louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00175994: Bioavailability and Metabolism of Voriconazole in Relation to Its Modulation by the CYP2C19 Genetic Polymorphism
Official title: Bioavailability and Metabolism of Voriconazole as a Function of the CYP2C19 Genotype
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: voriconazole
genotype
bioavailability
metabolic clearance
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purposes of this study are:

* To determine the absolute bioavailability of voriconazole after a single oral dose (400 mg voriconazole \[VFEND brand\]) in comparison to intravenous (i.v.) administration (400 mg VFEND, equivalent to two 10 mg/ml-infusates, each containing 200 mg voriconazole \[VRC\]) in healthy individuals stratified according to the three predominant CYP2C19 genotypes
* To investigate the possible pathways of metabolism and their modulation according to genetic polymorphism of CYP2C19 after i.v. and oral administration of VRC.

Detailed description: As CYPs are mainly involved in VRC metabolism it is likely that also gut wall metabolism by CYPs occurs. However, no substantial first pass metabolism of VRC has been reported. In humans the VRC metabolism has not been studied systematically. It is therefore important to assess VRC metabolism on its own and in addition the influence of CYP2C19 genetic polymorphisms on the formation of the different VRC metabolites.

Eligibility criteria: Inclusion Criteria:

* Good state of health (physically and mentally)

Exclusion Criteria:

* Any regular drug treatment within the last two months except for oral contraceptives in female participants
* Any intake of a substance known to induce or inhibit drug metabolising enzymes or transport system enzymes within a period of less than 10 times the respective elimination half-life
* Any acute or chronic illness or clinically relevant findings in the pre-study examination
* Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions
* Smoking (regular or irregular)
* Excessive alcohol drinking (more than approximately 30 g alcohol per day)
* Positive drug screening or known or admitted drug abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Clinical Research Unit, Department Internal Medicine VI
Study officials:
affiliation: Department Internal Medicine VI
name: Gerd Mikus, MD BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06877494: the Effects of Fish Oil Supplements on Choroidal Thickness and Blood Flow Perfusion in Children and Adolescents
Official title: Exploratory Study on the Effects of Fish Oil Supplements on Choroidal Thickness and Blood Flow Perfusion in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fish Oils
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to test the effect of fish oil supplement in terms of vision in children and adolescents. The main question it aims to answer is:

the differences in changes of choroidal thickness, choroidal blood flow, axial length, and visual acuity between the intervention group and the control group Participants will take the fish oil supplement. a baseline examination will be conducted, followed by follow-up visits at 15, 30, and 90 days after the start of the intervention.


Eligibility criteria: Inclusion Criteria:

1. Age range: 6-9 years old, gender unspecified;
2. Equivalent spherical power after unilateral cycloplegic eye ranging from 0.75D to -0.5D, with astigmatism not exceeding 1.5D;
3. Best corrected visual acuity of at least 1.0;
4. Ability to sign an informed consent form with the presence and understanding of a parent or guardian.

Exclusion Criteria:

1. Allergy or intolerance to ω-3 PUFAs or cycloplegics;
2. Strabismus, history of eye surgery (including strabismus correction surgery), other eye diseases, or systemic diseases;
3. Currently using myopia prevention measures.

Primary outcomes:
measure: Axial length
timeFrame: 15±2 days, 30±2 days, and 90±2 days
Secondary outcomes:
measure: change in equivalent spherical
timeFrame: 15±2 days, 30±2 days, and 90±2 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Disease Prevention and Treatment Center
state: Shanghai
Study officials:
References:
Clinical trial NCT05708794: Adjust-Unlikely PE
Official title: A Pilot Study to Assess Feasibility of Evaluating the Safety and Efficiency of a Simplified Diagnostic Approach for Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism (Diagnosis)
Keywords: emergency medicine
standardization of practice
diagnostics evaluation
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
First posted: 2023-02-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to emergency departments and urgent care centres with symptoms of PE.

Brief summary: The aim of this pilot study is to assess the feasibility of a larger study to determine the Adjust-Unlikely algorithm safety and efficiency for diagnosing PE.

The pilot study objectives are to:

1. Determine study recruitment rate, per site, per month
2. Determine study 90-day loss to follow up rate
3. Estimate of the proportion of enrolled patients who test negative for PE at initial assessment using the Adjust-Unlikely rule
4. Estimate of the Adjust-Unlikely algorithm efficiency
5. Compare excluded and missed-eligible patients to study participants: age, sex and prevalence of PE diagnoses at initial testing.

The pilot study hypothesis is that the investigators can recruit at least 20 patients per month and successfully follow at least 90% of patients for 90 days.


Eligibility criteria: Inclusion Criteria:

* Emergency physician decides to test for PE

Exclusion Criteria:

* Tested for PE without using the Adjust-Unlikely algorithm
* D-dimer level is known before Adjust-Unlikely assessment
* A new indication for anticoagulation on emergency department assessment (other than pulmonary embolism) in a patient not previously prescribed an anticoagulant
* Declines participation
* Is inaccessible for follow-up
* Has previously participated in this study

Primary outcomes:
measure: The proportion of patients who have PE excluded by the Adjust-Unlikely algorithm and who are subsequently diagnosed with either PE or lower limb DVT.
timeFrame: 90 days following index presentation
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
affiliation: Queen's University
name: Kerstin de Wit
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00480194: Evaluation of Safety of ZyComb® In Patients With Common Cold - ZIP 3000 (XY-005-IM)
Official title: A Non-interventional, Non-controlled, Post-marketing Study to Obtain Knowledge of the Safety of ZyComb® (Xylometazoline Hydrochloride 0.5 mg/mL and Ipratropium Bromide 0.6 mg/mL) for Symptoms of Common Cold in a Real-life OTC Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Common Cold
Lead sponsor: Nycomed
Sponsor class: INDUSTRY
First posted: 2007-05-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: For inclusion the patient must buy ZyComb® nasal spray with the intention to start using it either the same or the next day. Male or female patients over 18 years of age, visiting any of the participating pharmacies are eligible for inclusion.

Brief summary: The objectives of the study are to obtain knowledge about the safety in use, the patients' general impression of the treatment and the pattern of use of ZyComb® in an over-the-counter (OTC) setting.


Eligibility criteria: Inclusion Criteria:

* For inclusion the patient must buy ZyComb® nasal spray with the intention to start using it either the same or the next day.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Headquaters
name: Nycomed Clinical Trial Operations
role: STUDY_CHAIR
References:
Clinical trial NCT06479694: Real-life Dual-Task Training
Official title: Real-life Dual-Task Training for Older Adults at Risk to Fall
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fall
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Older adults have difficulty optimizing two tasks at once and typically experience greater interference than younger adults when dual-tasking, meaningful that there is greater decline in performance of at least one task when comparing single and dual-tasking. Difficulty dual-tasking may actually predict falls in community-dwelling older adults. Dual-task training has been shown to improve cognitive outcomes (attention, memory), motor outcomes (balance, gait), and dual-task performance in older adults; however, most dual-task training involves simulated tasks that do not reflect functional dual tasks in the real world. Greater dual-task improvements could be seen when training functionally specific tasks. One way to increase task specificity is to offer real-life, contextually-relevant, dual-task training embedded in instrumental activities of daily living (IADLs). Limited evidence exists for dual-task training interventions for older adults with T2DM; however there is early evidence of improvements in cognitive and motor effects with simulated dual-task training, which could translate to improved dual-task performance, reduced impact on everyday life, and reduced fall risk. Therefore, the purpose of this study is to assess feasibility, acceptability, and preliminary efficacy of a real-life dual-task training program for older adults at risk to fall.


Eligibility criteria: Inclusion Criteria:

* at least 65 years old
* ambulatory around the home with or without an assistive device
* answered yes to at least one of the fall risk questions with their therapist
* scheduled to receive occupational therapy services with instrumental activity of daily living goals through Covell Care.

Exclusion Criteria:

* Not fluent in English
* Self-reported diagnosis of dementia

Primary outcomes:
measure: Dual-Task Impact on Daily-living Activities Questionnaire
timeFrame: baseline, pre-intervention and immediately after the intervention
Secondary outcomes:
measure: Acceptability, Appropriateness, Feasibility
timeFrame: immediately after intervention
measure: Dual-Task Performance
timeFrame: baseline, pre-intervention and immediately after the intervention
measure: Frenchay Activities Index
timeFrame: baseline, pre-intervention and immediately after the intervention
measure: Self-reported Falls
timeFrame: baseline, pre-intervention and immediately after the intervention
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
References:
Clinical trial NCT04039594: Outcomes of Patients With Venoarterial Extracorporeal Membrane Oxygenation
Official title: Outcomes of Patients With Venoarterial Extracorporeal Membrane Oxygenation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Cardiac Arrest
Keywords: extracorporeal life support, extracorporeal membrane oxygenation, cardiogenic shock, cardiac arrest
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 500
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 receiving VA ECMO for cardiopulmonary support

Brief summary: Venoarterial extracorporeal membrane oxygenation (VA ECMO)-also referred to as extracorporeal life support-is a form of temporary mechanical circulatory support and simultaneous extracorporeal gas exchange. The objective of this observational, cohort study is to evaluate the short-term and long-term outcomes of patients with VA ECMO.


Eligibility criteria: Inclusion Criteria:

Patients receiving VA ECMO for cardiopulmonary support

Exclusion Criteria:

Refusal of consent

Primary outcomes:
measure: All-cause mortality
timeFrame: 30 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: 365 days
measure: Rate of successful weaning from ECMO
timeFrame: 30 days
measure: ECMO-related complications
timeFrame: 30 days
measure: Other complications
timeFrame: 30 days
measure: Duration stay at ICU and hospital
timeFrame: 365 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT05203094: Urdu Version of Tinetti Balance and Gait Assessment Scale,(POMA),Reliability and Validity Study
Official title: Urdu Version of Tinetti Balance and Gait Assessment Scale, (Performance-oriented Mobility Assessment) Reliability and Validity Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Balance; Distorted
Keywords: Assessment,balance ,older people, reliability,validity
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: older people,especially age-related impairments in balance and postural control that effect the performance of everyday activities, which are primary reasons for falls. about 28-35% of older people (65 years) are experiencing falls. the prevalence increases to 50%up to 80 years of age

Brief summary: In this study we will observe the reliability and validity of Tinetti Balance assessment scale,(POMA) in Urdu language in Pakistani geriatric population with balance impairment. Also, check the improvement in assessment and rehabilitation in geriatrics with balance problem.

Detailed description: The aim of study is to translate and culturally adapt Tinetti balance assessment scale (POMA) into Urdu language and secondly to investigate the reliability and validity of Tinetti Balance assessment scale (POMA) in geriatrics Pakistani population.This study will be cross sectional survey study in which convenience sampling technique will be used. Two scales will be performed by patient Tinetti Balance assessment scale and Berg Balance Scale (evaluate balance), Timed Up and Go Test (TUGT) (measure functional mobility) for comparison and data will be collected. The results of study will help to know the validity and reliability of Tinetti Balance assessment scale (POMA) in Urdu version with balance impairments in geriatric population.

Eligibility criteria: Inclusion Criteria:

* ability to walk a minimum of 6m with or without a walking Aid
* observed balance impairment evaluated subjectively by a physical therapist during the initial training session (Berg Balance scale and time up and go test )

Exclusion Criteria:

* people with amputated lower extremities using prosthetic leg
* those who underwent orthopedic surgery within the last 6 weeks
* Dependent on wheel chairs and bed ridden patients
* Dementia and Alzheimer's patients
* illiterate people

Primary outcomes:
measure: Tinetti balance and gait assessment scale (POMA)
timeFrame: 1st day
measure: Tinetti balance and gait assessment scale (POMA)
timeFrame: 2nd day
Secondary outcomes:
measure: berg balance scale
timeFrame: 1st day
Other outcomes:
measure: Timed Up and Go Test
timeFrame: 1st day
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT03220594: Serum AMH Levels in Patients Who Underwent Hypogastric Artery Ligation
Official title: Serum Antimullerian Hormone Levels in Patients Who Underwent Hypogastric Artery Ligation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AMH
Keywords: hypogastric artery
anti-mullerian hormone
ovarian reserve
postpartum
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had hypogastric artery ligation and/or hysterectomy during their delivery. Control group is age-matched postpartum patients.

Brief summary: To observe the effects of hypogastric artery ligation on serum antimullerian hormone levels.

Detailed description: To measure and compare serum antimullerian hormone levels in patients who underwent hypogastric artery ligation/ hypogastric artery ligation+ hysterectomy and postpartum control. The procedures performed as an emergency life saving method during delivery. The reasons for hypogastric artery ligation/ hypogastric artery ligation+ hysterectomy were obstetric hemorrhage mainly uterine atony.

The serum levels of antimullerian hormone were measured 6 months after the operations and compared with matching postpartum controls. Serum levels of FSH, LH, PRL and TSH were also measured 6 months after the operation. Further, antral follicle count measured along with the aforementioned blood tests.

Eligibility criteria: Inclusion Criteria:

* age 18- 40 years
* no systemic or endocrine diseases
* patients who had hypogastric artery ligation and/or hysterectomy
* healthy postpartum patients as controls

Exclusion Criteria:

* history of chemotherapy and/or radiotherapy
* Obese patients
* patients with previous/present endometriosis
* patients with PCOS

Primary outcomes:
measure: Ovarian reserve
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kanuni SSTRH
Study officials:
affiliation: Kanuni Sultan Suleyman Training and Research Hospital
name: Alev Atıs, MD,ObGyn
role: STUDY_DIRECTOR
References:
Clinical trial NCT06601894: The Relationship of Platelet Counts With Sickle Cell Anemia in the Eastern Region of Saudi Arabia
Official title: The Relationship of Platelet Counts With Sickle Cell Anemia in the Eastern Region of Saudi Arabia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sickle Cell Anaemia
SCD
Lead sponsor: Majmaah University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 650
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include a cohort of people with SCD who are registered at the Hereditary Blood center al-ahssa.

Brief summary: This study aims to evaluate the relationship between platelet counts and sickle cell disease in the eastern region of the Kingdom of Saudi Arabia.

Detailed description: Introduction:

This study aims to evaluate the relationship between platelet counts and sickle cell disease in the eastern region of the Kingdom of Saudi Arabia.

Purpose: This study aims to assess the prevalence and factors associated with elevated platelet counts in people with sickle cell disease in the eastern region of Saudi Arabia.

Methods: This cross-sectional study at Majmaah University will analyze prerecorded data frfom the eastern region of Saudi Arabia to investigate the relationship between platelet counts and sickle cell disease, identifying associated factors and assessing the link .

Importance: To assess the relationship between platelet counts and disease severity in Pationt with SCD.

Aim :To investigate the relationship between platelet counts and SCD in the eastern region of the Kingdom of Saudi Arabia.

Eligibility criteria: Inclusion criteria: All the diagnosed patients of sickle cell disease regardless of age and gender.

Exclusion criteria: Patients without having sickle cell disease regardless of age and gender.

Primary outcomes:
measure: Collecting platelet data for sickle cell anemia patients
timeFrame: From January 2023 to December 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Khalid Ali Majrashi
Study officials:
affiliation: Majmaah University
name: Khalid A Majrashi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wun T, Paglieroni T, Rangaswami A, Franklin PH, Welborn J, Cheung A, Tablin F. Platelet activation in patients with sickle cell disease. Br J Haematol. 1998 Mar;100(4):741-9. doi: 10.1046/j.1365-2141.1998.00627.x.
citation: Shome DK, Jaradat A, Mahozi AI, Sinan AS, Ebrahim A, Alrahim M, Ebraheem MS, Mansoor EJ, Majed KS, Azeez Pasha SA. The Platelet Count and its Implications in Sickle Cell Disease Patients Admitted for Intensive Care. Indian J Crit Care Med. 2018 Aug;22(8):585-590. doi: 10.4103/ijccm.IJCCM_49_18.
citation: Yee MEM, Batsuli G, Chonat S, Park S. Thrombocytosis with acquired von Willebrand disease in an adolescent with sickle cell disease. Clin Case Rep. 2020 Nov 20;9(1):457-460. doi: 10.1002/ccr3.3556. eCollection 2021 Jan.
Clinical trial NCT01995994: Continuous Glucose Monitoring System in Intensive Care Unit
Official title: Continuous Glucose Monitoring System in Intensive Care Unit - Preliminary Study Evaluating Accuracy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Blood Glucose Monitoring
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients planned to stay in intensive care units longer than 72 hours

Brief summary: To assess the accuracy, safety, and influence of sampling site of Real-time continuous glucose monitoring system (Medtronic Guardian).


Eligibility criteria: Inclusion Criteria:

* Older than 18 years old
* Staying in intensive care units longer than 72 hours

Exclusion Criteria:

* Skin disease
* DIC
* Immune suppressed patients

Primary outcomes:
measure: Difference between finger stick blood glucose and real-time continuous glucose monitoring
timeFrame: 72 hours
Secondary outcomes:
measure: Measurement error of real-time continuous glucose monitoring
timeFrame: 72 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: