louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06931184: Self- Sampling in Cervical Cancer Routine Screening
Official title: Self-Sampling In Cervical Cancer Routine Screening (FALCON)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cervical Cancer Screening
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 40000
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: SELF-SAMPLING IN CERVICAL CANCER ROUTINE SCREENING (FALCON) -Study implements a self-sampling option for the non-attendees of the national cervical cancer screening program in the Wellbeing Services County of Pirkanmaa. HPV primary testing is currently preferred method for cervical cancer screening. The HPV-DNA self-sampling has been shown to have screening performance equal to that of provider-obtained samples. In 2024, those turning 30, 35, 40, 45, 50, 55, 60, or 65 had the opportunity to participate in the FALCON study if they do not respond to the first invitation to cervical cancer screening. From March 2025 also women living in Kanta-Häme, Central Finland, Päijät-Häme, and Ostrobothnia can take part to the study.

The main objective of the FALCON study is to increase the current coverage of the cervical cancer screening program in the Pirkanmaa, Kanta-Häme, Central Finland, Päijät-Häme, and Ostrobothnia region and assess how acceptable self-sampling is for women.


Eligibility criteria: Inclusion Criteria:

* Women that do not respond to the first national cervical cancer screening invitation in 2024 and 2025 and to whom the reminder letter is sent to.
* Birth cohorts of women who will turn in screening year: 30, 35, 40, 45, 50, 55, 60 or 65 years old.

Exclusion Criteria:

* Women who do not belong to the screening year 2024 or 2025 invitation birth cohorts.

Primary outcomes:
measure: Change in screening participation in a screening year
timeFrame: From baseline to the end of screening year, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital and Tampere University
state: Pirkanmaa
Study officials:
References:
Clinical trial NCT00661284: A Study of Duration of Maintained Efficacy in Rheumatoid Arthritis (RA) Patients Off Treatment With MRA(a Development Code of Tocilizumab, an Anti IL-6 Receptor Monoclonal Antibody.)
Official title: A Study to Investigate the Duration of Maintained Efficacy in Patients With Rheumatoid Arthritis Who Had Treated With MRA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 189
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject who have participated in previous studies

Brief summary: A 52-week follow up study to investigate the duration of maintenance of efficacy in patients with RA and achieved low disease activity in clinical trials of MRA and stopped the treatment


Eligibility criteria: Inclusion Criteria:

* Patients who achieved DAS28 of \< 3.2 at the last observation and at least one time point among the two previous assessment time points in a previous studies.

Exclusion Criteria:

* Patients who receive DMARDs or immunosuppressants between the last observation in a previous studies and the first observation in this study

Primary outcomes:
measure: Proportion of patients who maintained efficacy during 52-weeks after the last infusion of MRA in the previous studies.
timeFrame: every 4th week up to the 48th week
measure: Relationship between serum IL-6 concentration at the last observation of the previous studies and the duration of maintenance of efficacy
timeFrame: throughout study
Secondary outcomes:
measure: Efficacy: Proportion of patients who maintained efficacy among patients whose DAS28 was <2.6 at the last observation of the previous studies.
timeFrame: throughout study
measure: Efficacy: Time course of DAS28 during the treatment-free period in the present study
timeFrame: throughout study
measure: Efficacy: Relationship between serum IL-6 concentration at the last observation of the previous studies and the time course of DAS28 during the treatment-free period in the present study.
timeFrame: throughout study
Other outcomes:
Locations:
city: Chugoku
country: Japan
facility: Chugoku region
city: Kanto
country: Japan
facility: Kanto region
city: Kyushu
country: Japan
facility: Kyushu region
city: Sikoku
country: Japan
facility: Sikoku region
city: Tohoku
country: Japan
facility: Tohoku region
Study officials:
affiliation: Chugai Pharmaceutical,Clinical Research Department 1
name: Yuji Kimura
role: STUDY_CHAIR
References:
Clinical trial NCT01556984: Changes of Endothelial Function Before and After DSA in Patients With Diabetes
Official title: Changes of Endothelial Function Before and After DSA in Patients With Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: diabetic foot
digital subtraction angiography
endothelial function
Patients with diabetes
Age 40 to 70 years old
Endothelial function are determined
Lead sponsor: Wuhan General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2012-03-19
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will select 200 patients with diabetes. DSA will be taken for this group. Endothelial function will be measured before and after DSA. In the meantime, 100 healthy subjects will be selected as controls.

Brief summary: Endothelial dysfunction is the early step of atherosclerosis. Therefore, the investigators hypothesize that digital subtraction angiography (DSA) can damage endothelial function. In this study, the investigators will select 200 diabetic patients who have a DSA for diabetic foot screening. Also, the investigators will select 100 healthy subjects as controls. The endothelial function will be determined by high resolution ultrasound before and after DSA. The investigators will observe the changes of endothelial function after DSA assay.


Eligibility criteria: Inclusion Criteria:

* Patients with diabetic foot
* Age 40 to 70 years old

Exclusion Criteria:

* Heart failure
* Renal failure
* Acute infection

Primary outcomes:
measure: The changes of endothelial function
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan General Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT05220384: Motivational, Movement and Self-Management Training for Adolescents in Pain
Official title: Motivational, Movement and Self-Management Training for Hungarian Adolescents Living With Chronic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
self-management
adolescent
motivation
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 198
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With this randomized controlled trial, we have three aims. First of all, to investigate underlying mechanisms that might contribute to the success of a physical activity focused self-management program in paediatric chronic pain.

Second of all, to determine the minimum intervention needed for improving physical activity amongst adolescents who live with chronic pain. For this we are comparing an in-person and a video-based motivational interviewing training combined with self-management techniques.

Third of all, to investigate the mediating effect of autonomy in adolescents with chronic pain.


Eligibility criteria: Inclusion Criteria:

* Age between 12-18 years
* Experiencing pain at least 3 months
* Good reading, writing and listening skills in Hungarian language
* Self-sufficient
* Access to internet and phone
* No active cancer.

Exclusion Criteria:

* Age is not between 12-18 years
* Experiencing pain less then 3 months
* Not able to read, write and listen in Hungarian
* Not self-sufficient
* No access to internet and phone
* Active cancer.

Primary outcomes:
measure: Child Self-Efficacy Scale
timeFrame: 3 months
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 3 months
measure: Revised Children's Anxiety and Depression Scale
timeFrame: 3 months
measure: State-Trait Anxiety Inventory for Children
timeFrame: 3 months
measure: Paediatric Pain Disability Index
timeFrame: 3 months
measure: Pain Stages of Change Questionnaire for Adolescents and for Parents
timeFrame: 3 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Health Services Management Training Centre
state: Pest State
Study officials:
References:
Clinical trial NCT05364684: The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
Official title: The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NAFLD
Nonalcoholic Fatty Liver
NASH - Nonalcoholic Steatohepatitis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label study with historical controls.
Primary purpose: TREATMENT

Brief summary: Nonalcoholic fatty liver disease (NAFLD), fatty infiltration of the liver in the absence of alcohol use, is an increasingly recognized complication of obesity, with prevalence estimates of about 30% of individuals in the United States. A subset of these will develop progressive disease in the form of nonalcoholic steatohepatitis (NASH), which can progress to cirrhosis and liver failure. The investigators hypothesize that LUM-201 (Ibutamoren mesylate) will decrease intrahepatic lipid accumulation as quantified by proton magnetic resonance spectroscopy (1H-MRS).


Eligibility criteria: Inclusion Criteria:

1. Age 21-60yo and generally healthy
2. BMI ≥ 25 kg/m2
3. Radiographic or histologic diagnosis of NAFLD / NASH
4. Insulin-like growth factor-1 (IGF-1) level \<3rd quartile of normal for age

Exclusion Criteria:

1. Contraindications to MRI imaging
2. Diabetes mellitus or use of diabetes medications
3. History of cancer, significant renal disease, decompensated or unstable cardiovascular disease
4. Cirrhosis or known liver disease other than NAFLD
5. Pregnancy or breastfeeding
6. Known pituitary or hypothalamic disease affecting the growth hormone axis
7. Chronic use of drugs causing hepatic steatosis in the past 12 months (chronic oral steroids, methotrexate, tamoxifen)
8. Treatment with medications that may interact with LUM-201 (ibutamoren mesylate)

Primary outcomes:
measure: Intrahepatic lipid content (IHL, %)
timeFrame: 6 Months
Secondary outcomes:
measure: Hepatic inflammation and fibrosis by LiverMultiScan corrected T1 (cT1) score
timeFrame: 6 Months
measure: Alanine aminotransferase (ALT)
timeFrame: 6 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Laura E. Dichtel, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01302184: Robotic Locomotor Experience Applied to Parkinson's Disease
Official title: Robotic Locomotor Experience Applied to Parkinson's Disease (ROLEP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Parkinson's Disease
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2011-02-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gait rehabilitation with treadmill has been reported to be useful in patients with Parkinson's disease. In the last years, interest in robotic devices for gait training has grew up for patients with different neurological disorders, since they minimize demands on physical therapists and may provide a more reliable and constant treatment.

The aim of this study is to evaluate if robotic gait training with Lokomat® can improve walking more than conventional gait training with treadmill in patients affected by Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* patients affected by PD with a disease stage \< III according to Hoehn and Yahr's classification and age \< 75 years;
* absence of motor fluctuations;
* able to ambulate independently;
* no treadmill training for at least 6 months before the study.

Exclusion Criteria:

* current levodopa therapy started more than 6 months before enrollment;
* medical or neurological pathology that contributed significantly to gait dysfunction, as musculoskeletal disease, severe osteoarthritis, peripheral neuropathy, previous lower limb joint replacement, cardiovascular disease (recent myocardial infarct, from less than 4 weeks or uncontrolled hypertension, with blood pressure \> 180/110 at rest);
* hearth failure (NYHA \>=3);
* orthostatic hypotension;
* body weight over 100 kg;
* respiratory disease;
* dementia;
* depression;
* uncorrected visual disturbances.
* patients that have undergone deep brain stimulation.

Primary outcomes:
measure: 6 minute walking test
timeFrame: Enrollment, after training completion, 3 and 6 months after training completion
Secondary outcomes:
measure: 10 meter walking test
timeFrame: Enrollment, after training completion, 3 and 6 months after training completion
measure: Time Up and Go test
timeFrame: Enrollment, after training completion, 3 and 6 months after training completion
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Azienda Ospedaliero-Universitaria "Maggiore della Carità"
Study officials:
affiliation: University of Eastern Piedmont "A. Avogadro" - Dep. Clinical & Experimental Medicine
name: Carlo Cisari, MD
role: STUDY_DIRECTOR
affiliation: Azienda Ospedaliera-Universitaria "Maggiore della Carità" - Novara
name: Stefano Carda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03137602: ATOMIC (Active Teens With MultIple sClerosis) Teens: A Feasibility Study
Official title: ATOMIC (Active Teens With MultIple sClerosis) Teens: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Multiple Sclerosis
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: Queen's University
First posted: 2017-05-03
Enrollment: 14
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Taking part in recommended levels of physical activity in youth with MS may have an important and positive impact on disease symptoms, long-term disability and health outcomes. Unfortunately, youth with MS are highly inactive. In order to address this issue, the investigators have developed an MS-specific mobile application for teens called Active Teens with Multiple Sclerosis (ATOMIC). In this research the investigators will evaluate the feasibility of using the ATOMIC program in youth with MS. The results of this pilot study will provide the data necessary to ensure the ATOMIC program aligns with the needs of youth with MS.


Eligibility criteria: Inclusion Criteria:

1. MS diagnosis following standard definitions (IPMSSG);
2. EDSS \<4.0;
3. Ability to speak English.

Exclusion Criteria:

1. Known cardiac disease, including cyanotic congenital heart disease;
2. inability to understand instructions and tolerate proposed testing or vigorous PA.

Primary outcomes:
measure: Feasibility of the ATOMIC program
timeFrame: Entire study - up to 24 weeks
measure: Utility of the ATOMIC program
timeFrame: Interview [30 minutes] at baseline
measure: Utility of the ATOMIC program
timeFrame: Interview [30 minutes] at 6 weeks
measure: Utility of the ATOMIC program
timeFrame: Interview [30 minutes] at 12 weeks
Secondary outcomes:
Other outcomes:
measure: Effect of our physical activity (PA) intervention on MVPA level and the mediators of SCT
timeFrame: Entire study - Social Cognitive Mediators and Moderators of Physical Activity scales are completed at baseline, 6 weeks, 12 weeks, and 24 weeks.
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
References:
Clinical trial NCT05402202: Clinical Performance and Accuracy of Healing Abutment With Scan Peg for Single Posterior Implant-supported Restorations
Official title: Clinical Performance and Accuracy of Healing Abutment With Scan Peg for Single Posterior Implant-supported Restorations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants, Single-Tooth
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 24
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: The aim of this randomized clinical trial is to evaluate the clinical performance through prosthodontic, periodontal and radiographic evaluation of single screw-retained implant-supported restorations fabricated by intraoral scanning of healing abutment with scan peg in comparison to scan body

Detailed description: Evaluation of the clinical performance through prosthodontic, periodontal and radiographic evaluation of single screw-retained implant-supported restorations fabricated by intraoral scanning of healing abutment with scan peg in comparison to scan body

Eligibility criteria: Inclusion Criteria:

* Adult patients who are classified as ASA I or II physical status and require mandibular single implants (single missing mandibular posterior teeth) with:

  1. Adequate interarch and mesiodistal space.
  2. Proper bone height and width.
  3. Adequate zone of keratinized tissue (at least 2 mm)

Exclusion Criteria:

1. Any systematic disease as uncontrolled diabetes mellitus or metabolic bone diseases
2. A history of head and neck radiation treatment.
3. Periodontal diseases.
4. Poor oral hygiene (Silness-Löe plaque index score 2 and 3) (32)
5. Parafunctional habits.
6. Malocclusion.

Primary outcomes:
measure: Scanning time (healing abutment-scan peg vs scan body)
timeFrame: Through study completion, an average of 1 year
measure: Quality of proximal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body
timeFrame: Through study completion, an average of 1 year
measure: Quality of occlusal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body
timeFrame: Through study completion, an average of 1 year
measure: Evaluation of occlusion by digital occlusal analyzer
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT01627002: A Phase 1, First in Human Study to Investigate the Safety and Tolerability of PA401
Official title: A Phase 1, FIH, Double-blind, Randomised Placebo-controlled Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of PA401, and the Effects of PA401 Following LPS Challenge, in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Phase 1
First in Human
Healthy Volunteers
Lipopolysaccharide Challenge
Lead sponsor: ProtAffin Biotechnologie AG
Sponsor class: INDUSTRY
First posted: 2012-06-25
Enrollment: 49
Sex: MALE
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: The purpose of this study is to examine the safety, tolerability, immunogenicity and the way the body absorbs, distributes, breaks down and excretes various increasing single and multiple subcutaneous doses of PA401 in healthy subjects.

This study will also look at the effect of PA401 on inflammation in the lungs following an inhaled lipopolysaccharide (LPS) challenge (LPS is a bacterial cell wall fragment) and sputum induction (a procedure performed to help to cough up sputum (phlegm)) after a single subcutaneous dose of two dose levels.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males aged 18 to 65 years

Exclusion Criteria:

* Subjects with a clinically relevant medical history

Primary outcomes:
measure: Treatment Emergent Adverse Events
timeFrame: up to 14 days post dose
measure: Immunogenicity
timeFrame: Up to 28 days post dose
measure: Assessment of the Effect of PA401 on Induced Sputum Total Neutrophils
timeFrame: 5.5 hours post dose
Secondary outcomes:
measure: Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to 12 time-points up to 48 hours post dose
measure: Pharmacokinetic Parameters: Time of Occurrence of the Maximum Observed Plasma Concentration (Tmax)
timeFrame: Up to 12 time-points up to 48 hours post dose
measure: Pharmacokinetic Parameters: Terminal Half-life (t1/2)
timeFrame: Up to 12 time-points up to 48 hours post dose
measure: Pharmacokinetic Parameters: Area Under the Plasma Concentration-time Curve From Zero to Infinity
timeFrame: Up to 12 time-points up to 48 hours post dose
measure: Assessment of the Effect of PA401 on Induced Sputum Percentage Neutrophils
timeFrame: 5.5 hours post dose
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Quintiles
Study officials:
affiliation: Quintiles, Inc.
name: Jim Ritter, MD
role: PRINCIPAL_INVESTIGATOR
References: