louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05310214: Effect of Acupuncture and Laser Acupuncture in the Treatment of People With Chronic Nonspecific Low Back Pain.
Official title: Effect of Acupuncture and Laser Acupuncture on Pain and Functional Capacity in People With Chronic Nonspecific Low Back Pain: a Randomised Controlled, Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Acupuncture
laser therapy
low back pain
acupuncture points
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised clinical trial
Primary purpose: TREATMENT

Brief summary: The aim of this randomized clinical trial will be to compare the efficacy between acupuncture and laser acupuncture on pain and disability in people with chronic nonspecific low back pain .

Detailed description: Forty-four patients with chronic cnLBP of more than three months duration will be randomly allocated to two groups: acupuncture group (ACP) (n = 22) and laser acupuncture group (LACP) (n = 22).Interventions will last one hour, and will happen twice a week for 5 weeks. The primary clinical outcomes will be pain intensity (11-point numeric pain rating scale) as measured and functional disability (Oswestry Disability Index).The secondary outcomes will be the Pain Catastrophizing Scale, Patient-Specific Functional Scale and fingertip-to-floor test. Evaluations will be performed before and after the first session, after 5 weeks of treatment, and three months after randomization (follow-up). The findings will be analyzed statistically considering a 5% significance level (p ≤ 0.05).

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years;
* Non-specific LBP for at least three months
* Pain intensity of at least 2 points measured using the Numeric Pain Rating Scale

Exclusion Criteria:

* Pregnancy;
* Any contraindication to ACP or having undergone treatment in the previous six months
* Having undergone spinal surgery in the previous six months;
* Serious spinal pathology (e.g. metastasis, spinal fracture, inflammatory, and infective diseases, caudal equine syndrome, canal stenosis, osteoporosis, rheumatoid arthritis and lumbar radiculopathy);
* Currently in an acute inflammatory phase of known gastrointestinal or urinary diseases (such as cholecysticis, renal calculi, peritonitis, appendicitis);

Primary outcomes:
measure: Pain intensity
timeFrame: 3 months
measure: Functional disability
timeFrame: 3 months
Secondary outcomes:
measure: Pain Catastrophizing
timeFrame: 3 months
measure: Functional independence.
timeFrame: 3 months
measure: Mobility of spine and pelvis
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01735214: An Observational Study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) Who Switched IOP-lowering Treatments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-11-28
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: POAG or OHT

Brief summary: This study is a prospective, observational study of changing from any IOP-lowering treatment to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications lies with the physician according to their standard practice.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT)
* Previously prescribed any IOP-lowering therapy which has been stopped and a new prostaglandin analogue -containing IOP-lowering therapy started

Exclusion Criteria:

* None

Primary outcomes:
measure: Change From Baseline in Intraocular Pressure (IOP) in the Right Eye
timeFrame: Baseline, Week 12
measure: Change From Baseline in Intraocular Pressure (IOP) in the Left Eye
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale
timeFrame: 12 Weeks
measure: Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale
timeFrame: 12 Weeks
measure: Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks
timeFrame: 12 Weeks
measure: Percentage of Participants Who Continue the New Treatment After 12 Weeks
timeFrame: 12 Weeks
measure: Physician Assessment of Adherence to New Treatment Using a 4-Point Scale
timeFrame: 12 Weeks
measure: Physician Assessment of Efficacy Using a 5-Point Scale
timeFrame: 12 Weeks
measure: Percentage of Participants Reaching Individual IOP Target After 12 Weeks
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Tamcelik N, Izgi B, Temel A, Yildirim N, Okka M, Ozcan A, Yuksel N, Elgin U, Altan C, Ozer B. Prospective, non-interventional, multicenter study of the intraocular pressure-lowering effects of prostaglandin analog/prostamide-containing therapies in previously treated patients with open-angle glaucoma or ocular hypertension. Clin Ophthalmol. 2017 Apr 19;11:723-731. doi: 10.2147/OPTH.S119963. eCollection 2017.
Clinical trial NCT03238014: Efficacy of High-intensity NPPV and Low-intensity NPPV in Patients With Chronic Hypercapnic COPD
Official title: Efficacy of High-intensity Noninvasive Positive Pressure Ventilation and Low-intensity Noninvasive Positive Pressure Ventilation in Patients With Chronic Hypercapnic Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Hypercapnic Respiratory Failure
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: High-intensity noninvasive positive pressure ventilation (NPPV), which can well improve the gas exchange and reduce the work of breathing of patients, is a new strategy targeted at maximally reducing arterial carbon dioxide. However, no definitive conclusions have been drawn to decide whether high-intensity NPPV is the best setting for treating patients with chronic hypercapnic COPD. For now, no unified method for setting up high-pressure NPPV has been established. Most of the trials utilized gradually increased inspiratory positive airway pressure depending on the patient's tolerance. However, from a respiratory physiology point of view, excessive inspiratory positive airway pressure may lead to lung hyperinflation, increased intrinsic positive end expiratory pressures, increased oxygen consumption, and ineffective work of breathing.Therefore, seeking a method to establish individualized high-intensity NPPV is of vital importance.


Eligibility criteria: Inclusion Criteria:

Clinically stable with chronic hypercapnic COPD (baseline arterial carbon dioxide pressure (PaCO2) of 50 mmHg or higher, measured resting in a sitting position and breathing room air without having used NPPV for at least 1 hour)

Exclusion Criteria:

* other lung/pleural diseases or thoracic deformity
* severe heart failure (New York Heart Association class IV), severe dysrhythmia
* unstable angina, or malignant comorbidity
* obesity (BMI ≥ 35 kg/m²)
* severe obstructive sleep apnea syndrome

Primary outcomes:
measure: Partial pressure of arterial blood carbon dioxide (PaCO2)
timeFrame: 12 weeks
Secondary outcomes:
measure: Severe Respiratory Insufficiency (SRI) Questionnaire
timeFrame: 12 weeks
measure: Baseline Dyspnea Index/Transition Dyspnea Index
timeFrame: 12 weeks
measure: Chromic Respiratory Questionnaire
timeFrame: 12 weeks
measure: COPD assessment test
timeFrame: 12 weeks
measure: Pulmonary function
timeFrame: 12 weeks
measure: 6-minute walk test
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Disease
state: Guangdong
Study officials:
affiliation: Guangzhou Institute of Respiratory Disease
name: Rongchang Chen
role: STUDY_DIRECTOR
References:
Clinical trial NCT00388414: Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication
Official title: Functional MRI Neural Correlates of Medication Efficacy in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2006-10-16
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Duloxetine has recently been shown to be effective in reducing the pain in chronic pain patients. Duloxetine is known to exert a central mechanism, however the precise human brain structures responsible for mediating its pain-relieving properties are not known. We will use functional magnetic resonance imaging (FMRI) to investigate the neural and functional correlates of pain.


Eligibility criteria: Inclusion Criteria:- Males aged 18-60

* Back Pain
* Must be able to comply with study visit schedule and other study requirements
* Capable of performing the experimental tasks Exclusion Criteria:- Contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body)
* Known hypersensitivity to duloxetine or any of the inactive ingredients
* Uncontrolled narrow-angle glaucoma

Primary outcomes:
measure: Pain
timeFrame: 3 months
measure: Neural Correlates of Pain Relief
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Sean Mackey
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02426814: Assessment of a Mobile Intervention to Increase Adherence to Asthma Medication Among Adolescents
Official title: Assessment of a Mobile Intervention to Increase Adherence to Asthma Medication Among Adolescents
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Asthma
Keywords: Patient Compliance
Mobile Applications
Lead sponsor: CoheroHealth
Sponsor class: INDUSTRY
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2015-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the use of a mobile health intervention to improve adherence to asthma medication among adolescents. The intervention consists of an inhaler sensor strap to monitor asthma inhaler use and a mobile phone application to remind and incentivize patients to use their medication. This study will assess medication use throughout a 12 week study in patients who receive a mobile app with reminders, asthma control as measured by the ACT \[asthma control test\], and lung function as measured by spirometry.


Eligibility criteria: Inclusion Criteria:

* Age 11-19
* Asthma diagnosis
* Currently prescribed a hydrofluoroalkane (HFA) asthma controller medication
* English-speaking
* Has a smartphone or access to a smartphone or tablet

Exclusion Criteria:

* Pregnant
* Foster Care
* Emancipated minor

Primary outcomes:
measure: Real-time medication adherence in patients using mobile app compared to standard care.
timeFrame: 12 weeks
Secondary outcomes:
measure: Asthma control in patients using mobile app compared to standard care
timeFrame: 12 weeks
measure: Change in lung function with use of a mobile health tool for asthma adherence
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Andrew Ting, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Michael Parides, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00974714: L-arginine Effects on Chronic Hypertension in Pregnancy
Official title: Effects of Oral L-arginine on Chronic Hypertension in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension in Pregnancy
Keywords: chronic hypertension in pregnancy
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
Collaborators: name: University of Modena
First posted: 2009-09-10
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of oral L-arginine administration on pregnant women at second trimester of gestation with chronic hypertension, respect with placebo.


Eligibility criteria: Inclusion Criteria:

* Pregnant women between 18-20 weeks of gestation with chronic hypertension

Exclusion Criteria:

* Other maternal or fetal systemic disease

Primary outcomes:
measure: to evaluate blood pressure changes during oral L-arginine or placebo administration in pregnant women with chronic hypertension at second trimester of gestation
timeFrame: 14 weeks
Secondary outcomes:
measure: evaluate if is necessary to add a conventional therapy for hypertension, to evaluate pregnancy outcomes and eventual complications, to evaluate safety of oral L-arginine administration
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Modena
country: Italy
facility: University of Modena and Reggio Emilia
state: Emilia Romagna
city: Modena
country: Italy
facility: University of Modena and Reggio Emilia
state: Mo
Study officials:
References:
Clinical trial NCT02416414: Performance Comparison of QuantiFERON Monitor in Solid Organ Transplant Recipients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cell-mediated Immune Response
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
First posted: 2015-04-15
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have either received a solid organ transplant or who are healthy.

Brief summary: To compare the performance of the QuantiFERON Monitor assay against existing methodology.


Eligibility criteria: Solid Organ Transplant Recipient

Inclusion Criteria:

* Provide Informed Consent
* Received a solid organ transplant

Exclusion Criteria:

* Pregnancy or recent lactation (\<1yr)
* Treatment of Rejection

Healthy Control

Inclusion Criteria:

* Provide Informed Consent

Exclusion Criteria:

* Currently taking any immunomodulatory medication
* A history of immunosuppressive disease or immunosuppression condition or history of autoimmune diseases
* Current pregnancy or recent lactation (\<1yr)
* Currently taking antiviral medication
* Currently being treated for infectious diseases

Primary outcomes:
measure: Cell-mediated immune response.
timeFrame: 1 day (At time of enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Transplant and Immunocompromised Host Infectious Diseases
name: Camille N Kotton, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05869214: Middle East African Registry Women CardioVascular Disease
Official title: Middle East African Registry Women CardioVascular Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Atrial Fibrillation
Valvular Heart Disease
Ischemic Heart Disease
Lead sponsor: Tunisian Society of Cardiology and Cardiovascular Surgery
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients having their consultation in the study participating site.

Brief summary: The MEA cardiology societies have joined forces to tackle the issue by establishing a tangible real-world data registry in every MEA country. This endeavor has resulted in the development of a multicenter registry called MEA-WCVD, which is being sponsored by each national cardiology society from participating countries. All data gathered will be consolidated into a singular registry for thorough analysis. Country specific analysis will be performed.


Eligibility criteria: Inclusion Criteria:

* All incomers in Cardiovascular (CV) diseases in hospital or out hospital facilities with one of the 4 diagnosis (Heart Failure (HF), Atrial fibrillation (AF), Valvular Heart disease (VHD), ischemic heart disease (IHD)
* Age over 18 years old
* Men and Women
* Signature of consent form

Exclusion Criteria:

Patients with diseases other than the 4 previously mentioned in inclusion criteria

Primary outcomes:
measure: Cardiovascular diseases care management in women will be compared to men in MEA countries according to current practice guidelines
timeFrame: 2 months
Secondary outcomes:
measure: Identify inequalities between both genders in terms of: • Healthcare insurance • Incomes • Access to healthcare
timeFrame: 2 months
Other outcomes:
Locations:
city: Sfax
country: Tunisia
facility: Hedi chaker Hospital
Study officials:
References:
Clinical trial NCT00645814: Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official title: Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis


Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate to severe chronic plaque psoriasis
* Active psoriasis, despite topical therapies

Exclusion Criteria:

* Other active skin diseases or skin infections
* Prior exposure to any anti-TNF therapy
* Subject has other active skin diseases
* Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
* Poorly controlled medical conditions
* History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease.
* History of cancer or lymphoproliferative disease
* History of active TB or listeriosis, or persistent chronic or active infections
* Known to have immune deficiency or is immunocompromised
* Clinically significant abnormal laboratory test results
* Erythrodermic psoriasis or generalized pustular psoriasis

Primary outcomes:
measure: Psoriasis Area and Severity Index
timeFrame: Week 12
measure: Adverse Events
timeFrame: Throughout Study Participation
Secondary outcomes:
measure: Psoriasis Area and Severity Index
timeFrame: Week 1, 2, 4, 8, 12
measure: DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
References:
citation: Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.
citation: Papp KA, Armstrong AW, Reich K, Karunaratne M, Valdecantos W. Adalimumab Efficacy in Patients with Psoriasis Who Received or Did Not Respond to Prior Systemic Therapy: A Pooled Post Hoc Analysis of Results from Three Double-Blind, Placebo-Controlled Clinical Trials. Am J Clin Dermatol. 2016 Feb;17(1):79-86. doi: 10.1007/s40257-015-0161-5.
Clinical trial NCT03804814: Motivational Interviewing for HCV Elimination
Official title: Assessing a Model for Hepatitis C Elimination: Measuring Patient and Health System Outcomes After Motivational Interviewing Interventions to Increase Treatment Engagement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatitis C
Keywords: Motivational Interviewing
Healthcare delivery
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study addresses a difficult barrier to hepatitis C elimination, specifically development and maintenance of a productive relationship between the health care provider and patient to ensure both treatment success and engagement in harm reduction services. Improvements in these domains may be observed through the use of a technique called "Motivational Interviewing" (MI). The aim of this study is to determine whether a customized motivational interviewing curriculum by general primary care and addictions medicine primary care providers changes rates of curative hepatitis C therapy completion.


Eligibility criteria: Patient Inclusion Criteria:

* Willingness to participate and provide informed consent
* Positive HCV RNA Result
* ≥18 years of age

Patient Exclusion Criteria:

* Unwilling or unable to provide consent

Health Care Provider Inclusion Criteria:

* Willingness to participate and provide informed consent
* Has a hepatitis C care experience

Health Care Provider Exclusion Criteria:

* Unwilling or unable to provide consent

Primary outcomes:
measure: HCV Treatment Completion
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Time from care engagement to treatment initiation
timeFrame: Through study completion, an average of 2 years
measure: Number of unique Hepatitis C related and unrelated health system visits
timeFrame: Through study completion, an average of 2 years
measure: Number of scheduled and attended medical care appointments
timeFrame: Through study completion, an average of 2 years
measure: Self-reported intent to initiate and maintain HCV treatment assessed by questionnaire
timeFrame: Through study completion, an average of 2 years
measure: Healthcare provider knowledge, attitudes, and behavior about motivational interviewing and training assessed by questionnaire
timeFrame: Through study completion, an average of 2 years
measure: Time to complete prescribed HCV treatment course
timeFrame: Through study completion, an average of 2 years
measure: Percentage of eligible individuals that initiate HCV therapy
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
Study officials:
References: