louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03288909: Ultra High Field Magnetic Resonance Imaging as a Biomarker for Premotor Parkinson's Disease
Official title: Ultra High Field Magnetic Resonance Imaging as a Biomarker for Premotor Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
REM Sleep Behavior Disorder
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2017-09-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Idiopathic Parkinson's disease within 1 year of motor symptom onset. Idiopathic REM sleep behavior disorder without signs/symptoms of Parkinson's disease.

Age-matched controls.

Brief summary: This is a prospective observational study investigating the utility of 7 Tesla MRI to quantify nigrosome1 signal in a cohort of individuals with recent onset Parkinson's disease and in at-risk cohorts at a premotor state of Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's disease within 1 year of motor symptom onset. Idiopathic REM sleep behavior disorder without signs/symptoms of Parkinson's disease.

Age-matched controls.

Exclusion Criteria:

* Atypical Parkinsonism
* Contraindications for MRI

Primary outcomes:
measure: Quantitative signal analysis of nigrosome 1
timeFrame: 1 year
Secondary outcomes:
measure: Change in quantitative signal analysis of nigrosome 1
timeFrame: 3 years
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Matthew Brodsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03168009: Brown Fat Activity and Bariatric Surgery
Official title: The Role of Alternatively Activated Brown Fat in Bariatric Surgery-mediated Metabolic Improvements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: BAT
Bariatric Surgery
Energy Metabolism
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The mechanisms of bariatric surgery-induced weight loss go beyond reductions in calorie intake and may involve several other pathways. Recently, brown adipose tissue (BAT) has been added as another potential player. Activation of BAT results in enhanced energy expenditure and promotes weight loss. Here, the investigators will study the effects of bariatric surgery on BAT function by PET/CT studies and molecular analyses of adipose biopsies. The investigators will explore different pathways that may affect BAT activation in this patient population.


Eligibility criteria: Inclusion Criteria:

* Age 20 - 50 years
* Body mass index (BMI) 35 - 55kg/m2

Exclusion Criteria:

* Endocrine disease (except hyperlipidemia and substituted hypothyroidism or type 2 diabetes with fasting glucose concentrations \<120mg/dl), kidney disease, inflammatory bowel disease, autoimmune or rheumatologic diseases that require immunosuppressive treatment, active oncologic disease, heart failure.
* Medication for any of the above mentioned conditions.
* Antibiotic treatment in the past three months
* Pregnancy

Primary outcomes:
measure: Changes in BAT activity after bariatric surgery
timeFrame: 4 years
Secondary outcomes:
measure: Bariatric surgery-induced changes in gut microbiota, bile acid composition and other circulating factors
timeFrame: 4 years
measure: Association between changes in BAT activity, transcriptional BAT markers and alterations in the gut microbiota profile or bile acid composition
timeFrame: 4 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Florian Kiefer, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00573209: Energy Specific Far Infrared Radiation Treatment for Erectile Dysfunction
Official title: Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Erectile Dysfunction.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Erectile Dysfunction
Keywords: Impotence
Male Impotence
Male Sexual Impotence
Lead sponsor: GAAD Medical Research Institute Inc.
Sponsor class: OTHER
First posted: 2007-12-14
Enrollment: 3
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A preliminary study to determine the possibility of using far infrared (FIR) radiation to treat impotency.

Detailed description: Erectile dysfunction is characterized by the regular or repeated inability to obtain or maintain an erection. Erection depends on a complex interaction of psychological, neural, vascular and endocrine factors.

We are proposing a non-drug and a non-invasive radiation treatment for the enhancement of erection.

Eligibility criteria: Inclusion Criteria:

* Persons with erection challenges

Exclusion Criteria:

* None

Primary outcomes:
measure: The primary end point is to determine the therapeutic effects of far infrared radiation on erectile dysfunction.
timeFrame: 1 year
Secondary outcomes:
measure: The effect of far infrared radiation on other male conditions like prostate cancer
timeFrame: 1 year
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: The Centre for Incurable Diseases
state: Ontario
Study officials:
affiliation: GAAD Medical Research Institute Inc.
name: Ken Nedd, M.D.
role: STUDY_DIRECTOR
affiliation: GAAD Medical Research Institute Inc.
name: Kwasi Donyina, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02209909: Effects of Low Dose Aspirin Pre-treatment on Platelet Activation Undergoing Off-pump Coronary Artery Bypass Surgery
Official title: Effects of Low Dose Aspirin Pre-treatment on Platelet Activation Undergoing Off-pump Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: preoperative aspirin use
platelet activation
off pump coronary artery bypass
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-08-06
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Platelet activation after off pump coronary artery bypass (OPCAB) surgery may affect thrombus formation. The purpose of this study is to assess the effects of preoperative continuation of aspirin on platelet activation after off pump coronary artery bypass surgery.

Detailed description: Patients undergoing OPCAB surgery will be randomized to continue preoperative aspirin or discontinue aspirin before surgery.

Platelet activation can be evaluated by measuring platelet p-selectin using flowcytometry. In this study, we will compare platelet-activated markers and conventional coagulation tests.

Eligibility criteria: Inclusion Criteria:

* age : 20-80
* elective OPCAB
* informed consent

Exclusion Criteria:

* coagulation disorder
* emergency operation, re-operation
* co-existing valvular disease
* less than 6 months after cerebral vascular accident
* heparin induced thrombocytopenia
* heparin resistance
* menstrual phase
* preoperative cardiopulmonary bypass, continuous veno-veno hemofiltration, intra-aortic balloon pump application
* less than 12 months after myocardiac infarction
* less than 10 days after unstable angina
* less than 30 days after percutaneous coronary intervention
* less than 6 wks after bare metal stent insertion
* less than 12 months after drug eluting stent insertion

Primary outcomes:
measure: change from baseline in platelet p-selectin at 48 hours after operation
timeFrame: after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation
Secondary outcomes:
measure: change from baseline in conventional coagulation tests at the time of end of operation, 24 hour after operation, and 48hr after operation
timeFrame: after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation
Other outcomes:
measure: change from baseline in platelet aggregation at the time of end of operation, 24 hour after operation, and 48hr after operation
timeFrame: after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yunseok Jeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02891109: Regulatory B Cells and Chronic Immune Thrombocytopenia
Official title: The Role of Regulatory B Cells in the Chronic Immune Thrombocytopenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Purpura, Thrombocytopenic, Idiopathic
Regulatory B Cells
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with a Purpura, Thrombocytopenic, Idiopathic, in chronic phase (\>12 months) and healthy volunteers as control residents in Brest town, France.

Brief summary: The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells, are known to control other cells. Their action in chronic immune thrombopenia is actually unknown.

Detailed description: The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells, are known to control other cells. Their action in chronic immune thrombopenia is actually unknown. In our cohort of chronic immune thrombopenia and controls, we realized a flow cytometry analyze of B and T cells and a co-culture to determine regulatory B cells functionality.

Eligibility criteria: Inclusion Criteria:

* Purpura, Thrombocytopenic, Idiopathic, chronic phase (\>12 months)
* no treatment or thrombopoietin receptor agonists

Exclusion Criteria:

* \< 18 years
* Purpura, Thrombocytopenic, Idiopathic, acute phase
* pregnancy
* others causes of thrombopenia

Primary outcomes:
measure: Regulatory B cells functionality
timeFrame: 1 week
Secondary outcomes:
measure: Cytometry immunophenotyping of B and T cells
timeFrame: 1 week
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU de Brest
name: Christophe Jamin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Brest
name: Lenaig Le Clech, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Brest
name: Brigitte Pan-Petesh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00105209: A Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension
Official title: A Double-Blind, Placebo-Controlled, Three Treatment Cross-Over Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension, Pulmonary
Keywords: Platelets
Lead sponsor: Kawut, Steven, MD
Sponsor class: INDIV
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Columbia University
First posted: 2005-03-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Rationale: Idiopathic pulmonary arterial hypertension (IPAH) is characterized by in situ thrombosis and increased thromboxane A2 (Tx-M) synthesis. While both may be attributable to abnormal platelet function, there are no studies of anti-platelet therapy in IPAH.

Objectives: The purpose of this study is to assess the effects of aspirin (ASA) and clopidogrel on platelet function and eicosanoid metabolism in patients with IPAH.

Detailed description: This is a randomized, double-blind, placebo-controlled crossover study of aspirin 81 mg once daily and clopidogrel 75 mg once daily. Platelet function is assessed with plasma P-selectin levels and aggregometry after exposure to adenosine diphosphate, arachidonic acid, and collagen. We will assess serum levels of thromboxane B2 and urinary metabolites of thromboxane A2 and prostaglandin I2 (Tx-M and PGI-M, respectively).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of IPAH
* ≥ 18 years of age
* NYHA functional class I, II, or III
* Clinical stability (i.e., without change in pulmonary arterial hypertension medical regimen within one month prior to enrollment).

Exclusion Criteria:

* Other forms of PAH
* A contraindication to ASA or clopidogrel
* Thrombocytopenia (defined as platelet count ≤ 75,000)
* History of intracranial hemorrhage or chronic thromboembolic disease
* Renal failure
* Inability or unwillingness to avoid non-steroidal anti-inflammatory agents, ASA, or warfarin use for the duration of the trial

Primary outcomes:
measure: Plasma P-selectin level
measure: Aggregometry
measure: Serum thromboxane B2
measure: Urinary Tx-M
measure: Urinary prostaglandin I2 (PGI-M)
Secondary outcomes:
measure: Adverse events
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University College of Physicians and Surgeons
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT00554307: Brain, Gut and Kidney Blood Flow During Medical Closure of PDA
Official title: Comparison of Cerebral, Renal and Mesenteric Perfusion Using Near Infrared Spectroscopy in Neonates During Patent Ductus Arteriosus Closure With Ibuprofen or Indomethacin.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Patent Ductus Arteriosus
Keywords: patent ductus arteriosus
indomethacin
neoprofen
blood flow
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2007-11-06
Enrollment: 0
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: Preterm infants with patent ductus arteriosus requiring medical intervention

Brief summary: The purpose of this study is to determine how the medications which are used to close the patent ductus arteriosus (PDA) in preterm infants affect brain, kidney and gut blood flow when compared to infants that are not treated with these medications. The medications being used for PDA closure are indomethacin and neoprofen.

Detailed description: All babies requiring medical treatment of their PDA will receive up to 3 doses of medication. For babies enrolled in the control group of this study, she/he will not be treated with either of these medicines.

Eligibility criteria: Inclusion Criteria:

* Less than or equal to 32 weeks gestation;
* Less than or equal to 1250 g;
* Mechanical ventilation;
* Echocardiographic findings of PDA with left to right shunting;
* Medical judgement of neonatologist for medical treatment;

Exclusion Criteria:

* Urine output less than 1 ml/k/hr over previous 12 hours;
* Serum creatinine greater than 1.5 mg/dL;
* Platelet count less than 100,000 per cubic mm;
* Significant skin breakdown at sensor areas;
* Significant congenital anomalies
* Intraventricular hemorrhage greater than or equal to grade III

Primary outcomes:
measure: Changes in blood flow from baseline in infants treated with indomethacin or neoprofen. Blood flow will be measured in the brain, kidney and mesentery.
timeFrame: 48-72 hours
measure: Measure oxygenation/blood flow to brain during PDA treatment
timeFrame: Study period
Secondary outcomes:
measure: Oxygenation during/after treatment with PDA therapy
timeFrame: Study period
Other outcomes:
Locations:
city: Lousiville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Dan L Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01466907: Secondary Prevention and Health Promotion After Stroke
Official title: Secondary Prevention and Health Promotion After Stroke A Nurse-led Randomized Controlled Open Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: complication
depression
follow-up
intervention
nurse-led
outcome
secondary prevention
stroke
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 597
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to examine to what extent a one year population of stroke patients at a university hospital had well regulated risk factors and health problems one year after stroke, and if a structured nurse-led previous follow-up in the intervention group including referrals if needed could influence health outcome and risk factors one year after stroke.

Detailed description: The follow-up protocol was categorized into Risk factors, Patients' self-reports, and Other health problems. Referral was sent to a physician if medical interventions were needed regarding risk factors measured above the limits as stated in the follow-up protocol in accordance with guidelines,and/or if any self-reported health problems were stated by the patients, or had been detected by the Specialist Nurse. Primary outcome was comparison between the intervention group and control group at one year after stroke regarding proportion of regulated risk factors, and self-reports on health outcome. Results of the two follow-ups of the intervention group were also compared.

Eligibility criteria: Inclusion Criteria:

WHO criteria for definition of stroke Signed consent

Exclusion Criteria:

Other diagnosis causing neurological symptoms

Primary outcomes:
measure: Risk factors and health outcome compared between intervention group and control group
timeFrame: Baseline to one year after stroke for both groups.
Secondary outcomes:
measure: Risk factors and health outcome at two follow-ups.
timeFrame: Baseline to one year after stroke
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: Department of Health Sciences, Lund University
name: Ann-Cathrin Jönsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00351507: A Study to Assess the Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes
Official title: A Double-blind, Crossover, Placebo-Controlled, Multiple-dose Study to Evaluate the Effects of Vildagliptin on Gastric Emptying, Gastric Volume and Satiety in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Vildagliptin
Type 2 diabetes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-07-13
Enrollment: 10
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was designed to directly assess the effects of vildagliptin on gastric emptying in people with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes for at least 6 months
* Blood glucose criteria must be met
* BMI in the range 22-40

Exclusion Criteria:

* History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
* Use of thiazolidinediones or need for insulin within 3 months prior to screening
* Significant concomitant diseases or complications of diabetes
* High fasting triglycerides as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Effect on gastric emptying
Secondary outcomes:
measure: Effect on gastric volume
measure: Effect on satiety
measure: Effect on endogenous glucose appearance, glucose appearance and glucose disposal
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic & Foundation
name: Adrian Vella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dalla Man C, Bock G, Giesler PD, Serra DB, Ligueros Saylan M, Foley JE, Camilleri M, Toffolo G, Cobelli C, Rizza RA, Vella A. Dipeptidyl peptidase-4 inhibition by vildagliptin and the effect on insulin secretion and action in response to meal ingestion in type 2 diabetes. Diabetes Care. 2009 Jan;32(1):14-8. doi: 10.2337/dc08-1512. Epub 2008 Oct 17.
Clinical trial NCT03709407: "Effects of Manual Lymphatic Drainage in the Neck in Healthy Subjects. Experimental Randomized Crossover Study"
Official title: "Effects of Different Manoeuvres of Manual Lymphatic Drainage in the Neck on Systems Nervous, Cardiovascular, Respiratory and Lymphatic in Healthy Subjects. Experimental Randomized Crossover Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Nervous System Diseases, Sympathetic
Heart Rate Low
Lymphatic Diseases
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Drainage manoeuvres described in different Manual Lymphatic Drainage methods, suggest modificactions in vital signs, by changes at nervous system, that would involve modifications to heart rate, breathing rate, blood pressure, cardiac vascular level (arteries and lymphatics). In addition this hypothetical relaxing effect could be beneficial for other types of pathologies associated with the presence of stress, cardiac problems, respiratory pathology, muscle tension, muscle trigger points, etc. With this study investigators compare different manoeuvres in the neck area to observe the results in the participants regarding the basal state.

Detailed description: Differentes drainage manoeuvres suggest changes at nervous system (sympathetic and parasympathetic nervous system) and other vital constants

Eligibility criteria: Inclusion Criteria:

* healthy men and women, physiotherapy students, to accept voluntarily participate and sign informed consent

Exclusion Criteria:

* systemic diseases, trauma history, neurological diseases, subjects with chronic pain, cardiovascular history of importance, depression, individuals who know the technique of MLD or that are under any medical treatment.

Primary outcomes:
measure: Blood pressure
timeFrame: 8 times for 4 weeks
Secondary outcomes:
measure: range of movement
timeFrame: 8 times for 4 weeks
measure: pain pressure threshold
timeFrame: 8 times for 4 weeks
measure: Respiratory rate
timeFrame: 8 times for 4 weeks
measure: oxygen saturation
timeFrame: 8 times for 4 weeks
measure: Heart rate
timeFrame: 8 times for 4 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Angela
Study officials:
affiliation: Universidad Europea de Madrid
name: Angela Rio
role: PRINCIPAL_INVESTIGATOR
References: