louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01851486: The Relationships Between the Noradrenergic, Opioid and Pain System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Experimental Pain Perception
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2013-05-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The role of alpha2 receptor agonist on pain perception and modulation will be examined. In addition whether this is mediated through the opioid system will be examined. Pain perception and modulation will be examined before and after administration of Clonidine or placebo together with Naloxone or saline.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Age 18-40
* No chronic disease

Exclusion Criteria:

* Subjects who suffer from chronic pain / pain syndrome
* use of anti-depressant or anti-psychotic drugs
* suffering from cardiovascular disease
* breast feeding

Primary outcomes:
measure: The changes in pain responses after administration of alpha 2 agonist and mu receptor antagonist
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
References:
Clinical trial NCT03718663: Predictors for Analgesic Effect to Standardized Exercise Therapy for Osteoarthritic Pain
Official title: Kliniske Smertetests Som prædiktorer for Effekten af GLA:D®-træningsforløb Hos Patienter Med Symptomgivende Slidgigt i knæene
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Healthy Subjects
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 25 patients with knee osteoarthritis scheduled for PEET.

Part 2 40 healthy subjects (age 18-28) signed up as recruits in Defence Command Denmark

Brief summary: Pain sensitization has been associated with pain severity in people with knee osteoarthritis (KOA) and a neuropathic pain component has been identified in up to 30% of KOA patients. In addition, exercise-induced hypoalgesia (EIH), a measure of descending pain control, has previously been found dysfunctional in a subgroup of people with painful KOA and has also been utilized as a predictive factor for pain progression following total knee replacement.

Measures of pain sensitization have been used prognostic to identify responders to treatment but EIH as a prognostic tool for Physiotherapy-guided Evidence-based Exercise Therapy (PEET) has not been investigated. The primary aim of this explorative study is to investigate if EIH assessed pre-PEET was associated with changes in pain, disability and PainDETECT (PDQ) score post-PEET. The secondary aim is to investigate if PEET changes EIH and PDQ score in patients with painful KOA.

Part 2:

Cross-sectional studies indicate, that daily level of activity influence the effectivity of the EIH mechanims, while pain patients (e.g. KOA patients) can have normal of dysfunctional EIH. It has not been investigated if EIH changes after prolonged exercise in healthy subjects. The aim of this secord part of the study, is to investigate if EIH changes after 6-9 weeks of intensive military training in healthy subjects


Eligibility criteria: Inclusion Criteria:

* The American College of Rheumatology for clinical knee osteoarthritis (excluding radiological OA assessment)

Exclusion Criteria:

* Known factors to influence pain and pain sensitization.

Part 2:

Inclusion Criteria

* starting as recruits in Defence Command Denmark

Exclusion Criteria:

* Known factors to influence pain and pain sensitization.

Primary outcomes:
measure: Pain Intensity
timeFrame: 1-2 weeks after last exercise session
measure: Part 2: Exercise-induced hypoalgesia (EIH)
timeFrame: 6-8 weeks into standardized pre-planned military training that continues after the tests
Secondary outcomes:
Other outcomes:
Locations:
city: Viby
country: Denmark
facility: Viby Fysioterapi
state: Midtjylland
Study officials:
affiliation: Aalborg University
name: Kristian K Petersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05346263: Efficacy of Intermittent Abdominal Pressure Ventilation in Neuromuscular Patients
Official title: Efficacy of Intermittent Abdominal Pressure Ventilation in Neuromuscular Patients: Multicentre, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuromuscular Diseases
Keywords: Neuromuscular Diseases;
Intermittent Abdominal Pressure Ventilation;
IAPV;
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 78
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-Invasive Ventilation (NIV) is an established treatment to manage respiratory muscles dysfunction in neuromuscular disease, preventing the progression of respiratory failure to intubation and/or a tracheotomy. NIV is commonly needed at first during the night, but when the disease worsens, it is required during the day. It is provided via nasal or oronasal masks, causing discomfort and/or aesthetic issues that result in poor compliance.

Intermittent Abdominal Pressure Ventilation (IAPV) is a valid, though unconventional, alternative to daytime NIV: it consists of a portable ventilator with an internal battery and a corset as interface. The IAPV corset is lightweight, comfortable and, thanks to velcro fasteners, easier and better fitting than a face mask. Cyclical inflation of a rubber bladder inside the corset moves the diaphragm upwards like a pneumobelt causing air to enter in the lungs via the upper airways as gravity draws the diaphragm back to its resting position.

IAPV is indicated in neuromuscular disease and has already been tested in few preliminary studies and case reports. This study wants to verify the hypothesis of its application in population of neuromuscular patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Neuromuscular Disease (Amyotrophic Lateral Sclerosis, Duchenne Muscular Dystrophy, Spinal Muscular Atrophy, Pompe Disease)
* Non Invasive Ventilation \> 16 hours/day
* Informed consent signed

Exclusion Criteria:

- Diagnosis of kyphoscoliosis

Primary outcomes:
measure: Blood Gas Analysis
timeFrame: 12 months
Secondary outcomes:
measure: Therapy adherence
timeFrame: 12 months
measure: Patients satisfaction to IAPV
timeFrame: 12 months
measure: Caregivers satisfaction to IAPV
timeFrame: 12 months
measure: Amelioration of Quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS S. Maria Nascente - Fondazione Don Carlo Gnocchi
Study officials:
References:
Clinical trial NCT02977663: Imaging Multiparametric/Multimodality for Lungcancer
Official title: Imaging Multiparametric/Multimodality (Magnetic Resonance Imaging Combined With Positron Emission Tomography) for Lungcancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lungcancer
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: General Electric
First posted: 2016-11-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 1. To build an imaging biobank of 200 patients with lungcancer, including pathologic and molecular characteristics of the tumor (mutational status, circulating DeoxyriboNucleic Acid (DNA) from serum biobank...), staging of the cancer (according to the new 2016 Tumor Node Metastasis (TNM) status, the table that classify non-small cell lungcancer) and follow-up informations (Response to first-line treatment (Response Evaluation Criteria in Solid Tumors (RECIST)), disease-free survival, 1-3 years survival).
2. To propose a simple severity scoring system based on tumor features such as size, doubling time (if available), location, amount of enhancement and necrosis. Such approach has been proposed for glioma evaluation (Visually Accessible Rembrandt Images (VASARI)) but is not available for the lung. The objective is to do better than the Tumor Node Metastasis (TNM) staging.
3. To develop and evaluate an IntraVoxel Incoherent Motion (IVIM) protocol for lungcancer evaluation.


Eligibility criteria: Inclusion Criteria:

* Adults over 18 years
* High suspicion of lungcancer confirmed
* Tumor \> 2 cm
* Incomplete cerebral staging or not yet realized in the initial consultation of screening

Exclusion Criteria:

* Lungcancer medical history
* During Pregnancy
* Contraindications to MRI
* Patient not able to understand the information of the protocol, taking into account the state of the brain
* Patient unable to keep lying in MRI the necessary time

Primary outcomes:
measure: Event-free survival of patients with lungcancer
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 months, 1 year, 2 years and 3 years
measure: Number of patients by histologic subtypes
timeFrame: 3 months, 1 year, 2 years and 3 years
measure: Number of patients by mutational profile
timeFrame: 3 months, 1 year, 2 years and 3 years
measure: Number of patients with metastases
timeFrame: 3 months, 1 year, 2 years and 3 years
measure: Number of patients with brain metastases
timeFrame: 3 months, 1 year, 2 years and 3 years
measure: Number of metastases by patient
timeFrame: 3 months, 1 year, 2 years and 3 years
measure: Therapeutic responses assessed by scanner/MRI and/or Positron Emission Tomography (PET) based on consensus criteria (RECIST 1.1 and PET Response Criteria in Solid Tumors (PERCIST))
timeFrame: 3 months, 1 year, 2 years and 3 years
Other outcomes:
Locations:
city: Bobigny
country: France
facility: BRILLET
Study officials:
References:
Clinical trial NCT05935163: Immediate Effects of Bowen Technique Versus Dynamic Soft Tissue Mobilization on Hamstrings Tightness in Chronic Non-specific Low Back Pain.
Official title: Immediate Effects of Bowen Technique Versus Dynamic Soft Tissue Mobilization on Hamstrings Tightness in Chronic Non-specific Low Back Pain.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hamstring Tightness
Keywords: Low back pain
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low back pain (LBP) is leading cause of disability and its burden is growing worldwide with an increasing and ageing of population. Poor flexibility or tightness of hamstring muscle has been associated with low back pain. It is a prominent cause of activity limitations and work absenteeism throughout world. Hence this study was designed to find out superior form of effective technique on active knee extension and experience of pain and disability in chronic nonspecific low back pain.

Detailed description: Low back pain (LBP) is leading cause of disability and it is most leading cause of work absenteeism throughout world. Poor flexibility or tightness of hamstring muscle has been associated with low back pain. Hence this study was designed to find out superior form of effective technique on hamstrings tightness and experience of pain and disability in chronic nonspecific low back pain. This study will also assist to set the foundation for further more studies designing magnificent protocols of treatment for affected population.

Eligibility criteria: Inclusion Criteria:

* The patients aged 18-45 years will be included in the study.
* Patients with chronic low back pain (more than 3 months) will be included.
* Both genders.
* 20 to 40 degrees active knee extension loss with hip in 90 degree flexion
* Pain Intensity (moderate to severe) NPRS (4-6 intensity)

Exclusion Criteria:

* Individuals who were receiving treatment for their pain with another(medical treatment) at the same time
* Patients who had undergone vertebral column surgery (less than three months before the time of this study).
* Patients with the infection, neoplasms, metastasis, rheumatoid arthritis, fractures or inflammatory processes were excluded.
* Dislocations of lower limb
* Hypermobility of lower limb joint
* Hamstrings injuries
* Nerve lesions of lower limb

Primary outcomes:
measure: Active knee extension test
timeFrame: 4 weeks
measure: Active straight leg raise (aSLR)
timeFrame: 4 weeks
measure: The sit-and-reach (SR) tests
timeFrame: 4 weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: 4 Weeks
measure: Disability
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Fauji Foundation Hospital Department of Rehabilitation
state: Punjab
Study officials:
References:
Clinical trial NCT01235663: Minimizing the Risk for Obesity During Infancy by Extensive Advisory Service
Official title: Does Advisory Support to Prolong the Breast-feeding Period Reduce the Risk for Obesity and Metabolic Dysfunction in Infants of Obese Mothers ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reduce the Risk of Obesity During Infancy
Reduce the Risk of Insulin Resistance
Keywords: obesity, insulin resistance
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2010-11-05
Enrollment: 226
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 0-hypothesis: advisory support does not

1. prolong the the breast-feeding period
2. minimize the risk of obesity and metabolic dysfunction in infants of obese mothers


Eligibility criteria: Inclusion Criteria:

Healthy, term infants Informed and written consent obtained from both parents -

Exclusion Criteria:

Sick infants Preterm infants No consent

-

Primary outcomes:
measure: fat tissue
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Department of Neonatology, Hvidovre University Hospital
Study officials:
References:
citation: Carlsen EM, Kyhnaeb A, Renault KM, Cortes D, Michaelsen KF, Pryds O. Telephone-based support prolongs breastfeeding duration in obese women: a randomized trial. Am J Clin Nutr. 2013 Nov;98(5):1226-32. doi: 10.3945/ajcn.113.059600. Epub 2013 Sep 4.
Clinical trial NCT03778463: Synovectomy in Primary Total Knee Arthrplasty
Official title: Synovectomy Versus no Synovectomy in Primary Total Knee Arthrplasty : A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Synovectomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of total knee arthroplasty is to achieve best patient functional outcomes, improve patient pain score and satisfaction. Synovial proliferation is a common finding in arthritic knees. Surgeons can't decide if synovectomy is a crucial step in the operation. Studies didn't prove the clear benefits of synovectomy. We are aiming to perform a randomized clinical trial trying to reach the best evidence in that matter.


Eligibility criteria: Inclusion Criteria:

* patients with primary osteoarthritis undergoing primary total knee arthroplasty

Exclusion Criteria:

* Inflammatory arthritis
* Revision knee arthroplasty

Primary outcomes:
measure: Functional outcome scores. e.g. knee society score (KSS)
timeFrame: one year
measure: knee pain e.g. visual analogue score (VAS) score
timeFrame: immediate postoperative
measure: Health related quality of life e.g. short form (SF12) scale
timeFrame: one year
measure: Revision rate
timeFrame: one year
measure: Reoperation rate
timeFrame: one year
measure: Range of motion
timeFrame: immediate postoperative
measure: Range of motion
timeFrame: 6 month
measure: Range of motion
timeFrame: One year
Secondary outcomes:
measure: Postoperative blood loss
timeFrame: immediate postoperative
measure: Postoperative hemoglobin level
timeFrame: immediate postoperative
measure: Infection rate
timeFrame: in first three month
measure: Wound complications
timeFrame: in first 3 months
measure: Number of patients requiring transfusion
timeFrame: immediate postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Univrsity
Study officials:
affiliation: Ain Shams University
name: Ahmed Saeed Younis, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Amr Amal Elsayed Amin, Dr.
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Wael Samir Osman, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT02651363: Diclofenac 25mg/Paracetamol 500 mg and Diclofenac 50 mg/Paracetamol 500 mg for Patients With Pain
Official title: Incidence of Adverse Events, Risk Factors, and Drug Utilization Factors Related to Treatment With Diclofenac 25 MG/Paracetamol 500 MG and Diclofenac 50 MG/Paracetamol 500 MG in Patients From Metropolitan Lima
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-01-11
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 18 years of age or and older from 6 medical centers from Metropolitan Lima, Peru who received at least one dose of Dolocordralan Extra 25 or Dolocordralan Extra Forte according to product label indications will be included in this study

Brief summary: The purpose of this study is to collect adverse events and identify risk factors in patients that are taking Dolocordralan Extra 25® and Dolocordralan Extra Forte®


Eligibility criteria: Inclusion Criteria:

* Patients who are prescribed Dolocordralan Extra 25 and Dolocordralan Extra Forte at any of the participating clinics
* Patients who sign the informed consent form
* Patients who agree to comply with the study procedures

Exclusion Criteria:

* Please see the protocol for further information on exclusion criteria

Primary outcomes:
measure: Incidence rate of adverse events (AEs) in patients receiving treatment with Dolocordralan Extra 25 and and Dolocordralan Extra Forte in patients from Metropolitan Lima records
timeFrame: Approximately 13 months
Secondary outcomes:
measure: Observed AEs in patients receiving treatment with Dolocordralan Extra 25 and Dolocordralan Extra Forte in patients from Metropolitan Lima records
timeFrame: Approximately 13 months
measure: Risk factors in patients experiencing adverse events while receiving treatment with Dolocordralan Extra 25 and Dolocordralan Extra Forte in patients from Metropolitan Lima records
timeFrame: Approximately 13 months
measure: Drug utilization factors in patients receiving treatment with Dolocordralan Extra 25 and Dolocordralan Extra Forte in patients from Metropolitan Lima records
timeFrame: Approximately 13 months
Other outcomes:
Locations:
city: San Miguel
country: Peru
facility: Local Institution
state: Lima
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01810263: The Efficacy of Intensive Nutritional Supplement in Patient With Stroke
Official title: The Efficacy of Intensive Nutritional Supplement in Patient With Stroke: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Stroke
Malnutrition
Keywords: stroke
malnutrition
high protein
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Myongji Hospital
First posted: 2013-03-13
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective randomized controlled study is to demonstrate the efficacy of Intensive Nutritional Supplement in Patient with Stroke.

Detailed description: Elderly patients, including those who have had a stroke, are more at risk of undernutrition than other groups because of reduced nutritional reserves, prolonged hospital stay and increased demands of repeated ill-health. Stroke may compound these problems because of physical and mental incapacity, problems with perception and communication, and swallowing disorders. The full extent of undernutrition and its independent contribution to stroke outcome is not presently known. It is also not known whether it can be corrected, and whether doing so would improve the outcome. The aim of this study is therefore to describe the efficacy of Intensive Nutritional Supplement in Patient with Stroke.

Eligibility criteria: Inclusion Criteria:

* 1 st onset stroke patient
* MRI confirms his/her stroke
* more than 2.5% weight los within 2 weeks
* initial serum albumin \< 35 g/l
* BMI \< 18.5
* more than MMSE 10
* medically stable

Exclusion Criteria:

* recurrent stroke patient
* malabsorption patient
* terminal cancer

Primary outcomes:
measure: Modified Barthel Index (MBI) Score at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Chemical Laboratory Findings
timeFrame: 6 months
Other outcomes:
measure: Body Mass Index
timeFrame: 6 months
measure: Triceps Skin Fold Thickness
timeFrame: 6 months
measure: Subjective Global Assessment
timeFrame: 6 months
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Korea, Gyeonggi-do
Study officials:
affiliation: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
name: Nam-Jong Paik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gariballa SE, Parker SG, Taub N, Castleden M. Nutritional status of hospitalized acute stroke patients. Br J Nutr. 1998 Jun;79(6):481-7. doi: 10.1079/bjn19980085.
citation: Axelsson K, Asplund K, Norberg A, Alafuzoff I. Nutritional status in patients with acute stroke. Acta Med Scand. 1988;224(3):217-24. doi: 10.1111/j.0954-6820.1988.tb19364.x.