louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00240279: The Effect of Rosuvastatin on Aortic Stiffness in Hemodialysis Patients in the AURORA Study
Official title: The Effect of Rosuvastatin on Aortic Stiffness in Hemodialysis Patients in the AURORA Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: high blood cholesterol levels
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of rosuvastatin compared to placebo on the aortic stiffness in hemodialysis patients as measured by pulse wave velocity (at 3, 6 and 12 months)


Eligibility criteria: Inclusion Criteria:

* Signed informed consent, between 50 and 80 years of age, end stage renal failure patients receiving hemodialysis

Exclusion Criteria:

* Received statins within past 6 months, a clear indication for use of lipid altering drug, contra indication for lipid altering drug, history of statin induced myopathy items in very

Primary outcomes:
measure: To investigate the effect of rosuvastatin compared to placebo on the aortic stiffness in hemodialysis patients as measured by pulse wave velocity (at 3, 6 and 12 months)
Secondary outcomes:
measure: To investigate the effect of rosuvastatin compared to placebo on the aortic pressure wave in hemodialysis patients (at 3 months/ 6 months and 12 months).
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Crestor Medical Sciences Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05537779: Safety and Performance of Optivantage Multi-use When Injecting Contrast Media for Contrast Enhanced CT Examination
Official title: Safety and Performance of Optivantage Multi-use Solution When Injecting Contrast Media to Subjects Requiring Contrast Enhanced CT Examination
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient Participation
Keywords: Safety
Performance
Power Injector
Optivantage
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2022-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects referred for contrast enhanced CT examination who meet the eligibility criteria

Brief summary: The study is a prospective, single-arm observational multicenter clinical investigation.

The primary objective is to confirm the safety and performance of the Optivantage® Injection System when injecting contrast media to subjects requiring contrast-enhanced CT imaging, in multi-patient use.

Detailed description: Each subject will undergo CT examination in multi-use context using Optivantage Dual-head Contrast Delivery System.

100 subjects are expected to be enrolled. The safety and performance of the injector will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Subject referred for a contrast-enhanced CT examination using a power injector
* Subject or legal representative for children, having provided written informed consent

Exclusion Criteria:

* Subject weighting less than 10 kg
* Pregnant or breastfeading woman subject
* Subject with known allergy or hypersensitivity to contrast media
* Subject has contra-indication(s) to CT scanner and/or contrast medium as per the Summary of Product Characteristics
* Subject with peripherally inserted central catheter, central venous line, or port-A-catheter inserted for injection
* Subject unlikely to comply with the CIP, e.g. uncooperative attitude and unlikelihood of completing the study

Primary outcomes:
measure: Safety of Optivantage
timeFrame: Per procedure
measure: Performance of Optivantage
timeFrame: Per procedure
Secondary outcomes:
measure: Safety of Optivantage
timeFrame: Per procedure
measure: Device deficiencies
timeFrame: Per procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05100979: Patient-Clinician Communication Skill Training: A Mobile Education Initiative
Official title: Patient-Clinician Communication Skill Training: A Mobile Education Initiative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Patient Engagement
Keywords: mobile health
medical education
patient-clinician communication
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is a pilot test of The Art of Medicine Series, a smartphone-based educational tool to improve clinician-patient communication. Investigators will enroll clinicians (residents, fellows, attending physicians) and family caregivers (most often parents) from the Children's Wisconsin neonatal intensive care unit (NICU). Participants will then receive a series of links to short, animated videos sent to their phone by text message. Each video teaches best-practice communication techniques such as how patients can prompt teach back and how clinicians can avoid biased phrasing in delivering news. Over the 4-week intervention (the length of resident's rotation), clinicians will receive 15 videos and patients will receive 8 videos. Communication skills of clinicians and patients will be assessed pre and post intervention using validated measures and participants' engagement with the videos will be tracked with software in the website.


Eligibility criteria: Inclusion Criteria:

Inclusion criteria - clinician:

* A resident, fellow, or attending physician
* On Team A rotation in the neonatal intensive care unit (NICU) of Children's Wisconsin.

Inclusion criteria - patient:

* A parent, grandparent, or other identified caregiver of a child on Team A of the NICU at Children's Wisconsin
* Expected to stay in the NICU for a further 3 weeks
* Have not previously participated in the study
* Are 18 years of age or older
* Able to speak and understand English.

Exclusion Criteria:

-

Primary outcomes:
measure: Clinician communication skills
timeFrame: Assessed at 4 weeks
measure: Patient communication skills
timeFrame: Assessed at 4 weeks
Secondary outcomes:
measure: Participant engagement with videos
timeFrame: Collected at 4 weeks
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT02519179: Influence of Bottle-Type of Infant Feeding Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bottle Feeding
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 48
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a within-subject study; mothers are observed during both feeding conditions.
Primary purpose: BASIC_SCIENCE

Brief summary: The objective this research is to conduct a within-subject, experimental study that will describe mothers' feeding practices during typical bottle-feeding conditions and will examine whether removal of visual cues related to the amount of milk/formula in the bottle will alter these feeding practices. The investigators hypothesize that mothers will show higher levels of infant-directed feeding practices and lower levels of mother-directed feeding practices when using opaque, weighted bottles compared to when using standard, clear bottles. The investigators also hypothesize that infants will consume less breast milk or formula when fed from opaque, weighted bottles compared to when fed from standard, clear bottles.


Eligibility criteria: Inclusion Criteria:

* Mothers must be 18 years or older
* Infants must be between 0-6 months of age
* Infants must be prior to the introduction of solid foods

Exclusion Criteria:

* Preterm birth
* Medical conditions that interfere with feeding

Primary outcomes:
measure: Infant intake
timeFrame: 3-hour period
measure: Maternal responsiveness
timeFrame: 3-hour period
Secondary outcomes:
measure: Maternal acceptance/perception of intervention
timeFrame: 3-hour period
Other outcomes:
Locations:
city: San Luis Obispo
country: United States
facility: California Polytechnic State University
state: California
Study officials:
affiliation: Assistant Professor
name: Alison K Ventura, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ventura AK, Pollack Golen R. A pilot study comparing opaque, weighted bottles with conventional, clear bottles for infant feeding. Appetite. 2015 Feb;85:178-84. doi: 10.1016/j.appet.2014.11.028. Epub 2014 Nov 28.
Clinical trial NCT06160479: The Incidence of Hypocalcemia in Pregnant Women at Siriraj Hospital
Official title: The Incidence of Hypocalcemia in Pregnant Women at Siriraj Hospital
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypocalcemia in Pregnancy
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 444
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Calcium is an essential element for fundamental physiological functions and during pregnancy. However, higher calcium intake can induce constipation, flatulence, nausea, or kidney stones. This study aims to evaluate the incidence of hypocalcemia among pregnant women in the first half of pregnancy in Thailand. Also, Comparison of calcium level in pregnant women in the third trimester who received and not received calcium during pregnancy.

Detailed description: The primary outcome is the incidence of hypocalcemia among pregnant women in the first half of pregnancy. This study also has secondary objectives. The one is associating factors with calcium level. After getting the results of maternal calcium level, the normal calcium level group will be divided into 2 groups for receiving calcium 1 g/day and no receiving calcium supplement. Another with hypocalcemia group will be decided into 2 groups for receiving calcium 1 g/day and 2 g/day. The calcium level was collected again in the third trimester.

Eligibility criteria: Inclusion Criteria:

* Pregnant women who attend antenatal care clinic in Siriraj Hospital
* Pregnant women with gestation less than 20 weeks of gestation
* Singleton pregnancy

Exclusion Criteria:

* Pregnant women who has underlying diseases including liver disease and vitamin D deficiency
* Pregnant women are malnutrition patients
* Pregnant women who receive calcium supplement before enrollment

Primary outcomes:
measure: The incidence of hypocalcemia in pregnant women at Siriraj Hospital
timeFrame: 1.5 year
Secondary outcomes:
measure: The demographic and pregnant factors are associating with maternal calcium level in the first half of pregnancy assessed by the questionnaire and scrupulous chart review
timeFrame: 1.5 year
measure: The calcium level in pregnant women in the third trimester
timeFrame: 2 year
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Tachjaree Panchalee, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06997679: Effects of Continuous Passive Movements vs Intermittent Compression in Patients With Post ACL Reconstruction Surgery
Official title: Effects of Continuous Passive Movements Versus Intermittent Compression in Patients With Post ACL Reconstruction Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: ACL Reconstruction Surgery remains a prevalent and debilitating condition, despite invasive and non-invasive approaches aimed at reducing pain and improving function. This study investigates the additional benefits of Continuous Passive Motion (device based exercise) and Intermittent Compression Therapy (device based program) in individuals with Post ACL Reconstruction Surgery.

Detailed description: The researcher employs a randomized controlled trial methodology. Participants are enrolled into two groups: one receiving Continuous Passive Motion (CPM), and the other receiving Intermittent Compression Therapy(IC).

Eligibility criteria: Inclusion Criteria:

* Diagnosed by Orthopedic Surgeon and patients who have undergone ACL reconstruction surgery
* Patients who have undergone arthroscopic ACL reconstruction surgery
* Both male and female
* Patients who are within 4th week post-operatively
* Aged between 20-50

Exclusion Criteria:

* Concomitant injuries such as meniscal tears or ligament sprains
* Patients who have undergone previous knee surgery, including ACL reconstruction
* Neurological Condition
* Cardiovascular disease
* Patients with allergies or sensitivities to the materials used in the CPM or IC devices

Primary outcomes:
measure: Visual analog scale VAS
timeFrame: 12 Months
measure: Knee injury and osteoarthritis outcome score KOOS
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shalamar Hospital
Study officials:
References:
Clinical trial NCT02454179: Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma
Official title: A Phase 2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Advanced Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of the Head and Neck
Lead sponsor: Acerta Pharma BV
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2015-05-27
Enrollment: 78
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: Study of the combination of acalabrutinib (ACP-196) and pembrolizumab in subjects with advanced head and neck squamous cell carcinoma.


Eligibility criteria: Inclusion Criteria:

* Men and women ≥ 18 years of age
* Histologically or cytologically confirmed recurrent, metastatic or unresectable HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that that has either progressed during or after platinum-based chemotherapy administered for metastatic disease or has recurred during or within 6 months after the completion of platinum-based neoadjuvant or adjuvant therapy
* Presence of radiographically measurable disease as defined by RECIST 1.1
* ECOG performance status of 0 or 1

Exclusion Criteria:

* Prior malignancy (other than HNSCC), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \< 2 years
* Known central nervous system metastases and/or carcinomatous meningitis
* A life-threatening illness, medical condition (including psychiatric conditions) or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of starting study drug

Primary outcomes:
measure: Number of Participants With Overall Response
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: 1-888-292-9613; acertamc@dlss.com
name: Acerta Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05033379: Healthcare Worker Resilience as Measured by Physiologic Feedback
Official title: Impact of Circadian Alignment, Autonomic Control, and Physiologic Feedback on Measures of Resilience: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Burnout, Professional
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2021-09-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Reliably achieving peak performance requires balancing the strain of the prior day with sufficient recovery to be ready for the next day. Surgery has a long standing tradition long hours of hard work often at the expense of adequate sleep. Decreased sleep and recovery has physiologic consequences which can be measured using biometric data. The goal of this study is to quantify surgeon performance and biometric data to understand how modifiable behaviors including mindfulness training and diet can maximize recovery and performance. The goal of this study is to quantify the impact if modifiable daily behaviors including sleep, nutrition, in order to understand the factors that contribute to high level performance, burnout, and physician wellbeing in surgical trainees and attendings.

Detailed description: Informed consent will be obtained prior to participation in the research study. A member of the research team will provide the participant with the consent form and allow them adequate time to read and ask questions prior to giving consent. If consent is not obtained, the participant will not be allowed to participate in the research study.

Participants will be asked to wear a biometric sensor for six months. The biometric sensor (The WHOOP strap) collects heart rate, heart rate variability, activity, and sleep metrics. Half of the participants will complete coaching to improve resilience with Arena Strive and half will be a control group instructed that sleep is important. In the latter 3 months of the study, the control group will have the opportunity to wear a continuous glucose monitor. At the completion of the study period all participants will have access to Arena strive coaching.

Other data gathered will be in the form of surveys and comments from subjects on wellness, burnout, modifiable activities including sleep, nutrition, glucose levels using continuous glucose monitoring, exercise and mindfulness.

Eligibility criteria: Inclusion Criteria:

* Study participants will include full time clinically active healthcare workers

Exclusion Criteria:

* Exclusion criteria will be anyone who is not a full-time clinical healthcare worker

Primary outcomes:
measure: Recovery
timeFrame: 6 months
Secondary outcomes:
measure: Burnout
timeFrame: 6 months
measure: Health Habits
timeFrame: 6 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care
state: California
Study officials:
References:
Clinical trial NCT03985579: Influence of Kinesiology Taping Application on Severity of Signs and Symptoms in Breast Engorgement.
Official title: Influence of Kinesiology Taping Application on Severity of Signs and Symptoms in Breast Engorgement at Early Lactation Stage.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lactation Disorders
Lead sponsor: Żelazna Medical Centre, LLC
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the research is to asses the efficacy of kinesiology taping application in breast engorgement in early postpartum stage.

Kinesiology application will be performed by women's health physiotherapist. Patient's perceived improvement and milk outflow following application will be assessed.


Eligibility criteria: Inclusion Criteria:

* cesarian section or vaginal delivery
* delivery between 37 and 41 gestational week
* signs and symptoms of breast engorgement (significant increase of breast between 2nd and 10th day postpartum, pain, obstructed milk outflow)
* VAS 4 and more
* volume of milk outflow less than 20ml
* 6 point self-rated engorgement scale between 3 and 6

Exclusion Criteria:

* age less than 18 and more than 45
* patients after extensive surgical breast intervention or having breast implants
* allergy to kinesiology taping

Primary outcomes:
measure: Visual Analogue Scale (VAS) change from baseline till 24 hours after intervention
timeFrame: assessment at the baseline 24 hours after intervention
measure: Human milk outflow change from baseline till 24 hours after intervention
timeFrame: assessment at the baseline and 24 hours after intervention
measure: 6 point self-rated breast engorgement scale
timeFrame: assessment at the baseline
measure: 5 point perceived improvement scale
timeFrame: assessment 24 hours after intervention
measure: The Breastfeeding Self-Efficacy Scale
timeFrame: assessment at the baseline
Secondary outcomes:
measure: Visual Analogue Scale (VAS) change from baseline till 3 hours after intervention
timeFrame: assessment at the baseline 3 hours after intervention
measure: Human milk outflow change from baseline till 3 hours after intervention
timeFrame: assessment at the baseline and 3 hours after intervention
measure: 5 point perceived improvement scale
timeFrame: assessment 3 hours after intervention
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Żelazna Medical Centre, St. Sophia Hospital
Study officials:
affiliation: Centre of Postgraduate Medical Education
name: Dorota Sys, PhD
role: STUDY_CHAIR
References:
citation: Zakarija-Grkovic I, Stewart F. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2020 Sep 18;9(9):CD006946. doi: 10.1002/14651858.CD006946.pub4.
Clinical trial NCT06937879: Investigation of Factors Affecting Upper Extremity Function in Healthy Young Adults
Official title: Investigation of Factors Affecting Upper Extremity Function in Healthy Young Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Function
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy young adults

Brief summary: The aim of this study was to determine the effects of grip strength, motor imagery and two-point discrimination on upper extremity function in healthy young adults.


Eligibility criteria: Inclusion Criteria:

* Being a university student,
* Being between the ages of 18-35
* Not having any known upper extremity problems

Exclusion Criteria:

* Upper extremity surgery history
* Neurological problems
* Chronic diseases

Primary outcomes:
measure: Function
timeFrame: Baseline
Secondary outcomes:
measure: Grip strength
timeFrame: Baseline
measure: Motor imagery
timeFrame: Baseline
measure: Two-point discrimination
timeFrame: Baseline
Other outcomes:
Locations:
city: Karatay
country: Turkey
facility: KTO Karatay University
state: Konya
Study officials:
References: