louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06664632: Effectiveness of Knee Sync Partner and Strengthening Exercises Versus Strengthening Exercises in Knee Osteoarthritis.RCT
Official title: Effectiveness of Knee Sync Partner and Strengthening Exercises Versus Strengthening Exercises in Knee Osteoarthritis. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study explores the effectiveness of a novel treatment approach for knee osteoarthritis (OA) by comparing the combined use of a new device, "Knee Sync Partner," which provides electrical knee traction with stimulation and strengthening exercises, to traditional strengthening exercises alone. Knee osteoarthritis is a leading cause of chronic pain and disability worldwide, significantly impacting the quality of life for many individuals, especially with the growing elderly population.

Detailed description: While strengthening exercises are a well-established treatment for improving joint stability and mobility in knee OA patients, the potential benefits of integrating electrical stimulation and traction therapy remain underexplored. This research addresses the gap by conducting a randomized controlled trial to assess whether this combined approach leads to superior outcomes in terms of pain relief, functional improvement, and joint health. The findings could provide valuable insights into more effective, non-invasive management strategies for knee OA, expanding therapeutic options in physical therapy.

Eligibility criteria: Inclusion Criteria:

* having pain in knee for more than 3 months in most days of week
* age between 40 and 70 years
* patient who filled Kellgren-Lawrence radiographic criteria

Exclusion Criteria:

* joint injection in the previous three months.
* The exclusion criteria were patients who had inflammatory arthritis
* osteoarthritis of the hips.

Primary outcomes:
measure: WOMAC Scale
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
state: Punjab
Study officials:
References:
Clinical trial NCT02300532: Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)
Official title: Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Glioma
Keywords: Malignant Glioma
Glioblastoma Multiforme
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-25
Enrollment: 561
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosed malignant glioma treated by surgery

Brief summary: Post-marketing surveillance to investigate the clinical safety and effectiveness in patients of all implantation of Gliadel with malignant glioma in the actual medical setting.


Eligibility criteria: Inclusion criteria:

* All-patient of Gliadel implantation

Exclusion criteria:

* None

Primary outcomes:
measure: Number of Adverse Events/Serious Adverse Events
timeFrame: Up to 3 months
Secondary outcomes:
measure: Survival rate
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
References:
Clinical trial NCT01285232: The Effect of Anakinra on Insulin Secretion
Official title: The Effect of Interleukin-1 Receptor Antagonist on Insulin Secretion in Subjects With Beta Cell Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glucose Intolerance
Impaired Insulin Secretion
Diabetes Mellitus Type 2
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2011-01-27
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Rationale: Once diabetes develops, β-cell function progressively deteriorates and therapeutic approaches that prevent of delay loss of β-cell function are needed in the treatment of type 2 diabetes mellitus. Recent findings suggest that interleukin-1 (IL-1) may be involved in the progressive β-cell dysfunction in type 2 diabetes mellitus.

Objective: to determine whether blocking IL-1β by recombinant human IL-1ra (anakinra) improves beta-cell function in subjects with β-cell dysfunction.


Eligibility criteria: Inclusion Criteria:

* Impaired glucose tolerance assessed by oral glucose tolerance test and/or impaired fasting glucose ( ≥ 5.6 mmol/L) and/or HbA1c levels of 5.7-6.4%
* BMI \>25 kg/m2
* Age 40-70 years

Exclusion Criteria:

* Known diabetes mellitus
* Fasting plasma glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5%
* Immunodeficiency or immunosuppressive treatment (including TNFα blocking agents and corticosteroids)
* Use of anti-inflammatory drugs ( including corticosteroids and non steroidal anti-inflammatory drugs, 100 mg or less of aspirin is allowed)
* Signs of current infection (fever, C-reactive protein \>30 mmol/L, treatment with antibiotics, previous or current diagnosis of tuberculosis)
* A history of recurrent infections
* Pregnancy or breastfeeding (contraception of at least 3 months before inclusion is required)
* Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range
* Renal disease defined as MDRD \< 60 ml/min/1.73m2
* Neutropenia \< 2x 109/L
* Inability to understand the nature and extent of the trial and the procedures required.
* Any medical condition that might interfere with the current study protocol
* Participation in a drug trial within 60 days prior to the first dose

Primary outcomes:
measure: To determine the effect of anakinra on insulin secretion, as derived from hyperglycemic clamps .
timeFrame: after 4 weeks of treatment with anakinra
Secondary outcomes:
measure: To determine the effect on anakinra on insulin sensitivity.
timeFrame: after 4 week treatment of anakinra
measure: Effects of anakinra on fat cell morphology and gene expression
timeFrame: after 4 weeks of treatment with anakinra
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: C.J. Tack, MD, PhD, Prof. of Diabetology
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05911932: Investigating Genetic Status in Patients Presenting to Clinic
Official title: Investigating Genetic Status in Patients Presenting to Clinic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dementia, Frontotemporal
Alzheimer Dementia (AD)
Lewy Body Dementia (LBD)
Keywords: Neurodegenerative disorders
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons presenting to the cognitive clinic with a neurodegenerative disorder (for example, AD, FTD, LBD, ALSP, and related conditions);

Biological family members of someone diagnosed with a neurodegenerative disorder, presenting to clinic;

Brief summary: The causes of neurodegenerative dementias such as Frontotemporal Dementia, Lewy Body Disease and Alzheimer's disease are still largely unknown. While the contribution of some genetic mutations and polymorphisms is associated with autosomal dominant patterns of inheritance of these dementias, in many cases, the specific causative mutation in these families is not yet identified. Further, in many patients, polygenic risk is thought to give rise to pathophysiologic changes, but which specific genes affect risk are largely yet unknown. By examining genotypes in patients that present to our Cognitive Neurology and Alzheimer's Research Clinic with suspected or confirmed neurodegenerative dementia, or have a history of a familial dementia, we aim to help identify and characterize genetic mutations or polymorphisms that give rise to neurodegenerative diseases.


Eligibility criteria: Inclusion Criteria:

* Persons presenting to the cognitive clinic with a neurodegenerative disorder (for example, AD, FTD, LBD, ALSP, and related conditions);
* Biological family members of someone diagnosed with a neurodegenerative disorder, presenting to clinic;
* Age 18+ years old;
* Consenting to a blood draw.

Exclusion Criteria:

• Persons declining / unwilling / not able to have a blood draw.

Primary outcomes:
measure: Blood draw for genetic status or polymorphism result.
timeFrame: A one-time visit, taking the participant approximately 20 minutes total for all study procedures.
Secondary outcomes:
measure: Demographic information.
timeFrame: A one-time visit, taking the participant approximately 20 minutes total for all study procedures.
measure: Medical history/Clinical diagnoses.
timeFrame: Typically within 1 month of the clinic visit, taking approximately 5 minutes.
measure: Pathological diagnoses.
timeFrame: Typically within 1 month of the clinic visit, taking approximately 5 minutes.
Other outcomes:
Locations:
city: London
country: Canada
facility: Parkwood Institute
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Elizabeth Finger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03157232: Rainbow DCI vs. R1-25 Sensor SpHb Sub-Range Performance Equivalence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-05-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions. Data collected in the study was in the sub-range of 11-17 g/dL in the device's 8-17 g/dL specification range.

The purpose of the study was to evaluate a change in the sensor component and to assess performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not uniform across the accuracy range.


Eligibility criteria: Inclusion Criteria:

* Subjects must understand and consent to be in the study.
* American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

Exclusion Criteria:

* Subjects who have any systemic disease at all.
* Subjects who do not understand the study and the risks.
* Smokers.
* Subjects who are pregnant.
* Subjects having either signs or history or peripheral ischemia. Others deemed ineligible by the clinical staff.

Primary outcomes:
measure: Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation
timeFrame: 1-5 hours per subject
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo
state: California
Study officials:
References:
Clinical trial NCT01346332: Healthy Volunteer Study
Official title: Performance of the Iontophoresis System With Headset in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia of Tympanic Membrane
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2011-05-03
Enrollment: 106
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The study will recruit healthy volunteers to undergo the iontophoresis procedure using the Acclarent Iontophoresis System with Headset.


Eligibility criteria: Inclusion Criteria:

* At least 2 years old

Exclusion Criteria:

* Pregnant or lactating females
* Subject with a history of sensitivity or reaction to lidocaine, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution
* Significant atrophic or perforated tympanic membrane
* Otitis externa
* Damaged or denuded skin in the auditory canal
* Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
* Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
* Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure

Primary outcomes:
measure: Pain scores on visual analog scale
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: East Palo Alto
country: United States
facility: CEI Medical Group
state: California
Study officials:
affiliation: CEI Medical Group
name: Joseph Roberson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04011332: Nurse-led Integrated Care in COPD Patients With a Pulmonary Exacerbation
Official title: Nurse-led Integrated Care to Improve Quality of Life in COPD Patients With a Pulmonary Exacerbation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD Exacerbation
Keywords: integrated care
self-management
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: monocentric parallel cluster design with a baseline period
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to evaluate the effect and effectiveness of the nurse-led integrated care programme for the management of COPD (Chronic Obstructive Pulmonary Disease) exacerbations on patients' quality of life, rehospitalisation and exacerbation rate, illness-related emotional distress, selected health behaviours and cost-utility at three months. Furthermore, understanding barriers and facilitators to implementation success is of interest.


Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed diagnosis of COPD (GOLD 1-4)
* Hospitalisation due to a COPD exacerbation and decision to start with steroids and/or antibiotics (severe exacerbation)
* Age ≥ 18

Exclusion Criteria:

* Cognitive impairment (dementia, delirium)
* Not speaking German, French, Italian, English, Spanish, Portuguese, Serbian, Tamil, Hindi, Turkish or Slovakian

Primary outcomes:
measure: Change in CRQ (Chronic Respiratory Questionnaire) scores
timeFrame: at week one and week 13
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References:
Clinical trial NCT00960232: Vitamin D, Blood Pressure, Lipids, Infection and Depression
Official title: Vitamin D, Blood Pressure, Lipids, Infection and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypovitaminosis D
Keywords: vitamin D
blood pressure
lipids
infection
depression
Lead sponsor: University of Tromso
Sponsor class: OTHER
First posted: 2009-08-17
Enrollment: 250
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are numerous indications for a relation between low serum levels of 25(OH)D and blood pressure, lipid levels, frequency of infections and tendency towards depression. Whether it is a causal relationship it is not known, and can best be studied with a vitamin D intervention. The investigators hypothesis is that supplementation with a high dose vitamin D (40.000 IU per week) will have a beneficial effect on these parameters.


Eligibility criteria: Inclusion Criteria:

* men and women 30 - 75 years of age
* low serum 25(OH)D levels

Exclusion Criteria:

* diabetes
* other serious diseases
* hypercalcemia

Primary outcomes:
measure: Depression score
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: Lipid profile
timeFrame: 6 months
measure: Frequency of infections
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University of Tromsø
Study officials:
affiliation: University of Tromso
name: Rolf Jorde, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kjaergaard M, Waterloo K, Wang CE, Almas B, Figenschau Y, Hutchinson MS, Svartberg J, Jorde R. Effect of vitamin D supplement on depression scores in people with low levels of serum 25-hydroxyvitamin D: nested case-control study and randomised clinical trial. Br J Psychiatry. 2012 Nov;201(5):360-8. doi: 10.1192/bjp.bp.111.104349. Epub 2012 Jul 12.
Clinical trial NCT05256732: Study of AT-527 in Healthy Subjects Under Fasting Conditions or With a Meal
Official title: Phase 1, Multiple Dose, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-527 Following Oral Administration Under Fasting Conditions or With a Meal in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-25
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 following oral administration under fasting conditions or with a meal in healthy adult subjects


Eligibility criteria: Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities

Primary outcomes:
measure: Pharmacokinetics (PK) of AT-527
timeFrame: Day 1
measure: Pharmacokinetics (PK) of AT-527
timeFrame: Day 1
measure: Pharmacokinetics (PK) of AT-527
timeFrame: Day 1
measure: Proportions of subjects experiencing treatment-emergent adverse events
timeFrame: Day 1-10
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Atea Study Site
state: Montreal, Quebec
Study officials:
References:
Clinical trial NCT03835832: Self-Assessment Tuberculin Skin Test
Official title: Innovation of Self-Assessment Tuberculin Skin Test for Latent TB Screening in HIV Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculin Skin Test
Keywords: Tuberculin skin test
latent TB infection
HIV/TB co-infected participants
Sensitivity
Specificity
positive predictive value (PPV)
negative predictive value (NPV)
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: Taksin Hospital
First posted: 2019-02-11
Enrollment: 215
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: HIV-infected adults with documented HIV diagnosis who do not have any signs or symptoms of active TB.

Brief summary: The research team/investigator/nurse/professional health care workers will teach the participants how to read the results for TST test. The investigator will compare the reading results done by the participants to the results read by the nurses.

Detailed description: This is a cross-sectional study of HIV-infected patients from 2 HIV clinics in Bangkok: HIV-NAT, Thai Red Cross AIDS Research Centre and Taksin Hospital. Research team/investigator/nurse/professional health care workers will assess whether the reading of TST test between the participants and the nurses are the same or not. The investigator and team believe that the readings of the TST tests between the participants and the nurses will be the same. If the investigator and team hypothesis is correct, then this will lessen the workload of the nurses and reduce the number of times the participants have to come to the clinic to see the nurses and the doctors. This is a pilot study to test this innovative method to teach the participants to read the TST results by themselves. If this technique is successful, then the investigator and team can expand the method to other hospitals in Thailand as well as in the region.

Eligibility criteria: Inclusion Criteria:

1. Documented HIV-1 infection
2. Aged ≥18 years old
3. No sign and symptom of active TB

Exclusion Criteria:

1. Refuse to read TST by themselves

Primary outcomes:
measure: self-assessment versus nurse reading
timeFrame: 6 months
measure: self-assessment versus nurse reading
timeFrame: 6 months
measure: self-assessment versus nurse reading
timeFrame: 6 months
measure: self-assessment versus nurse reading
timeFrame: 6 months
Secondary outcomes:
measure: In house questionnaire to assess the patients' satisfaction of reading TST by themselves
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: HIV-NAT, Thai Red Cross AIDS Research Centre
city: Bangkok
country: Thailand
facility: Taksin Hospital
Study officials:
affiliation: HIV-NAT, Thai Red Cross - AIDS Research Centre
name: Sivaporn Gatechompol, MD
role: PRINCIPAL_INVESTIGATOR
References: