louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04919902: Prague Registry of Electric Cardioversion
Official title: Prague Registry of Electric Cardioversion for Supraventricular Arrhythmias
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Atrial Flutter
Atrial Arrhythmia
Atrial Tachycardia
Keywords: Anticoagulants
Anticoagulation
Cardioversion
NOAC
DOAC
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
First posted: 2021-06-09
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hemodynamically stable patients scheduled for ambulatory electric cardioversion for atrial arrhythmias based on established clinical indications.

Brief summary: This single-center observational registry follows contemporary efficacy and short-term complications of elective electric cardioversion.


Eligibility criteria: Inclusion Criteria:

* Consecutive out-patients undergoing electric cardioversion for atrial fibrillation, atrial tachycardia, or typical atrial flutter

Exclusion Criteria:

* Unstable patients with acute conditions requiring unplanned hospitalization

Primary outcomes:
measure: Acute major complications
timeFrame: Within 24 hours from the procedure
measure: Subacute major complications
timeFrame: 24 hours to 30 days after the procedure
Secondary outcomes:
measure: Acute minor complications
timeFrame: Within 24 hours from the procedure
measure: Acute efficacy
timeFrame: Within 2 hours from the procedure
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine (IKEM)
Study officials:
References:
Clinical trial NCT06026202: Non-Eosinophilic Biological Effects of IL-5
Official title: Non-Eosinophilic Biological Effects of Interleukin 5 (IL-5) - Role of IL-5 in Suppressing Anti-Viral Immunity in Bronchial Epithelial Cells and Dendritic Cells in Asthma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Keywords: Interleukin 5
Bronchial epithelial cells
Peripheral blood mononuclear cells
Peripheral dendritic cells
Interferon
Rhinovirus
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those with mild asthma on as required salbutamol only.

Brief summary: This study aims to investigate the role of IL-5 in suppressing anti-viral immune responses in bronchial epithelial cells (BECs) and in peripheral blood mononuclear cells (PBMCs) from 5 people with asthma.

Detailed description: IL-5 has been shown to be present in higher levels in those with asthma, more so during viral infection. The investigators know from existing evidence that having increased levels of interferon (IFN) reduces asthma exacerbations and viral load. The investigators suspect that IL-5 reduces the immune response during viral infection in bronchial epithelial cells (BECs) and peripheral blood mononuclear cells (PBMCs) by reducing levels of IFN. The aim is to investigate if increased IL-5 in stable eosinophilic asthma and asthma exacerbations suppresses anti-viral immunity in bronchial epithelial cells and in peripheral blood mononuclear cells directly via IL-5 receptor signalling, suppressing rhinovirus induction of IFNs. The investigators also will evaluate if anti-IL-5 therapies suppress IL-5 concentrations in stable and exacerbated asthma in vivo and whether suppression of IL-5 in vivo restores deficient anti-viral immunity in BECs and PBMCs, thereby protecting against asthma exacerbations.

Eligibility criteria: Must be eligible for the study 'Mechanisms of Adverse Effects of Long-Acting Beta-Agonists in Asthma' (MAELABA) (19SM5101).

Primary outcomes:
measure: IL-5 suppresses anti-viral immunity in BECs and in PBMCs/pDCs directly via IL-5 receptor signalling suppressing RV induction of IFNs.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
References:
Clinical trial NCT02384902: Effect of Low GI/ Glycemic Load (GL) Diet in Diabetic Nephropathy Patients
Official title: Effect of Dietary Glycemic Index/Load on Kidney-related Biomarkers and Inflammation in Diabetic Nephropathy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Nephropathy
Medication Compliance
Keywords: glycemic index
diabetic nephropathy
low glycemic load
inflammation
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: low GI and low GL diet have more beneficial effect for diabetic nephropath patients compared with conventional diet.

low GL may have more favorable effect than low GI diet.

Detailed description: According to body weight status of participants, the investigators considered a slight calorie restriction ranged from 200 to 300 Kcal/d. Planed meals and exchange list prescribed for all volunteers. Dietary records forms were given to all subjects and they were educated how to record their dietary intakes. The investigators asked subjects not to change their physical activity level during the study and monitored them for their physical activity level by 3 days physical activity records monthly.

Eligibility criteria: Inclusion Criteria:

* diabetic nephropathy, medication stable

Exclusion Criteria:

* poor adherence of dietary recommendations, any changes in kind or dosage of medications

Primary outcomes:
measure: Serum creatinine (and blood urea nitrogen (BUN) (mg/dL) were measured by colorimetric method and enzymatic colorimetric method using commercial assay kit.
timeFrame: baseline, wk 12
Secondary outcomes:
measure: Serum levels of high sensitive C- reactive protein (hs-CRP) (mg/L) were quantified by using an ultrasensitive latex-enhanced immunoturbidimetric assay (Randox Laboratory Ltd., Belfast, United Kingdom).
timeFrame: baseline, wk 12
Other outcomes:
measure: Fasting blood sugar (FBS) and lipid profile concentrations (mg/dl) were measured using commercially available enzymatic reagents adopted to an auto-analyzer system.
timeFrame: baseline, wk 12
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Leila Azadbakht
Study officials:
affiliation: Isfahan University of Medical Sciences
name: leila azadbakht, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03175302: PREsurgical Cognitive Evaluation Via Digital clockfacEdrawing
Official title: PREsurgical Cognitive Evaluation Via Digital clockfacEdrawing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognitive Dysfunction
Keywords: cognitive processes
perioperative cognition
neurocognitive impairment
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2017-06-05
Enrollment: 25240
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \>/= 65 years of age scheduled for screening within the UF Health Preoperative clinic

Brief summary: This study leverages a modernized digital version of a well-known cognitive screening tool to examine pre and post operative cognitive function after surgery in adults age 65 years or more. Machine learning algorithms will be applied to the hospital wide standard of care cognitive metric to identify risk for post-operative cognitive complications.

Detailed description: This proposal innovatively leverages a brief but informative digital test with machine learning to examine the subtlety of pre-surgery cognition within an extremely large number of older individuals screened preoperatively within an academic tertiary medical center. It also incorporates a unique group of well characterized non-surgery peers for demographic matching to assist with normal versus abnormal machine learning analyses.

Eligibility criteria: Inclusion Criteria:

* \>/= 65 years of age
* screening within the University of Florida (UF) Health Preoperative clinic
* presurgical cognitive screening with the digital Clock Drawing Tool (dCDT)

Exclusion Criteria:

* \< 65 years of age
* did not complete screening within the UF Health Preoperative clinic
* did not complete the presurgical cognitive screening with the digital Clock Drawing Tool (dCDT)

Primary outcomes:
measure: Control and pre-surgery differences between digital behaviors
timeFrame: up to one year
Secondary outcomes:
measure: Predictive validity of digital behaviors on outcome
timeFrame: up to 1 year
measure: Change over time in digital behavior between groups
timeFrame: up to 6-weeks
measure: Change over time in digital behavior between groups
timeFrame: up to 3-months
measure: Change over time in digital behavior between groups
timeFrame: up to one year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Catherine Price, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Patrick Tighe, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bandyopadhyay S, Dion C, Libon DJ, Price C, Tighe P, Rashidi P. Variational autoencoder provides proof of concept that compressing CDT to extremely low-dimensional space retains its ability of distinguishing dementia. Sci Rep. 2022 May 14;12(1):7992. doi: 10.1038/s41598-022-12024-8.
Clinical trial NCT00698802: Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes
Official title: Assessment of Safety and Efficacy of Biphasic Human Insulin IU 100 to EX1000 on Glycaemic Control in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 397
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: This trial is conducted in Asia and Africa. This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes for at least 12 months
* Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs
* Body Mass Index (BMI) less than or equal to 40.0 kg/m2
* HbA1c less than or equal to 9.5%
* FPG (SMPG) less than or equal to 12 mmol/L

Exclusion Criteria:

* Treatment with more than 1IU/kg insulin daily
* Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
* Known or suspected allergy to trial products or related products
* Receipt of any investigational drug within one month prior to this trial
* Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers

Primary outcomes:
measure: HbA1c
timeFrame: after 8 weeks of treatment
Secondary outcomes:
measure: HbA1c
timeFrame: For the duration of the trial
measure: Fructosamine
timeFrame: For the duration of the trial
measure: FPG
timeFrame: For the duration of the trial
measure: 4-point SMPG profiles
timeFrame: For the duration of the trial
measure: Incidence of hypoglycaemic episodes
timeFrame: For the duration of the trial
measure: Frequency and severity of adverse events (including injection site reactions)
timeFrame: For the duration of the trial
measure: Laboratory safety parameters (haematology, biochemistry and lipids)
timeFrame: For the duration of the trial
measure: Physical examination and vital signs
timeFrame: For the duration of the trial
measure: Total daily insulin dosages
timeFrame: For the duration of the trial
Other outcomes:
Locations:
city: Vijayawada
country: India
city: Johannesburg
country: South Africa
state: Gauteng
city: Abu Dhabi
country: United Arab Emirates
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04436302: Exergaming in People With Major Neurocognitive Disorder
Official title: The Efficacy of Exergaming in People With Major Neurocognitive Disorder Residing in Long-term Care Facilities: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Randomised Controlled Trial
Major Neurocognitive Disorder
Long-term Care Facility
Physical Activity
Cognitive Impairment
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial explores the efficacy of an 8-week standing exergaming program in people with major neurocognitive disorder (MNCD) residing in long-term care facilities.

Detailed description: This randomized controlled trial explores the efficacy of an 8-week standing exergaming program in people with major neurocognitive disorder (MNCD) residing in long-term care facilities. Fifty inpatients with mild to moderate MNCD will be randomly assigned to three times weekly for eight weeks 15 min of exergaming versus watching preferred music videos. The Montréal Cognitive Assessment (MoCA), Short Physical Performance Battery (SPPB), Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), Dementia Quality of Life (DQoL), Katz activities of daily living (ADL) and Instrumental ADL (IADL) are measured at baseline and post intervention.

Eligibility criteria: Inclusion criteria included:

* a Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 diagnosis of MNCD (American Psychiatric Association, 2013)
* aged 65 years or older
* a score of minimum 10 on the Mini-Mental State Examination (MMSE)
* residing at least two weeks in the care facility at the time of inclusion
* being physically capable of doing standing exercises (whether or not with extra support).

Possible causes of MNCD were vascular dementia, Alzheimer's disease, mixed dementia, Parkinson's disease or Lewy body disease.

Exclusion criteria consisted of:

* any unstable cardiovascular or other health condition which according to the American College of Sports Medicine Standards might lead to unsafe participation
* a score lower than 10 on the MMSE
* a planned transfer to another setting within the following two months.

Primary outcomes:
measure: MoCA
timeFrame: 2 years
measure: SPPB
timeFrame: 2 years
measure: NPI
timeFrame: 2 years
measure: CSDD
timeFrame: 2 years
measure: DQOL
timeFrame: 2 years
measure: (I)ADL
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Long-term care facility 'de Wingerd'
state: Vlaams Brabant
Study officials:
References:
citation: Swinnen N, Vandenbulcke M, de Bruin ED, Akkerman R, Stubbs B, Firth J, Vancampfort D. The efficacy of exergaming in people with major neurocognitive disorder residing in long-term care facilities: a pilot randomized controlled trial. Alzheimers Res Ther. 2021 Mar 30;13(1):70. doi: 10.1186/s13195-021-00806-7.
Clinical trial NCT00788502: Stress Reduction During In Vitro Fertilization
Official title: Stress Reduction During In Vitro Fertilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-11-11
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine the effect of Healing Touch (HT) on the stress, anxiety, and self-efficacy experiences of women undergoing in vitro fertilization (IVF) in a randomized, controlled design. HT is a gentle, non-invasive form of energy-balancing work that promotes relaxation.

Detailed description: Once enrolled, each participant will be randomized to one of three groups: the Healing Touch (HT) treatment arm, the Desensitization Therapy (DT) arm, or the no-intervention arm.

Subjects in Group 1 will receive three, 45-minute HT sessions during the first two weeks of their IVF cycle prior to oocyte retrieval. Group 2 will receive three, 45-minute DT sessions during the first two weeks of their IVF cycle prior to oocyte retrieval. Group 3 will receive no intervention. Subjects in Group 3 will be offered two HT sessions after completing study participation.

All subjects and their partners will be asked to complete the Spielberger State Trait Anxiety Inventory (STAI), the Perceived Stress Scale (PSS) and the Infertility Self-Efficacy Scale (ISES) at three time points: 1) baseline 2) one day prior to oocyte retrieval and 3) 5-7 days post embryo transfer. In addition, subjects in all groups will complete a short pre-study questionnaire to assess expectation of therapeutic effect, and subjects in the two intervention groups will complete a short post-study questionnaire to evaluate their treatment experience. Demographic and pregnancy outcome data will be collected for all subjects.

Eligibility criteria: Inclusion Criteria:-Age \<43

* FSH \<= 14
* About to enter an IVF cycle at the Stanford Fertility and Reproductive Medicine Center
* Planning a transfer of their own fresh embryos during this cycle
* Speak and read English fluently
* Not planning to use concomitant energy work interventions (HT, Reiki, QiGong, acupuncture)during the IVF cycle.

Primary outcomes:
measure: Spielberger State Trait Anxiety Inventory
timeFrame: 30 days
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: 30 days
measure: Infertility Self-Efficacy Scale
timeFrame: 30 days
measure: Pregnancy outcome
timeFrame: 30 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Kathy Turner RN, NP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01950702: Laryngoscope Asssited Lightwand Intubation
Official title: Laryngoscope Assisted Lightwand Can Provide More Successful Intubation Than Lightwand Alone in Patients With Cervical Spine Injury : A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Spine Surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-09-25
Enrollment: 168
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the success rate for intubation of laryngocope assisted lightwand intubation.

Detailed description: Light wand intubation is well known for safety intubation in cervical injury patiets. Traditional method of using light wand can damage the supraglottic cavity by scooping the apparatus. The investigators try to evaluate the efficacy of laryngoscope assisted light wand intubation compared to traditional method of using light wand alone.

Eligibility criteria: Inclusion Criteria:

* Patient scheduled for cervical spine surgery under general anesthesia

Exclusion Criteria:

* congenital or acquired abnormalities of the upper airway, tumours, polyps, trauma, abscesses, inflammation, or foreign bodies in the upper airway
* history of gastro-esophageal reflux disease, previous airway surgery, an increased risk of aspiration, coagulation disorders
* American Society of Anesthesiologists physical status ≥ 3

Primary outcomes:
measure: The success rate of intubation
timeFrame: up to 60 seconds
Secondary outcomes:
measure: lightwand search (=intubation) time
timeFrame: from the insertion of the lightwand or laryngoscope into the oral cavity to the point of transillumination over the cricothyroid membrane within 60 sec.
measure: The times of scooping of lightwand
timeFrame: within 1min after insertion of lightwand
Other outcomes:
measure: score of postoperative sorethroat
timeFrame: at postanesthetic care unit (PACU) within 1hr after end of anesthesia
measure: Incidence of moderate to severe postoperative sorethroat
timeFrame: at postanesthetic care unit (PACU) within 1hr after end of anesthesia
measure: other possible postoperative complications
timeFrame: just after extubation, an expected average of 1hr
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University of Hospital
state: Jongno-Gu
Study officials:
affiliation: Professor
name: Hee-Pyung Park, MD PhD
role: STUDY_DIRECTOR
affiliation: fellow
name: Eugene Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00044902: Monoclonal Antibody Treatment for Non-Hodgkin's Lymphoma (Low-Grade)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2002-09-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Epratuzumab is currently being studied in combination with rituximab, for the treatment of patients with low-grade NHL who failed previous chemotherapy and have never received rituximab or who received rituximab as a single agent or in combination with chemotherapy as their last treatment and who demonstrated a partial response or complete response for at least 12 months.


Eligibility criteria: * Diagnosis of relapsed or refractory low-grade, CD20+, B-cell NHL \* Received and failed at least 1 prior regimen of chemotherapy \* Rituximab-naive or received prior rituximab in their last treatment (single agent or in combination with chemotherapy) and demonstrated a time to progression of at least 12 months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: