louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05527067: A Registered Cohort Study on α-Synucleinopathy
Official title: A Registered Observational Cohort Study on α-Synucleinopathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: α-synucleinopathy
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 500
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a clinical diagnosis of PD, DLB and MSA.

Brief summary: α-Synucleinopathy is a cluster of neurodegenerative disease with motor and non-motor symptom. The data to be collected is intended to help healthcare providers make important medical decisions concerning α-synucleinopathy, through an enhanced understanding of the natural history, progression and multi-omics datasets of α-synucleinopathy.

Detailed description: α-Synucleinopathy is a cluster of neurodegenerative disease with motor and non-motor symptom, including Parkinson's disease (PD), multiple system atrophy (MSA) and dementia with lewy bodies (DLB). The data to be collected is intended to help healthcare providers make important medical decisions concerning α-synucleinopathy, through an enhanced understanding of the natural history, progression and multi-omics datasets of α-synucleinopathy. Datas will be accumulated retrospectively at research entry and prospectively during follow up.

Eligibility criteria: Inclusion Criteria:

* Participants with a clinical diagnosis of primary α-synucleinopathy
* Unrelated healthy controls

Exclusion Criteria:

* Patients with secondary α-synucleinopathy that cannot be excluded.
* Patients with other neurological disorders.
* Pregnant or lactating women.

Primary outcomes:
measure: UPDRS /UMSARS scores
timeFrame: Baseline
Secondary outcomes:
measure: H&Y stage
timeFrame: Baseline
measure: MoCA scores
timeFrame: Baseline
measure: ACE-III scores
timeFrame: Baseline
measure: Mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg)
timeFrame: Baseline
measure: HRV (ms)
timeFrame: Baseline
measure: Plasma α-synuclein levels (ng/ml)
timeFrame: Baseline
measure: Vic
timeFrame: Baseline
measure: PAF (Hz)
timeFrame: Baseline
measure: Vic
timeFrame: 1 year after Baseline
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT01156467: Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants
Official title: Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilation
Keywords: Neurally adjusted ventilatory assist NAVA
Premature infant
Edi-signal
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2010-07-02
Enrollment: 60
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out, whether it is possible to improve the ventilatory care of premature infants by using Neurally adjusted ventilatory assist (NAVA).

The study hypothesis is that by using NAVA-technology and/or by monitoring Edi-signal (the electrical signal of diaphragm), it is possible to accomplish ventilatory care to premature infants more individually.

Detailed description: Asynchrony means that the timing of support given by the ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications especially in premature infants with immature lungs.

In this study investigators will compare currently used ventilation methods to a new neurally adjusted ventilatory assist (NAVA). The aim is to find out, whether by using this new method it is possible to decrease the complications associated to ventilatory care and to shorten the need for mechanical ventilation.

Eligibility criteria: Inclusion Criteria:

* All children of postconceptional age from 28+0 to 36+6 weeks needing mechanical ventilation for at least 60 minutes

Exclusion Criteria:

* severe birth asphyxia, malformations, chromosomal abnormality or other condition, which will decrease the length of life
* condition which prevents the positioning of an oro-/nasogastric tube

Primary outcomes:
measure: The duration of mechanical ventilation
timeFrame: 1 hour - 6 weeks
Secondary outcomes:
measure: Complications associated to mechanical ventilation
timeFrame: 1 hour - 6 weeks
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: University hospital of Oulu
state: Pohjois-Pohjanmaa
Study officials:
affiliation: Oulu University Hospital
name: Timo Saarela, MD, PhD
role: STUDY_DIRECTOR
affiliation: Oulu University Hospital
name: Merja Ålander, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05408767: Accelerated Brain Volume Loss in People With Multiple Sclerosis
Official title: Accelerated Brain Volume Loss in People With Multiple Sclerosis: do Real-world Observations Align With Standardized Research Findings?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retrospective Study
Lead sponsor: National MS Center Melsbroek
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple Sclerosis

Brief summary: To explore whether brain volume loss (BVL) in people with multiple sclerosis (MS), assessed on magnetic imaging (MRI) data obtained during routine medical follow-up (and thus outside a standardized research environment), differs from that of healthy controls and correlates with measures of physical and/or cognitive disability, the latter also gathered during regular clinical practice.

Detailed description: This project will not be the first study on real-world data in an existing MS cohort. A NMSC research group has already reported on the contribution of a single brain volumetric assessment to the prediction of MS-related disability10 - with distinct patterns for the Expanded Disability Status Scale (EDSS) as a measure of physical disability11, and Symbol Digit Modalities Test (SDMT) as a measure of cognitive disability12 - and found a threshold effect for the lowest brain volumes with regard to SDMT worsening over time10. Ghione and co-workers, in turn, have demonstrated a positive correlation between annualized BVL and EDSS progression based on the EDSS in a very large sample containing nearly 2,000 individuals13. The novelty of this new study lies in the fact that the investigators want to explore the correlations between BVL and changes in an expanded set of routinely collected clinical variables in our center - in addition to the EDSS score - such as Timed 25-Feet Walk Test (T25FWT)14, 9-Hole Peg Test (9HPT)15 and SDMT.

Eligibility criteria: Inclusion Criteria:

* MRI and volumetry performed minimum 48 and maximum 60 months apart

Exclusion Criteria:

* none

Primary outcomes:
measure: The primary endpoint of this study will be the difference in annualized whole brain volume percentage change between the MS and control cohort
timeFrame: 4 - 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Melsbroek
country: Belgium
facility: Nationaal Multiple Sclerose Centrum Melsbroek
state: Vlaams-Brabant
Study officials:
affiliation: National MS center
name: Miguel D'haeseleer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00900367: Nutrition-Related Biomarkers in Predicting Breast Cancer Risk in Women
Official title: Nutrition Modulated Metabolism as a Disease Risk Factor
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 1500
Sex: FEMALE
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women enrolled in the NHS I study; Group selected by Drs. Willett and Hankinson

Brief summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about nutrition-related changes that identify biomarkers related to cancer. It may also help doctors predict a woman's risk of developing breast cancer.

PURPOSE: This laboratory study is looking at nutrition-related biomarkers in predicting breast cancer risk in women.

Detailed description: OBJECTIVES:

* To complete characterization of metabolic serotypes based on the metabolome, and to adapt these profiles for human epidemiological studies.
* To determine the extent to which metabolic profiles that are reflective of or independent of long-term caloric intake predict breast cancer risk in nested case-control studies.
* To identify critical serum metabolites.

OUTLINE: Laboratory studies, including metabolome profiling by high performance liquid chromatography; and small molecule identification by mass spectroscopy, are performed on previously collected blood samples.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Confirmed breast cancer that was diagnosed at least 2 years after blood sample collection (case)

    * No prior diagnosis of cancer
  * Healthy participant (control)
* Enrolled in the Nurses' Health Study
* Banked blood samples available
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Generation of metabolome profiles that reflect nutritional status
timeFrame: ongoing
measure: Utility of rat metabolome profiles for human epidemiological studies
timeFrame: ongoing
measure: Utility of metabolome profiles in predicting relative risk of developing breast cancer
timeFrame: ongoing
measure: Identification of critical serum metabolites
timeFrame: ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber/Brigham and Women's Cancer Center
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Bruce S. Kristal, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01013467: CoCo: Colour Coded Blood Pressure Control
Official title: Does a Colour-coded Blood Pressure Diary Improve Blood Pressure Control for Patients in General Practice? A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: blood pressure
control
adherence
behaviour
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insufficient blood pressure control is a frequent problem despite the existence of effective treatment. One of the causes is insufficient self-monitoring and a lack of adherence to therapy. Blood pressure self-measurement at home (Home Blood Pressure Measurement, HBPM) has positive effects on treatment adherence and is helpful in achieving the target blood pressure.

Only a few studies have investigated whether the adherence for HBPM can be improved through simple measures and better blood pressure monitoring can be achieved.

Objective Improvement of self-monitoring by means of blood pressure self-measurement and improved blood pressure control by using a new colour-coded blood pressure diary


Eligibility criteria: Inclusion criteria:

* Age \>18 years
* BP \> 140/90 mmHg Two consecutive measurements carried out in the practice (measured by the general practitioner at the start of the study).
* Unchanged anti-hypertension treatment for one month before inclusion
* Patient able to measure blood pressure at home
* Written informed consent

Exclusion criteria: • Blood pressure reading over 180 mmHg systolic and/or 110 mmHg diastolic.

* Serious general or psychological illness (malignant tumor, serious depressive episodes or evidence of dementia).
* Insufficient knowledge of the German language for instruction and blood pressure recording with a booklet.

Primary outcomes:
measure: Primary outcome: change in systolic and/or diastolic blood pressure 6 months after using the new colour-coded blood pressure diary.
timeFrame: 6months
Secondary outcomes:
measure: adherence with home blood pressure measurements
timeFrame: 6 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Institute of General Practice
state: ZH
Study officials:
affiliation: University Hospital Zurich, Institute of General Practice
name: Thomas J. Rosemann, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steurer-Stey C, Zoller M, Chmiel Moshinsky C, Senn O, Rosemann T. Does a colour-coded blood pressure diary improve blood pressure control for patients in general practice: the CoCo trial. Trials. 2010 Apr 14;11:38. doi: 10.1186/1745-6215-11-38.
Clinical trial NCT06318767: Predictive Value of Systolic Rise Time of the Plantar Arch on the Risk of Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) in Peripheral Artery Disease (PAD) at Critical Ischaemia Stage
Official title: Predictive Value of Systolic Rise Time of the Plantar Arch on the Risk of Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) in Peripheral Artery Disease (PAD) at Critical Ischaemia Stage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Adverse Limb Events
Major Adverse Cardiovascular Events
Peripheral Artery Disease
Critical Limb Ischemia
Hemodynamic Measure
Keywords: major adverse limb events
major adverse cardiovascular events
peripheral artery disease
critical limb ischemia
hemodynamic measure
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Peripheral artery disease (PAD), vascular disease of atheromatous origin, is a frequent pathology, with a steady and significant increase in prevalence over the last decades. It has various symptoms ranging from mild arterial claudication to critical limb ischemia. The critical ischaemia stage in PAD is defined by rest pain or trophic disorders and is a special situation because of the number of cardiovascular deaths at 1 year (25%), 60% at 5 years and acute ischaemic recurrence at 1 year (25%).

It is a medico-surgical pathology. A haemodynamic marker is needed to monitor patients, as it is predictive of limb progression, cardiovascular events and mortality. The Systolic Rise Time (SRT) of the plantar footpad is a recently described haemodynamic measurement of proven value in the diagnosis of PAD. The aim of this study is to show the prognostic value of the Systolic Rise Time on Major Adverse Limb Events (MALE).


Eligibility criteria: Inclusion Criteria:

* patients at least 18 years old,
* willing and able to provide written informed consent,
* with documented atherosclerosis critical limb ischemia (pain rest and/or ulcer and gangrene manifestations)
* with hemodynamic measures (ankle pressure less than 50mmHg and/or TBI less than 30mmHg and/or TcPO2 less than 30 mmHg),
* followed or send to CHU Amiens Picardie, and eligible to chirurgical revascularization.

Exclusion Criteria:

* with non atherosclerosis arteriopathy,
* ineligible to the gold standard treatment such as the chirurgical revascularization,
* with life expectancy less than 3 months.

Primary outcomes:
measure: occurrence of limb ischemia
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT05620667: Effects of Citrus Reticulate Unripe Fruit Extraction on Body Weight and Body Fat.
Official title: Effects of Citrus Reticulate Unripe Fruit Extraction on Body Weight and Body Fat in Human Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: TCI Co., Ltd.
First posted: 2022-11-17
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the effects of immature ponkan (Citrus reticulate) extract on body weight and body fat in overweight and obese adults.

Detailed description: This randomized, placebo-controlled clinical trial will be conduct for 8 weeks with three hundred adults. Subjects will be recruited and randomly assigned into three groups: (1) placebo, n = 100; (2) immature ponkan extract, n=100; (3) immature ponkan extract with time restricted feeding, n=100. During the 8 weeks intervention, the subjects should take 25mL liquid of placebo or immature ponkan extract a day (drink 25mL for once, and once a day). The two drinks are supplied in aluminum foil packages, and both the products taste the same. Subjects also should complete the assessment of anthropometric measurement, intestinal questionnaire , food record, feces and blood collection at week 0, 4 and week 8.

Eligibility criteria: Inclusion Criteria:

* male or female
* aged 20-60 years old
* body mass index is greater than or equal to 24 kg/m2, or body fat more than 30%

Exclusion Criteria:

* Subjects diagnosed with cancer and on curative care.
* Subjects diagnosed with heart disease and on curative care.
* Subjects who use other drugs whose pharmacological effects may affect the experiment or may aggravate the effects of the drug.
* Subjects with systemic infection requiring antibiotics.

Primary outcomes:
measure: Change from baseline body weight at week 8
timeFrame: Week 0, Week 8
Secondary outcomes:
measure: Change from baseline body fat at week 8
timeFrame: Week 0, Week 8
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
state: South
Study officials:
affiliation: Chung Shan Medical University
name: Yu-Jou Chien, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung Shan Medical University
name: Ying-Ching Feng, MS student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01812967: Mechanism of Action of Milk and Its Components on Glycemic Control in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Control
Gastrointestinal Hormone Response
Healthy Young Men
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that the physiological effects of milk on satiety and glycemic control are mediated by the interaction between its macronutrient components by both insulin-dependent and independent mechanisms.


Eligibility criteria: Inclusion Criteria:

* Healthy young men
* 20-30 years of age
* BMI: 20-24.9 kg/m2

Exclusion Criteria:

* Smoking
* Dieting
* Skipping breakfast
* Lactose intolerance or allergies to milk
* Taking medications that may affect glucose metabolism or appetite
* Diabetes (fasting blood glucose ≥ 7.0 mmol/L) or other metabolic diseases

Primary outcomes:
measure: Glucose
timeFrame: 0-180 min
Secondary outcomes:
measure: Insulin
timeFrame: 0-180 min
Other outcomes:
measure: Gastrointestinal hormones and gastric emptying rate
timeFrame: 0-180 min
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
References:
citation: Panahi S, El Khoury D, Kubant R, Akhavan T, Luhovyy BL, Goff HD, Anderson GH. Mechanism of action of whole milk and its components on glycemic control in healthy young men. J Nutr Biochem. 2014 Nov;25(11):1124-1131. doi: 10.1016/j.jnutbio.2014.07.002. Epub 2014 Jul 31.
Clinical trial NCT01637467: Effect of Electrical Muscle Stimulation in Critically Ill Patients
Official title: The Effects of Electrical Muscle Stimulation (EMS) on Muscle Atrophy and Functional Outcomes in Critically Ill Patients; a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Critical Illness
Keywords: critical illness
myopathy
electrical muscle stimulation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: The Lung Association
First posted: 2012-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Electrical muscle stimulation (EMS) is the therapy used to passively activate muscles using electrodes on the surface of the skin. EMS may be helpful in preserving muscle function in people who are on bedrest due to critical illness in the intensive care unit. The purpose of this study is to determine the safety and feasibility of implementing EMS in critically ill patients who are on mechanical ventilation for greater than 7 days, and examine the effects of 4 weeks of EMS on leg muscle size, muscle strength and functional outcomes in these patients. The investigators hypothesize that EMS will be safe and feasible and that critically ill patients receiving EMS will show a smaller loss of muscle size and strength than those in the control group, who do not receive EMS.


Eligibility criteria: Inclusion Criteria:

* admitted to the medical-surgical ICU or cardiovascular ICU
* walking independently prior to admission
* mechanically ventilated for more than 7 days (i.e. prolonged ventilation)
* receiving enteral or parenteral nutrition.

Exclusion Criteria:

* history of neurological or psychiatric disease
* primary muscle disease (e.g. muscular dystrophy, polymyositis)
* catastrophic neurological event
* receiving palliative care
* contraindications to EMS (e.g. cardiac pacemaker/defibrillator, pregnancy, infected or cancerous lesions in proximity of electrode sites)
* inadequate access to electrode sites due to medical devices
* lower extremity edema affecting the thighs or buttocks
* BMI \> 35 kg/m2
* allergies to adhesives or latex

Primary outcomes:
measure: feasibility of EMS treatment
timeFrame: 4 weeks
Secondary outcomes:
measure: muscle strength
timeFrame: baseline, 2 weeks and 4 weeks
measure: muscle thickness
timeFrame: baseline, 2 weeks, 4 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Vincent Lo, BSc(PT)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Sunita Mathur, PhD
role: PRINCIPAL_INVESTIGATOR
References: