louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00596076: Back School Efficacy on Low Back Pain and Quality of Life of Workers. COPCORD STUDY (Stage II)
Official title: The Efficacy of Back School on Low Back Pain and Quality of Life of Workers of a Pharmaceutics Company in Tehran Suburb. COPCORD Study (Stage II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Keywords: Low back pain
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-01-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is an intervention, Phase II COPCORD study. (COPCORD= Community Oriented Program to Control Rheumatic Diseases). The purpose of this study is to find if Back School training has any benefit on low back pain of the workers in a pharmaceutical factory in Tehran suburbs.

Detailed description: A back school will be held on at the Modava Pharmaceutical Factory, in Tehran suburbs. We estimate that this prospective study will include almost one third of the 70 workers in the factory. The study provides objective data and subjective information from patients. The clinical benefits of back school on low back pain and quality of life will be reported at the beginning and the end of intervention and after a period of 6 months follow up.

Eligibility criteria: Inclusion Criteria:

* History of mechanical low back pain in the last six months

Exclusion Criteria:

* History of inflammatory spinal diseases
* Severe scoliosis
* History of spinal surgery
* History of spinal malignancy

Primary outcomes:
measure: 1- Comparison of quality of life in patients with low back pain before and after Back school training. 2- Comparison of low back pain based on a visual analogue scale before and after back school training.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rheumatology Research Center
Study officials:
affiliation: Rheumatology Research Center, Medical Sciences/University of Tehran
name: Fereydoun Davatchi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02770976: Respiratory Pattern During Neurally Adjusted Ventilator Assist (NAVA) in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome In Premature Infants
Preterm Infants
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is to investigate the effect of a wide range of assistance levels on respiratory pattern, breathing variability including tidal volume and peak inspiratory pressure during neurally adjusted ventilatory assist (NAVA) in preterm infants. The investigators also aim to explore whether the effects of NAVA on the electrical activity of diaphragm (Edi) signal amplitude, work of breathing and comfort of preterm infants.


Eligibility criteria: Inclusion Criteria:

* preterm infants born before 36 weeks of gestational age
* who received mechanical ventilatory care through the endotracheal tube at least 24 hours for respiratory distress
* no use of anesthetics or analgetics

Exclusion Criteria:

* with major congenital anomalies (facial, gastrointestinal tract, cardiac, etc)
* with phrenic nerve palsy or injuries

Primary outcomes:
measure: maximum Edi
timeFrame: the middle 2 minutes duration out of the total interval of 10 minutes
Secondary outcomes:
measure: comfort score
timeFrame: the 5-min point in the total 10-min period
measure: peak inspiratory pressure
timeFrame: the middle 2 minutes duration out of the total interval of 10 minutes
measure: tidal volume
timeFrame: the middle 2 minutes duration out of the total interval of 10 minutes
measure: inspiratory time in excess
timeFrame: the middle 2 minutes duration out of the total interval of 10 minutes
measure: electrical time product
timeFrame: the middle 2 minutes duration out of the total interval of 10 minutes
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
References:
citation: Nam SK, Lee J, Jun YH. Neural feedback is insufficient in preterm infants during neurally adjusted ventilatory assist. Pediatr Pulmonol. 2019 Aug;54(8):1277-1283. doi: 10.1002/ppul.24352. Epub 2019 May 11.
Clinical trial NCT05023876: The Effect of Instrument Assisted Soft Tissue Mobilization on Respiratory Functions in Chronic Obstructive Pulmonary Disease
Official title: Effect of Instrument Assisted Soft Tissue Mobilization in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Pulmonary Function
Soft Tissue Mobilization
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of instrument-assisted soft tissue mobilization applied to the hamstring muscle on respiratory function in patients with COPDThe patients to be included in the study will be divided into two groups by simple randomization. A group will be given breathing exercises (pursed lip breathing, diaphragmatic breathing and thoracic expansion exercises) as a home program. The other group will be given breathing exercises in the form of a home program in addition to 1 session of EDYM per week. Both groups will be evaluated before and 4 weeks after treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with GOLD stage I-II COPD
* Between the ages of 40-65
* COPD in stable period
* No other respiratory disease that impairs respiratory functions such as asthma
* Knee flexion angle of 15 degrees and above in the hamstring muscle shortness test,
* Individuals without musculoskeletal problems in their lower extremities were included.

Exclusion Criteria:

* COPD patients who receive home oxygen therapy or who need oxygen therapy frequently
* COPD exacerbation, hospitalization with acute exacerbation in the last 15 days
* Pregnancy
* Kyphoscoliosis, advanced postural disorder
* Prior thoracic surgery
* Advanced heart failure
* Patients with primary pulmonary hypertension or have had a pulmonary embolism,
* Having serious neurological diseases such as Parkinson's, hemiplegia, multiple sclerosis,
* Neuromuscular disease
* Having dementia, Alzheimer's or advanced cognitive problems,
* Diagnosed with lung cancer or other malignancy,
* People with morbid obesity will not be included in the study.

Primary outcomes:
measure: Respiratory Function
timeFrame: 5 minute
Secondary outcomes:
measure: Chest circumference measurement
timeFrame: 5 minute
measure: Popliteal angle test
timeFrame: 3 minutes
measure: Finger-floor distance measurement
timeFrame: 3 minutes
measure: Hand grip strength
timeFrame: 3 minutes
measure: 6-minute walk test
timeFrame: 6 minute
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Emine
Study officials:
References:
Clinical trial NCT05195476: Neural Correlates of Compulsivity
Official title: Neural Correlates of Compulsivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obsessive-Compulsive Disorder
Keywords: Compulsivity
Obsessive-Compulsive Disorder
Exposure and Response Prevention
Electroencephalogram
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: International OCD Foundation
First posted: 2022-01-19
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with OCD and healthy controls

Brief summary: This study aims to collect data from individuals with obsessive-compulsive disorder (OCD) and healthy controls in order to clarify how learning strategies are employed differently by individuals with compulsive psychopathology and healthy individuals. Behavioral and electroencephalogram (EEG) data will be collected during one experimental reinforcement learning tasks from participants diagnosed with OCD (n = 30) and healthy controls (n = 30). Computational modeling, an advanced data analytic approach that can directly link neural measures with behavior, will be used to quantify learning processes. These parameters then will be related to measures of neural events obtained using EEG, a neuroimaging method that has high temporal resolution, to test for evidence of neurocognitive alterations.

Detailed description: Learning and decisions making are thought to be directed by multiple parallel cognitive systems. These systems account for automatic, inflexible responding to stimuli, as well as more deliberate, effortful representations of relationships in an environment. It has long been suggested than an imbalance in these cognitive control systems explains the emergence of compulsivity, a trait in which behaviors persist despite adverse outcomes. Compulsivity is a characteristic of a number of psychological disorders, however, current theories of how abnormalities in cognitive systems involved in learning and decision making lead to the onset of these disorders remain incomplete.

Eligibility criteria: Inclusion Criteria:

* Between 18-50 years of age
* English-speaking
* Capacity to provide informed consent
* Primary diagnosis of OCD with at least moderate severity

Exclusion Criteria:

* Current or lifetime history of psychiatric disorders other than OCD that may increase the risk of participation
* History of any significant medical condition that may increase the risk of participation
* Alcohol or substance use disorder in the past year
* Exposure and response prevention for OCD within the last six weeks
* Currently taking psychotropic medication

Primary outcomes:
measure: Neural Activity
timeFrame: One-time study visit
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia University
name: Amy Rapp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04205591: Comparative Study Between Porcine and Autologous Cortical Plates
Official title: Split Bone Block Technique: Clinical and Radiographic Study Between Autologous and Porcine Xenogeneic Cortical Plates. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Regeneration
Keywords: split bone block
RCT
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 16 patients referred for implant placement and with insufficient bucco-lingual (BL) alveolar bone width (\<4 mm) were included in the study.. Patients included in the clinical trial were randomly allocated by a blinded assistant in two groups: in the autogenous cortical plate group (ACP), and xenogeneic cortical plate group (XCP).
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the outcome of three-dimensional bone regeneration procedures using thin cortical porcine xenograft plates in combination with autogenous bone chips compared with thin autogenous cortical plates and autogenous bone chips.

Detailed description: Materials and methods: 16 patients referred for implant placement and with insufficient bucco-lingual (BL) alveolar bone width (\<4 mm) were included in the study. Patients received autogenous cortical plates (ACP) of either porcine xenogeneic (XCP). The aforementioned groups were compared in regards to bone augmentation using General Estimating Equations (GEE) and logistic regression. Demographic data, trabecular bone density, graft site, postoperative pain, and time consuming were also analyzed

Eligibility criteria: Inclusion Criteria:

- Patients were enrolled in the study on the basis of having insufficient bone height (\<6mm), width (\<3mm) or both, in either maxilla or mandible

Exclusion Criteria:

Patients with severe systemic disease (American Society of Anesthesiology III or IV) were excluded from the study.

In addition, patients who were pregnant, or patients with diseases affecting bone, such as:Paget's disease, osteomalacia, diabetes, vitamin D deficiency, alcoholism, hyperthyroidism cancer or osteoporosis as well as those on medications that might affect bone metabolism, such as bisphosphonates, corticosteroids or antiepileptic medicaments were also excluded from the study.

Primary outcomes:
measure: Volume of bone augmentation
timeFrame: 4 months
Secondary outcomes:
measure: Postoperative pain
timeFrame: 4 months
measure: Bone box time consuming
timeFrame: Minutes
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Complutense de Madrid
name: Jesus Torres, Associate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01509391: Keyhole Limpet Hemocyanin in Chronic Hepatitis C
Official title: Keyhole Limpet Hemocyanin in Chronic Hepatitis C and Compensated Cirrhosis - Pilot Study IM1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Hepatitis C
Liver Cirrhosis
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2012-01-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study the investigators examine the safety and efficacy of Keyhole-limpet-hemocyanin in patients with chronic hepatitis c infection and liver cirrhosis. The investigators hypothesize that administration of keyhole-limpet-hemocyanin reduces the viral load in patients infected with hepatitis c.


Eligibility criteria: Inclusion Criteria:

* Chronic Hepatitis C infection
* no previous therapy
* at least one contraindication to interferon therapy
* liver cirrhosis
* age between 18-80 y
* women of not childbearing age

Exclusion Criteria:

* Hypersensitivity against keyhole-limpet hemocyanin
* previous treatment against hepatitis c
* autoimmune disorders
* immunosuppression
* hepatocellular carcinoma or other malignancies
* coinfection with hepatitis b or HIV
* pregnancy
* cardiovascular event during the last 6 months (stroke or MCI)
* uncontrolled diabetes
* renal insufficiency (GFR \< 50 ml/min) or chronic hemodialysis

Primary outcomes:
measure: Hepatitis C viral load at week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: Hepatitis c viral load at weeks 1,2,4,8,12,18,32
timeFrame: 1,2,4,8,12,18,32 weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Rudolf E Stauber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01574391: A Comparison Study Of Two Different Techniques For Identifying The Epidural Space In Parturients In Labour
Official title: A COMPARISON STUDY OF TWO DIFFERENT TECHNIQUES FOR IDENTIFYING THE EPIDURAL SPACE IN PARTURIENTS IN LABOUR: A PILOT PROSPECTIVE RANDOMIZED STUDY.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labouring Parturients Requiring/Requesting Epidural Analgesia as Part of Their Peri-partum Care
Lead sponsor: National Maternity Hospital, Ireland
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the use of the Epidrum device to identify the epidural space in labouring parturients reduces morbidity, when compared to standard loss of resistance techniques.


Eligibility criteria: Inclusion Criteria:

* Parturients receiving epidural analgesia for labour

Exclusion Criteria:

* parturients that withold consent
* parturients less than 18 years old

Primary outcomes:
measure: RATE OF OCCURRENCE OF DURAL PUNCTURE
timeFrame: FIRST 48 HRS
Secondary outcomes:
measure: RATE OF EPIDURAL BLOOD PATCH
timeFrame: I MONTH AFTER LAST PATIENT RECRUITED
measure: RATE OF EPIDURAL FAILURE REQUIRING RE-SITING OF CATHETER
timeFrame: 24 HOURS
measure: RATE OF FAILURE IN IDENTIFYING EPIDURAL SPACE REQUIRING CHANGE OF OPERATOR
timeFrame: 24
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: National Maternity Hospital
state: Co Dublin
Study officials:
References:
Clinical trial NCT03463291: Role of MRI Diffusion in Differentiation Between Benign and Malignant Bony Lesions
Official title: Role of MRI Diffusion in Differentiation Between Benign and Malignant Bony Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Efficacy of MRI Diffusion in Differentiation Between Benign and Malignant Bony Lesions
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited outpatient clinic of Assiut General hospital and Assiut university hospital.

Brief summary: Bone tumors are categorized according to their tissue of origin into cartilagenous, osteogenic, fibrogenic, fibrohistiocytic, haematopoietic, vascular, and lipogenic tumors.

Magnetic resonance imaging (MRI) is now indispensable for the preoperative workup and therapeutic follow-up of patients with musculoskeletal tumors.

The application of DW-MRI in bone marrow is today an established examination technique that provides a unique contrast and that can help in the detection of bone-marrow pathologies and the differentiation of benign and malignant bone-marrow lesions.

Diffusion MRI provides quantitative and qualitative assessments of tissue cellularity and cell-membrane integrity. It is widely used for tumour detection, characterisation, and monitoring during treatment. Diffusion MRI supplies functional information that complements the structural evaluation.

In combination with standard structural MRI parameters, the ADC value improves tumour characterization. Diffusion MRI can also be used to monitor tumours during chemotherapy. Tumour necrosis results in loss of cell membrane integrity and in expansion of the extracellular compartment, leading to greater water-molecule diffusion with an increase in the ADC value.


Eligibility criteria: Inclusion Criteria:

* All patients with bony lesions will be included in the study.

Exclusion Criteria:

* Patient with cardiac pacemaker.
* Patients with metallic prosthesis in the region of examination.
* Patients with claustrophobia.
* Patient with recent history of surgical or imagining guided biopsy from the bony lesion.

Primary outcomes:
measure: The ADC value of MRI diffusion in benign and malignant bony lesions ( considering ADC value <1.2 ..malignant while ADC>1.2 ..benign)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04461691: Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure
Official title: Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Heart Failure
Cryoballon Ablation
Lead sponsor: St. Josefs-Hospital Wiesbaden GmbH
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 1402
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Open label
Primary purpose: TREATMENT

Brief summary: The combination of atrial fibrillation (AF) and heart failure (HF) is common and implies a poor prognosis. Pulmonary vein isolation is an established method for the treatment of symptomatic AF in patients with normal heart function and has been shown to be more effective than drug therapy. Recently, radiofrequency ablation has shown a positive effect in patients with AF and HF. POLAR-HF has been designed to investigate efficacy and safety of cryoballoon pulmonary vein isolation in patients with paroxysmal or persistent AF and severe HF (LVEF ≤ 40%).


Eligibility criteria: Inclusion Criteria:

* Symptomatic paroxysmal or persistent atrial fibrillation
* Patients with severe heart failure (LVEF ≤40%, assigned to heart failure group)
* Patients with normal cardiac function (assigned to control group)
* Age \> 18 years
* Consent capacity

Exclusion Criteria:

* Age under 18 years
* Pregnancy
* Lack of consent capacity

Primary outcomes:
measure: Primary Outcome Measures (Number of recurrence)
timeFrame: 60 months
measure: Primary Outcome Measures (number of safety events)
timeFrame: 60 months
Secondary outcomes:
measure: Secondary Outcome Measures (number of deaths)
timeFrame: 60 months
measure: Secondary Outcome Measures (procedural success)
timeFrame: 60 months
measure: Secondary Outcome Measures (rehospitalization)
timeFrame: 60 months
measure: Secondary Outcome Measures (procedure duration)
timeFrame: 60 months
measure: Secondary Outcome Measures (total time)
timeFrame: 60 months
measure: Secondary Outcome Measures (total contrast use)
timeFrame: 60 months
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: St. Josefs-Hospital Wiesbaden GmbH
Study officials:
affiliation: St. Josefs-Hospital Wiesbaden GmbH
name: Joachim Ehrlich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Josefs-Hospital Wiesbaden GmbH
name: Andreas Boehmer, MD
role: PRINCIPAL_INVESTIGATOR
References: