louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03850496: DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency
Official title: Dosing of Electrical Stimulation in Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Venous Stasis
Venous Insufficiency
Keywords: Venous
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Actegy Ltd.
First posted: 2019-02-21
Enrollment: 76
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 study is designed to describe the difference in varicose vein outcomes found from using a neuromuscular electrical stimulation device for different amounts of time - Group A (control - no device), Group B (device for 30 mins per day) and Group C (device for 60 mins per day). The groups are assessed after 6 weeks of intervention.


Eligibility criteria: Inclusion Criteria:

Patients with chronic venous insufficiency who have the following are eligible for the study:

* Able to understand the study and provide meaningful written informed consent for the study.
* Willing, able, and committed to participate in the procedures for the full length of the study.
* All ethnic groups, male or female above the age of 18 years.
* Diagnosis of chronic venous insufficiency (C3-C5 CEAP Classification)
* Blood pressure currently under moderate control (\< 160/100mmHg)
* No current foot ulceration

Exclusion Criteria:

Patients meeting any of the following criteria are to be excluded:

* Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) that would affect compliance with protocol
* Pregnant
* Has a cardiac pacemaker, AICD or other implanted electrical device
* Has an Existing DVT.
* Has recent lower limb injury or lower back pain
* Has current foot ulceration or other skin ulcers
* Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.
* Has an ABPI \< 0.8

Primary outcomes:
measure: Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
timeFrame: 0 and 6 weeks
Secondary outcomes:
measure: Venous Flow Parameters - PV
timeFrame: 0 and 6 weeks
measure: Venous Flow Parameters - VF
timeFrame: 0 and 6 weeks
measure: Microcirculatory Blood Flow
timeFrame: 0 and 6 weeks.
measure: Limb Volume
timeFrame: 0 and 6 weeks
measure: Venous Clinical Severity
timeFrame: 0 and 6 weeks.
measure: Patient Compliance
timeFrame: 6 weeks.
measure: Generic Quality of Life - EQ-5D-5L
timeFrame: 0 and 6 weeks
measure: Generic Quality of Life - SF-12
timeFrame: 0 and 6 weeks
measure: Generic Quality of Life - EQ-VAS
timeFrame: 0 and 6 weeks
measure: Disease Specific Quality of Life
timeFrame: 0 weeks and 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Imperial College London
name: Raveena Ravikumar, MRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00869596: Study of Biomarkers of Airway Inflammation (0000-128)
Official title: A Randomized Clinical Trial to Assess the Effects of Inhaled Fluticasone on Sputum Neutrophils After Low-dose Inhaled Endotoxin Challenge in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Airway Inflammation
Keywords: Sputum inflammatory biomarkers
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-03-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate the effects of inhaled fluticasone on cell counts and inflammatory mediators measured in sputum of healthy volunteers following exposure to inhaled lipopolysaccharide.


Eligibility criteria: Inclusion Criteria:

* Female subjects who can have children must have a negative pregnancy test at screening and agree to use two methods of birth control throughout the study
* Male subjects with female partner(s) who can have children agree to use an acceptable method of birth control throughout the study
* Subject is a nonsmoker
* Subject is in generally good health
* Subject is willing to comply with the diet, alcohol, and caffeine study restrictions

Exclusion Criteria:

* Subject is a nursing mother
* Subject has taken oral corticosteroids within 8 weeks or inhaled/nasal corticosteroids within 4 weeks of screening
* Subject has nasal polyps, recent nasal surgery, or an ongoing upper or lower respiratory tract infection
* Subject has a recent history of allergic rhinitis at screening
* Subject has any respiratory disease at screening
* Subject has daily phlegm or a chronic cough
* Subject is unable to refrain from the use of any prescription or non-prescription drugs or herbal remedies during the study
* Subject consumes excessive amounts of alcohol or caffeine
* Subject has had major surgery, or donated or lost 1 unit of blood within 4 weeks of screening
* Subject has a history of stroke, seizures, or major neurological disorders
* Subject regularly uses illicit drugs or has a history of drug/alcohol abuse
* Subject received a vaccination within 3 weeks of screening

Primary outcomes:
measure: Sputum percent neutrophils
timeFrame: 6 hours following inhaled LPS challenge
Secondary outcomes:
measure: Sputum absolute neutrophils (per mL)
timeFrame: 6 hours following inhaled LPS challenge
measure: Sputum levels of IL1beta and IL8
timeFrame: 6 hours following inhaled LPS challenge
measure: Sputum mRNA expression levels of CD14 and IL1beta
timeFrame: 6 hours following inhaled LPS challenge
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00803296: Incretin Effect in Lean and Obese Subjects
Official title: The Impact of Obesity and Insulin Resistance on the Incretin Effect in Patients With Type 2 Diabetes and Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incretin Effect
Insulin Resistance
Type 2 Diabetes
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lean and obese patients with type 2 diabetes; and matched healthy control subjects.

Brief summary: The incretin effect is markedly reduced in patients with type 2 diabetes. Data support the notion that this deficiency is a consequence of the diabetic state. However, the impact of insulin resistance on the incretin effect in obese individuals who uphold a normal glucose tolerance (NGT) despite their insulin resistant state remains to be elucidated. The primary aim of the present study is to evaluate the separate impact of one of the cornerstones of type 2 diabetic pathophysiology, namely insulin resistance, on the incretin effect in lean and obese patients with type 2 diabetes and in two matched normal-glucose tolerant groups of healthy control subjects.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes for at least 3 months
* Normal blood hemoglobin
* Informed consent

Exclusion Criteria:

* Liver disease
* Diabetic nephropathy
* Treatment with medication that can not be stopped for 12 hours

Primary outcomes:
measure: Incretin effect
timeFrame: 2 days
Secondary outcomes:
measure: Insulin resistance
timeFrame: 2 days
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital, University of Copenhagen
state: Copenhagen
Study officials:
affiliation: Department of Internal Medicine F, Gentofte Hospital, University of Copenhagen
name: Tina Vilsbøll, MD DMSc
role: STUDY_CHAIR
References:
Clinical trial NCT04046796: Genetic Causes of Discrepant Clinic in Monogenic Twins
Official title: Genetic Causes of Discrepant Clinic in Monogenic Twins
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rare Diseases
Genetic Predisposition to Disease
Keywords: Rare Diseases
Genetic Predisposition
Omics Technology
Next Generation Sequencing (NGS)
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twin pair monozygotic clinically (phenotypic) discordant twins

Brief summary: In the DISCO-TWIN study (prospective, open-label molecular-genetic study), twin pairs with one healthy and one affected twin with molecularly undiagnosed diseases will be analysed by means of omics technologies and/ or re-analysed using existing datasets. Phenotype and omics data will be shared within the University Hospital Tübingen and with external collaborators to improve the diagnostic rate of the subjects included in the study.


Eligibility criteria: Inclusion Criteria:

* Twin pair monozygotic clinically (phenotypic) discordant twins
* Unclear diagnosis
* Suspected (mono-)genetic cause of the disease in one twin

Exclusion Criteria:

* Missing informed consent of both twin/ legal representative
* No distinct phenotype

Primary outcomes:
measure: Number of new Candidate Genes
timeFrame: Day 1
Secondary outcomes:
measure: Number of putative disease causes
timeFrame: Day 1
measure: Number of diagnosis
timeFrame: Day 1
measure: Number of molecular causes of diagnostically unclear rare diseases
timeFrame: Day 1
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen
Study officials:
affiliation: University Hospital Tübingen
name: Jeannette Hübener-Schmid, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06030596: SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Official title: SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: SPECT
Myocardial Blood Flow
Myocardial Flow Reserve
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2023-09-11
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Suspected or known CAD

Brief summary: Recent evidences have demonstrated improved diagnostic accuracy for detecting coronary artery disease (CAD) when myocardial blood flow (MBF) is quantified in absolute terms using single photon emission tomography (SPECT) compared to conventional myocardial perfusion imaging (MPI). However, there are no uniformly accepted cutoff values of MBF and MFR derived from SPECT for diagnosing hemodynamically significant CAD. Particularly, the diagnostic performance for quantitative SPECT has not been validated using fractional flow reserve (FFR). The aim of this prospective study is to determine optimal cutoff values of absolute MBF and MFR derived from NaI (Tl)-based SPECT and to evaluate the diagnostic efficacy of this quantitative technology utilizing invasive coronary angiography (ICA) in combination with FFR results as the reference standard in patients with suspected or known CAD.


Eligibility criteria: Inclusion Criteria:

* Age 18 \~ 79 years old
* At least one CAD risk factor
* Intermediate to high pre-test likelihood for CAD
* Suspected or known CAD, clinically referred for invasive coronary angiography
* Able and willing to comply with the study procedures
* Written informed consent

Exclusion Criteria:

* History or risk of severe bradycardia
* History of myocardial infarction, dilated cardiomyopathy, hypertrophic cardiomyopathy, valve issue or congenital heart disease
* Wheezing asthma or COPD
* Known second- or third-degree AV block
* Known hypersensitivity to dipyridamole or adenosine
* Known coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) prior to screening
* Breastfeeding or pregnancy
* Claustrophobia or inability to lie still in a supine position
* Unwillingness or inability to provide informed consent

Primary outcomes:
measure: The diagnostic accuracy of MBF and MFR derived from SPECT
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: Fuwai Hospital, Beijing, China
name: Wei Fang, MD/PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06463496: Balance and Executive Function in Middle-age and Older Patients With Heart Failure in Post-Acute Care Program
Official title: Balance and Executive Function in Middle-age and Older Patients With Heart Failure in Post-Acute Care Program
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure
Keywords: Heart Failure
Balance Function
Executive Function
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Middle-aged and older patients with heart failure in in Post-Acute Care Program

Brief summary: This trial is a single-center clinical trial in Taiwan with an expected enrollment of 60 people in Taiwan. The purpose of this trial is to compare the performance of middle-aged and elderly patients with subacute heart failure with that of a healthy control group in terms of balance function and executive function, as well as to investigate whether there is a correlation between balance function and executive function in middle-aged and elderly patients with heart failure and to track the changes in balance and executive function one month and three months after discharge from the hospital. Please think carefully before deciding whether to participate in this trial.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with heart failure and receiving post-acute care program for heart failure
* Left ventricular ejection fraction≦40%
* Age ≥ 45
* No cognitive impairment
* Ambulate independently or with the use of aids
* Clinical symptoms are stable
* Voluntary participation

Exclusion Criteria:

* Use of medications that cause dizziness or interfere with balance
* Have other diagnoses that may affect balance, such as stroke, Parkinson's disease
* Color blindness, severe hearing or visual impairment that prevents reading questions and listening to instructions

Primary outcomes:
measure: Berg Balance Scale
timeFrame: T0 : Baseline ； T1: one month after discharge； T2: three months discharge
measure: Timed Up and Go Test
timeFrame: T0 : Baseline ； T1: one month after discharge； T2: three months discharge
Secondary outcomes:
measure: Color Trails Test
timeFrame: T0 : Baseline ； T1: one month after discharge； T2: three months discharge
measure: The Stroop Color and Word Test
timeFrame: T0 : Baseline ； T1: one month after discharge； T2: three months discharge
measure: Digit Span Test
timeFrame: T0 : Baseline ； T1: one month after discharge； T2: three months discharge
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01229696: Continuous Popliteal Nerve Blocks: Effect of Perineural Catheter Tip Location Relative to the Sciatic Nerve Bifurcation on Postoperative Analgesia
Official title: Continuous Popliteal Nerve Blocks: Effect of Perineural Catheter Tip Location Relative to the Sciatic Nerve Bifurcation on Postoperative Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Popliteal Nerve Block
Foot Surgery
Ankle Surgery
Popliteal Bifurcation
Keywords: Popliteal
UCSD
Postoperative pain
Foot surgery
Ankle surgery
Popliteal Catheter
Popliteal Nerve Block
Lower extremity surgery
Bifurcation
Catheter Insertion Site
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2010-10-28
Enrollment: 150
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: Research study to determine the relationship between perineural catheter tip location relative to the sciatic nerve bifurcation and postoperative analgesia for continuous popliteal nerve blocks.

Detailed description: Hypothesis: During a continuous popliteal nerve block, postoperative analgesia will be improved with the perineural catheter tip at the level of the sciatic nerve bifurcation compared to when the catheter tip is 5 cm cephalad/proximal to the bifurcation.

Eligibility criteria: Inclusion Criteria:

* undergoing surgery with a popliteal perineural catheter for postoperative analgesia
* age 18 years or older

Exclusion Criteria:

* pregnancy
* inability to communicate with the investigators and hospital staff
* incarceration
* clinical neuropathy in the surgical extremity
* chronic high-dose opioid use
* a history of opioid abuse
* surgery outside of ipsilateral sciatic and saphenous nerve distributions

Primary outcomes:
measure: Average Pain
timeFrame: 1 Day following surgery
Secondary outcomes:
measure: Analgesic Use
timeFrame: 1 day following surgery
measure: Sleep Disturbances
timeFrame: 1 day following surgery
measure: Infusion Side Effects
timeFrame: 1 day following surgery
measure: Satisfaction of pain control
timeFrame: 1 day following surgery
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Centers (Hillcrest and Thornton)
state: California
Study officials:
affiliation: University of California, San Diego
name: Brian M Ilfeld, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02293096: Pharmacogenetic Prediction of Metoprolol Effectiveness
Official title: Pharmacogenetic Prediction of Metoprolol Effectiveness
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Keywords: Genotype
CYP2D6
ADRB1
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2014-11-18
Enrollment: 462
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators will prospectively follow a population of patients with uncontrolled high blood pressure beginning metoprolol succinate therapy to determine the drug effect in an observational clinical trial. The investigators will determine each individual's genotype for both CYP2D6 and Adrenoceptor Beta 1 (ADRB1). Metabolomic markers will be identified to determine if specific metabolites are associated with drug response. The investigators' overall objective is to determine if genetics predicts metoprolol succinate response better than clinical factors such as age, race, body mass index, dose, and medication co-ingestion.


Eligibility criteria: Inclusion Criteria:

1. Subjects between age \>30 years and \< 80 years
2. Subjects have diagnosis of uncontrolled essential hypertension.

Exclusion Criteria:

1. end stage liver disease,
2. end stage renal disease,
3. pregnant females,
4. American Society of Anesthesiologists (ASA) classification of \>3,
5. wards of the state, prisoners,
6. decisionally challenged,
7. HR\<60 bpm,
8. AV block\>240 msec,
9. active reactive airway disease,
10. illicit drug abuse in the preceding 30 days,
11. hypersensitivity to metoprolol or its derivatives
12. severe peripheral arterial circulatory disorders.

Subjects will have a screening physical exam performed by Dr. Monte prior to enrollment in the study.

Primary outcomes:
measure: Blood Pressure Decline
timeFrame: 4-6 weeks status post initiation
Secondary outcomes:
measure: Heart Rate Decline
timeFrame: 4-6 weeks
measure: Adverse Drug Events: CYP2D6 Metabolizer Status
timeFrame: 6 weeks
measure: Adverse Drug Events: ADRB1 Genotype
timeFrame: 6 weeks
Other outcomes:
measure: Metabolomic Factors
timeFrame: 0-6 weeks
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver; Emergency Department
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Andrew Monte, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brocker CN, Velenosi T, Flaten HK, McWilliams G, McDaniel K, Shelton SK, Saben J, Krausz KW, Gonzalez FJ, Monte AA. Metabolomic profiling of metoprolol hypertension treatment reveals altered gut microbiota-derived urinary metabolites. Hum Genomics. 2020 Mar 11;14(1):10. doi: 10.1186/s40246-020-00260-w.
Clinical trial NCT06913296: PTeye in Parathyroid Adenoma
Official title: Do PTeye Score Correlate With Biochemical Markers in Parathyroid Adenoma?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parathyroid Adenoma
Keywords: parathyroid adenoma
near-infrared autofluorescence
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 50
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: Patients undergoing surgery for parathyroid adenoma

Brief summary: Identifying the parathyroids is compulsory for success of parathyroidectomy for parathyroid adenoma. Near-infrared autofluorescence devices have been proposed as useful intraoperative tools for the identification of parathyroid glands. The aim of the present study is to evaluate the correlation of PTeye autofluorescence device with biochemical data of parathyroid adenoma patients.

Detailed description: Identifying the parathyroids is compulsory for success of parathyroidectomy for parathyroid adenoma. Near-infrared autofluorescence devices have been proposed as useful intraoperative tools for the identification of parathyroid glands. Two approaches are available to surgeons to perform near-infrared autofluorescence: (i) Camera-based systems (CBS) and (ii) Probe-based systems such as PTeye™ (Medtronic, Minneapolis, MN).The aim of the present study is to evaluate the correlation of PTeye autofluorescence device with biochemical data of parathyroid adenoma patients.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years old
* primary hyperparathyroidism caused by adenoma
* patient's informed consent acquired

Exclusion Criteria:

* Secondary and tertiary hyperparathyroidism
* Re-operation for adenoma
* Previous neck surgery
* Patient enrolled in another study that may affect the results of this study

Primary outcomes:
measure: assess the correlation of PTeye values with biochemical data
timeFrame: intraoperatively and 1st postoperative day
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Aristotle Univeristy of Thessaloniki
Study officials:
affiliation: Euromedica Kyanos Stavros
name: Moysis Moysidis, Dr
role: STUDY_CHAIR
affiliation: Euromedica Kyanos Stavros
name: Chrysa Papadopoulou
role: STUDY_CHAIR
References: