louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06890936: Clinical Characteristics and Outcomes of Patients Requiring Mechanical Ventilation in an ICU- a Registry Based Study
Official title: Clinical Characteristics and Outcomes of Patients Requiring Mechanical Ventilation- a Nepalese Single Center Retrospective Study of 5 Years.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation
Intensive Care Unit
Keywords: mechanical ventilation
intensive care unit
outcomes
Lead sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the ICU

Brief summary: Rationale: Patients admitted to the Intensive Care Unit (ICU) often require respiratory support in terms of mechanical ventilation (either non-invasive or invasive). Though these patients may be diverse in clinical characteristics, the need of respiratory support in itself is in many conditions a factor relating poorer outcomes. The exact association of the requirement of respiratory support in our patient population is missing in the current literature. This study will look at 5-year data of patients admitted to the ICUs of Tribhuvan University Teaching Hospital and try to characterize these patients according to their clinical profile. Further, this study will also help to generate data regarding the outcomes of such patients.

Study Objective: To characterize the patients requiring respiratory support in the ICUs of TUTH and find their outcomes in terms of ICU mortality.

Design: A registry based, retrospective, descriptive, cohort study. Sample size: Convenience sampling of all the patients who are admitted to the ICU.

Duration: Retrospective data from the 5-year period between November 1, 2019 to December 31, 2024.

Place: Intensive care units (ICUs), Tribhuvan University Teaching Hospital (TUTH).

Interventions: Not applicable Expected results: The study will help determine the clinical characteristics of patients admitted to the ICUs of TUTH requiring respiratory support and their associated outcomes.


Eligibility criteria: Inclusion Criteria:

* Age\>18 years
* Admission to the ICU

Exclusion Criteria:

None

Primary outcomes:
measure: ICU mortality
timeFrame: At the end of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Maharajganj
country: Nepal
facility: Tribhuvan University Teaching Hospital
state: Bagmati
Study officials:
References:
Clinical trial NCT06998836: Constructing and Evaluating the Effectiveness of a Community-based Older Adults Dementia Prevention Education Program
Official title: Exploring the Construction and Intervention Effectiveness of Dementia Prevention Education Programs for Older Adults: A Mixed-Methods Study Based on the Health Belief Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: dementia prevention
health beliefs
Lead sponsor: Chang Gung University of Science and Technology
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 142
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study adopted a mixed-methods approach and was conducted in two exploratory phases. The first phase focused on development and involved three focus group interviews with community-dwelling older adults. These qualitative focus group discussions were used to inform the development of a dementia prevention education program based on the analysis results.

In the second phase, community-dwelling older adults were recruited to participate in the study. The experimental group received the dementia prevention education program, while the control group received general health education leaflets. Participants were assessed before the intervention, immediately after the intervention, and again three months later. The assessments measured changes in dementia-related knowledge, dementia-related worry, health beliefs, and willingness to engage in preventive actions.

This study aimed to examine the effects of the intervention on older adults' dementia knowledge, health beliefs, and willingness to undertake preventive actions.


Eligibility criteria: Inclusion Criteria: (1) 55 years old or above; (2) conscious and able to speak Mandarin and Taiwanese; and (3) willing to participate in this study and complete the consent form -

Exclusion Criteria:(1) diagnosed with dementia; or (2) diagnosed with severe physical or mental illness by a physician.

-

Primary outcomes:
measure: Dementia Knowledge Score
timeFrame: Baseline, immediately post-intervention, 3-month follow-up
Secondary outcomes:
measure: Dementia-Related Worry Score
timeFrame: Baseline, immediately post-intervention, 3-month follow-up
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung University of Science and Technology
Study officials:
References:
Clinical trial NCT00465036: Effect of Flaxseed on Lipid Uptake and Appetite
Official title: Effect of Whole Flaxseeds and Flaxseed Mucilage on Lipid Absorption, Glucose and Insulin Metabolism and Appetite Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: fat absorption
fibres
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2007-04-24
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Randomized trial to test the effect of flaxseed fractions on appetite regulation and intestinal lipid absorption.

Detailed description: Randomized multiple crossover trial in 18 healthy males aged 18 to 40 years each are required to complete a total of five iso-caloric meal tests lasting approximately 8½ hours. Test meals will be given as breakfast meals, in which different fractions of flaxseeds are incorporated into baked products. Appetite will be registered using visual analogue scales during 7 hours after the test meal and a total of 10 blood samples will be drawn to evaluate TAG in chylomicrons, plasma LDL, HDL and total cholesterol, plasma TAG, insulin, glucose and appetite hormone levels. At the end of the test day an ad libitum meal will be served and food intake registered.

Eligibility criteria: Inclusion Criteria:

* Healthy males aged 18-40 years
* Normal weight or moderately overweigh (BMI 25-30 kg/m2)

Exclusion Criteria:

* Blood drawing/donation less than six months prior to start of the study
* Hemoglobin concentration \<8mmol/L
* Chronic diseases (i.e. diabetes, CVD), hypertension, hyperlipidemia
* Consumption of dietary supplements including vitamin tablets
* Smoking
* Excess physical activity (\>10h of intense physical activity per week)
* Medicine use (not including occasional consumption of pain killers)

Primary outcomes:
measure: TAG in chylomicrons
measure: serum TAG
measure: HDL, LDL and total cholesterol
measure: appetite scores
measure: ad libium food intake
measure: appetite hormone levels
Secondary outcomes:
measure: free fatty acid profile
measure: plasma glucose
measure: plasma insulin
measure: meal macronutrient composition
measure: meal energy content
measure: meal pleasantness
Other outcomes:
Locations:
city: Frederiksberg C
country: Denmark
facility: Institute of Human Nutrition
Study officials:
affiliation: Institute of Human Nutrition
name: Søren Toubro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02309736: OTX-14-002: Device Exposure Registry
Official title: Device Exposure Registry: A Post-Approval Observational Registry of ReSure Sealant to Track the Incidence of Endophthalmitis After Sealing Corneal Incisions in Patients Undergoing Clear Corneal Cataract Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Endophthalmitis
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-05
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE

Brief summary: The objective of the study is to collect post-approval data relative to the incidence of endophthalmitis for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under commercial use conditions


Eligibility criteria: All patients that receive at least one application of the ReSure Sealant on the operative eye following cataract surgery will be enrolled.

Primary outcomes:
measure: Occurrence of endophthalmitis
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02433236: Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy
Official title: A Phase 2, Multi-Centre, Open Label Extension Study of Fostamatinib in the Treatment of IgA Nephropathy for Patients Who Participated in Study C-935788-050
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: IGA Nephropathy
Lead sponsor: Rigel Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-05-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase 2, multi-center, open label extension study to evaluate 2 dose regimens of fostamatinib in approximately 25 subjects. The study will consist of 11 visits over 15 months.


Eligibility criteria: Inclusion Criteria:

* Completed Study C-938788-050, including having received a post-treatment renal biopsy, and having had a clinically meaningful response (i.e. decreased proteinuria or improved renal histology)
* Able and willing to give written informed consent

Exclusion Criteria:

* Unresolved Grade 2 or greater toxicity in Study C-935788-050

Primary outcomes:
measure: Number of Participants with mean change of Proteinuria as measured by spot urine protein/creatinine ratio (sPCR)
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rigel Pharmaceuticals,Inc.
name: Rigel Pharmaceuticals, Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03884036: Effect of Vitamin D in Burn Patients
Official title: Effect of Vitamin D in Burn Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burn Surgery
Lead sponsor: Hangang Sacred Heart Hospital
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
First posted: 2019-03-21
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate pre-operative vitamin D levels in patients with burn injuries and evaluate the effect of vitamin D on postoperative complications and duration of hospitalization.

Detailed description: Vitamin D deficiency often occurs in burn patients, which may include longer hospitalization and respiratory and cardiac complications.

The purpose of this study is to evaluate pre-operative vitamin D levels in patients with burn injuries and evaluate the effect of vitamin D on postoperative complications and duration of hospitalization.

Eligibility criteria: Inclusion Criteria:

* vitamin D \<30 ng/ml
* patients undergoing burn surgery

Exclusion Criteria:

* age \< 18 years old
* hypercalcemia
* renal disease
* cardiac disease ( EF\<40%, MI, angina)
* respiratory disease (ARDS, pneumonia)
* intubated patients
* electrical burn

Primary outcomes:
measure: Incidence of postoperative complications
timeFrame: Within postoperative 1 month
Secondary outcomes:
measure: Vitamin D level
timeFrame: Within postoperative 14 days
Other outcomes:
measure: Hospital stay
timeFrame: Time from operation to discharge (approximately within 1 month)
Locations:
city: Seoul
country: Korea, Republic of
facility: Hangang Sacred Heart Hospital
Study officials:
affiliation: Asan Medical Center
name: Young-Kug Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00806936: Observational Study to Investigate the Efficacy and Safety of Human Insulin or Insulin Analogue Treatments in Type 2 Diabetes Subjects
Official title: A 16-week Multicentre, Open Label, Non-interventional, Observational Study to Investigate the Status of Human Insulin or Insulin Analogue Treatments With Focusing on Efficacy and Safety in Type 2 Diabetes Subjects Inadequately Controlled With Two or More Oral Antidiabetic Drugs in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-12-11
Enrollment: 4847
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetic subjects inadequately controlled with two or more oral antidiabetic drugs (OAD) and currently treated with either human insulin or insulin analogues at the discretion of physicians

Brief summary: This study is conducted in Asia. The aim of this observational study is to investigate the percentage of patients reaching the treatment target on blood glucose control after treatment with either human insulin or insulin analogues in type 2 diabetes subjects inadequately controlled with two or more oral antidiabetic drugs in China. Further the safety profiles will be evaluated.


Eligibility criteria: Inclusion Criteria:

* After the investigator has taken the decision to use human insulin or insulin analogues to treat the subject, any type 2 diabetic previously inadequately controlled with two or more OADs is eligible for the study
* The selection of the subjects will be at the discretion of the individual investigator

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Subjects who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit
* Subjects who previously enrolled in this study
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
* The receipt of any investigational product within 3 months prior to this trial

Primary outcomes:
measure: Percentage of patients achieving HbA1c below 7.0%
timeFrame: at 16 weeks
Secondary outcomes:
measure: HbA1c change from baseline
timeFrame: at 16 weeks
measure: Incidence of major, minor and symptoms only hypoglycaemic episodes
timeFrame: at 16 weeks
measure: Comparison of scores of Insulin Treatment Appraisal Scale (ITAS)
timeFrame: at baseline and at 16 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06680336: Cognitive Recovery After Post Stroke Delirium (RECOVER)
Official title: Cognitive Recovery After Post Stroke Delirium [RECOVER] a Longitudinal Pilot Proof of Concept Study in Stroke Patients With/without Delirium
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Stroke Delirium
Cognitive Functioning After Stroke
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Longitudinal study with 3 measurements (S1, S2, S3) and two groups of stroke patients (post-stroke-delirium (PSD) patients, non PSD patients)
Primary purpose: OTHER

Brief summary: RECOVER is a Proof-of-Concept study on cognitive functioning following a longitudinal design with three measurements (during the acute- and post-acute phases of a stroke and a 3-month follow-up) and two equally-sized stroke patient groups: a post-stroke delirium(PSD), and a non-PSD group (control group). Cognitive functioning will be assessed using a multi-component neuropsychological assessment and tasked-based functional MRI (introducing a modified working memory task).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 60 years
* Ischemic stroke: Stroke Onset ≤ 96h, hospital admission ≤ 48h
* NIHSS ≥ 1
* Informed consent by patient or legal guardian

Exclusion Criteria:

* Aphasia
* Pre-existing conditions such as Dementia, psychiatric disorders (e.g., Depression, Schizophrenia)
* MRI contraindication such as certain metal implants
* Reduced consciousness, defined as Glasgow Coma Scale (GCS) ≤ 8
* Delirium onset before study enrollment

Primary outcomes:
measure: Global post-stroke cognitive functioning
timeFrame: 90 days
Secondary outcomes:
measure: Domain specific post-stroke cognitive functioning
timeFrame: 90 days
measure: Prediction of global post-stroke cognitive outcome
timeFrame: 5 - 90 days
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Department of Neurology, University Hospital Tuebingen
Study officials:
References:
Clinical trial NCT01785836: An Extension Study to Assess the Safety, Tolerability, Efficacy, and Treatment Adherence of Dapsone in Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-02-07
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability, and efficacy of dapsone in subjects with acne vulgaris following 12 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Participation in Allergan study 225678-004

Exclusion Criteria:

* Anticipates the need for surgery or hospitalization during the study

Primary outcomes:
measure: Change from Baseline in Inflammatory Lesion Count
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change from Baseline in Non-Inflammatory Lesion Count
timeFrame: Baseline, Week 12
measure: Change from Baseline in Total Lesion Count
timeFrame: Baseline, Week 12
measure: Percentage of Subjects With a Global Acne Assessment Score (GAAS) of 0 or 1
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03525236: The Oncoflavour Study
Official title: Product Validation by Cancer Patients - Oncoflavour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Nutricia, Inc.
First posted: 2018-05-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Oral nutritional supplements (ONS) are often prescribed for malnourished patients to help improve nutritional status. Commonly in cancer patients taste and smell alterations and side effects of treatment can affect the palatability and compliance to ONS. A variety of flavours and styles are available of ONS however research of the palatability of these in cancer patients is limited. This study aims to evaluate specific flavours created based on the taste changes occuring during treatment.

We aim to evaluate the patient liking and evaluation of 5 flavors in 3 different types of flavour-sensations:

* Warming/spicy sensation: to trigger the senses and bring new sensations
* Cooling/fresh sensation: to have a fresh mouthfeel and lighter base perception
* Neutral: to avoid that patients experience additional flavour and let them the opportunity to mix it with other food


Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* Ability to complete and comprehend questionnaires provided
* Undergoing systemic cancer treatment (chemotherapy or concurrent chemoradiotherapy, radiotherapy, targeted therapy or immunotherapy)

Exclusion Criteria:

* Uncertainty about the willingness or ability of the patient to comply with the protocol requirements (no impairment and no cognitive impairments)
* Coexisting-morbidities affecting taste or smell function
* Lactose Intolerance or Galactosaemia
* Dysphagia
* Diabetics
* Food allergies/intolerances to ingredients present in the product
* No rejection of lemon, red fruits, exotic fruit, yellow fruit flavours.

Primary outcomes:
measure: Liking of 5 different oral nutritional supplements with adapted flavors
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: An KL Reyners, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Haan JJ, Renken RJ, Moshage Y, Kluifhooft DA, Corbier C, Daly LE, Blanchard H, Reyners AKL. Self-reported taste and smell alterations and the liking of oral nutritional supplements with sensory-adapted flavors in cancer patients receiving systemic antitumor treatment. Support Care Cancer. 2021 Oct;29(10):5691-5699. doi: 10.1007/s00520-021-06049-4. Epub 2021 Feb 25.