louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06575816: Effect of Augmented Reality on Pain, Anxiety, and Fear in Children During Blood Collection
Official title: Effect of Augmented Reality on Pain, Anxiety and Fear During Blood Collection in Children: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Fear
Anxiety
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 70
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In recent years, technological advances have enabled the development of innovative intervention methods in healthcare. This study aims to examine the effect of augmented reality (AR) technology on pain, anxiety and fear in children during pediatric blood collection procedures. The study is based on a randomized controlled design. Participants were randomized into two groups, the group receiving AR intervention and the control group receiving standard care. Pain, anxiety and fear levels will be assessed with pre and post intervention measurements.


Eligibility criteria: Inclusion Criteria:

* Both parent and child voluntarily agree to participate in the study
* No language barrier

Exclusion Criteria:

* Parents or children who refused to participate in the study
* Problems with looking at the screen

Primary outcomes:
measure: Pain Level
timeFrame: Five minutes before and 5 minutes after blood collection
Secondary outcomes:
measure: Fear Level
timeFrame: Five minutes before and 5 minutes after blood collection
Other outcomes:
measure: Anxiety Level
timeFrame: Five minutes before and 5 minutes after blood collection
Locations:
city: İzmir
country: Turkey
facility: Emine Zahide Özdemir
Study officials:
References:
Clinical trial NCT01758016: Haptoglobin and Diabetes Complications in Pregnancy
Official title: Haptoglobin and Diabetes Complications in Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes in Pregnancy
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2012-12-31
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Pregastetional diabetic patients currently pregnant
2. Gestational diabetes patients currently pregnant

Brief summary: Pregnancies of patients with Diabetes are associated with increase adverse pregnancy outcome . The risk for vascular complications including: Intra uterine growth restriction (20%), hypertension (31%), preeclampsia (15%), eclampsia and placental abruption are significantly greater than those in background populations. The risk of developing vascular complications in diabetes pregnancies although is correlated with the severity and length of the disease is not fully understood. Enhanced oxidation has been suggested to be the underlying abnormality responsible for some of the complications of diabetes.

Haptoglobin (Hp) is an abundant plasma glycoprotein produced in the liver. The best understood function of Hp is to bind free hemoglobin (Hb) released from red blood cells. Extracorpuscular Hb is a potent Fenton reagent.capable of of inflicting oxidative tissue damage. Hp binds to Hb and serves to inhibit the oxidative potential of Hb by preventing the release of heme iron.

The haptoglobin (Hp) gene at chromosomal locus 16q22 is polymorphic, with two common alleles denoted 1 and 2. the prevalence of Hp 1-1, Hp 1-2 and Hp 2-2 genotypes is approximately 16%, 48% and 36%, respectively. In the western world. A total of five independent longitudinal studies have demonstrated that DM individuals with Hp 2-2 genotype have a two to five-fold increased risk of CVD as compared to DM individuals without the Hp 2-2 genotype We sought to determine whether HP genotype plays important role in development of vascular complications in pregastational pregnancies. and whether Hp genotype 2-2 is a risk factor for developing gestational diabetes (GDM)


Eligibility criteria: Inclusion Criteria:

* Diabetes in pregnancy

Exclusion Criteria:

* Not willing to participate

Primary outcomes:
measure: vascular complications in pregnancy
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Be'er Sheva'
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Cmpus
city: Kfar Saba
country: Israel
facility: Meir Hospital
Study officials:
References:
Clinical trial NCT00718016: Assessment of the Cyberlink Control System for Use by the Amyotrophic Lateral Sclerosis (ALS) Patient
Official title: Assessment of the Cyberlink Control System for Use by the ALS Patient
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Amyotrophic Lateral Sclerosis
Neurodegenerative Disease
Motor Neuron Disease
Keywords: Amyotrophic Lateral Sclerosis
Cerebrospinal Fluid
Neurodegenerative Disease
Motor Neuron Disease
Autonomic Nervous System
Neurodegenerative Diseases
Movement Disorders
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: MDA/ALS Center of Hope
First posted: 2008-07-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALS clinic patients at MDA/ALS Center of Hope.

Brief summary: The goal of this project is to determine whether this device is a practical and realistic means for ALS patients to operate their computers with only the use of facial, brainwave, and eye movements. This study is intended to evaluate both the complexity of the system and the degree to which complications of ALS (such as severity of involuntary movements) may interfere with the use of cyberlink.


Eligibility criteria: Inclusion Criteria:

* Those aged 18-75 diagnosed with probable or definite ALS.

Exclusion Criteria:

* Those with decision impairment will not be considered.

Primary outcomes:
measure: Usability of the Cyberlink System
timeFrame: 4 1-hr sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: MDA/ALS Center of Hope
state: Pennsylvania
Study officials:
affiliation: MDA/ALS Center of Hope
name: Terry Heiman-Patterson, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05608616: Maternal and Fetal Outcomes in Pregnant Women With COVID -19,a Cross Sectional Study
Official title: COVID-19 and Pregnancy Maternal and Fetal Outcomes,A Retrospective Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pandemic
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A retrospective analysis of prospectively collected data of pregnant women confirmed as COVID-19 infected.

Maternal and fetal morbidities and adverse obstetrical outcomes among those with COVID-19 will be analyzed.

Maternal outcomes will include:Venous thromboembolic events,pregnancy outcome,mode of delivery,frequency of admission to ICU,need for assistive ventilation,mortality rate Fetal outcomes will include:Frequency of NICU admission,Preterm birth,Intrauterine growth restriction,Intrauterine fetal death,Congenital fetal malformations.

Brief summary: The spread of a new coronavirus (SARS-CoV-2) from Wuhan, China, has been fast, and the World Health Organization (WHO) declared a pandemic on March 11th, 2020 .It has now spread worldwide and is one of the most severe public health threats.The clinical characteristics of COVID-19 and the likelihood of transmission vertically or during delivery in pregnant women are still unknown.

Detailed description: In this cross sectional study,the following questions require immediate attention: whether COVID-19 symptoms in pregnant women differ from symptoms in non-pregnant women; whether disease complications and mortality rates are higher in pregnant women than in non-pregnant women; and whether there is a risk of premature delivery, foetal mortality, or even vertical transmission of the disease. These questions must be answered in order to plan optimal obstetrical management for pregnant women with COVID-19

Eligibility criteria: Inclusion Criteria:

* Pregnant women of any gestational age with confirmed COVID 19 diagnosis attended and admitted at inpatient ward for management and follow up from April 2020 to December 2021at Kasr El Ainy hospital,Cairo university

Exclusion Criteria:

* there is no exclusion criteria

Primary outcomes:
measure: Outcomes of Pregnancy with COVID-19
timeFrame: 32 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT03844516: Pacing in Left Ventricular Assist Device Recipients
Official title: Work Intolerance in Left Ventricular Assist Device Recipients: Impact of Pacing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Rate
Chronotropic Incompetence
Pacing
Keywords: Chronotropic incompetence
pacing
heart rate
exercise
peak oxygen uptake
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Implantation with left ventricular assist device (LVAD) in patients with end-stage heart failure (HF) leads to improvements in survival and quality of life, however, work capacity remains disappointingly low, at half of the expected value. Complex central and peripheral hallmarks of heart failure attribute to the continued work intolerance, to which heart rate may be a contributing factor.

The purpose of this study is to clarify the impact of heart rate (by means of pacing) on work capacity (measured as peak oxygen uptake) in LVAD recipients.

Detailed description: While implantation with left ventricular assist devices (LVADs) in patients with end-stage heart failure (HF) improve survival and quality of life, work capacity remains at a disappointing 50% of the expected value.

Due to the worldwide (increasing) shortage of donor hearts, LVADs are increasingly used as destination therapy which makes it crucial for physicians to persistently identify opportunities to improve management, lower the adverse events and maximize the benefits of this treatment option.

In recent years it was found that upregulation of device pump speed improves the maximal work capacity of LVAD recipients with no side effects. More recently it was found that the patients' heart rate reserve also was of importance in this regard, however, the latter was shown in a retrospective study and needs to be confirmed in a prospective randomized double-blinded intervention study. As a large portion of LVAD recipients are already implanted with a pacing device (and suffer from chronotropic incompetence) such a study is possible to conduct by controlling their heart rate during exercise by pacing (ie randomized crossover design).

Eligibility criteria: Inclusion Criteria:

* Implanted with a left ventricular assist device
* Implanted with a pace-device ensuring the possibility of pacing
* Age \> 18

Exclusion Criteria:

* Not able to undergo a peak oxygen uptake test
* No consent

Primary outcomes:
measure: Peak oxygen uptake (pVO2)
timeFrame: 1 Day
Secondary outcomes:
measure: Heart rate
timeFrame: 1 Day
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: DK
Study officials:
References:
Clinical trial NCT04283916: Botulinum Toxin Injection in the Treatment of Open Abdomen
Official title: Botulinum Toxin Injection in the Treatment of Open Abdomen
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Open Abdomen
Botulinum Toxin Injection
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 consecutive open abdomen patients

Brief summary: Botulinum toxin has been widely approved and utilized in the treatment of complex abdominal wall hernias. Botulinum toxin has been only randomly studied in the treatment of open abdomen.

Detailed description: 30 consecutive patients who have open abdomen for any indication, will have 300 IU botulinum toxin injected in three spots in either sides of the abdomen within 72 hours of the start of open abdomen. The hypothesis is botulinum toxin relaxes abdominal wall musculature to ensure better and faster closure of the open abdomen.

Eligibility criteria: Inclusion Criteria:

* Open abdomen

Exclusion Criteria:

* Previous incisional hernia in midline
* Patient is not in active treatment

Primary outcomes:
measure: Abdominal wall closure
timeFrame: 30 days
Secondary outcomes:
measure: Intensive care time
timeFrame: 30 days
measure: Hospitalization
timeFrame: 30 days
measure: Hernia
timeFrame: 2 years
measure: Re-laparotomies
timeFrame: 30 days
measure: Enterocutaneus fistula
timeFrame: 30 days
measure: Abdominal wall closure success rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
References:
Clinical trial NCT05949216: The Impact of Musical Engagement on Medical Resident Well-being
Official title: The Impact of Musical Engagement on Medical Resident Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout
Student Burnout
Physical Disability
Resident Doctor
Music Therapy
Music
Stress
Wellness, Psychological
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is common knowledge that music has a positive impact on human well-being. It is also well-known that medical residents are frequently stressed and burnt out. With these two thoughts in mind, the investigators want to explore how participating in a musical engagement program may positively impact medical resident well-being. The investigators hope to do this by hosting four informal musical engagement sessions with medical residents, which will involve playing instruments, improvising, and reading sheet music. To study the impact that this program has on participants, investigators will ask participants to complete a survey. The investigators hope to find that participants are positively impacted by participation in the study, in terms of factors like stress reduction and minimized burnout symptoms. Hopefully, the study results may inform residency program curriculum designers in the future may incorporate music into wellness programming.


Eligibility criteria: Inclusion Criteria:

1. Participants will be residents in the Family Medicine program at McMaster University, in any year of study
2. Participants may be on any rotation in their program schedule and located at any site
3. Participants may be of any gender identity, age, ethnicity, and sexual orientation
4. Must identify as a "musician", whether casual, professional, or somewhere in between - however, they require enough musical training so that they may comfortably participate in the planned sight reading and improvisation within the study
5. Participants must be able to supply their own physical instrument for sessions
6. Must be aged 18 or over
7. Must be English-speaking

Exclusion Criteria:

1. Potential participant may not be a resident of any other residency program, or be from a university other than McMaster
2. If a participant is unable to participate in two or more musical sessions, they will not be included in this study
3. If a participant is unable to complete the qualitative and quantitative survey forms in their entirety, they will not be included in this study

Primary outcomes:
measure: Improvement of burnout symptoms
timeFrame: Eight weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References:
Clinical trial NCT01336816: A Pilot Study to Evaluate the Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Crossover, Pilot Study to Evaluate the Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge, Containing Tobacco and Silver Salt - in Healthy Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tobacco Use Disorder
Smoking
Keywords: smoking
smokeless
aversion
nicotine
nicotine replacement
Lead sponsor: Star Scientific, Inc
Sponsor class: INDUSTRY
First posted: 2011-04-18
Enrollment: 43
Sex: ALL
Minimum age (years): 23
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This is a study to determine the safety and effectiveness of silver salt in Ariva® Silver Wintergreen Lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when tobacco is smoked.

Detailed description: Each subject will be given an Ariva® Silver Wintergreen lozenge or a Placebo Wintergreen lozenge on a random basis.

Once the lozenge has dissolved in the mouth, subjects will smoke one of their own cigarettes, and will answer questions about the experience and their craving for a cigarette.

After a washout period, each subject will repeat the steps with the second type of lozenge.

Eligibility criteria: Inclusion Criteria:

* healthy adult smoker
* smoking for at least 5 years
* smoking at least one (1) pack of cigarettes a day
* interest in quitting smoking

Exclusion Criteria:

* known allergy to silver or silver salts
* pregnant or breast-feeding
* current drug or alcohol abuse, and/or history of drug or alcohol dependence within 3 months of study

Primary outcomes:
measure: Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Martinsburg
country: United States
facility: Comfort Inn
state: West Virginia
Study officials:
affiliation: Star Scientific, Inc
name: Maria Varga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03242616: PemVin vs Vin in Previously Treated Metastatic Breast Cancer
Official title: Randomized Phase II Trial of Pemetrexed Plus Vinorelbine Versus Vinorelbine in Patients With Recurrent or Metastatic Breast Cancer Previously Treated With or Resistant to Anthracycline and Taxane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pemetrexed is a multi-targeted anti-folate, that is used for non-small cell lung cancer and mesothelioma. There are several clinical studies of pemetrexed in breast cancer, but these are largely done before the wide use of premedication (steroid and vitamin B12) for pemetrexed. Moreover, it has not been studied in combination with vinorelbine, which is a commonly used drug for anthracycline- and taxane-pretreated metastatic breast cancer.

This is a randomized phase II study of pemetrexed plus vinorelbine versus vinorelbine in patients with recurrent or metastatic breast cancer previously treated with or resistant to an anthracycline and taxane.


Eligibility criteria: Inclusion Criteria:

1. histologically confirmed, recurrent or metastatic breast cancer
2. HER2-negative
3. ECOG PS 0-2
4. Age ≥ 20 years
5. Anthracycline- and Taxane-pretreated
6. Wash-out period of 3 weeks for cytotoxic chemotherapy
7. Wash-out period of 2 weeks for hormone therapy or radiotherapy
8. measurable or non-measurable lesions by RECIST v1.1
9. Adequate hematological functions : ANC ≥1,500/mm3, Platelet ≥100,000/mm3, Hb≥ 9g/dL
10. Adequate liver functions
11. Adequate renal functions : sCr≤1.5mg/dL
12. Subjects willing to follow study protocol
13. Informed consent before study entry

Exclusion Criteria:

1. More than 3 lines of chemotherapy for metastatic breast cancer
2. Pregnant or breastfeeding women
3. Previous exposure to Pemetrexed or Vinorelbine
4. Neuropathy (grade 2 or more)
5. Symptomatic CNS metastasis
6. History of malignant disease within 5 years (except for cured basal cell cancer or squamous cell cancer of skin, cured thyroid cancer, in-situ cervical cancer)
7. Hypersensitivity to study medication or related drugs
8. Concomitant vaccination for yellow fever

Primary outcomes:
measure: progression free survival
timeFrame: response assessment every 6 weeks, for up to 2 years
Secondary outcomes:
measure: response rate
timeFrame: response assessment every 6 weeks, for up to 2 years
measure: duration of response
timeFrame: response assessment every 6 weeks, for up to 2 years
measure: overall survival
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: