louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06350513: The Effect of Animated Movies and Storybooks on Fear and Anxiety Levels in Children With Type 1 Diabetes
Official title: The Effect of Animated Film and Storybook on Fear and Anxiety Levels in Children With Newly Diagnosed Type 1 Diabetes: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Child, Only
Anxiety
Fear
Nurse
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 64
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Group (Experiment-Control) Randomized Controlled Experimental
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes.

Detailed description: This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes. In the study, newly diagnosed children in the experimental group will be shown a 10-minute movie and read the educational booklet. Routine care will continue for the control group.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study,
* Parental approval
* Being between the ages of 7-12,
* Being diagnosed with T1D for the first time,
* Being literate and able to communicate in Turkish

Exclusion Criteria:

* Having a mental, visual, hearing or communication impairment,
* Having mental and spiritual health problems,

Primary outcomes:
measure: State Anxiety Inventory for Children (STAI-C)
timeFrame: Initial assessment will be performed at baseline (pre-intervention)
measure: State Anxiety Inventory for Children (STAI-C)
timeFrame: The second evaluation will be made after the first evaluation (after watching the animated movie and reading the story book (approximately 1 hour later)).
measure: State Anxiety Inventory for Children (STAI-C)
timeFrame: The third evaluation will be made approximately 3 days after the second evaluation.
Secondary outcomes:
measure: Children's Fear Scale
timeFrame: Initial assessment will be performed at baseline (pre-intervention)
measure: Children's Fear Scale
timeFrame: The second evaluation will be made after the first evaluation (after watching the animated movie and reading the story book (approximately 1 hour later)).
measure: Children's Fear Scale
timeFrame: The third evaluation will be made approximately 3 days after the second evaluation.
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: NecmettinEU
state: Meram
city: Konya
country: Turkey
facility: Semra Köse
state: Meram
city: Konya
country: Turkey
facility: Necmettin Erbakan Üniversity
Study officials:
References:
Clinical trial NCT02567513: Cost-Effectiveness of Weight Loss Prevention in Nursing Homes: A Controlled Trial
Official title: Cost-Effectiveness of Weight Loss Prevention in Nursing Homes: A Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: food and fluid intake
nursing homes
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2015-10-05
Enrollment: 154
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Low oral food and fluid intake and unintentional weight loss are common problems among long-stay nursing home (NH) residents and are associated with adverse, costly clinical outcomes. This study will use a controlled, intervention design to determine the cost-effectiveness of oral liquid nutrition supplements with an alternative nutrition intervention that offers NH residents a choice between supplements and other foods and fluids (i.e., snacks) between meals in a group of 200 residents across 4 NH sites. Residents with an order for supplementation will be included in this study and randomized into one of three groups: (1) usual care control; (2) oral liquid nutrition supplementation intervention; or (3) choice intervention. The usual care control group will continue to receive standard NH care for supplement or snack delivery. Research staff will provide the same supplements used by the NH (group two) or a choice between supplements and other foods and fluids (group three) twice daily, five days per week, for 24 weeks and document the daily costs of intervention implementation when also providing a prompting protocol known to improve intake and enhance independence in eating. Based on extensive preliminary data, it is anticipated that both groups two and three will require significantly more staff time than usual care (group one). Thus, the labor costs of these interventions will be documented and compared to effectiveness measures. Effectiveness measures include the following resident outcomes: improvements in total daily caloric intake, weight, nutrition and hydration status and quality of life. These outcomes will be independently monitored for all three groups across 24-weeks by trained research staff using standardized, validated protocols.


Eligibility criteria: Inclusion Criteria:

* Long-stay nursing home residents,
* capable of oral food and fluid intake,
* physician or dietitian order for caloric supplementation.

Exclusion Criteria:

* Short-stay nursing home residents (rehabilitation),
* feeding tube,
* hospice care.

Primary outcomes:
measure: Total caloric intake during and between meals
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University
name: Sandra F Simmons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03816813: Assessement of Hepcidin in Saliva in Human Volunteers
Official title: Detection of Hepcidin in Saliva and Its Utility as a Diagnostic Marker for Iron Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepcidin, Saliva
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: healthy volunteers, male and female

Brief summary: Iron deficiency with or without anemia is considered the most widespread nutritional deficiency in the world. To diagnose iron deficiency anemia (hemoglobin and ferritin measurement), a venous blood sample is necessary. Whole saliva is a potentially attractive fluid for disease biomarker discovery and diagnostic efforts, because it is readily available from most individuals, can be easily collected and the collection procedure is non-invasive. The iron storage protein ferritin is too big, to be secreted into saliva. However, the main iron regulatory protein hepcidin is a very small protein and there is some evidence for hepcidin detection in saliva. The production of serum hepcidin positively correlates with serum ferritin, thereby reflecting patient's iron status. Whether hepcidin is detectable in saliva and whether saliva hepcidin correlates with serum hepcidin with current assays, needs to be tested.


Eligibility criteria: Inclusion Criteria:

* Normal-weight (BMI 18-24.9kg/m2)
* fasting
* Participants Need to have brushed their teeth at least 1 hour before the visit

Exclusion Criteria:

* acute, chronic illness
* use of long-term medication other than contraception
* medical Problems known to affect Fe homeostasis
* smoking

Primary outcomes:
measure: Saliva hepcidin
timeFrame: Day 1am
measure: Serum hepcidin
timeFrame: Day 1am
measure: Serum ferritin
timeFrame: Day 1am
Secondary outcomes:
measure: Hemoglobin
timeFrame: Day 1am
measure: Transferrin receptor
timeFrame: Day 1am
measure: c-reactive protein
timeFrame: Day 1am
measure: alpha-glycoprotein
timeFrame: Day 1am
measure: Saliva hepcidin
timeFrame: Day 1pm
measure: Saliva hepcidin
timeFrame: Day 2am
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Laboratory of Human Nutrition
Study officials:
References:
Clinical trial NCT01669213: Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension
Official title: Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension After Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypotension
Shivering
Nausea and Vomiting
Vasopressor
Keywords: 5-HT3 receptor antagonist
hypotension
spinal anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to estimate effects of different kinds, different dose of 5-HT3 receptor antagonists on prevention of hypotension after spinal anesthesia


Eligibility criteria: Inclusion Criteria:

* patients undergoing spinal anesthesia

Exclusion Criteria:

* hypersensitivity on 5-HT3 receptor antagonists hypertension cardiovascular disease intake of selective serotonin reuptake inhibitor

Primary outcomes:
measure: prevention of hypotension by calcaulation the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia.
timeFrame: up to 30mins after spinal anesthesia
Secondary outcomes:
measure: prevention of hypotension bycalculation the gap baseline systolic and diastolic blood pressure and lowerst systolic and diastolic blood pressure
timeFrame: up to 30mins after spinal anesthesia
Other outcomes:
measure: occurrence ratio of shivering, nausea and vomiting, and usage doses of vasopressor (ephedrine or phenylephrine), and atropine
timeFrame: up to 30 min after spinal anesthesia
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT04161313: Respiratory Function, Exercise Capacity and Peripheral Muscle Strength Among Patients With CF, PCD and Healthy Children
Official title: Comparison of Respiratory Function, Exercise Capacity and Peripheral Muscle Strength Among Patients With Cystic Fibrosis, Primary Ciliary Dyskinesia and Healthy Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Ciliary Dyskinesia
Cystic Fibrosis
Keywords: respiratory functions
exercise capacity
muscle strength
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 76
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children diagnosed with cystic fibrosis and primary ciliary dyskinesia and age matched healthy volunteers who do not have any diagnosed chronic diseases

Brief summary: The aim of this study is to compare pulmonary function, respiratory muscle strength, exercise capacity and peripheral muscle strength of patients with CF, PCD and healthy childrens.

Detailed description: The impaired airway clearence and pulmonary functions, exercise intolerance, low physical activity level and decreased peripheral muscle strength make physiotherapy approaches important in the management of CF and PCD.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cystic fibrosis or primary ciliary dyskinesia

Exclusion Criteria:

* Hospitalization history in past month
* Diagnosis of other chronic pediatric diseases which may impair exercise tolerance such as cerebral palsy or neuromuscular disease
* Candidates for lung transplantation or history of lung transplantation

Primary outcomes:
measure: Six-minute walk test distance
timeFrame: 15 minutes
Secondary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: 5 minutes
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 5 minutes
measure: Peak Expiratory Flow (PEF)
timeFrame: 5 minutes
measure: M. Quadriceps strength
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
Study officials:
affiliation: Bezmialem Vakif University
name: Hilal Denizoglu Kulli, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06610513: Guided Imagery on Pregnancy Stress and Sleep Quality in Risky Pregnancy
Official title: Effect of Guided Imagery on Pregnancy Stress and Sleep Quality in Risky Pregnancy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Effect of Guided Imagery Application on Pregnancy Stress and Sleep Quality in Risky Pregnant Women Will Be Checked
Keywords: Guided imagery
pregnancy
stress
sleep quality
risky pregnancy
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 48
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: In this thesis study, it is thought that with the guided imagery application to the hospitalized pregnant women, there will be a decrease in their stress levels and an increase in their sleep quality. In our country, there is no study where guided imagery application is used in risky pregnant women. It is thought that new information will be added to the literature as a result of this study. This study will be conducted to determine the effect of guided imagery application on pregnancy stress and sleep quality in risky pregnant women.


Eligibility criteria: Inclusion Criteria:

* Education level should be primary school or above
* Being in the 20th week of pregnancy or above
* Being planned to stay in the hospital for at least 5 days
* Being hospitalized for the first time during pregnancy
* Being within the first 3 days of hospitalization
* Knowing and speaking Turkish
* Being able to communicate verbally

Exclusion Criteria:

1. Having had guided imagery before
2. Having a diagnosis of mental illness
3. Having become pregnant through infertility treatment

Primary outcomes:
measure: Pregnancy Stress Assessment Scale
timeFrame: During 5 days after the first meeting with participant
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana City Training and Research Hospital
state: Sariçam
Study officials:
References:
Clinical trial NCT00622713: A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (EXTRA)
Official title: A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE 10-26)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
cholinesterase inhibitor
rivastigmine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-02-25
Enrollment: 228
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm\^2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting


Eligibility criteria: Inclusion Criteria:

* Males, and females of at least 50 years old with a primary caregiver
* Probable Alzheimer's disease
* Mini-Mental State Examination (MMSE) score of ≥ 10 and ≤ 26
* Patients initiating therapy for the first time with a Cholinesterase (ChE) inhibitor (patients prescribed both rivastigmine and memantine are allowed) or patients who failed to benefit from previous ChE inhibitor treatment
* Residing with someone in the community throughout the study or, if living alone, in contact with the responsible caregiver everyday

Exclusion Criteria:

* Patients not treated according to the product monograph for capsules
* Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application)
* History of allergy to topical products containing any of the constituents of the patches

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Patients Who Achieved and Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8 Weeks During 24 Weeks Study
timeFrame: 24 weeks
Secondary outcomes:
measure: Clinical Global Impression of Change (CGI-C) by Physician
timeFrame: Baseline and week 24
measure: Mean Change From Baseline to Week 24 in the 4-item Instrumental Activities of Daily Living (4-IADL) Score
timeFrame: Baseline to week 24
measure: Mean Change From Baseline to Week 24 in the Mini-Mental State Examination (MMSE) Score
timeFrame: Baseline to week 24
measure: Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score
timeFrame: Baseline to week 24
Other outcomes:
Locations:
city: Rueil-Malmaison
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharma S.A.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01903213: Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphatemia Receiving Peritoneal Dialysis
Official title: Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphatemia Receiving Peritoneal Dialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Renal Failure
Keywords: Peritoneal dialysis
Bixalomer
Chronic renal failure patients with Hyperphosphatemia
Kiklin®
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-07-19
Enrollment: 123
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Chronic renal failure with Hyperphosphatemia receiving Peritoneal dialysis

Brief summary: To evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.


Eligibility criteria: Inclusion Criteria:

* Chronic renal failure patients with Hyperphosphatemia receiving peritoneal dialysis

Primary outcomes:
measure: Safety assessed by the incidence of adverse events (including adverse drug reactions), vital signs and laboratory tests
timeFrame: Baseline and 1, 2, 3, 6, 12 months after administration
Secondary outcomes:
measure: Serum phosphorous levels
timeFrame: Baseline and 1, 2, 3, 6, 12 months after administration
measure: Serum albumin level
timeFrame: Baseline and 1, 2, 3, 6, 12 months after administration
measure: Serum calcium level
timeFrame: Baseline and 1, 2, 3, 6, 12 months after administration
measure: Serum intact PTH (parathyroid hormone) level
timeFrame: Baseline and 1, 2, 3, 6, 12 months after administration
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kanto
country: Japan
city: Kyushu
country: Japan
city: Shikoku
country: Japan
city: Tohoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT04635813: The Impact of COVID-19 Pandemic on Thyroid Surgery in Italy: Results From a Nation-wide Multicentric Study
Official title: The Impact of COVID-19 Pandemic on Thyroid Surgery in Italy: Results From a Nation-wide Multicentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Disease
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 3800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with thyroid disease

Brief summary: Italy has been on the frontline of the COVID-19 pandemic, caused by the coronavirus SARS-CoV-2, the need to focus resources to deal with the pandemic led to a disruption of routine surgical care, as well as activity for oncologic and chronic disease. The aim of this study was to evaluate the impact of COVID-19 pandemic on surgical activity of the Italian Units of Endocrine Surgery belonging to the SIUEC (Italian Society of Endocrine Surgery), the most important national scientific society of endocrine surgery.The aim of this study was to evaluate the impact of COVID-19 pandemic on surgical activity of the Italian Units of Endocrine Surgery belonging to the SIUEC (Italian Society of Endocrine Surgery), the most important national scientific society of endocrine surgery.


Eligibility criteria: Inclusion Criteria:

* patients that had undergone thyroidectomy during COVID-19 pandemic (from the 9th March to the 31st August 2020), defined as case group, or during the same period of the previous year (from the 9th Match to the 31st August 2019), defined as control group.

Exclusion Criteria:

* incomplete data

Primary outcomes:
measure: Quantify the overall reduction of surgical activity for thyroid disease
timeFrame: 1 year
Secondary outcomes:
measure: Quantify if the number of thyroid cancers operated during COVID-19 pandemic was significant different from the number of patients operated during the same period of the previous year
timeFrame: 1 year
measure: Quantify the number of aggressive tumors operated during COVID-19 pandemic and the same period of the previous year
timeFrame: 1 year
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: AOU Cagliari
state: CA
Study officials:
References:
Clinical trial NCT06344013: The ABCDEF Bundle in Critical Care: a French National Survey Still a Long Way to go!
Official title: The ABCDEF Bundle in Critical Care: a French National Survey Still a Long Way to go!
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: ABCDEF bundle, ICU delirium, sedation, exercise, family
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 341
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: French ICU doctors

Brief summary: The goal of this observational study is to evaluate the knowledge and compliance of French intensive care units with the ABCDEF (A: Assessment, Prevention, Management of Pain, B: Both Spontaneous Awakening Trials and Spontaneous Breathing Trials, C: Choice of Sedation and Analgesia, D: Delirium Assessment, Prevention, and Management, E: Early Mobility and Exercise, F: Family Engagement and Empowerment) bundle. French ICU doctors will be asked to answer a questionnaire available online.


Eligibility criteria: Inclusion Criteria:

French ICU doctors

Primary outcomes:
measure: knowledge and compliance of French intensive care units with the ABCDEF
timeFrame: one-time evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References: