louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00892905: Comparing Point of Care Clotting Tests in the OR Versus Standard Laboratory Clotting Tests
Official title: Comparison Between Point of Care INR and aPTT Hemochron Jr Whole Blood Measurement With Standard Laboratory in Patients Having Elective First Time on Pump Coronary Artery Bypass Grafting (CABG)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Bypass Grafting
Keywords: coagulation
INR
aPTT
point of care
laboratory
CABG
surgery
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2009-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient undergoing elective on pump CABG

Brief summary: The purpose of this study is determine the agreement of point of care (POC) clotting tests (INR and aPTT) by the POC device by Hemochron Jr versus standard laboratory clotting tests (INR and aPTT) in patients undergoing elective cardiac surgery.

Detailed description: The study is a correlation between POC Hemochron Jr INR and aPTT with the standard.

Eligibility criteria: Inclusion Criteria:

* did not receive anticoagulants or clopidogrel within 5 days preoperatively

Exclusion Criteria:

* history of coagulopathy
* heparin resistance
* receiving heparin or warfarin
* hepatic or renal dysfunction
* pregnancy
* urgent or emergency cases

Primary outcomes:
measure: Correlation between pre cardiopulmonary bypass (CPB) and post CPB POC INR and PTT with standard laboratory INR and PTT
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Summer Syed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01214005: Smoking Abstinence and Lapse Effects in Smokers With Schizophrenia and Controls
Official title: Smoking Abstinence and Lapse Effects in Smokers With Schizophrenia and Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Disorder
Schizophrenia
Keywords: nicotine
reinforcement
craving
relapse
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2010-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This project tests two hypotheses concerning the low smoking cessation rates in smokers with schizophrenia. The first hypothesis is that smokers with schizophrenia experience stronger and more sustained effects of smoking abstinence on negative mood and smoking urge than control smokers without psychiatric illness. The second hypothesis is that smokers with schizophrenia experience stronger reinforcing effects of a smoking lapse (i.e., more rewarding effects of smoking after a period of abstinence) than control smokers without psychiatric illness.

Detailed description: In this study, smokers with schizophrenia and smokers without psychiatric illness participate in a nicotine preference task before and after a 3-day period of continuous smoking abstinence. The investigators will experimentally control abstinence by providing participants with high-value cash incentives contingent upon smoking abstinence verified with breath carbon monoxide levels. The investigators will measure nicotine withdrawal and smoking urge during the abstinence period. In the nicotine preference task, participants will make choices between nicotine-containing and denicotinized cigarette puffs to provide a measure of nicotine reinforcement, and the investigators will also measure the effects of smoking on mood. After the second nicotine preference task, participants will receive a small-value reinforcer if they continue to abstain for another day, and the investigators will measure time to the second lapse.

Eligibility criteria: Inclusion Criteria:

* cigarette smokers, 20-50 cigarettes per day
* schizophrenia or no psychiatric illness
* age 18 or older
* male or female

Exclusion Criteria:

* unstable symptoms or medication
* not interested in quitting smoking within 6 months

Primary outcomes:
measure: Withdrawal symptoms
timeFrame: 3 days
measure: urge to smoke
timeFrame: 3 days
measure: nicotine preference
timeFrame: before and after 3 days of abstinence
measure: positive and negative mood
timeFrame: before and after 3 days of abstinence
Secondary outcomes:
measure: time to lapse
timeFrame: 192 hours
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University, 121 South Main Street
state: Rhode Island
Study officials:
affiliation: Brown University
name: Jennifer Tidey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00894205: Neuropsychological Effects of Strengthening Exercise for Older Adults
Official title: Neuropsychological and Physiological Effects of Low-Impact Exercise for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cognitive Ability, General
Keywords: neuropsychological function
cognitive function
exercise
older adult
Lead sponsor: Union College, New York
Sponsor class: OTHER
First posted: 2009-05-06
Enrollment: 29
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study aims to examine the benefits to thinking processes of a low intensity, strengthening exercise program for older adults.

Detailed description: The neuropsychological benefits, especially executive function impacts, of four weeks of a low intensity, strengthening exercise program will be examined for community residing older adults.

Eligibility criteria: Inclusion Criteria:

* independent living
* older adult
* interested in strengthening exercise program

Exclusion Criteria:

* must meet Strong Bone's screening criteria or have physician's approval

Primary outcomes:
measure: Neuropsychological Function
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Schenectady
country: United States
facility: Strong Bones community class locations
state: New York
Study officials:
affiliation: Union College
name: Cay Anderson-Hanley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04371705: Efficacy of Ultrasound Guided Erector Spinae Plane Block
Official title: Efficacy of Ultrasound Guided Erector Spinae Plane Block in Patients Undergoning Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Instability
Patient Satisfaction
Postoperative Pain
Regional Block
Keywords: ESPB
postoperative pain
Regional block
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 65
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Thoracic epidural and paravertebral blocks are the most widely regional technique used for postoperative analgesia after surgery, but they are difficult to perform and carry a risk of serious complication. In this study, investigator asses the efficacy of ultrasound ESPB on intraoperative and postoperative hemodynamics and patient satisfaction

Detailed description: This prospective, double-blinded, randomized, controlled study was conducted at the period from October 2018 to December 2019. Sixty adults' patients ASA I-III, their ages ranged from 25-60 years undergoing abdominal surgery under general anesthesia. Each patient assigned written informed consent before the block performance.

Patients refused, known allergy to the used drugs, with history of coagulopathy, major organ failure and obesity (BMI\>40 kg/m2) were excluded from the study.

Patients were randomly allocated into two equal groups by a computerized randomization table: ESPB group, and control group. The patient and the staff providing the postoperative care were blinded to the group assignment.

ESPB group: Will undergo ESP block with 40 ml bupivacaine 0.25% (20 ml on each side) control group: anesthetized with the protocol followed by Minia University Hospital.

Anesthetic technique was standardized for all patients.

Eligibility criteria: Inclusion Criteria:

1. Age18-70 .
2. Both gender.

4. ASA I-III .

Exclusion Criteria:

1. patient refuse
2. Drug allergy.
3. Morbid obesity (BMI \>40 kg/m2).
4. Psychiatric disorder.
5. Opioid dependence .

Primary outcomes:
measure: Postoperative Total Fentanyl Requirement
timeFrame: 24 hours
Secondary outcomes:
measure: Time of First Post Operative Analgesic Request
timeFrame: 24 hours
measure: heart rate (HR)
timeFrame: 24 hours
measure: mean arterial pressure (MAP )
timeFrame: 24 hours
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
state: Minia
Study officials:
affiliation: Minia University Hospital
name: Nagy S. Ali, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02267005: The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis
Official title: The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Juvenile Dermatomyositis
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 13
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project will bring together a multidisciplinary team of pediatric rheumatologists, neurologists, metabolic geneticists and exercise physiologists to determine the effect of creatine (CR) supplementation on muscle function and muscle metabolism in children with Dermatomyositis (DM). The investigators propose using well-established exercise testing techniques as well as new, powerful exercise imaging protocols in order to better delineate the effects of CR on muscle pathophysiology in a non-invasive way. Evidence from this study will provide information regarding the effect of creatine supplementation on muscle function in DM. Improvements in muscle function and fatigue through CR use may also contribute to an improvement in quality of life and have significant clinical implications for the treatment of children with DM.


Eligibility criteria: Inclusion Criteria:

* Ages 7 to 18 years
* Diagnosis of probable JDM (onset \<16 years) according to Bohan and Peter criteria
* Subjects on a stable course of medication (unlikely to change over study treatment period as determined by the treating physician)
* Minimum height of 132.5cm

Exclusion Criteria:

* Subjects newly diagnosed with JDM within the previous 6 months
* Subjects unable to cooperate with study procedures, or too weak to participate in the exercise testing
* Subjects with impaired kidney function as determined from baseline visit screening lab values
* Subjects who are currently pregnant or planning to become pregnant within the study period
* Subjects who are shorter than 132.5cm

Primary outcomes:
measure: Muscle function
timeFrame: 6 months
Secondary outcomes:
measure: Muscle metabolism
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Disease Activity
timeFrame: 6 months
measure: Muscle Strength
timeFrame: 6 months
measure: Fatigue
timeFrame: 6 months
measure: Adherence
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
Clinical trial NCT01002105: Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients
Official title: Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients and Its Effect on Quality of Life, Clinical and Psychosocial Features: A 12-Week Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcohol Dependence
Keywords: Baclofen
Alcohol
Baclofen as add-on to standard treatment of alcohol
Lead sponsor: Sha'ar Menashe Mental Health Center
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Israel
First posted: 2009-10-27
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients.

Detailed description: Double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations. The percentages of heavy drinking days and abstinent days were the primary outcome measures, and craving; distress and depression levels; self-efficacy; social support from family, friends and significant others; and health-related quality of life (HRQL) were secondary outcomes. Tolerability was also examined.

Eligibility criteria: Inclusion Criteria:

1. ICD-10 diagnosis of alcohol dependence (World Health Organization, 1993);
2. Seeking treatment with the aim to stop alcohol consumption;
3. Age ranging from 18 to 60 years;
4. Last alcohol intake reported in the 24 h preceding observation;
5. Presence of a referred family member;
6. Written informed consent provision.

Exclusion Criteria:.

1. Serious hepatic, kidney, lung, neurological and cardiovascular, diseases);
2. Suicide risk, acute psychosis, severe depression, organic brain syndromes;
3. Dependence on psychoactive substances other than nicotine.

Primary outcomes:
measure: Percent Abstinent Days
timeFrame: one year
Secondary outcomes:
measure: Obsessive-Compulsive Drinking Scale Scores
timeFrame: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
measure: General Health Questionnaire
timeFrame: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
measure: General Self-Efficacy Scale
timeFrame: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
measure: Multidimensional Scale of Perceived Social Support
timeFrame: Baseline, 52 weeks
measure: Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
timeFrame: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Alexander Grinshpoon
Study officials:
affiliation: Ministry of health, State of Israel
name: Alexander M Ponizovsky, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05095805: Weight-bearing Exercise for Trans-tibial Amputees
Official title: Weight-bearing Training Exercise May Improve Loading of Trans-tibial Prosthesis and Functional Gait
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Keywords: trans-tibial prosthesis
weight-bearing
balance
centre of pressure
Lead sponsor: University Rehabilitation Institute, Republic of Slovenia
Sponsor class: OTHER
Collaborators: name: Slovenian Research Agency
First posted: 2021-10-27
Enrollment: 20
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: A simple weight-bearing exercise has been designed using off-the-shelves devices (Nintendo Wii Balance Board) and centre of pressure (COP) analysis software (Python) for trans-tibial amputees receiving their first prosthesis. A pilot randomised control study will be conducted to check the progress with weight-bearing training using COP-based objective measures. Additionally, gait and functional task performance will be assessed by means of clinical test. Participants will be divided into 2 groups: test group (performing additional weight-bearing exercises) and control group (receiving only conventional training for fitting of initial prosthesis).

Detailed description: Each patient meeting the inclusion criteria will be randomised to either the test group or the control group. The patients will perform ten training sessions with the initial prosthesis, each session lasting for about 30 minutes, within the period of two weeks. They will be assessed at baseline and after the training program.

Eligibility criteria: Inclusion Criteria:

* trans-tibial amputation,
* fitted with first trans-tibial prosthesis,
* independent mobility for 50m with or without assistive aid,
* Functional Independence Measure (FIM) Stairs locomotion scale ≥ 5,
* ability to follow the instructions, Mini Mental State Examination (MMSE) \> 25,
* no severe visual problems, ble to see computer screen,
* willing to participate.

Exclusion Criteria:

* bilateral lower limb amputation or any other level of unilateral lower limb amputation,
* not candidates for prosthetic fitting.

Primary outcomes:
measure: Change in centre of pressure (COP) from baseline
timeFrame: Assessment at baseline and after two weeks
measure: Change in weight distribution in quiet standing
timeFrame: Assessment at baseline and after two weeks
Secondary outcomes:
measure: Change in 10m walk test
timeFrame: Assessment at baseline and after two weeks
measure: Change in L-test
timeFrame: Assessment at baseline and after two weeks
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Rehabilitation Institute, Republic of Slovenia
Study officials:
affiliation: University Rehabilitation Institute, Republic of Slovenia
name: Helena Burger, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05529797: Effect of a Single Virtual Reality Exposure on Depressive Symptoms (Veovita-VR)
Official title: Effect of a Single Virtual Reality Exposure on Depressive Symptoms (Veovita-VR): Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Virtual Reality
Depression
Lead sponsor: Gaia AG
Sponsor class: INDUSTRY
First posted: 2022-09-07
Enrollment: 128
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 trial aims to evaluate the effectiveness of a novel virtual reality (VR) intervention (Veovita-VR) designed to expose people with at least moderate depressive symptoms to positive emotional stimuli and positive behavioral activation, thereby reducing depressive symptoms. Therefore, 128 adults with at least moderate depressive symptoms (operationalized as a Patient Health Questionnaire (PHQ-9) score ≥ 10) will be recruited and randomized into two groups: (1) a control group that may undergo depression treatment (Care-as-Usual, CAU) and receive access to Veovita-VR 5 weeks post-baseline (i.e., CAU control group), or (2) to an intervention group that receives one Veovita-VR session immediately after randomization and may also use CAU. The primary endpoint is depressive symptom level as assessed with the Patient Health Questionnaire (PHQ-9) 4 weeks post-baseline. Additionally, depressive symptoms (PHQ-9) will be assessed 1 week post-baseline.


Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* PHQ-9 score ≥ 10

Exclusion Criteria:

* apparent mental health problems other than depression (e.g., diagnosis of substance use disorder, psychotic disorder or bipolar disorder)
* acute suicidality

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 4 weeks after baseline
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 1 week after baseline
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Gaia AG
Study officials:
affiliation: Gaia AG
name: Gitta Jacob, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04324697: Radiographic and Histological Evaluation of Regenerated Bone After Grafting Using Allograft Shell and Autogenous Chips
Official title: Evaluation of Anterior Alveolar Ridge Reconstruction With Allogenic Bone Plate and Autogenous Cortical Bone Chips: A Radiographic and Histological Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alveolar Bone Resorption
Keywords: Allograft
Autogenous chips
Horizontal augmentation
Khoury shell technique
Lead sponsor: October 6 University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2020-03-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Reconstruction of the localized deficient anterior maxilla using an allograft cortical bone plate, which was fixed at a distance from the alveolar ridge using two micro-screws, and the created gap between the allograft plate and the alveolar ridge was filled with autogenous cortical bone chips harvested intraorally using a bone scrapper.
Primary purpose: TREATMENT

Brief summary: The clinical cases in the present study described the khoury shell technique using an allograft plate and autogenous chips, for horizontal reconstruction of the anterior alveolar ridge in the esthetic zone. Without need to use autogenous bone graft techniques that are characterized by more aggressive surgery.


Eligibility criteria: Inclusion Criteria:

* Patients with class IV of Cawood and Howell classification in the anterior maxilla.
* Males and females 18-50 years of age.
* Patients with adequate oral hygiene.
* Patients with healed sites for at least 6 months after tooth extraction.
* Patients with an inter-arch distance of at least 6 mm.
* Compliance with all requirements in the study and signing the informed consent.

Exclusion Criteria:

* Patients with diseases of the immune system or systemic disease affecting bone healing
* Patients who are chronic users of medications known to affect the periodontal status.
* Patients with history of intravenous and/or oral bisphosphonate use.
* Pathologic lesions or acute infection in the area of defect.
* Patients who are pregnant or lactating mothers.
* Heavy smokers who smoke more than 10 cigarettes a day.
* Patients with poor oral hygiene that are not amenable to motivation and improvement.
* Patients with history of irradiation of the head and neck region.
* Vulnerable patients.

Primary outcomes:
measure: Alveolar Bone quantity
timeFrame: 6 months
Secondary outcomes:
measure: Alveolar Bone quality
timeFrame: 7 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Ain Shams University
Study officials:
References: