louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04424849: Thorax Computed Tomography Severity Score and Outcome in COVID-19 Patients
Official title: Initial Thoracic CT Findings and Mechanical Ventilation Requirement in Patients Admitted to Intensive Care Unit With COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Tepecik Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient admitted to the intensive care unit with COVID-19 pneumonia confirmed by RT-PCR

Brief summary: The most common thorax Computed tomography (CT) findings are multifocal ground-glass opacities and peripheral consolidation in patients with COVID-19. Septal thickening, bronchiectasis, pleural thickening, and subpleural involvement may also be observed. Although these findings are not specific to COVID-19, the severity of pulmonary involvement is expected to be correlated with thorax CT findings.

Detailed description: Thorax computed tomography severity score defined by Yang et al. can be used to evaluate the severity of pulmonary involvement in COVID-19 patients. We aimed to investigate whether the initial thorax computed tomography severity score can predict mechanical ventilation requirement and mortality in COVID-19 patients.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* COVID-19 confirmed by positive RT-PCR and/or antibody testing
* CT scan at intensive care unit admission

Exclusion Criteria:

* Loss of CT data
* Chronic lung disease findings by CT that may lead to misinterpretation
* RT-PCR results unavailable or negative
* Terminal cancer

Primary outcomes:
measure: Invasive respiratory support in patients with COVID-19
timeFrame: 120 days
Secondary outcomes:
measure: Mortality in patients with COVID-19
timeFrame: 120 days
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Tepecik Training and Research Hospital
state: Izmir, Konak
Study officials:
References:
Clinical trial NCT00732849: The Impact of the Type and Route of Nutritional Support on Infectious Complications After Upper Gastrointestinal Surgery
Official title: The Impact of the Type and Route of Nutritional Support on Infectious Complications After Upper Gastrointestinal Surgery - A Prospective, Randomized, Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Surgery
Keywords: immunonutrition
surgical patients
postoperative period
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2008-08-12
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients following elective upper GI surgery

Detailed description: All patients qualified between June 2002 and December 2007 to total and distal subtotal gastrectomy or pancreaticoduodenectomy were screened for eligibility to participate in the study. Malnutrition was defined by the Nutritional Risk Index (NRI), calculated according to the formula used in the Veterans Administration Cooperative Group trial.{, 1991 #70} Additional eligibility criteria included: age between 18 and 80 years, Karnofsky performance status score of 80 or more, and adequate organ function measured by routine blood tests. Patients without features of malnutrition, as well as those with disseminated tumors, serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5), and renal or liver failure were excluded. The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients following elective upper GI surgery. Therefore, patients were randomly assigned in a 2×2 factorial design to four groups receiving immunostimulating versus normal diets, and enteral versus intravenous nutritional support. The secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 80 years,
* Karnofsky performance status score of 80 or more,
* adequate organ function measured by routine blood tests

Exclusion Criteria:

* patients \<18 or \> 80
* Karnofsky performance \< 50

Primary outcomes:
measure: Immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients
timeFrame: Immunonutrition
Secondary outcomes:
measure: To evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay
timeFrame: morbidity
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: 1st Department of SUegy
state: _30978
Study officials:
affiliation: Jagiellonian University
name: Stanislaw Klek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03683706: Learning Through Play (LTP) in My Own Way Plus CBT
Official title: Feasibility Trial of Learning Through Play (LTP) in My Own Way Plus CBT A Parent-Based Intervention for Depressed Mothers With ID Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intellectual Disability
Depression
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Aim of the study is to evaluate the acceptability and feasibility of LTP in My Own Way Plus with depressed mothers of ID children.

Detailed description: Having a child with a chronic medical problem or an intellectual disability increases anxiety and depression in parents. There is some growing evidence that families of ID children are able to meet the challenges. The purpose of the present study is to adapt LTP in my own way plus to test its acceptability and determine if it improves mothers knowledge about their child development and reduce their level of distress.

The study has two phases: quantitative phase and qualitative phase. Quantitative phase: A single blind randomised controlled trial in school settings in Karachi Pakistan.

Objectives:

1. Help mothers cope better with their depression.
2. Teach mothers play activities that will stimulate their children's development and improve mother-child interaction.

Qualitative Phase: This will help to determine acceptability of the intervention and identify perceived mechanisms of change and any barriers and facilitators to LTP in my own Plus intervention. In-depth digitally recorded interviews and focus groups will be conducted with the parents and teachers to understand their beliefs, views, and feelings about caring for ID children.

Eligibility criteria: Inclusion Criteria:

* Mothers of ID children aged 3 to 6 years, screened positive for depression
* Ability to complete a baseline assessment
* Ability to communicate in Urdu or English

Exclusion Criteria:

* Have a diagnosed serious medical or psychiatric condition
* Mothers of children with other medical illness
* Temporary residents unlikely to be available for follow-up

Primary outcomes:
measure: Session Log (Feasibility and acceptability)
timeFrame: change in baseline to 12 weeks
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2003):
timeFrame: change in baseline to 12 weeks
measure: Generalized Anxiety Disorder (GAD) 7 (Spitzer, Kroenke, Williams, & Löwe, 2006):
timeFrame: change in baseline to 12 weeks
measure: Vineland Adpative Behaviour Scales (VABS-II) VABS-II (Sparrow et al., 2005):
timeFrame: change in baseline to 12 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: A private school in Karachi
Study officials:
affiliation: Pakistan Institute of Living & Learning
name: Nasim Chaudhry
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02351206: Lumbar Disc Space Height in Young Disc Herniation and Degeneration Patients
Official title: Lumbar Intervertebral Disc Space Height in Disc Herniation and Degeneration Patients in Their Early 20s
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intervertebral Disc Displacement
Intervertebral Disc Degeneration
Low Back Pain
Keywords: X-Rays
Magnetic Resonance Imaging
Sensitivity and Specificity
Lead sponsor: Jaseng Hospital of Korean Medicine
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 389
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients visiting Jaseng hospital of Korean Medicine, a spine specializing Korean medicine hospital designated by the Korean ministry of health and welfare, from January, 2010 to October 2014

Brief summary: As low back pain (LBP) imposes a heavy socioeconomic burden, early detection of pathologic intervertebral disc change in young adults holds high clinical relevance as a common structural cause of LBP. The investigators therefore assessed the feasibility of using X-ray disc space height measurements as a predictive evaluation method of lumbar disc herniation (LDH) and degeneration in LBP patients in their early 20s.


Eligibility criteria: Inclusion Criteria:

* Age 20-25 years
* L-spine X-ray and L-spine MRIs taken within a week of the other test
* Native Korean ethnicity

Exclusion Criteria:

* Scoliosis with a Cobb's angle of ≥20°
* Significant vertebral deformity of any etiology (e.g. spondylolisthesis, fracture, spondylitis, neoplasm)
* Previous spinal surgery

Primary outcomes:
measure: The distance between the 2 midpoints of the inferior and superior borders of the vertebral bodies surrounding the L4/5 intervertebral disc space divided by the AP diameter of the inferior border of the L4 vertebral body
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02357706: Comparison of Auto-Adjusting Positive Airway Pressure Devices
Official title: Comparison of Auto-Adjusting Positive Airway Pressure Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2015-02-06
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.


Eligibility criteria: Inclusion Criteria:

* Males aged ≥ 18 years
* Recently diagnosed with OSA (AHI ≥15). Recently defined as less than 3 months before study entry
* Naive to CPAP therapy
* Participants willing and able to give written informed consent

Exclusion Criteria:

* Participants requiring Bi-level PAP
* Participants requiring supplemental oxygen
* Participants who are pregnant
* Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury)

Primary outcomes:
measure: Mean Apnoea-Hypopnoea-Index (AHI)
timeFrame: 1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex)
measure: Mean Oxygen Desaturation Index (ODI)
timeFrame: 1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B.
Secondary outcomes:
measure: Obstructive Apnoea Index (OAI)
timeFrame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
measure: Central Apnoea Index (CAI)
timeFrame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
measure: Mixed Apnoea Index (MAI)
timeFrame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
measure: Hypopnoea-Index HI
timeFrame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
measure: Respiratory Effort Related Arousals RERAs
timeFrame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
measure: Flow Limitation (%)
timeFrame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
measure: Mean O2 Saturation
timeFrame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Center of Sleep Medicine, Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite Center of Sleep Medicine
name: Ingo Fietz, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00143806: Transitioning From Cyclosporine to Alefacept in Psoriasis
Official title: Investigator-Initiated, Use Study of Alefacept (Amevive) in Combination With Tapering Doses of Cyclosporine in Patients With Moderate to Severe Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: psoriasis
cyclosporine
transition
alefacept
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2005-09-02
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept.

Detailed description: The purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept. Patients in the study are well controlled on cyclosporine and desire to switch to alefacept. The study is done in three phases. In Phase 1 (12 week duration) the two drugs will be overlapped, with cyclosporine slowly tapering. Both drugs will be discontinued after 12 weeks. In Phase 2 (12 weeks duration), patients are off both drugs. In Phase 3 (24 weeks long), patients are on a second course of alefacept alone for 12 weeks and then off for 12 weeks. Topical and UV light treatments are allowed throughout the study. Total length of study is one year.

Eligibility criteria: Inclusion Criteria

* Adult psoriasis patients (18 to 80 years old), who are well controlled on cyclosporine (Static PGA score of mild, minimal or clear) and who need or desire to stop cyclosporine and start alefacept.

Exclusion Criteria

* CD4 \<400
* Active infection (other than trivial URI, etc.)
* History of AIDS or Hepatitis B, C
* Inability to understand consent or comply with study requirements
* Pregnancy or Lactation
* History of heart or liver disease

Primary outcomes:
measure: Static physicians global assessment (PGA) and quality of life as measured by DLQI
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: UMDNJ Clinical Research Center
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Alice Gottlieb, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05550506: Duloxetine on Bone Metabolism
Official title: The Effect of Duloxetine on Bone Metabolism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Fibromyalgia
Keywords: duloxetine
chronic pain
fibromyalgia
bone metabolism
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who use duloxetine for at least 3 months due to chronic pain or fibromyalgia

Brief summary: The aim of the study was to determine the effect of duloxetine as monotherapy on biochemical markers and bone mineral density.

Detailed description: 51 patients diagnosed with chronic pain or fibromyalgia syndrome who were using duloxetine for at least 3 months and age and sex matched 51 healthy individuals were recruited for this cross-sectional study. Bone mineral density of both groups were measured by dual energy x ray absorbsiometry(DXA), bone biochemical markers, serum calcium, and vitamin D levels were investigated.

Eligibility criteria: Inclusion Criteria:

* \>18 years or \<50 years
* patients using duloxetine for at least 3 months due to chronic pain or fibromyalgia

Exclusion Criteria:

* postmenopausal women
* clinical conditions which cause secondary osteoporosis
* patients using medication that cause secondary osteoporosis
* pregnancy and malignity

Primary outcomes:
measure: DXA
timeFrame: 3 months
measure: CTX
timeFrame: 3 months
measure: OC
timeFrame: 3 months
measure: 25-OH VITD3
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Çukurova Üniversitesi
Study officials:
affiliation: Cukurova University Faculty of Medicine Department of Physical Medicine and Rehabilitation
name: Burak Demir, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00838006: Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
Official title: Identification of and At-Risk Interventions for Pre-deployment Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Keywords: post-traumatic stress disorder
post-deployment
prediction
prevention
Lead sponsor: Biomedical Research Foundation
Sponsor class: OTHER
First posted: 2009-02-06
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions.

Detailed description: The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions. The objective predictors will be based on: 1) physiologic reactivity (heart rate, heart rate variability, eye blink startle, skin conductance) to virtual reality (VR) environments depicting common Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF) combat scenarios and 2) cognitive bias assessment using a recognition memory paradigm. We hypothesize that a model combining physiologic reactivity and cognitive bias predictors will be superior to either the physiologic reactivity or cognitive bias model alone for predicting post-deployment PTSD. We also will test two pre-deployment resiliency interventions: heart rate variability biofeedback and cognitive bias modification training that we have designed to target physiologic and cognitive responses to stress, respectively. We will compare the prevention interventions to a no intervention control group. We hypothesize that the prevalence of post-deployment PTSD will be lower in the intervention groups compared to the control group.

Eligibility criteria: Inclusion Criteria:

* Army National Guard members who are scheduled to deploy for OIF/OEF operations within the next 12 months, age 18 to 60, and willing to provide the name and phone number of at least one person to help locate the member for the follow-up assessments if necessary.

Exclusion Criteria:

* Implantable pacemaker or cardiac defibrillator
* Unable to wear a virtual reality headset

Primary outcomes:
measure: The PTSD Checklist - Military Version
timeFrame: pre-deployment, 3-, and 12-months post-deployment
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: pre-deployment, 3-, and 12-month post-deployment
Other outcomes:
Locations:
city: Blackstone
country: United States
facility: Virginia Army National Guard
state: Virginia
Study officials:
affiliation: Central Arkansas Veterans Healthcare System
name: Jeffrey M Pyne, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06009406: Comparison of the Effect of Graston Technique and Static Stretching in Athletes
Official title: Comparison of the Instantaneous Effects of Graston Technique and Static Stretching on Ankle Range of Motion and Vertical Jump Performance in Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Therapy
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In our study, we aimed to compare the effects of both Graston technique and static stretching on ankle range of motion and vertical jump performance in the light of the literature. Our study will guide clinicians about the uncertainty in the application of Graston technique and static stretching to the gastrocnemius, soleus muscles and Achilles tendon and examine the applicability of Graston in athletes. It is also aimed to investigate the relationship between ankle range of motion and vertical jump performance.


Eligibility criteria: Inclusion Criteria:

* The participant has volunteered and agreed to participate with the consent form
* The participant is between the ages of 18-40
* The participant is able to perform the squat movement pattern
* Participant must be an active and licensed athlete

Exclusion Criteria:

* Health problem that will affect the participant's mobility or jump performance
* The participant has had a surgical procedure involving the ankle and knee in the last 6 months
* The presence of orthopedic injury of the participant's foot and ankle
* Participant has a neurological diagnosis
* The participant is pregnant
* The participant has an acute lower extremity injury

Primary outcomes:
measure: Vertical Jump Test (VJT)
timeFrame: Change from Baseline VJT at 10 minutes
measure: Universal Goniometric Measurement (UGM)
timeFrame: Change from Baseline UGM at 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: FizyoMove
state: Üsküdar
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: İsmail Uysal, PhD
role: STUDY_DIRECTOR
References: