louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05823805: Approaches For ThE pRioritization of Patients in priMAry Care Post-COVID To Reduce Health Inequities (AFTERMATH)
Official title: Approaches For ThE pRioritization of Patients in priMAry Care Post-COVID To Reduce Health Inequities (AFTERMATH): Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Keywords: primary health care
primary care
schizophrenia
bipolar disorder
cluster randomized controlled trial
community health worker
randomized controlled trial
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The COVID-19 pandemic significantly impacted primary care across Canada. Inequities in prevention activities and chronic disease management likely increased but the extent is unknown. Pragmatic interventions are required to prioritize patients and improve the quality of primary care post-COVID. In AFTERMATH, the investigators will conduct a pragmatic cluster randomized controlled trial (cRCT) at the largest primary care Practice-Based Research Network (PBRN) in Ontario, focused on a highly marginalized population: adults living with mental illness and one or more additional chronic diseases. The investigators will test an intervention that builds on the investigators' past work and combines data and supports to primary care providers to improve quality of life, reduce gaps in prevention activities and improve chronic disease management. The investigators' project will result in new evidence on ways to improve access to care and reduce inequities, and inform future efforts to use data beyond COVID-19.


Eligibility criteria: Inclusion Criteria:

A. Family Physicians: Any family physician in the University of Toronto Practice-Based Research Network (UTOPIAN) with 10+ community-dwelling patients living with depression, schizophrenia or bipolar disorder plus one or more additional chronic disease (COPD, diabetes, hypertension, osteoarthritis, dementia, epilepsy and Parkinson's).

B. Patients: Patients from the included family physician practices living with depression, schizophrenia or bipolar disorder plus one or more additional chronic disease (COPD, diabetes, hypertension, osteoarthritis, dementia, epilepsy and Parkinson's).

Exclusion Criteria:

A. Family Physicians: None

B. Patients: Patients under 18

Primary outcomes:
measure: health-related quality of life
timeFrame: 9 months
Secondary outcomes:
measure: preventive care activities
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
affiliation: Unity Health Toronto
name: Andrew Pinto, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02380105: Effectiveness of a Counseling Program for Temporomandibular Disorders (TMD) Treatment
Official title: Effectiveness of a Counseling Program for TMD Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorders
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effectiveness of counseling on pain, function and well-fare outcomes for the management of patients with temporomandibular disorder (TMD).

Detailed description: In this study, 51 patients were allocated to one of the research groups. In Group I, it was instituted counseling therapy. For Group II was conducted treatment as usual with occlusal splint. Patients were followed for returns at 7, 15, 30 and 60 days after baseline. At baseline, all patients were examined and assessed Research Diagnostic Criteria/Temporomandibular Disorder (RDC/TMD form). In addition, the patients were referred for specific treatment according to the group to which belonged. In each session, patients were also surveyed about pain intensity using a Numeric Scale. To analyze the impact of pain on quality of life, Oral Health Impact Profile (OHIP-14) questionnaire was used.

Eligibility criteria: Inclusion Criteria:

* Female individuals
* Positive diagnosis of TMD according to RDC/TMD
* Presence of pain in the orofacial region persisting for at least a week of at least moderate intensity, according to the Numeric Scale of pain

Exclusion Criteria:

* TMD treatment for ongoing pain
* Presence of pulpal or periodontal disease
* Orthodontic treatment in progress
* Daily use of analgesics, antidepressants or muscle relaxants
* History of radiotherapy to the head and neck, or any adverse systemic condition that may favor presentation of symptoms involved

Primary outcomes:
measure: Pain as measured by Visual Analogue Scale (VAS)
timeFrame: Baseline, 7, 15, 30, 60 days
Secondary outcomes:
measure: Quality of life measured by Oral Health Impact Profile (OHIP)
timeFrame: Baseline, 7, 15, 30, 60 days
measure: Functional Evaluation measured by TemporoMandibular Index (TMI)
timeFrame: Baseline, 7, 15, 30, 60 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02616705: Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis
Official title: Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IgG4-related Sclerosing Cholangitis
IgG4-related Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Nagoya University
First posted: 2015-11-30
Enrollment: 511
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: Cases with biliary stricture(s) of any cause

Brief summary: Immunoglobulin G4-related disease (IgG4-RD) is an uncommon inflammatory disorder that may affect multiple organ systems, including the biliary tree. IgG4-sclerosing cholangitis (IgG4-SC) can be difficult to distinguish from primary sclerosing cholangitis (PSC) or cholangiocarcinoma (CCA). The investigators aim to evaluate the sensitivity and specificity of bile for the diagnosis of IgG4-SC. Bile samples of patients with biliary strictures of various causes, including IgG4-SC, PSC, and CCA, will be collected during clinical cholangiography procedures. IgG4 will be measured in bile specimens and bile IgG4 concentrations compared between IgG4-SC, PSC, CCA, and other types of biliary strictures.

Detailed description: This study will recruit cases from Mayo Clinic Rochester and Japanese institutions such as Nagoya City University Hospital, Nagoya Daini Red Cross Hospital, and Kurashiki Central hospital. Participants will be individuals who will receive endoscopic retrograde cholangiography (ERC), endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) or percutaneous transhepatic cholangiography (PTC). Bile samples collected from the target cases will be assayed for IgG4 concentration.

Eligibility criteria: Inclusion Criteria:

* The presence of a biliary stricture
* 18 years and older
* Consented to IRB 707-03

Exclusion Criteria:

* Younger than 18 years of age
* Unable to collect a bile sample
* Abnormal postsurgical anatomy preventing collection of a bile sample

Primary outcomes:
measure: Ability of bile IgG4 concentration to distinguish between IgG4-SC, PSC, and CCA.
timeFrame: 2 year
Secondary outcomes:
measure: Correlation between bile and serum IgG4 concentrations.
timeFrame: 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Nagoya
country: Japan
facility: Nagoya City Universty Graduate School of Medical Sciences
Study officials:
affiliation: Mayo Clinic
name: Lewis R Roberts, MB, ChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05123105: Effect of Dry Cupping and Ischemic Compression on the Trigger Point on the Upper Trapezius Muscle
Official title: Effect of Dry Cupping and Ischemic Compression on the Trigger Point on the Upper Trapezius Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigger Point Pain, Myofascial
Keywords: ischemic compression
cupping
algometer
trapezius muscle
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each person participated in three tests with an interval of approximately one week between them. The following study protocol was followed; (short version)

1. cupping therapy;

   - a minimum interval of 7 days;
2. control test;

   - a minimum interval 7 days;
3. ischemic compression.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Ischemic compression is considered the fastest and most common method for providing relief in trigger point therapy, whereas cupping therapy is not a method often used for this purpose. The muscle that has a great impact on tension-type headaches and neck pain is the trapezius, whose upper fibres are where the most common trigger point in the back is located.

The aim of this study was to evaluate and compare the effectiveness of single ischemic compression and single dry cupping therapy on the most common trigger point, on the descending part of the trapezius muscle.


Eligibility criteria: Inclusion Criteria:

* age 18-30
* student of The Józef Piłsudski University of Physical Education in Warsaw
* written consent to participate in the study

Exclusion Criteria:

* past or current injury to the trapezius.
* past or current injury of the cervical spine limiting mobility of this segment.
* broken skin at the examination site.
* cardiological disease and use of blood pressure medication, histamine medication and analgesics
* elevated body temperature, illness symptoms and a period of convalescence.
* a missed anti-Covid procedure before each examination.
* inability to find trigger points.

Primary outcomes:
measure: Pain pressure threshold test (PPT)
timeFrame: changes from baseline in pain pressure threshold at 2 minutes after the session
measure: Cervical spine mobility test
timeFrame: changes from baseline in cervical spine mobility at 2 minutes after the session
Secondary outcomes:
measure: Height
timeFrame: Measurements were taken before the first session
measure: Weight
timeFrame: Measurements were taken before the first session
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Józef Piłsudski University of Physical Education in Warsaw
state: Mazowieckie
Study officials:
affiliation: Józef Piłsudski University of Physical Education in Warsaw
name: Agnieszka Zdrodowska, PH.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02256605: Vitamin D3 Supplementation in Pediatric IBD: Weely vs Daily Dosing Regimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease (IBD)
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: NASPGHAN Foundation
First posted: 2014-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with IBD, aged 5 to 17, who are vitamin D insufficient or deficient will be recruited at the time of a rountine clinic visit or lab draw that includes a 25(OH)D level as part of a clinical practice/standard of care.

Brief summary: The purpose of this prospecitve randomized controlled trial is to compare effectiveness and patient/family adherence of weekly or daily Vitamin D-3 dosing regimens in children with Inflammatory Bowel Disease (IBD) who are 25-hydroxyvitamin D \[25(OH)D\] insufficient or deficient. The primary aim of this pilot study is to evaluate the effectiveness of once weekly verses daily D-3 dosing regimens based on the most current IBD supplementation guidelines in improving 25(OH)D levels. A seconary aim is to determine if there is difference in adherence between dosing regimns.


Eligibility criteria: Inclusion Criteria:

* Subjects aged 5 to 17 years with a diagnosis of Inflammatory Bowel Disease, who have a 25(OH)D level below 30 ng/ml within 2 weeks of enrollment
* Subject/family must be able and willing to take oral medications, complete a 3 day dietary record, and return for 8 week concluding visit or clinicl visit

Exclusion Criteria:

* Subjects will not be eligible if they are intolerant of vitamin supplementation or any ingredients in the chosen supplment, are unable or unwilling to take oral supplements, or are on specific medical therapy for diminished bone mineral density
* Children with parathryoid disease, granulomatous disorders or William's syndrome will also be excluded from the study

Primary outcomes:
measure: 25 \(OH)D level will be recorded at baseline and at 8 weeks as an absolute value (ratio data) and the percentage and direction (increase or decrease) of change between baseline and end of treatment level.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
Study officials:
References:
Clinical trial NCT05888805: Effectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope - Auxiliary Group
Official title: Effectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope - Auxiliary Group
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Keywords: Myopia
Defocus
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: HOYA Lens Thailand LTD.
First posted: 2023-06-05
Enrollment: 59
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the efficacy and performance of the Defocus Incorporated Multiple Segments (DIMS) Spectacle lenses on controlling myopia progression in fast progressing myopic children.

Detailed description: DIMS spectacle lens is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.

Participants will be prescribed a pair of DIMS spectacle lenses. Their cycloplegic refraction and axial length will be monitored every 6 months over 2 years.

Eligibility criteria: Inclusion Criteria:

* SER: -1.00D or below
* Documented history of fast progressing myopia, either in SER or AL
* SER progression: 0.50D/year or more
* AL elongation: 0.27mm/year or more
* Best-corrected monocular visual acuity (VA) in both eyes: 0.00 logMAR (equivalent) or better
* Acceptance of random group allocation and the masked study design
* Anisometropia of 1.50 D or less
* Astigmatism of 2.00 D or less

Exclusion Criteria:

* Strabismus and binocular vision abnormalities
* Ocular and systemic abnormalities
* Prior experience of myopia control

Primary outcomes:
measure: Cycloplegic refraction change in spherical equivalent refraction (SER)
timeFrame: Baseline, 1st year and 2nd year
Secondary outcomes:
measure: Axial length change
timeFrame: Baseline, 1st year and 2nd year
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: School of Optometry, The Hong Kong Polytechnic University
Study officials:
affiliation: School of Optometry, The Hong Kong Polytechnic University
name: Dennis Yan Yin Tse, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03933605: Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Official title: Comparison of Palonosetron With Combined Palonosetron and Midazolam for Preventing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea
Postoperative Vomiting
Keywords: postoperative nausea and vomiting
midazolam
palonosetron
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 88
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the present study, midazolam and palonosetron in combination were more effective than palonosetron alone in lowering the incidence and severity of postoperative nausea and vomiting in the initial 2 h after laparoscopic cholecystectomy. Postoperative clinical complications were not different in both groups.


Eligibility criteria: Inclusion Criteria:

* The patients (aged 20 to 65 years) scheduled for laparoscopic cholecystectomy with American Society of Anesthesiologists (ASA) physical status classification of 1 or 2

Exclusion Criteria:

* The patients with a history of allergy to any other drugs used in this study, gastrointestinal disorder, previous PONV, pregnant woman, breastfeeding woman, use of antiemetics within 24 hours or body mass index \> 30 kg/m2

Primary outcomes:
measure: incidence of postoperative nausea and vomiting
timeFrame: 24 hours after surgery
measure: severity of postoperative nausea and vomiting
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Eun kyung Choi
state: Korea (the Republic Of)
Study officials:
References:
Clinical trial NCT05267405: Mainz Epilepsy Registry
Official title: Study on Disease Course and Quality of Life in Patients With Epilepsy (Mainz Epilepsy Registry)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Dissociative Seizures
Status Epilepticus
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 700
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: All patients treated in Mainz Comprehensive Epilepsy and Sleep Medicine Center

Brief summary: Prospective longitudinal observational registry study of all patients with epilepsy treated in the Mainz Comprehensive Epilepsy and Sleep Medicine Center with the focus on the course of the disease and quality of life.

Detailed description: Clinical parameters of patients, such as onset of the disease, prior medication, disease severity, which are important for the data analysis also collected retrospectively before the initiation of the registry. Data on the quality of life is collected only prospectively.

Eligibility criteria: Inclusion Criteria:

* Epileptic or psychogenic seizures

Exclusion Criteria:

* age\<18
* patients who cannot provide informed consent and don't have a legal guardian

Primary outcomes:
measure: monthly seizure frequency after 6 months
timeFrame: 6 months
measure: European Quality of Life 5 dimensions Index (EQ 5D Index)
timeFrame: 6 months
measure: monthly seizure frequency after 12 months
timeFrame: 12 months
measure: European Quality of Life 5 dimensions Index (EQ 5D Index)
timeFrame: 12 months
measure: Seizure freedom
timeFrame: 6 months
measure: Seizure freedom
timeFrame: 12 months
measure: interruption of status epilepticus
timeFrame: 48 hours
Secondary outcomes:
measure: Resilience Scale 13
timeFrame: 12 months
measure: Resilience Scale 13
timeFrame: 24 months
measure: Multidimensional Fatigue Inventory
timeFrame: 12 months
measure: Multidimensional Fatigue Inventory
timeFrame: 24 months
measure: Beck Depression Inventory II
timeFrame: 12 months
measure: Beck Depression Inventory II
timeFrame: 24 months
measure: Berlin Social Support Scales (BSSS)
timeFrame: 12 months
measure: Berlin Social Support Scales (BSSS)
timeFrame: 24 months
measure: World Health Organization Quality of Life-BREF (WHOQOL-BREF)
timeFrame: 12 months
measure: World Health Organization Quality of Life-BREF (WHOQOL-BREF)
timeFrame: 24 months
measure: Pittsburgh Sleep Quality Index
timeFrame: 12 months
measure: Pittsburgh Sleep Quality Index
timeFrame: 24 months
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Mainz Comprehensive Epilepsy and Sleep Medicine Center
state: Rheinland-Pfalz
Study officials:
affiliation: Mainz Comprehensive Epilepsy and Sleep Medicine Center
name: Yaroslav Winter, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01451905: GLP-1 Receptors in Normal Skin and Skin From Patients With Psoriasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reduction of Psoriasis Following Liraglutide Therapy in Terms of PASI and DLQI
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2011-10-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To examine GLP-1 receptors in skin of psoriasis patients compared with the skin of humans with no skin disease


Eligibility criteria: 4.3 Inclusion Criteria

* Caucasians above 18 years of age
* Plaque psoriasis
* PASI score \>10
* No treatment or stable treatment of psoriasis during at least 3 months before inclusion
* Steady weight through 3 months with a body mass index (BMI) above 27 kg/m2
* Normal blood pressure
* Spiral or hormonal birth control for fertile women during the entire treatment period and at least 3 days after the end of the treatment period (\~5 times the plasma half-life) 4.4 Exclusion Criteria
* Psoriasis arthritis
* Fasting plasma glucose \> 7.5 mmol/L or HbA1c \> 7.5%
* Type 1 diabetes
* Treatment for type 2 diabetes with GLP-1-based medicine (DDP-4-inhibitors or GLP-1-receptor-agonists)
* Heart failure, NYHA class III-IV
* Uraemia, end-stage renal disease, or any other cause of impaired renal function with s-creatinine \>150 µM and/or albuminuria
* Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) \>2 x upper normal serum levels)
* Anaemia
* Acute or chronic pancreatitis
* Struma or thyroid cancer
* Pregnancy or breast feeding
* Inability to complete the study

Primary outcomes:
measure: Changes in PASI and DLQI
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital
Study officials:
References: