louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01517620: Total Glucosides Paeony Capsules in Maintaining Clinical Remission in Patients With Ankylosing Spondylitis Which Achieve Clinical Remission After Anti-TNF Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 38
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, open-label clinical trial to evaluate the efficacy and safety of total glucosides paeony capsules in maintaining clinical remission in patients with ankylosing spondylitis which achieved clinical remission after anti-TNF therapy. Patients will be divided into two groups randomly, one group receive non-steroid anti-inflammatory drugs(NSAID) mono-therapy and the other group receive total glucosides paeony capsules plus NSAID therapy for 24 weeks. The primary clinical endpoint is the proportion of patients which disease activity reaches relapse criteria. The investigator's hypothesis the proportion of relapse in total glucosides paeony capsules plus NSAID group would be lower than the NSAID mono-therapy group.


Eligibility criteria: Inclusion Criteria:

* Aged from 16-65 years, sign the Informed Consent
* Fulfill 1984 modified NewYork classification criteria for AS
* Achieved clinical remission after at least 12 weeks' therapy of anti-TNF therapy
* Hb≥9g/dl, ALT/AST≤ 2 folds of upper level normal range, creatine≤120mol/L(≤1.4mg/dl)
* Commitment to contraceptive for woman

Exclusion Criteria:

* History of psoriasis and/or inflammatory bowel diseases
* Receive intra-articular injection of cortisone within 3 months before enrollment
* History of the listed diseases: heart failure, Multiple sclerosis, severe chronic obstructive pulmonary disease, frequent infections, lymphoma or other cancers, tuberculosis
* Pregnant and lactating women
* Mentally ill, Alcoholics and drug addicts

Primary outcomes:
measure: the proportion of patients which disease activity reaches relapse criteria
timeFrame: 24 weeks
Secondary outcomes:
measure: BASDAI score comparing to baseline
timeFrame: 24 weeks
measure: BASFI score comparing to baseline
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
Study officials:
References:
Clinical trial NCT00546520: Effect of Inhaled Ciclesonide in Adult Patients With Asthma (BY9010/M1-125)
Official title: A 3-period Double-blind, Cross-over Study on the Onset of Action of Inhaled Ciclesonide (7 Days of 400 mcg Sid Versus 800 mcg Bid Versus Placebo) on Airway Responsiveness to Adenosine Monophosphate (AMP), Sputum Eosinophiles and Exhaled Breath Nitric Oxide (NO) in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Ciclesonide
Airway hyperresponsiveness
Sputum
Nitric oxide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-10-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Ciclesonide is a novel inhaled corticosteroid for the treatment of asthma. In this study the effect of ciclesonide on airway hyperresponsiveness (AHR), exhaled nitric oxide (NO), and induced sputum inflammatory biomarkers will be evaluated.


Eligibility criteria: Main inclusion criteria:

* Out-patients
* Written informed consent
* History of atopic disease
* History of perennial bronchial asthma for at least 6 months as defined by ATS criteria
* Current use of only inhaled short acting beta-2-agonist as required (for at least 4 weeks prior to baseline period B0)
* Stable asthma, i.e. no exacerbation or relevant respiratory tract infection within 2 months prior to study start
* FEV1 ≥ 70% predicted
* Hyperreactivity to AMP (PC20FEV1 \< 25 mg/ml)
* Good health with the exception of asthma
* Non-smokers as well as ex-smokers with either = 10 pack-years or more than 6 months of smoking abstinence

Main exclusion criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids (e.g. lung tuberculosis)
* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
* Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
* Pregnancy or intention to become pregnant during the course of the study, breast feeding, lack of safe contraception in heterosexually active female patients of child-bearing potential, or postmenopausal for less than one year
* COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases
* Known or suspected hypersensitivity to inhaled steroids or to the other excipients of the metered dose inhalers
* Immunotherapy within one month prior to B0 and/or during the entire study duration

Primary outcomes:
measure: PC20FEV1 (AMP)
Secondary outcomes:
measure: Baseline FEV1 from spirometry, exhaled NO, eosinophils, basophils, and mast cells determined from induced sputum; Safety variables: Physical examination, vital signs, ECG, laboratory work-up, and adverse events
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: "Altana Pharma/Nycomed"
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
Clinical trial NCT01934920: Identifying Patients With Unrecognized Treatable Diabetic Macular Edema
Official title: Identifying Patients With Unrecognized Treatable Diabetic Macular Edema
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Macular Edema
Lead sponsor: Elman Retina Group
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2013-09-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients identified through medical records or admitted into Franklin Square Hospital with a history of diabetes

Brief summary: This trial will assess the incidence of new and/or undiagnosed diabetic macular edema (DME) in diabetic patients that undergo a DME screening exam. The screening exam will consist of medical history, Electronic ETDRS visual acuity assessment, SD-OCT and color fundus photography


Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 18 years
* Patient related considerations
* Patients with diabetes mellitus
* Disease related considerations
* Diabetes mellitus

Exclusion Criteria:

* Prior admission screening within twelve months.
* Inability to sit for evaluation

Primary outcomes:
measure: Assess the incidence of new and/or undiagnosed diabetic macular edema.
timeFrame: 1 day (Patients are only seen once for assessments)
Secondary outcomes:
measure: Streamlining and identification of patients at risk of diabetic macular edema
timeFrame: 1 day (Patients only seen once for assessments)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Aaron Goldberg, Primary Care
state: Maryland
city: Baltimore
country: United States
facility: MedStar Hospital
state: Maryland
Study officials:
affiliation: Elman Retina Group, P.A.
name: Michael J Elman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05444920: The Italian Transthyretin Amyloidosis Web-Network
Official title: The Italian Transthyretin Amyloidosis Web-Network (ITA-WebNet)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ATTR Amyloidosis
Keywords: amyloidosis
systemic amyloidosis
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be entered the database pending on expressing an informed consent of the use of their data for research purposes. Data of deceased patients will be used only if they have expressed their consent to the use of their clinical data

Brief summary: The study aims, by generating a large registry of patients with ATTR amyloidosis, including data at diagnosis and during follow up, to describe the natural history of ATTR amyloidosis in a real-world setting and to define and validate prognostic models, response criteria applicable at any point of the disease. The registry will also be used for data sharing and to allow the possibility of a close collaboration amongst the amyloidosis experts of the ARTC and all the physicians around the Country involved in the diagnosis and management of systemic amyloidosis. Thanks to the online registry, the diagnostic facility of the ARTC will be made available to requesting physicians.


Eligibility criteria: Inclusion Criteria:

1. Suspected diagnosis of systemic and localized amyloidosis;
2. age .18 years;
3. ability to understand and willingness to sign an informed consent (patients who already sign informed consent for clinical data to be used in retrospective analyses will be accepted);
4. planned (or ongoing) follow-up at participating center.

Exclusion Criteria:

1. Diagnosis of light chain (AL) amyloidosis

Primary outcomes:
measure: Establishing an online tool for data-sharing, available for health care providers
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
Study officials:
References:
Clinical trial NCT02600520: Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis
Official title: 1.2% Rosuvastatin Versus 1.2% Atorvastatin Local Drug Delivery in Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Periodontitis
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical and radiographic efficacy of two local drug delivery systems containing 1.2% RSV gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.

Detailed description: Background: Rosuvastatin (RSV) and Atorvastatin (ATV) are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of 1.2% RSV and 1.2% ATV gel as local drug delivery systems in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis (CP).

Methods: A total of 90 intrabony defects were treated with either 1.2% RSV, 1.2% ATV or placebo gel LDD after SRP. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth and clinical attachment level) were recorded at baseline and 6 months. Radiographic intrabony defect depth change was calculated on standardized radiographs by using image analysis software at 6 months.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy patients with PD ≥5mm or CA loss ≥4mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included

Exclusion Criteria:

* Patients with a known systemic disease;
* known or suspected allergy to statin group;
* on systemic statin therapy;
* with aggressive periodontitis;
* who used tobacco in any form;
* alcoholics;
* immunocompromised patients;
* pregnant or lactating females were excluded from the study

Primary outcomes:
measure: Change in intrabony defect depth from baseline to 6 months
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in plaque index (PI) from baseline to 6 months
timeFrame: Baseline to 6 months
measure: Change in modified sulcus bleeding index (mSBI) from baseline to 6 months
timeFrame: Baseline to 6 months
measure: Change in probing depth (PD) from baseline to 6 months
timeFrame: Baseline to 6 months
measure: Change in clinical attachment (CA) level from baseline to 6 months
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06507020: Health Education for Preventing Falls in Older Adults Living in the Community
Official title: Health Education for Preventing Falls in Older Adults Living in the Community: a Factorial Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Accidental Falls
Older Adults
Lead sponsor: Guangzhou Center for Disease Control and Prevention
Sponsor class: OTHER_GOV
Collaborators: name: Southern Medical University, China
First posted: 2024-07-18
Enrollment: 888
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This clinical trial aims to evaluate the effectiveness of three health education intervention modules in preventing falls among older adults living in the community. The study is designed as a factorial randomized controlled trial, assessing the impact of three health education intervention modules: Fall prevention knowledge education，Exercise education, and Home hazard reduction education. Each module will have a 'yes' and 'no' version, resulting in eight experimental conditions.

The primary questions it seeks to address are: (1) What is the main effect of different health education intervention modules on preventing falls in older adults living in the community? (2)What is the interactive effect of different health education intervention modules on preventing falls in older adults living in the community?

The trial will be conducted in twenty four sub-district in Baiyun District, Guangzhou City. An estimated 37 participants will be recruited from each of the 24 sub-districts, with the sub-districts being randomly assigned to one of the eight experimental groups by a statistician independent of the research team using computer-generated random numbers.


Eligibility criteria: Inclusion Criteria:

* Age 60-80 inclusive
* Live in the community
* Expected to live in their current place of residence for the next 12 months
* can walk 50 metres without the assistance of an assistive device

Exclusion Criteria:

* Exclusion of subjects with acute illness or acute stages of chronic disease

Primary outcomes:
measure: The rate of falling in each group
timeFrame: Baseline, 6-month, 12-month
Secondary outcomes:
measure: Fall efficacy in each group
timeFrame: Baseline, 6-month, 12-month
measure: Quality of life in each group
timeFrame: Baseline, 6-month, 12-month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03904420: An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
Official title: An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sensorineural Hearing Loss, Bilateral
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2019-04-05
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who are receiving a Nucleus® CI512, CI522, or CI532 electrodes
* 18 years and older
* Postlingual onset of hearing loss (onset of hearing loss \>two years of age)
* Individuals who qualify for cochlear implantation using the clinics current CI candidacy criteria
* Individuals who have recently been implanted but not yet had their external device activated
* Willingness to participate in a study and comply with all study requirements
* Fluent in spoken English

Exclusion Criteria:

* Ossification or any other cochlear anomaly that might prevent insertion of less than 10 electrodes of the electrode array
* Diagnosis of retro-cochlear pathology
* Diagnosis of auditory neuropathy
* Subject considering an acoustic component in the implanted ear
* Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
* Unwillingness or inability to comply with all investigational requirements
* Severe-profound sensorineural hearing loss \>30 years
* Previous cochlear implant in the contralateral ear. Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the investigator

Primary outcomes:
measure: Change in Time Spent With Audiologist
timeFrame: 6 months post activation
Secondary outcomes:
Other outcomes:
Locations:
city: Wichita Falls
country: United States
facility: Head and Neck Surgical Associates
state: Texas
city: Edmonds
country: United States
facility: Puget Sound ENT
state: Washington
Study officials:
References:
Clinical trial NCT04213820: TMS and Body Image Treatment for Anorexia Nervosa
Official title: TMS Treatment for Anorexia Nervosa: Effects on Body Image Processing and Clinical Outcome Measures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: Region Östergötland
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate if TMS together with a body image intervention is an efficacious treatment for anorexia nervosa compared to treatment as usual.


Eligibility criteria: Inclusion Criteria:

* Being enrolled as a patient at the eating disorder unit of the Child and adolescent psychiatric clinic and Psychiatric clinic in Linköping
* Having a DSM-5 diagnosis of anorexia nervosa, atypical anorexia (restrictive type)
* Being at least 18 years of age
* Having a BMI of 20 or under.
* Being free of psychotropic medications or on stable (at least three months on the same dose) medication.

Exclusion Criteria:

* Clinical diagnosis of schizophrenia or psychotic disorder
* Clinical diagnosis of bipolar disorder
* Alcohol/drug dependence
* Ongoing treatment with antipsychotics or tricyclic antidepressants
* Previous severe head injury
* Birth before 33 weeks of gestation
* Hearing impairment
* Earlier epilepsy or seizures of other causes
* Having severe claustrophobia
* Being pregnant
* Having a cognitive disability

Primary outcomes:
measure: Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: Change from baseline at 4 weeks and at 6 months
measure: Body Attitude Test (BAT)
timeFrame: Change from baseline at 4 weeks and at 6 months
measure: Body Shape Questionnaire (BSQ)
timeFrame: Change from baseline at 4 weeks and at 6 months
measure: Figure Rating Scale
timeFrame: Change from baseline at 4 weeks and at 6 months
measure: Body Mass Index (BMI)
timeFrame: Change from baseline at 4 weeks and at 6 months
Secondary outcomes:
Other outcomes:
measure: Extrastriatal body area (EBA) activation during fMRI
timeFrame: Change from baseline at 4 weeks and at 6 months
measure: Extrastriatal body area (EBA) connectivity during resting state fMRI
timeFrame: Change from baseline at 4 weeks and at 6 months
Locations:
city: Linköping
country: Sweden
facility: Region Östergötland BUP-kliniken
Study officials:
affiliation: Region Östergötland/Linköping university
name: Maria A Zetterqvist, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05844020: Perceptions of Trauma and Violence Informed Care
Official title: Assessment of Survivor and Provider Perceptions of Trauma and Violence Informed Care Among Black Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intimate Partner Violence
Lead sponsor: Meharry Medical College
Sponsor class: OTHER
Collaborators: name: Matthew Walker Comprehensive Health Center
First posted: 2023-05-06
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to adapt, implement and evaluate a trauma and violence informed care intervention designed for Black women in middle Tennessee.

Detailed description: The primary goal is the adaptation, implementation and evaluation of a trauma and violence informed care (TVIC) intervention designed for Black women in middle Tennessee. In this 5-year RCMI project, the investigators propose 3 aims. Aim 1) Engage a stakeholder committee of patients, providers, and experts (COPE) to adapt a TVIC intervention for Black women and their healthcare providers at Meharry. \[Years 1-2\]. Aim 2) Implement and prospectively evaluate the adapted TVIC intervention at the healthcare provider-level, measuring changes in Meharry healthcare provider's self-efficacy for TVIC implementation and alignment with TIC knowledge, attitudes, and practices. \[Years 2-3\] Aim 3) Implement the adapted TVIC intervention at the patient-level to provide trauma-informed IPV screening, brief interventions, and referrals to treatment (SBIRT), and rigorously evaluate this TVIC intervention's impact on the primary outcome of patient-perceived usefulness of intervention and reported linkage to IPV services, and the secondary outcome of changes at the clinic-level relative to climate and culture, through a non-randomized pragmatic trial design. \[Year 4-5\].

Eligibility criteria: Inclusion Criteria:

* Meharry or Matthew Walker Comprehensive Health Center female patients
* Self-identify as Black
* Self-identify as intimate partner violence survivors
* English or Spanish language fluency

Exclusion Criteria:

* Not Black female intimate partner violence survivor of Meharry or Matthew Walker Comprehensive Health Center
* Those without English or Spanish language fluency

Primary outcomes:
measure: Number of patients who received appropriate intimate partner violence screening and trauma/mental health services referral
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
Study officials:
References: