louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00136136: Validation of Bispectral Index (BIS)-Monitor in 3 Groups of Newborn Children
Official title: Validation of BIS-monitor in 3 Groups of Newborn Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behavior
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2005-08-26
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn children

Brief summary: This study will evaluate the registration of the bispectral index and spectral edge frequency in relation to the behavioural state.


Eligibility criteria: Inclusion Criteria:

* Group 1: normal healthy term newborns
* Group 2: Ill term newborns without brain damage
* Group 3: Preterm newborns without brain damage

Exclusion Criteria:

* Abnormal brain ultrasound
* Abnormal neurological examination
* Major congenital abnormalities
* Use of analgesics, sedatives, antiepileptic drugs or curarisation

Primary outcomes:
measure: Validation of the Bispectral Index(BIS)-Monitor
timeFrame: Short after birth of the newborn
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Claudine De Praeter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05158036: Comparison of the Effects of Different Massage Techniques in Women With Primary Dysmenorrhea
Official title: Comparison of the Effects of Different Massage Techniques in Women With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Dysmenorrhea
Lead sponsor: Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly divided into two groups
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the effects of different massage techniques on pain, primary dysmenorrhea (PD)-related symptoms and functional and emotional influence in women with PD.

Detailed description: Primary dysmenorrhea is defined as painful menstrual cramps without an underlying pelvic pathology or organic problem. Massage, which is one of the physiotherapy methods that reduces pain by acting on the autonomic nervous system and circulation, has an important place in the management of PD among non-pharmacological treatment approaches. In the literature, there are studies on the use of classical massage and connective tissue massage in women with PD for reducing menstrual pain and PD-related symptoms. However, to the best of our knowledge, no study has been found comparing classical massage and connective tissue massage in PD management.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Women with a complaint of primary dysmenorrhea,
* Volunteer women who have a regular menstrual cycle (28 ± 7 days)
* Women who have menstrual pain intensity greater than 40 mm according to the Visual Analogue Scale considering the last 6 months

Exclusion Criteria:

* Having gastrointestinal, urogynecological, autoimmune, psychiatric diseases and/or other chronic pain syndromes,
* Those who have given birth,
* Those who have a pregnancy status,
* Those who use intrauterine devices,
* Those who have had pelvic surgery,
* Those who use chronic medications, including oral contraceptives or antidepressants, for at least 6 months before the study,
* Those with a pathological history and radiological findings showing secondary dysmenorrhea

Primary outcomes:
measure: Pain intensity
timeFrame: change from baseline at an average of 2 weeks
Secondary outcomes:
measure: Pressure pain threshold
timeFrame: change from baseline at an average of 2 weeks
measure: Primary dysmenorrhea (PD)-related symptoms
timeFrame: change from baseline at an average of 2 weeks
measure: Functional and emotional effects
timeFrame: change from baseline at an average of 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06504836: Kinematic Biofeedback on Gait Quality in Stroke
Official title: Effects of Kinematic Biofeedback on Gait Quality in People With Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Biofeedback
Gait symmetry
Gait variability
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Walking disorder is the most common and concerning issue for individuals with stroke. Previous studies have often used improvements in walking speed and distance as reference indicators for the advancement of gait performance in individuals with stroke. However, for individuals with chronic stroke, considering gait symmetry and variability to enhance gait quality as the primary intervention target may be more crucial. According to a literature review, it can be inferred that the application of biofeedback to detect gait quality may be an effective approach to improve gait symmetry and variability in individuals with stroke. However, there is still insufficient research evidence on this issue. Therefore, this study aims to investigate the effects of a kinematic biofeedback device system, which detects hip joint angles, on gait quality in individuals with chronic stroke.


Eligibility criteria: Inclusion Criteria:

* First stroke
* Stroke onset time ≥ 6 months
* Functional Ambulation Category ≥3
* Passive range of motion of affected hip extension is at least 10 degrees
* Mini-Mental State Measurement score ≥ 24 points

Exclusion Criteria:

* Modified Ashworth Scale of affected ankle plantar flexors ≥ 2
* Muscle strength of affected ankle plantar flexors via Manual Muscle Testing ≤ 1
* Uncorrected auditory impairment
* Severe cardiovascular disease or uncontrolled hypertension
* Other orthopedic diseases that may affect walking ability
* Other neurological disease except stroke

Primary outcomes:
measure: Gait symmetry
timeFrame: 1 day
measure: Gait variability
timeFrame: 1 day
Secondary outcomes:
measure: Propulsive force
timeFrame: 1 day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
Study officials:
References:
Clinical trial NCT03183336: Horizontal Ridge Augmentation of the Mandible Autogenous Block Grafts
Official title: Horizontal Ridge Augmentation of the Mandible Using Interpositional Autogenous Block Grafts Versus Onlay Block Grafts; Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Horizontal Ridge Deficiency
Block Graft
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 20
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: 20 subjects presenting with horizontal mandibular ridge width less than 5 mm were selected and randomly divided two groups (10 in each group). the first group received interpositional block grafts (harvested from the chin and ramus) covered with Platelet-rich fibrin membrane. the second group received onlay block grafts (harvested from the chin and ramus) and covered with Platelet-rich fibrin membrane. the grafts are left for 4 months. the alveolar ridge width dimensions is then measured using radiographic analysis using cone-beam computed tomography scans


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes with a minimum vertical bone height above the inferior alveolar canal of 10mm in the edentulous region.

Patients should have ridge thickness less than 5mm measured 2mm from the alveolar crest Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.

Exclusion Criteria:

* Patients with any systemic disease that may affect normal bone healing. Patients with drug allergies, drug or alcohol abuse, periodontal diseases or poor oral hygiene

Primary outcomes:
measure: alveolar ridge width gained
timeFrame: 4 months
Secondary outcomes:
measure: patient morbidity following the surgical procedure
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00500136: The Psychosocial Effect of Thoughts of Personal Mortality on Cardiac Risk Assessment by Medical Students
Official title: The Effects of Religion and Motivation on Medical Decision Making: A Terror Management Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prejudice
Keywords: bias
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-07-12
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This study was designed to examine if provoking thoughts of mortality among medical students can influence cardiac risk assessments depending on the religion of the target patient.

Detailed description: This study was designed to examine whether and how provoking thoughts of mortality among medical students can influence cardiac risk assessments depending on the religion of the target patient.

Eligibility criteria: Inclusion Criteria:

* medical students

Exclusion Criteria:

* non-medical students

Primary outcomes:
measure: Responses on a scale of 0-100 to each of three cardiac risk questions
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jamie Arndt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greenberg J, Solomon S, Pyszczynski T. Terror management theory of self-esteem and cultural worldviews: Empirical assessments and conceptual refinements. In: Zanna MP, ed. Advances in Experimental Social Psychology. San Diego, CA: Academic Press; 1997:61-139.
Clinical trial NCT04016636: A Study to Evaluate Impact of Ibrutinib on the Quality of Life (QOL) in Patients With Chronic Lymphocytic Leukemia
Official title: "Impact of Ibrutinib on the Quality of Life (QOL) in Patients With Chronic Lymphocytic Leukemia (CLL): Argentinian Experience"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CLL
Lead sponsor: Fundaleu
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag Ltd.
First posted: 2019-07-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes patients with diagnosis of CLL with prescribed ibrutinib monotherapy as first-line or with prior therapies before or on the enrollment day as per routine clinical practice.

Brief summary: The aim of this study is to evaluate the impact of Ibrutinib monotherapy in the QoL of subjects with Chronic Lymphocytic Leukemia (CLL) based in European Quality of Life 5 Dimensions (EQ-5D) and FACIT- fatigue questionnaires assessment from baseline to 1 year of treatment in Argentinian routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained prior to any screening procedure
* Patients 18 years or older, to be treated with Ibrutinib, able to answer the complete QoL questionnaires.
* Diagnosis of CLL, according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria, with pathology confirmation (World Health Organization 2008).
* Patients with CLL in first-line or with prior therapies or treatment-naïve patients that harbours deletion 17p according to fluorescence in situ hybridization (FISH) standards with an indication of treatment with ibrutinib.

Exclusion Criteria:

* Pregnant and breast-feeding patients
* Impairment of ingestion and/or absorption of ibrutinib
* Mental or physical limitation to complete the QoL questionnaires.

Primary outcomes:
measure: Change From Baseline
timeFrame: 6 months
Secondary outcomes:
measure: Health-Related Quality of Life as Measured by European Quality of Life-5 Dimensions; 5 Levels Questionnaire (EQ-5D-5L)
timeFrame: At 0,1,3,6,12 months
Other outcomes:
measure: Number of patients with Clinically Significant Change in hemoglobin
timeFrame: At 0,1,3,6,12 months
Locations:
city: Buenos Aires
country: Argentina
facility: Fundaleu
Study officials:
affiliation: Fundaleu
name: Maria Jose Mela, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundaleu
name: Miguel A Pavlovsky, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01771536: The PCI Choice Trial: a Pilot Randomized Trial of a Decision Aid for Patients With Stable Coronary Artery Disease
Official title: The PCI Choice Trial: a Pilot Randomized Trial of a Decision Aid for Patients With Stable Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Angina
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Despite several large clinical trials clearly establishing that coronary revascularization (i.e. percutaneous coronary intervention - PCI) does not prolong survival or prevent myocardial infarction (MI) for stable coronary artery disease (CAD), patients with stable angina continue to believe that PCI is performed to improve these outcomes. Additionally, recent concerns have emerged of overuse of PCI among patients with little or no angina. Thus there is a compelling need to share with patients the risks and benefits of PCI prior to treatment to reach an informed decision.

This study is designed to answer the question of whether a decision aid can improve patient knowledge, decisional conflict and patient satisfaction with decision-making compared to usual care for the treatment of stable angina.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of stable angina - As judge by clinician, eligible for medication therapy or PCI - agree to be available for follow-up survey 3 months after treatment decision

Exclusion Criteria:

* has major communication barrier (severe hearing/vision impairment, dementia, cannot communicate with clinician in English)

Primary outcomes:
measure: Efficacy of the PCI Choice Decision aid vs. Usual Care assessed by Patient and Provider Surveys, and encounter Video/Audio Recordings
timeFrame: Baseline to Three Months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nilay Shah, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coylewright M, Dick S, Zmolek B, Askelin J, Hawkins E, Branda M, Inselman JW, Zeballos-Palacios C, Shah ND, Hess EP, LeBlanc A, Montori VM, Ting HH. PCI Choice Decision Aid for Stable Coronary Artery Disease: A Randomized Trial. Circ Cardiovasc Qual Outcomes. 2016 Nov;9(6):767-776. doi: 10.1161/CIRCOUTCOMES.116.002641. Epub 2016 Nov 1.
Clinical trial NCT02612636: The Effect of Ear Plug and Eye Mask on Sleeping Quality in Critically Ill Patients
Official title: The Effect of Ear Plug and Eye Mask on Sleeping Quality in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: Delirium
Ear Plug
Eye Mask
Mechanical ventilation
Sleep
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Sleep is a complex physiologic and behavioral process essential for rest, repair, well-being, and survival. Sleep is defined as a periodic, reversible state of cognitive and sensory disengagement from the external environment. Critically ill patients experience poor sleep quality. Surveys of ICU survivors have shown that sleep disruption, pain and intubation for mechanical ventilation are the major sources of anxiety and stress during the ICU stay. Many physiological, psychological and environmental factors contribute to the incidence of sleep disruption for the ICU patients. The primary physiologic factors documented in the literature are pain, medications and illness.The primary psychological factors documented in the literature are stress and worry. Environmental factors include noise, patient care activities and therapeutic modalities as mechanical ventilation. Our research aim will be the impact of effective interventions like use of ear plugs and eye mask on decreasing light exposure and promoting sleep in ICU patients.

Detailed description: 50 patients in the age range 18- 60 years admitted to ICU of Assiut university hospitals will be randomly allocated into into two groups (control group and intervention group).

Eligibility criteria: Inclusion Criteria:

* Age \>18 years old.
* Mechanically ventilated patient.
* Conscious patient.
* No hearing problems.
* No eye disease.
* Not receiving narcotic drugs five to six hours before sleep time at night.
* No underlying disease that is affecting sleep such as rheumatoid arthritis and migraine.

Exclusion Criteria

* Head injury.
* Psychiatric disease.
* Shocked patients

Primary outcomes:
measure: Sleep quality .
timeFrame: four days
Secondary outcomes:
measure: Urine Melatonin
timeFrame: four days
measure: Cortisol level
timeFrame: four days
measure: Delirium assessment
timeFrame: four days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: associate professor
name: sayed abd elshafy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06758336: Caffeinated Chewing Gum & Wrestling Performance
Official title: Caffeinated Chewing Gum Improves Sympathetic Nerve Activity and Simulates Wrestling Performance: a Double-blind Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffeine
Control
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 16
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: a randomized crossover double-blind study design
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate the effect of caffeinated chewing gum on sympathetic nerve activity on wrestling simulation match.

Detailed description: The purpose of this study was to investigated whether caffeine intake is effective in improving the performance of wrestlers in a simulated competition. The study was designed to involve 16 healthy adult male athletes who had been trained in professional wrestling and were divided into caffeine trial (CAF trial) and placebo trial (PL trial) in a randomized crossover double-blind study design. After three days of dietary control, participants arrived at the laboratory in the afternoon of the day of the trial to collect saliva samples in a quiet state and were fitted with a heart rate monitor. Participants chewed either caffeine-containing gum at 3 mg/kg body weight (CAF trial) or placebo-containing gum without caffeine (PL trial) for 10 minutes and then spit it out. Participants then underwent a 15-minute dynamic warm-up. At the end of the warm-up, participants performed 2 rounds of 3-minute wrestling-specific simulated matches, and the number of falls in the simulated matches was recorded. After the simulation match, saliva samples were collected from the participants again. The saliva samples were analyzed for caffeine alpha-amylase concentration. Differences between the two trials were analyzed using a paired sample t-test and significance was set at α\<0.05.

Eligibility criteria: Inclusion Criteria:

* more than 6years of professional wrestling training;
* more than 6 months of continuous training;
* recovering from sports injuries such as strains and contusions for at least 3 months.

Exclusion Criteria:

* non-professionally wrestling athlete;
* none regular training in the past 6 months;
* less than 3 months of recovery from a sports injury, or present epilepsy, hypertension, hyperlipidemia, heart disease, arthritis, osteoporosis, or brain injury;
* a history of caffeine allergy.

Primary outcomes:
measure: The number of falls in the simulated matches
timeFrame: 15 minutes after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: National Taiwan University of Sport
state: North
Study officials:
affiliation: Sport Science Research Center
name: Chih-Hui Chiu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00333736: Study to Assess Safety and Quality of Life of Patients Using Biojector Versus Needles for Fuzeon Administration
Official title: Prospective Study to Assess Patient Satisfaction, Quality of Life and Adverse Events of Patients Using the Biojector Versus Standard Needles for Enfuvirtide Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Human Immunodeficiency Virus
Keywords: Injection site reactions
enfuvirtide administration
Lead sponsor: Canadian Immunodeficiency Research Collaborative
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2006-06-06
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypothesis: Patients using enfuvirtide with the Biojector have an improved quality of life, greater satisfaction, and fewer adverse events compared with using the standard needle.

Detailed description: This study is a "N of one" trial where the patient is their own control. We will provide the quality of life questionnaire, the MOS-HIV questionnaire; ISR questionnaire and a satisfaction questionnaire to patients that have used a standard need to inject enfuvirtide for at least one month. As well, demographics and laboratory data will be collected. The same procedures will be given 1 month after the use of Biojector in a follow-up visit.

Eligibility criteria: Inclusion Criteria:

Patients who have taken enfuvirtide for at least one month

Exclusion Criteria:

Patients with hemophilia

Primary outcomes:
measure: To compare quality of life, satisfaction, and adverse events in patients using a Biojector® versus using a standard needle system for administration of enfuvirtide.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Maple Leaf Medical Clinic
state: Ontario
Study officials:
affiliation: University of Toronto
name: Mona Loutfy, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References: