louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06282744: Cross Cultural Adaptation, Validity and Reliability Test of the Arabic Version of the Outpatient Physical Therapy Improvement in Movement Assessment Log
Official title: Cross Cultural Adaptation, Validity and Reliability Test of the Arabic Version of the Outpatient Physical Therapy Improvement in Movement Assessment Log
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Physical Performance
Outpatients
Keywords: Questionnaire
OPTIMAL
Validity testing
Arabic version
Psychometric properties
Reliability Testing
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian adults who took at least a month of physiotherapy sessions.

Brief summary: Purpose of the study:

To translate, culturally adapt, and to test the validity and reliability of the Outpatient Physical Therapy Improvement in Movement Assessment Log in Arabic speaking language.

Detailed description: The OPTIMAL assessment log was produced in English and later on it was being validated into Italian and Spanish versions. It hasn't been produced into Arabic yet so the aim of this study is to test the validity , reliability and psychometric properties of this assessment tool when being translated into Arabic and used among the Arabic Egyptian people.

Eligibility criteria: Inclusion Criteria:

1. Participants are adult outpatients who took at least a month of physiotherapy sessions.
2. Both genders will be included.
3. At least 18 years of age.
4. Participants must be conscious and ambulant.
5. Participants able to read, write Arabic as a mother tongue and understand the instructions, questions in the questionnaire.

Exclusion Criteria:

Participants having the following conditions will be excluded from the study:

1. Patients who are not able to provide informed consent.
2. Patients who are unable to complete the OPTIMAL instrument.
3. Patients who have a severe cognitive impairment.
4. Patients who are not receiving physical therapy.
5. Patients who are not Arabic-speaking.
6. Patients who have a history of malingering

Primary outcomes:
measure: validity and reliability of the Egyptian Arabic language version of Outpatient Physical Therapy Improvement Movement Assessment Log on physical therapy outpatients.
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05509244: Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Laparoscopic Gynecology Surgery
Official title: Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Laparoscopic Gynecology Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Disease
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 64
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acetaminophen and ibuprofen has been safely used for a long time and reduces postoperative pain and opioid dosages. Investigators are planning to compare the efficacy of 1) acetaminophen only and 2) acetaminophen and ibuprofen combination at postoperative pain after laparoscopic gynecologic surgery.

Detailed description: Acetaminophen and ibuprofen has been safely used for a long time and reduces postoperative pain and opioid dosages. Investigators are planning to compare the efficacy of 1) acetaminophen 1g only and 2) the combination of acetaminophen 1g and ibuprofen 300mg at postoperative pain after laparoscopic gynecologic surgery. Some recovery valuables such as the postoperative pain and opioid requirements will be assessed.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled gynecologic laparoscopic surgery

Exclusion Criteria:

1. Refusal to be enrolled in the study
2. Emergency surgery
3. On chronic pain medications
4. Psychiatric disorders
5. Pregnant, lactating women
6. Allergy or contraindication to the medication drugs

Primary outcomes:
measure: postoperative pain
timeFrame: during 30 minutes after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
state: Seocho-gu
Study officials:
affiliation: Seoul St. Mary's Hospital
name: youngeun moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06221644: Synapse Alterations in MSA Patients
Official title: Synapse Alterations in MSA Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple System Atrophy
Keywords: synaptic density; PET; SV2A
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 patients diagnosed with MSA were recruited. The patient cohort consisted of 30 MSA-C and 30 MSA-P cases, diagnosed according to the 2008 Second Consensus Criteria and confirmed by two experienced neurologists. Additionally, 30 gender and age-matched HCs were included.

Brief summary: Synaptic loss has been implicated in various neurodegenerative conditions, yet its understanding in multiple system atrophy (MSA) remains limited.

The aim of this study was to examine spatial synaptic density alterations in MSA patients and evaluate the potential of \[18F\]SynVesT-1 PET as an imaging biomarker for MSA in both diagnosis and monitoring disease severity.

Detailed description: 60 MSA patients (30 MSA-P subtype and 30 MSA-C subtype) and 30 age-matched healthy controls (HCs) underwent \[18F\]SynVesT-1 PET/CT for synaptic density assessment. Visual, voxel, and volumetric region-of-interest (VOI) analyses were employed to elucidate synaptic density patterns in the MSA brain and establish visual diagnostic criteria. VOI-based computer-assisted analyses were utilized to develop diagnostic models for MSA.

Eligibility criteria: Inclusion Criteria:

The MSA patient were diagnosed according to the 2008 Second Consensus Criteria and confirmed by two experienced neurologists.

Exclusion Criteria:

encompassed MRI contraindications, a history of epilepsy, stroke, or brain surgery, intracranial organic lesions unrelated to MSA, usage of levetiracetam or brivaracetam, and a history of alcohol or drug abuse

Primary outcomes:
measure: Spatial synaptic density alterations in MSA patients
timeFrame: 10 months
measure: [18F]SynVesT-1 PET as an imaging biomarker for MSA
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Jian Li
state: Hunan
Study officials:
affiliation: Shuo Hu
name: Shuo Hu
role: STUDY_CHAIR
References:
Clinical trial NCT01873144: High Flow Therapy vs Hypertonic Saline in Bronchiolitis
Official title: High Flow Therapy vs Hypertonic Saline in Bronchiolitis Treatment. Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Viral Bronchiolitis
Keywords: Bronchiolitis
Hypertonic saline solution
High-flow oxygen therapy
Respiratory distress
Comfort
Lead sponsor: Ministry of Health, Spain
Sponsor class: OTHER_GOV
First posted: 2013-06-07
Enrollment: 75
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that heated, humidified, high-flow nasal cannula (HHHFNC) is superior to hypertonic saline solution (HSS) in the treatment of moderate acute viral bronchiolitis in infants in improving respiratory distress and comfort and reducing length of hospital stay (LOS) and admission to Pediatric Intensive Care Unit (PICU).


Eligibility criteria: Inclusion Criteria:

* Children aged 6 months or less
* Moderate (Respiratory Distress Assessment Instrument score of 4 or greater) viral bronchiolitis (as defined by McConnockie)
* Meeting Admission criteria

Exclusion Criteria:

* History of prematurity
* Chronic lung disease
* Cystic fibrosis
* Congenital heart disease
* Neuromuscular disease
* Airway anomalies
* Immunodeficiency
* Those requiring immediate intubation and ventilation.

Primary outcomes:
measure: Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered
timeFrame: Every 4h for three consecutive times beginning in the moment of inclusion in the study and after every 8h for three consecutive times (average of 36h)
Secondary outcomes:
measure: Difference in mean comfort score along the monitoring period between groups
timeFrame: Every 8h for 6 consecutive times (two days) beginning in the moment of inclusion in the study
Other outcomes:
measure: Length of hospital stay (LOS) in days in both groups
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: Admission to Pediatric Intensive Care Unit PICU (rate) in both groups
timeFrame: Transfer to PICU at any time during hospitalization
Locations:
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
state: Madrid
city: Leganes
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
Study officials:
affiliation: Department of Pediatrics and Neonatology. Hospital Universitario Fundacion Alcorcon. Madrid. SPAIN
name: Mercedes Bueno, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bueno Campana M, Olivares Ortiz J, Notario Munoz C, Ruperez Lucas M, Fernandez Rincon A, Patino Hernandez O, Calvo Rey C. High flow therapy versus hypertonic saline in bronchiolitis: randomised controlled trial. Arch Dis Child. 2014 Jun;99(6):511-5. doi: 10.1136/archdischild-2013-305443. Epub 2014 Feb 12.
Clinical trial NCT00162344: A Study of Stress Heart Imaging in Patients With Diabetes at Risk for Coronary Disease.
Official title: AceP-D: Non-invasive Assessment of Atypical Chest Pain in Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study is designed to see if stress heart imaging can be used as a screening exam in patients with diabetes and risk factors of developing of coronary artery disease and experiencing future cardiac events.


Eligibility criteria: Inclusion Criteria:

* History of diabetes for at least 5 years, with a least 2 risk factors (i.e. hypertension, elevated cholesterol levels, history of or current smoker, obese, family history of heart disease) \& atypical chest pain.

Exclusion Criteria:

* Typical chest pain being treated with medication, unable to exercise, previous confirmed heart disease

Primary outcomes:
measure: Examine the prevalence of ischemic heart disease in population of patients with diabetes mellitus and atypical chest pain.
Secondary outcomes:
measure: Determine the accuracy of myocardial perfusion imaging (MPI) and exercise tolerance testing (ETT) for the detection of coronary artery disease (CAD) in a subset of patients undergoing clinically indicated coronary angiography.
measure: Determine the relative value of ETT, Duke Treadmill Score (DTS), MPI, ejection fraction (EF), clinical risk factors, and C-Reactive Protein (CRP) values for identifying patients at risk for cardiac events.
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Local Institution
state: California
city: Rancho Santa Fe
country: United States
facility: Local Institution
state: California
city: San Diego
country: United States
facility: Local Institution
state: California
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Indianapolis
country: United States
facility: Local Institution
state: Indiana
city: Detroit
country: United States
facility: Local Institution
state: Michigan
city: Minneapolis
country: United States
facility: Local Institution
state: Minnesota
city: Albany
country: United States
facility: Local Institution
state: New York
city: Roslyn
country: United States
facility: Local Institution
state: New York
city: Columbus
country: United States
facility: Local Institution
state: Ohio
city: Houston
country: United States
facility: Local Institution
state: Texas
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Martin Rosenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01567644: Extracorporeal Shockwave Therapy for the Treatment of Refractory Chronic Angina Pectoris
Official title: Clinical Trial Evaluating the Treatment of Patients With Refractory Chronic Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Refractory Angina Pectoris
Keywords: Extracorporeal Shockwave Therapy
Myocardial Ischemia
Refractory Angina
Lead sponsor: Medispec
Sponsor class: INDUSTRY
Collaborators: name: Heart and Diabetes Center North-Rhine Westfalia
First posted: 2012-03-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.

The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.

Detailed description: Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to myocardial ischemic tissue. Shockwaves are created by a special generator and are focused using a shockwave applicator device. The treatment is guided by standard echocardiography equipment. The shockwaves are delivered in synchronization with Patient R-wave to avoid arrhythmias. The treatment is painless.

At first, the patient undergoes stress- PET testing to identify the ischemic areas. Following that, the same area is localized by the ultra-sound device and the shockwaves are focused to the ischemic area. Several treatments are required for optimal results.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with chronic stable angina pectoris.
* Documented myocardial segments with reversible ischemia
* AP CCS class of III-IV.
* Stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
* Exercise tolerance time \< 10 min (modified Bruce)
* Two ETT tests results (within two weeks) averaging no more than 25% of their mean
* Documented epicardial coronary artery disease not amenable to angioplasty or CABG.
* Signed an IRB approved informed consent form.
* Life expectancy of \> 12 months.

Exclusion Criteria:

* Intraventricular thrombus
* Malignancy in the area of treatment
* Severe COPD
* No smoking during the study procedure
* MI less \< 3 months prior to treatment
* Severe Valvular disease
* Child bearing potential

Primary outcomes:
measure: Change in AP-CCS
timeFrame: 6 Months
Secondary outcomes:
measure: Exercise tolerance time
timeFrame: 6 Months
measure: Change in PET scan
timeFrame: 6 months
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center North-Rhine Westfalia
Study officials:
affiliation: Heart and Diabetes Center North-Rhine Westfalia
name: Lothar Faber, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04709744: Impact of Vitamin D Level and Supplement on SLE Patients During COVID-19 Pandemic
Official title: Impact of Vitamin D Level and Supplement on SLE Patients During COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: SLE patients infected with COVID-19

Brief summary: Aim of the work Impact of serum vit D level in SLE patients with COVID-19 disease on severity of infection, duration of COVID-19 disease course, fatigue development as a complication for both SLE and COVID-19 and assess impact of prior chloroquine on COVID-19 disease outcomes Patients and methods 38 SLE patients previously diagnosed and on different lines of lupus management. Participants were presented to chest outpatient clinic and emergency hospital, Mansoura University with manifestation suggesting COVID-19 infection. Serum vit D was measured in serum by ELISA.

Detailed description: Primary objective: assess the impact of serum vit D level in SLE patients with COVID-19 disease on severity of infection and pandemic treatment outcome.

Secondary objectives:

* Effect of serum vit D level in SLE patients on duration of COVID-19 disease course and fatigue development as a complication for both SLE and COVID-19
* Impact of prior chloroquine on COVID-19 disease outcomes
* Correlation of serum vit D level with different laboratory investigations at time of COVID-19 outbreak

Eligibility criteria: Inclusion Criteria:

* - SLE patients previously diagnosed
* Patients are not suffering from malignancies.
* Patients have no organ failure nor uncontrolled medical illness.
* Recent COVID-19 infection

Exclusion Criteria:

* - Pregnant, lactating females
* Concurrent malignancies
* Patients with other autoimmune disease

Primary outcomes:
measure: Level of serum vitamin D in SLE infected with COVID-19
timeFrame: 6 months
Secondary outcomes:
measure: Vitamin D level with COVID-19 severity
timeFrame: 6 months
Other outcomes:
measure: Impact of serum vit D level in SLE patients on duration of COVID-19 disease course
timeFrame: 6 months
measure: Impact of prior chloroquine on COVID-19 disease outcomes
timeFrame: 6 months
measure: Serum vitamin D level and development of fatigue
timeFrame: 6 months
measure: Correlation of serum vit D level with different laboratory investigations at time of COVID-19 outbreak
timeFrame: 6 months
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
state: DK
Study officials:
affiliation: Mansoura University Hospital
name: yasmin ElbaiomyAdel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03724344: Correlation Study Between Mental Behavioral Symptoms in Dementia Patients and Mood Disorders of Caregivers
Official title: Correlation Analysis Between Mental Behavioral Symptoms in Dementia Patients and Mood Disorders of Caregivers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dementia
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients and community dementia patients and their primary caregivers

Brief summary: Traditionally, the more severity of dementia patients, the heavier the burden of the comparators, and in the clinical observation,the dementia patients with rich mental behavior symptoms are more burdened. Therefore, exploring the impact of psychological burden and different subtypes of different dimensions with Behavioral and psychological symptoms (BPSD) will more comprehensive understanding of the factors affecting the burden of caregivers.

The starting point of this project is to analyze the relationship between the types of mental behavior symptoms of dementia patients and the emotional disorders of caregivers. The topic will analyze the correlation of psychological burden of caregivers and different symptom dimensions from the perspective of refinement, helping more effective identifying high-burden mental behavior symptoms in clinically , judging the risk of emotional problems in caregivers, and adopting better humanities or medical care, so that dementia patients can better adapt to care and improve the mental health of caregivers.


Eligibility criteria: Inclusion Criteria:

1. Age is greater than 18 years old, gender is not limited
2. Comply with ICD-10 diagnostic criteria, diagnosed with dementia, including Alzheimer's disease, vascular dementia, frontotemporal dementia, dementia with Lewy body, dementia caused by Parkinson's disease

Exclusion Criteria:

1. senile schizophrenia;
2. senile depression;
3. cognitive impairment caused by endocrine system diseases (such as decreased thyroid and adrenal function);
4. Cognitive impairment or dementia caused by serious diseases such as cardiovascular, lung, liver, kidney, and hematopoietic system;
5. Cognitive impairment or dementia caused by alcohol, drug use, psychotropic drugs; 6）Other physical or chemical factors that cause cognitive impairment or dementia-

Primary outcomes:
measure: Neuropsychiatric inventory questionnaire
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huangpu District Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Zhenghui Yi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01756144: rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport
Official title: rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pseudarthrosis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-12-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: When there is a bone defect, bone transport is used to bridge the defect. Frequently, the bone in the docking site (where the transported bone comes together) doesn't heal.

The objective is to study the effectivity of rhBmp-2 (inductos) to stimulate bone healing, in order to find new techniques to treat non-union of long bones.

The method of the study is a randomized controlled trial, to compare rhBMP-2 and autologous bone grafting in stimulating bone healing in the docking site.


Eligibility criteria: Inclusion Criteria:

* Patients treated with bone transport (Ilizarov technique) and have non-union of the docking site, which is characterized by absence of bridging callus after two months of compression in the docking site.

Exclusion Criteria:

* Allergy for inductos
* active growth,
* malignancy
* infection
* PAD
* pathological fracture

Primary outcomes:
measure: Bone healing in the docking site
timeFrame: up to 4 months
Secondary outcomes:
measure: Infection
timeFrame: up to one year
measure: Edema
timeFrame: up to one year
measure: cancer
timeFrame: up to one year
Other outcomes:
Locations:
Study officials:
References: