louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06844006: Investigating the Impact of Nudging Cardiologists to Prescribe Guideline-directed Medical Therapy in Heart Failure Patients
Official title: Assessment of Digital Care on Clinical Impact and Efficiency Using a Stepped Wedge Cluster RCT in Heart Failure Patients: the ADMINISTER II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Digitial Care
Home monitoring
Heart Failure
Nudging
Lead sponsor: Medisch Spectrum Twente
Sponsor class: OTHER
Collaborators: name: Onze Lieve Vrouwe Gasthuis
name: St. Antonius Hospital
name: Martini Hospital Groningen
name: Catharina Ziekenhuis Eindhoven
name: Canisius Wilhelmina Ziekenhuis (CWZ)
name: Maasstad Hospital, Rotterdam
First posted: 2025-02-25
Enrollment: 1320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Stepped Wedge Randomized Controlled Trial.
Primary purpose: TREATMENT

Brief summary: This study investigates the impact of a nudge-based intervention on improving guideline directed medical therapy (GDMT) prescription among cardiologists. Using a stepped wedge randomized controlled trial design, we assess whether digital decision support-leveraging home monitoring and clinical data-enhances adherence to guideline-recommended medication titration. The primary outcomes include HF related hospitalization rates and all cause mortality.


Eligibility criteria: Inclusion Criteria:

* All heart failure diagnoses
* \>18 years

Exclusion Criteria:

* Not understanding the Dutch Language.
* Allergies that make uptitration impossible.
* Admission to hospice or palliative care.
* Severe psychological disorders.

Primary outcomes:
measure: HF related hospitalization
timeFrame: From enrollment to the end of the design (15 months).
measure: All cause death
timeFrame: All cause death rate during the 15 month duration of the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overijssel
Study officials:
References:
citation: Man JP, Koole MAC, Meregalli PG, Handoko ML, Stienen S, de Lange FJ, Winter MM, Schijven MP, Kok WEM, Kuipers DI, van der Harst P, Asselbergs FW, Zwinderman AH, Dijkgraaf MGW, Chamuleau SAJ, Schuuring MJ. Digital consults in heart failure care: a randomized controlled trial. Nat Med. 2024 Oct;30(10):2907-2913. doi: 10.1038/s41591-024-03238-6. Epub 2024 Aug 31.
Clinical trial NCT05212506: Correlation Analysis of Covid-19 IgG Antibody Level in Seminal Plasma and Semen Index
Official title: Association of Seminal Plasma SARS-Cov19 IgG Level With Semen Parameters and Embryological Characteristics in Vaccinated Normozoospermic Men
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
IgG Antibody
Semen Index
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 100
Sex: MALE
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The man's semen quality is normal and has been injected covid-19 vaccine

Brief summary: Since December 2019, more and more cases of unexplained pneumonia appeared after exposure to the South China Seafood Market in Wuhan City, Hubei Province. Later, the disease were confirmed to be acute respiratory infectious diseases caused by the 2019 new coronavirus infection.

Even though we have had great victories in the war against this pandemic, there is still a very large number of deaths early on. As research progresses, vaccines for this infectious disease are already being developed. There are currently two vaccines in widespread use worldwide: mRNA vaccines and inactivated vaccines. In China, inactivated vaccines are more commonly used. At present, some studies believe that mRNA vaccine does not affect the pregnancy rate and abortion rate of women, but the study sample size is small, and the conclusions are limited. The effects of inactivated vaccines on fertility are still in the blank. We now hope to conduct prospective studies, mainly to study the effect of inactivated vaccine injection on male semen, and whether it has an effect on the quality of embryos in IVF patients


Eligibility criteria: Inclusion Criteria:

1. The man's semen quality is normal,
2. The couple meets the indications for IVF,
3. injected with the covid-19 vaccine

Exclusion Criteria:

1. In vitro fertilization due to male factors
2. Azoospermia
3. The quality of the man's semen is abnormal
4. unvacced

Primary outcomes:
measure: semen index
timeFrame: 2022.01-2022.03
Secondary outcomes:
measure: Fertilization rate
timeFrame: 2022.01-2022.04
measure: embryo quality
timeFrame: 2022.02-2022.05
measure: clinical pregnant rate
timeFrame: 2022.03-2022.05
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Health Hospital
Study officials:
affiliation: covid-19 vaccine
name: zhiqin chen1
role: STUDY_DIRECTOR
References:
Clinical trial NCT01631006: Effects of Continous Positive Airway Pressure (CPAP) in Hypertrophic Cardiomyopathy
Official title: Acute Hemodynamic Effects of Continous Positive Airway Pressure (CPAP) in Patients With Hypertrophic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-obstructive Hypertrophic Cardiomyopathy
Obstructive Hypertrophic Cardiomyopathy
Keywords: CPAP
Hypertrophic cardiomyopathy
Blood Pressure
The focus of the present study is to evaluate the acute hemodynamic effects of CPAP in patients with non-obstructive and obstructive hypertrophic cardiomyopathy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiac disease, is a cause of disability including heart failure, atrial fibrillation, and sudden death, with an annual mortality varying from 1% to 6%. Obstructive sleep apnea (OSA) is extremely common among patients with established cardiovascular disease, including hypertension and atrial fibrillation and when present may contribute to worse cardiovascular outcome. Although patients with HCM do not necessarily have typical characteristics of patients with OSA, such as obesity and increasing age, there is recent evidence that OSA is extremely common among patients with HCM, with a prevalence ranging from 32% to 71%. The presence of OSA among patients with HCM is independently associated with worse structural and functional impairment of the heart, including atrial and aorta enlargement, worse New York Heart Association functional class, and worse quality of life. Therefore, the recognition and treatment of OSA is a new area of research that may impact in the management of patients with HCM.


Eligibility criteria: Inclusion Criteria:

* both genders
* over 18 years-old
* hemodynamically stable
* with no other cardiac disease
* consent form signed

Exclusion Criteria:

* presence of pacemaker
* spontaneous withdrawal
* previous cardiorespiratory arrest
* atrial fibrilation during echocardiography

Primary outcomes:
measure: Cadiac performance by echocardiography
timeFrame: acutely
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute
Study officials:
References:
citation: Nerbass FB, Salemi VMC, Pedrosa RP, Portilho NP, Ferreira-Filho JCA, Moriya HT, Antunes MO, Arteaga-Fernandez E, Drager LF, Lorenzi-Filho G. Acute Effects of Nasal CPAP in Patients With Hypertrophic Cardiomyopathy. Chest. 2016 Nov;150(5):1050-1058. doi: 10.1016/j.chest.2016.05.004. Epub 2016 May 7.
Clinical trial NCT05640206: Effect of Injectable Platelet-rich Fibrin on Disc Displacement Without Reduction
Official title: Effect of Intra-articular Injection of Injectable Platelet-rich Fibrin on Disc Displacement Without Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disc Disorder
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical study was conducted on patients with disc displacement without reduction. Patient was selected one of the two study groups: control group received only arthrocentesis or test group received arthrocentesis + injectable platelet-rich fibrin (i-PRF). As primary outcome variable, pain was recorded at preoperatively and at postoperatively 1, 2, 3, 6 and 12 months. Maximum mouth opening, lateral and protrusive movements were formed as secondary outcome variables.

Detailed description: This randomized clinical study was conducted on patients with disc displacement without reduction. Patient was selected one of the two study groups: control group received only arthrocentesis or test group received arthrocentesis + i-PRF. Arthrocentesis procedure was performed for all groups with two needle technique. For test group, intra-articular i-PRF was made. As a primary outcome variable, pain was recorded at preoperatively and at postoperatively 1, 2, 3, 6 and 12 months. Maximum mouth opening, lateral and protrusive movements were formed as secondary outcome variables.

Eligibility criteria: Inclusion Criteria:

* unilateral or bilateral disc displacement without reduction
* localized pain on temporomandibular joint
* decreased mouth opening, lateral and protrusive movements

Exclusion Criteria:

* Malignant or inflammatory disorders
* prior surgical history of temporomandibular joint

Primary outcomes:
measure: Change of pain
timeFrame: at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively
Secondary outcomes:
measure: Change of maximum mouth opening
timeFrame: at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively
measure: Change of lateral movements
timeFrame: at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively
measure: Change of protrusive movements
timeFrame: at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Dentistry
state: Bornova
Study officials:
affiliation: Ege University
name: Gözde Işık
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05722106: Improving Adherence to COVID-19 Prevention Behaviours: Test of Persuasive Messages
Official title: Improving Adherence to COVID-19 Prevention Behaviours: Test of Persuasive Messages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 3746
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this randomized online experiment was to test the effectiveness of using various persuasive appeals (deontological moral frame, empathy, identifiable victim, goal proximity, and reciprocity) at improving intentions to adhere to prevention behaviors.

Participants indicated their intentions to follow public health guidelines, saw one of six flyers featuring a persuasive appeal or no appeal, then rated their intentions a second time. Known correlates of attitudes toward public health measures were also measured.

Detailed description: Adherence to non-pharmaceutical interventions (NPIs) for COVID-19, including physical distancing, masking, staying home while sick, and avoiding crowded indoor spaces remain critical for limiting the spread of COVID-19.

This study tests the effectiveness of using various persuasive appeals (deontological moral frame, empathy, identifiable victim, goal proximity, and reciprocity) at improving intentions to adhere to prevention behaviors.

A randomized online experiment using a representative sample of adult Canadian residents with respect to age, ethnicity, and province of residence was conducted between March 3-6, 2021. Participants indicated their intentions to follow public health guidelines, saw one of six flyers featuring a persuasive appeal or no appeal, then rated their intentions a second time. Known correlates of attitudes toward public health measures were also measured.

Eligibility criteria: Inclusion Criteria:

* Adult Canadian residents
* Target quotas for province of residence, age, gender, and ethnicity were set to obtain a demographically representative sample based on the 2016 census data

Exclusion Criteria:

* Province of residence, age, gender, and ethnicity once quotas are filled

Primary outcomes:
measure: Change in intentions to engage in prevention behaviours
timeFrame: Same day
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Lucid Marketplace
state: Alberta
Study officials:
affiliation: University of Calgary
name: Mehdi Mourali, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03158506: Human Mass Balance Study of HMS5552 in Healthy Subjects
Official title: An Open-Label, Single Center Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of 50 mg (90 uCi) [14C]-HMS5552 in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subject
Lead sponsor: Hua Medicine Limited
Sponsor class: INDUSTRY
First posted: 2017-05-18
Enrollment: 6
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, single center, 1-period study in healthy adult male subjects to assess absorption, metabolism, and excretion of HMS5552 after a single oral administration of 50 mg (90 μCi) of \[14C\]-HMS5552.


Eligibility criteria: Inclusion Criteria:

* Healthy, adult, male 19-55 years of age
* Weight at least 50 kg, and BMI within the range of 18-30 kg/m2
* Written informed consent must be obtained before any assessment is performed

Exclusion Criteria:

* History or presence of clinically significant medical, surgical or psychiatric condition or disease in the opinion of the Investigator or designee which might significantly alter the absorption, distribution, metabolism and excretion of drugs.
* History or presence of alcoholism or drug abuse.
* Smoker.
* Abnormal bowel habits.

Primary outcomes:
measure: Total radioactivity in blood, plasma urine and feces
timeFrame: Up to 168 hours
measure: Total radioactivity in blood, plasma urine and feces
timeFrame: Up to 168 hours
measure: Total radioactivity in blood, plasma urine and feces
timeFrame: Up to 168 hours
measure: Total radioactivity in blood, plasma urine and feces
timeFrame: Up to 168 hours
Secondary outcomes:
measure: Concentrations of HMS5552 and its metabolites in plasma, urine and feces
timeFrame: Up to 168 hours
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Up to 168 hours
measure: Concentrations of HMS5552 and its metabolites in plasma, urine and feces
timeFrame: Up to 168 hours
measure: Concentrations of HMS5552 and its metabolites in plasma, urine and feces
timeFrame: Up to 168 hours
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Celerion
name: Charles Tomek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06708806: Cell Ongrowth and Biocompatibility Study of Two Different (Hydrophobic Acrylic) Intraocular Lenses: IOL XY1 vs. IOL XY1A
Official title: Cell Ongrowth and Biocompatibility Study of Two Different (Hydrophobic Acrylic) Intraocular Lenses: IOL XY1 vs. IOL XY1A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Biocompatibility
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intra-individual comparison of the biocompatibility of two different IOLs. Investigated IOLs will be implanted subsequently according to the study protocol with one IOL type in the eye with no astigmatism and the other IOL type in the eye with astigmatism.
Primary purpose: DIAGNOSTIC

Brief summary: The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.


Eligibility criteria: Inclusion Criteria:

* Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned
* Age 40 and older
* Astigmatism of at least 0.75Diopters in one eye
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Diabetes mellitus
* Pseudoexfoliation syndrome
* Systemical anticoagulation
* Antiphlogistic therapy
* Antiglaucomatosa
* Uncontrolled systemic or ocular disease
* Preceding ocular surgery or trauma
* Intraoperative complications
* Pregnancy/Nursing
* Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days

Primary outcomes:
measure: Foreign Body Giant Cells
timeFrame: 6 weeks
Secondary outcomes:
measure: Foreign Body Giant Cells
timeFrame: 5 months
measure: small round cells
timeFrame: 5 months
measure: PCO
timeFrame: 5 months
measure: anterior chamber reaction
timeFrame: 5 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT06641206: Intra-Articular Dexmedetomidine: A Treatment for Chronic Knee Pain
Official title: Intra-articular Dexmedetomidine for Treatment of Chronic Knee Pain: A Prospective Case-Control Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Knee Pain
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic knee osteoarthritis (KOA) is a painful condition with limited treatment options. Non-pharmacological approaches often fall short, leading to decreased quality of life. Ozone therapy, a simple and affordable treatment, has shown promise for pain relief. Dexmedetomidine (DEX), a sedative and analgesic, has been used successfully as an adjuvant to anesthesia and local anesthetics. Given its potential for pain management, exploring DEX as a treatment for KOA could offer a new and promising approach.


Eligibility criteria: Inclusion Criteria:

* Patients were not assigned for surgical intervention;
* Patients were free of exclusion criteria

Exclusion Criteria:

* Patients were assigned for surgical intervention;
* Patients who had uncontrolled hypertension and/or diabetes mellitus;
* Patients who had uncompensated cardiac, renal, or hepatic diseases;
* Patients with coagulopathy, spinal deformity, allergy, or contraindication for the used drugs;
* Patients who refused to sign the informed consent were excluded from the study.

Primary outcomes:
measure: Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post-intra-articular Injection.
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El Gharbyia
Study officials:
References:
Clinical trial NCT04647799: Effect of Use Smartphone in Forward Head Position and Neutral Position on Upper Limbs Nerves
Official title: Electrophysiological Studies Of Induced Forward Head Position And Hand Use Of Mobile Phone
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mobile Phone Use
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 150
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: normal subjects

Brief summary: To compare between two different positions (forward head position and neutral position) when using mobile phone by hand using nerve conduction velocity and F-wave of upper limb nerves ( ulnar, median and radial) in 4 different times.

Detailed description: PURPOSE:

* To compare between forward head position and hand use of mobile phone on conduction velocity of upper limb nerves
* To investigate the F responses of upper limbs nerves.
* To investigate the compound muscle action potential (CMAP) amplitudes of median nerves

BACKGROUND:

Forward head position may affect the cervical nerve root so it can also affect nerve conduction velocity due to continues stretch on nerves, also the over use of smart phone by hand may be affected the hand nerves, so this study determine which one of them has more influence than the other.

If the forward head position has the worst effect on the upper limb nerves investigators must avoid the incorrect position of the head to avoid stretch and compression of the nerves.

HYPOTHESES:

There are no statistical difference between forward head position and hand use of mobile phone on conduction velocity of the nerves of upper limb.

SUBJECTS:

Normal one hundred fifty non-athketic adolescents of both genders will participate in this study. Their age ranges from 14-18 years.

METHODS FOR ASSESSMENT

1. Electromyography (EMG) will be used to measure nerve conduction velocity, F-wave, motor action potential
2. Soft collar will used to fixed the craniovertebral angle during used mobile phone Universal goniometer
3. Goniometer pro iPhone application

Eligibility criteria: Inclusion Criteria:

1. Their ages range from 14-18 years.
2. Not rolled on any regular athletic activity

Exclusion Criteria:

1. Individual with neck pain
2. Congenital deformity for upper limb
3. Peripheral neuropathy due to diabetes mellitus type I
4. Rheumatoid arthritis
5. History of surgical intervention at nerves of the upper extremity

Primary outcomes:
measure: motor and sensory nerve conduction velocity and f-wave in neutral position
timeFrame: 1 day
Secondary outcomes:
measure: motor and sensory nerve conduction velocity and f-wave measured in forward head position during use mobile phone
timeFrame: 1 day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Pysical Therapy, 6 Oct University
Study officials:
References: