy or diagnosis of adynamic bone disease (with bone biopsy)

Primary outcomes:
measure: Differences in bone turnover
timeFrame: 1 year
Secondary outcomes:
measure: Bone microarchitecture
timeFrame: 1 year
measure: Changes in Bone Mineral Density
timeFrame: 1 year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Elias David-Neto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06798389: CMSL Ambulatory Sensitive Condition Nudge
Official title: Nurse Follow-up to Reduce Inappropriate Emergency Department Utilization in Adult Patients Seen for Ambulatory Sensitive Conditions in CMSL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Intervention
Emergency Department Visits
Nurse Care Coordination
Keywords: Nudge
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 3016
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The project aims to evaluate a nurse-led intervention to reduce inappropriate emergency department (ED) use among adult patients seen at Geisinger's Community Medicine Service Line (CMSL) clinics. The intervention occurs immediately following an appointment where they received a diagnosis of an ambulatory sensitive condition (ASC). The evaluation will compare eligible patients with an ASC who were randomly assigned to receive follow-up outreach from a nurse (who was automatically prompted via the Epic electronic health record system to initiate outreach) with those who were randomly assigned to receive standard care. Analyses will be intent-to-treat. The primary outcome is ED use in the week following the appointment.


Eligibility criteria: Inclusion Criteria:

* Age 18 years +
* Has a visit in CMSL with an ambulatory sensitive condition (ASC) encounter diagnosis

Primary outcomes:
measure: ED Visit (yes/no)
timeFrame: within 7 days following day of appointment
Secondary outcomes:
Other outcomes:
measure: Nurse call to patient
timeFrame: Within 7 days post-appointment
Locations:
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01376089: Iodixanol Versus Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic Imaging of Abdomen/Pelvis
Official title: A Phase 4 Randomized, Double-blind Study Comparing Patient Comfort and Safety Between Iodixanol 320 mg I/mL and Iopamidol 370 mg I/mL in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patient Comfort and Safety
Keywords: Safety
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: i3 Statprobe
First posted: 2011-06-20
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate and compare overall patient comfort profile between the Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing Contrast-Enhanced Computed Tomographic (CECT) imaging of the abdomen/pelvis.


Eligibility criteria: Inclusion Criteria:

* The subject is over 18 years old.
* Subjects are referred to undergo a CECT imaging of the abdomen/pelvis as part of their routine clinical care.

Exclusion Criteria:

* The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM.
* The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within the 24 hour follow-up period.
* The subject is pregnant.
* The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure.
* The subject manifests thyrotoxicosis or is on dialysis.

Primary outcomes:
measure: Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
timeFrame: Within 10 minutes post contrast administration
measure: Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
timeFrame: Within 10 minutes post contrast administration.
Secondary outcomes:
measure: Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
timeFrame: Ten minutes post contrast administration.
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Lauren Lim, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01409889: Comparing Diabetes Prevention Programs
Official title: Comparative Effectiveness of Practice-Based Diabetes Prevention Programs - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre Diabetes
Diabetes
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the effectiveness and costs of two programs,the Diabetes Prevention Program and the community-developed Healthy Living Program, delivered in an primary care practice.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* diagnosed with pre-diabetes

Exclusion Criteria:

* diagnosed with diabetes
* pregnant or nursing
* unable to walk 2-3 blocks in 10 minutes
* unable to read and speak English

Primary outcomes:
measure: Participant Weight
timeFrame: 22 weeks
Secondary outcomes:
measure: Minutes of Physical Activity
timeFrame: 22 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Anthony Jordan Health Center
state: New York
city: Rochester
country: United States
facility: Rochester General Medical Associates
state: New York
city: Rochester
country: United States
facility: Unity Health System
state: New York
city: Rochester
country: United States
facility: Westside Health Services
state: New York
Study officials:
References:
Clinical trial NCT03050489: Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG
Official title: AMIRI-CABG: Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Coronary Artery Disease
Ischemic Reperfusion Injury
CABG
Keywords: CABG
Off-Pump CABG
On-Pump CABG
ischemic-reperfusion injury during CABG
comparison of On- and Off- Pump CABG
Ischemic Heart Disease
Myocardial ischemia-reperfusion and myeloperoxidase
Myocardial ischemia-reperfusion biomarkers
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2017-02-13
Enrollment: 336
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ischemic heart disease.

Brief summary: Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG.

Detailed description: Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG is monitored by intraoperative measurement of serum level of myeloperoxidase before sternotomy and after sternal closure.

Eligibility criteria: Inclusion Criteria:

* ischemic heart disease

Exclusion Criteria:

* valve disease
* diabetes millitus

Primary outcomes:
measure: Myeloperoxidase
timeFrame: Level of serum myeloperoxidase just after sternal closure
Secondary outcomes:
measure: Low Cardiac Output Syndrome
timeFrame: Up to 30 days after surgical procedure
measure: Length of Stay in Intensive Care Unit
timeFrame: During 30 days after procedure or more
measure: Length of Stay in Hospital
timeFrame: During 30 days after procedure or more
measure: Cumulative Dose of Inotrope
timeFrame: Up to 30 days after procedure
measure: Days of Administration of Inotrope
timeFrame: During 30 days after procedure or more
measure: Pulmonary Ventilation
timeFrame: During 30 days after procedure or more
measure: Systolic Function
timeFrame: Up to 14 days after surgical procedure
measure: Diastolic Function
timeFrame: Up to 14 days after surgical procedure
measure: Number of Participants With Reoperation
timeFrame: Up to 30 days after procedure
measure: Renal Dysfunction
timeFrame: Perioperative (before sternotomy and after sternal closure)
measure: Atrial Fibrillation.
timeFrame: Up to 30 days after procedure
Other outcomes:
measure: Death
timeFrame: During 30 days after procedure
measure: Stroke
timeFrame: During 30 days after procedure
Locations:
city: St. Petersburg
country: Russian Federation
facility: First Pavlov State Medical University of St. Petersburg
Study officials:
affiliation: PSPbGMU
name: Alexander S Nemkov, PhD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03028389: Effects of Limb Remote Ischemic Preconditioning for Prevention of Delirium in Elderly Patients After Non-cardiac Surgery
Official title: Effects of Limb Remote Ischemic Preconditioning for Prevention of Delirium in Elderly Patients After Non-cardiac Surgery:a Randomised, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elderly Patients
Non-cardiac Surgery
Keywords: elderly patients
non-cardiac surgery
ischemic preconditioning
delirium
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 611
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate whether limb remote ischemic preconditioning (LRIP) could safely decrease the incidence of delirium in elderly patients after non-cardiac surgery.

Detailed description: Remote ischaemic preconditioning may confer the cytoprotection in critical organs. We hypothesized that limb remote ischemic preconditioning (RIPC) would safely decrease the incidence of delirium in elderly patients after non-cardiac surgery.The primary outcomes included the incidence of delirium in the first 7 days after surgery using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.The quality of recovery over a 6-month period was evaluated as well.Secondary endpoints included length of stay in the hospital after surgery (from day of surgery to hospital discharge), occurrence of non-delirium postoperative complications, and all-cause 6-month mortality.

Eligibility criteria: Inclusion Criteria:

* elderly patients received elective non-cardiac surgery with general anesthesia
* anticipated surgery time \> 2 hours

Exclusion Criteria:

* age \< 65 years old
* Acute coronary syndrome or myocardial infraction within 3 months
* Chronic obstructive pulmonary emphysema
* Serious hepatic dysfunction (Child-Pugh class C)
* serious renal dysfunction (undergoing dialysis before surgery)
* Ejection fraction less than 40%
* Poor pulmonary function (PaO2 \<60mmHg)
* Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis
* Inability to communicate in the preoperative period (coma, profound dementia, or language barrier)
* Brain injury or neurosurgery

Primary outcomes:
measure: the incidence of delirium
timeFrame: in the first 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nanfang Hospital, the Southern Medical University
name: Ke-Xuan Liu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: