louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05767606: Concomitant Administration of the Novavax Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years
Official title: Safety and Immunogenicity of Concomitant Administration of the Novavax Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years: a Four-arm, Double-blind, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: COVID-19
Pneumococcal Infections
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 256
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Vaccination is a key strategy for preventing respiratory illnesses. Pneumococcal vaccination is recommended for all adults aged over 60 or 65 years (depending local guidelines) who have never received a pneumococcal vaccine or whose previous vaccination history is unknown. Given their wide application, co-administration of pneumococcal and Covid-19 vaccines may support broad population-wide coverage. However, it is unclear whether the co-administration of the Novavax (NVX) vaccine and a 20-valent pneumococcal conjugate vaccine (PCV20) results in lower immunogenicity than the administration of either alone.

The investigators will thus conduct a 4-four arm study with the following treatments: NVX plus placebo (NVX arm), PCV20 plus placebo group (PCV20 arm), NVX plus PCV20 (Combination arm), and placebo plus placebo group (Placebo arm). Vaccines and/or placebo will be administered as single doses, given as intramuscular injections on Day 1 (one in each shoulder). Subjects will be randomly assigned to one of the four arms.

The outcome will be the antibody levels after 28 days.


Eligibility criteria: Inclusion Criteria:

* Age: 60 years or older
* Males and females
* Able and willing (in the investigator's opinion) to comply with all study requirements.
* Participants, who already received three Covid-19 vaccines, of which the third was a mRNA vaccine (BNT162b2 or mRNA-1273) and at least 16 weeks ago
* Only applicable for women: last menstrual bleeding more than one year ago

Exclusion Criteria:

* Use of immunosuppressants
* Congenital or acquired immunodeficiency (eg, history of HIV infection, hematological disease, current malignancy, or others)
* Chronic condition that may significantly interfere with the immune response in the opinion of the investigator
* History of Covid-19 within 16 weeks before study vaccination
* Previous pneumococcal vaccination
* Contraindication against any ingredient of the NVX or the PCV20 vaccine

Primary outcomes:
measure: Immunogenicity
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02427906: Effect of Transjugular Intrahepatic Portosystemic Shunt on Gut Microbiota in Cirrhotic Patients
Official title: Effect of Transjugular Intrahepatic Portosystemic Shunt on Gut Microbiota and Associated Inflammatory Factors in Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cirrhosis
Acquired Portal-systemic Shunt Due to Cirrhosis
Hepatic Encephalopathy
Keywords: cirrhosis
gut microbiota
transjugular portosystemic shunt
hepatic encephalopathy
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cirrhotic patients undergoing transjugular intrahepatic portosystemic shunt for any indication at West China Hospital

Brief summary: The purpose of this study is to determine the effect of transjugular intrahepatic portosystemic shunt on gut microbiota and associated inflammatory factors in cirrhotic patients.

Detailed description: Cirrhosis is associated with qualitative and quantitative changes in the gut microbiota that can potentiate disease progression and complications such as hepatic encephalopathy (HE) and infections. Dysbiosis or altered gut microbiota, due to decreased autochthonous or commensal taxa, has been found in stool and colonic mucosa in cirrhotic patients, which is in turn linked with disease severity and systemic inflammation.

TIPS can decompress the hypertensive portal vein,so that the intestinal congestion can be decrease too. Hence we summarize that TIPS may have effect on gut microbiota and associated inflammatory factors in cirrhotic patients.

Eligibility criteria: Inclusion Criteria:

* Cirrhotic patients who received TIPS;
* Treatment-naive to TIPS and major operation involving liver such as surgical shunt, hepatic resection and liver transplantation)

Exclusion Criteria:

* Uncontrolled infection or sepsis;
* Hepatobiliary or pancreatic malignancy or biliary obstruction;
* Vital organ dysfunction;
* Administration of antibiotics (after TIPS and 2 weeks before TIPS);
* Cachexia;
* Pregnant or breeding women

Primary outcomes:
measure: Changes in fecal microbiota
timeFrame: baseline and 6 month
Secondary outcomes:
measure: Incidence of hepatic encephalopathy
timeFrame: 6 month
measure: Changes of blood inflammatory parameter including IL-2（interleukin 2）,IL-6,IL-10,IL-8，TNF-α
timeFrame: baseline and 6 month
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Zhu Wang, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04536506: Bobath and Vojta Therapy for DS
Official title: Comparison of the Effectiveness of Bobath Therapy and Vojta Technique in Babies With Down Syndrome Aged 0-24 Months: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Motor Performance
Bobath Therapy
Vojta Technique
Keywords: infant with Down Syndrome
Bobath therapy
Vojta technique
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 23
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Different physiotherapy approaches and education programs are applied to minimize motor and mental impairment in children with Down syndrome (DS). The present study was conducted with the aim of comparing the effectiveness of two different physiotherapy approaches in babies with Down syndrome in the early period.

A total of 23 babies with DS aged between 0-24 months were included in the study. Infants were randomly divided to two groups: Bobath therapy (BT) group included 12 infants (6 girls and 6 boys) and Vojta technique (VT) group included 11 infants (4 girls and 7 boys). The infants were applied a total of 12 sessions of physiotherapy (twice weekly during 6 weeks). Alberta Infant Motor Scale (AIMS) was used for comparison of motor development level before and after the therapy. Emotional status of the mothers was evaluated with Beck Depression Scale (BDS) and quality of life was evaluated with Nottigham Health Profile (NHP).


Eligibility criteria: Inclusion Criteria:

* being between 0 and 2 years
* being diagnosed with DS

Exclusion Criteria:

* having an additional neuro-motor disease

Primary outcomes:
measure: Alberta Infant Motor Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Beck Depression Scale
timeFrame: 12 weeks
measure: Nottingham Health Profile
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References:
Clinical trial NCT02583906: Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment
Official title: Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep-Disordered Breathing
Pulmonary Arterial Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 8
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: Evaluation of the effect of CPAP (continuous positive airway pressure ) treatment in PAH (pulmonary arterial hypertension) and CTEPH (chronic thromboembolic pulmonary hypertension) patients suffering from sleep disordered breathing.

Detailed description: The primary endpoint of the study is to evaluate the effect of CPAP therapy on pulmonary vascular resistance in PAH and CTEPH patients suffering from sleep disordered breathing.

The secondary endpoints are the effect of CPAP on right atrium and right ventricle diameter and ejection fraction measured by echocardiography, 6 minutes walk distance, NYHA class, QOL, endothelial function, sympathetic activity and prognosis.

Eligibility criteria: Inclusion Criteria:

* minimum 18 years old
* diagnosed with PAH or non-operable CTEPH or operated CTEPH with peristent pulmonary hypertension
* diagnosis of PAH based on cardiac catherisation
* diagnosis of CTEPH confirmed by contrast-enhanced spiral chest CT, pulmonary angiography and V/Q scintigraphy
* recent diagnosis of sleep disordered breathing (polysomnography realized within 3 months before inclusion showing AHI above 15) stable clinical condition for at least 3 months before inclusion as defined by NYHA and a walking distance difference within 10% of the previous 3 months and no change in medical therapy during this 3 months

Exclusion Criteria:

* congenital heart disease
* moderate and severe restrictive or obstructive pulmonary disease with a TLC and a FEV1\<60% of the predicted value
* BMI 35kg/m2 or more
* patients already treated with CPAP
* patients with severe sleepiness (epworth sleepiness scale from 18 to 24/24)

Primary outcomes:
measure: Change in PVR (pulmonary vascular resistance)
timeFrame: change in PVR from inclusion at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Catharina Belge, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03652506: The Impact of Anterior Abdominal Wall Tissue Oxygenation During Pneumoperitoneum of Regional Anesthesia Methods
Official title: Investigation the Effect of Regional Anesthesia Methods Anterior Abdominal Wall Tissue Oxygenation on Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopy
Abdominal Wall
Regional Anesthesia
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-08-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective,randomized
Primary purpose: DIAGNOSTIC

Brief summary: During laparoscopic surgery, the abdomen is inflated with carbon dioxide for abdominal imaging and increased intraabdominal pressure affects intraabdominal structures and abdominal wall.

Detailed description: The investigators aimed to investigate the effects of regional anesthesia methods administered during laparoscopic cholecystectomy on abdominal wall oxygenation and postoperative pain scores.

Eligibility criteria: Inclusion Criteria:

* Patients who were in the American Society of Anesthesiologists (ASA) I-III class
* Underwent laparoscopic cholecystectomy

Exclusion Criteria:

* Previous surgeon surgeon
* Local anesthetic allergy,
* Bleeding is a diathesis disorder
* Mental impairment,
* Allergic to the drugs used,
* Patients who are not reluctant to participate in the study,
* Presence of infection in the block area,
* Patients whose body mass index is over 30

Primary outcomes:
measure: rso2
timeFrame: peroperative 2 hours
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: Postoperative 24 hours
measure: tramadol consumption
timeFrame: Postoperative 24 hours
measure: additional analgesic use
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: Korgün Ökmen, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02647606: Comparison of the Videolaryngoscopes With Manual In-line Stabilization
Official title: Comparison of the McGrath Videolaryngoscope and the Pentax-AWS With the Macintosh Laryngoscope for Nasotracheal Intubation in Patients With Manual In-line Stabilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Surgery
Maxillofacial Surgery
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Videolaryngoscope is useful to improve the laryngeal view, especially during difficult intubation. There are several kinds of videolaryngoscopes and it is applicable during nasotracheal intubation. In this study, the investigators will compare the McGrath videolaryngoscope and Pentax-AWS with Macintosh laryngoscope for nasotracheal intubation in patients with manual in-line stabilization.


Eligibility criteria: Inclusion Criteria:

* oral or maxillofacial surgery
* ASA class I, II

Exclusion Criteria:

* anticipated difficult intubation
* necessity for rapid sequence induction
* cervical spine injury
* bleeding tendency

Primary outcomes:
measure: time for intubation
timeFrame: from holding the laryngoscope until the 1st ventilation after intubation, within 90 seconds
measure: Cormack Lehane Laryngeal view
timeFrame: when laryngoscope is appropriately placed during intubation, approximately 2 seconds
measure: POGP score
timeFrame: when laryngoscope is appropriately placed during intubation, approximately 2 seconds
Secondary outcomes:
measure: external laryngeal manipulation
timeFrame: when laryngoscope is appropriately placed during intubation, approximately 2 seconds
measure: magill forceps
timeFrame: when laryngoscope is appropriately placed during intubation, approximately 5 seconds
measure: IDS (intubation difficulty scale)
timeFrame: during intubation, approximately 90 seconds
measure: numeric rating scale for intubation
timeFrame: during intubation, approximately 90 seconds
measure: grade of bleeding
timeFrame: 10 seconds after completion of intubation
Other outcomes:
Locations:
Study officials:
affiliation: Ajou University School of Medicine
name: Go Un Roh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roh GU, Kwak HJ, Lee KC, Lee SY, Kim JY. Randomized comparison of McGrath MAC videolaryngoscope, Pentax Airway Scope, and Macintosh direct laryngoscope for nasotracheal intubation in patients with manual in-line stabilization. Can J Anaesth. 2019 Oct;66(10):1213-1220. doi: 10.1007/s12630-019-01409-5. Epub 2019 May 29.
Clinical trial NCT00559806: The Effect of Aging and Immobilisation on Muscle
Official title: The Effect of Aging and Immobilisation on Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: immobilisation
aging
resistance training
atrophy
The effect of immobilisation in elderly compared to young individuals
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2007-11-16
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The debilitating effects of immobilisation on muscle strength and size in young individuals are well documented. Moreover, sarcopenia has long been recognized as a major cause of muscle strength loss in old age, however, changes in muscle mass and architecture with immobilisation in the elderly has not previously been investigated. This is contrasted by the fact that the elderly population more often undergoes periods of immobilization and disuse not only due to joint pain but also due to a higher degree of co morbidity and hospitalisation.The purpose of the present study was to compare the effect of a 2 week period of unilateral immobilisation on the physiological muscle cross sectional area, maximal isometric muscle strength, specific force, muscle fascicle length and muscle fibre pennation angle in young and old healthy men.


Eligibility criteria: Inclusion Criteria:

* Young healthy males (age 20-30 yrs)or old healthy males (age 60-80 yrs)

Exclusion Criteria:

* Musculoskeletal disorder
* Diabetes
* Cardiovascular disease
* Neurological diseases; or
* Cognitive disorders

Primary outcomes:
measure: muscle cross sectional area, maximal isometric muscle strength, specific force, muscle fascicle length and muscle fibre pennation
timeFrame: 2 weeks of immobilisation and 4 weeks of resistance training
Secondary outcomes:
measure: single muscle fiber area, expression of myostatin and IGF-1 (RNA), changes in satellite activation and number
timeFrame: 2 weeks of imm and 4 weeks of resistance training
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Sports Medicine, Bispebjerg Hospital
Study officials:
affiliation: Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
name: Charlotte Suetta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06435806: Medical Illustration Design Characteristic Evaluation
Official title: Advancing Medical Illustration in Patient Education Materials: From Art to Science. Study 1: Medical Illustration Design Characteristic Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Northeastern University
Sponsor class: OTHER
Collaborators: name: Tufts Medical Center
name: Boston University
First posted: 2024-05-30
Enrollment: 8200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: We will select 10 binary distinctions of medical illustration design elements and test each in a two-arm between-subjects evaluation.
Primary purpose: OTHER

Brief summary: The goal of this study is to understand what people understand from medical illustrations, and what meaning and emotions (such as anxiety) they derive from different design elements.

Detailed description: The investigators will conduct cognitive interviews to understand the meaning laypersons obtain from different illustrations, their opinions on illustration styles, and their level of anxiety after viewing illustrations.

The investigators will also study the effect of systematically varying medical illustration designs on layperson understanding and anxiety.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Speaks English or Spanish ﬂuently
* Is able to independently consent
* Has adequate corrected vision to read patient education documents

Exclusion Criteria:

\* None

Primary outcomes:
measure: Knowledge
timeFrame: Baseline and 30 minutes
measure: State Anxiety scale from State-Trait Anxiety Inventory
timeFrame: 30 minutes
Secondary outcomes:
measure: Satisfaction with the medical illustration
timeFrame: 30 minutes
measure: Reading Effort
timeFrame: 30 minutes
measure: Acceptability
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
Study officials:
affiliation: Northeastern University
name: Timothy Bickmore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05497999: Racial Inequality in Inhaler Fills for COPD - A Trial of Reduced Cost-Sharing
Official title: Racial Inequality in Inhaler Fills for COPD - A Trial of Reduced Cost-Sharing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Cost sharing
Health insurance
Inhalers
Adherence
Disparities
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
Collaborators: name: Humana Co.Ltd.
First posted: 2022-08-11
Enrollment: 19113
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In partnership with a large Medicare Advantage (MA) insurer (Humana, Inc.) and as part of a Center for Medicare and Medicaid Innovation demonstration program of Value-Based Insurance Design (VBID), the investigators propose to study a randomized controlled quality improvement trial in which Humana randomized MA beneficiaries with COPD to receive proactive outreach for a VBID benefit that provided large reductions in cost-sharing for their maintenance inhalers and telephone-based COPD medication management services in 2020 and 2021. The investigators will analyze changes in racial disparities for inhaler fills, clinical outcomes, health care spending, and acute care utilization.


Eligibility criteria: Inclusion Criteria:

* Has COPD diagnosis
* Receives health services and prescription drug benefits through a Humana Medicare Advantage plan that includes Part D coverage
* Has at least one prior fill of a COPD maintenance inhaler in the prior 12 months
* Not fully adherent to maintenance inhaler (PDC \< 80%) in year prior to randomization

Exclusion Criteria:

* Enrolled in Part D Low-Income Subsidy program
* On hospice
* Has end-stage renal disease
* Has mild COPD (i.e., COPD diagnosis but no maintenance inhaler fill, no pulmonary function tests in year prior year, and no acute care use for COPD)
* Enrolled in Humana plan for less than 3 months
* In the coverage gap phase of MA plan at time of assignment
* Receives primary care at select locations of Humana subsidiaries (CenterWell or Conviva)

Primary outcomes:
measure: Maintenance inhaler adherence
timeFrame: 1 Year
Secondary outcomes:
measure: Frequency of acute moderate-to-severe exacerbations
timeFrame: 1 Year
measure: Number of short-acting inhaler filled
timeFrame: 1 Year
measure: Total spending
timeFrame: 1 Year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Louisville
country: United States
facility: Humana, Inc.
state: Kentucky
city: Boston
country: United States
facility: Harvard Medical School
state: Massachusetts
Study officials:
References: