louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04018105: Influence of Preprandial Metformin Administration on Carbohydrate Absorption
Official title: Influence of Preprandial Metformin Administration on Carbohydrate Absorption: Pilot Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Impaired Glucose Tolerance
Type2 Diabetes
Keywords: Impaired glucose tolerance
type 2 diabetes
obesity
carbohydrate absorption
metformin
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Type 2 diabetes is spreading worldwide as well as obesity. Metformin is the most prescribed antidiabetic medication. One suggested mechanism of action is by decreasing carbohydrate absorption.

It is usually recommended to take metformin during the meal to decrease gastrointestinal side effects. However, if metformin decreases carbohydrate absorption, this might not be the most efficient intake.

To study the influence of preprandial metformin administration on carbohydrate absorption, it will repeat 3 oral glucose tolerance test on obese dysglycemic patients, without metformin or with metformin administer 30 or 60 minutes before. We will also evaluate how it impacts gastrointestinal tolerance.


Eligibility criteria: Inclusion Criteria:

* Obesity (BMI ≥30 kg/m2)
* Dysglycemia (HbA1c≥ 6,0 %)
* No anti diabetic medication

Exclusion Criteria:

* No obesity (BMI \< 30 kg/m2)
* No dysglycemia (HbA1c \<6,0%)
* Treatment that might interfere with carbohydrate absorption (anti diabetic medication, antibiotics, probiotics, steroids)
* Anemia (Hb \<12 g/dL)
* Organ failure
* Inflammatory Bowel Disease

Primary outcomes:
measure: Area under the curve of D-Xylose
timeFrame: During the 3 hours OGTT
Secondary outcomes:
measure: Number of Participants with gastrointestinal side effects
timeFrame: During the 3 hours OGTT
measure: Area under the curve of blood glucose
timeFrame: During the 3 hours OGTT
measure: Area under the curve of insulin
timeFrame: During the 3 hours OGTT
measure: Area under the curve of GLP-1
timeFrame: During the 3 hours OGTT
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: camille Marciniak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01262105: Device to Reduce Surgery Site Contamination - Spine
Official title: Reduction of Airborne Microbes in the Surgical Field During Spine Procedures Using Directed Local Airflow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: CFU
surgery site
Lead sponsor: Nimbic Systems, LLC
Sponsor class: INDUSTRY
First posted: 2010-12-17
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g. bacteria) present at a surgery site during spinal procedures.

Detailed description: The Air Barrier System is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the Air Barrier System can reduce the presence of airborne colony-forming units at the surgery site during spinal procedures.

Eligibility criteria: Inclusion Criteria:

* Candidate for instrumented posterior lumbar interbody fusion

Exclusion Criteria:

* Prior history of infection
* Revision surgery
* Screens positive for MRSA

Primary outcomes:
measure: Surgery Site CFU Density
timeFrame: Ten-minute intervals throughout procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Orthopedic Hospital
state: Texas
Study officials:
affiliation: Fondren Orthopaedic Group
name: David Wimberley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stocks GW, Self SD, Thompson B, Adame XA, O'Connor DP. Predicting bacterial populations based on airborne particulates: a study performed in nonlaminar flow operating rooms during joint arthroplasty surgery. Am J Infect Control. 2010 Apr;38(3):199-204. doi: 10.1016/j.ajic.2009.07.006. Epub 2009 Nov 12.
Clinical trial NCT00590005: Redox Determinants of Severe Asthma (a Substudy of the Severe Asthma Research Program)
Official title: Redox Determinants of Severe Asthma: A Substudy of the NHLBI Severe Asthma Research Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: severe asthma
poorly controlled asthma
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
First posted: 2008-01-10
Enrollment: 225
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of children with physician-diagnosed asthma in the Atlanta, Georgia area across a wide range of asthma severities (mild, moderate, severe)

Brief summary: Hypotheses: 1) Airway pH regulation is abnormal in severe asthma; 2) In severe asthma, there is formation of cytotoxic nitrogen oxides and loss of beneficial nitrogen oxides in the airways

Detailed description: Specific Aim 1:Test hypothesis that airway pH regulation is abnormal in severe asthma.

1a) Determine the effects of systemic corticosteroids on breath pH in children with severe and mild to moderate asthma.

1b) Examine whether breath condensate pH and other biomarkers of oxidant stress can predict clinical outcomes in children with severe and mild to moderate asthma.

1c) Identify whether increased Th1/Th2 cytokine ratio, and abnormalities in airway glutaminase, G-SNO-reductase, VATPase, and carbonic anhydrase are associated with airway pH disturbance in children with severe asthma.

1d) Test whether rhinovirus infections, which reduce airway pH, persist longer or are more frequent in children with severe asthma than in children with mild to moderate asthma.

1e) Examine the relationship between gastroesophageal reflux and proximal airway pH in children with severe asthma and mild to moderate asthma.

Eligibility criteria: Inclusion Criteria:

* At least 6 years old
* Asthma diagnosis by physician
* Current treatment with an inhaled corticosteroid medication

Exclusion criteria:

* Bronchiectasis
* Cystic Fibrosis
* Chronic Obstructive Pulmonary Disease

Primary outcomes:
measure: Exhaled Nitric Oxide at Baseline and Over the Observational Period
timeFrame: baseline and after 21 days
Secondary outcomes:
measure: Reduction in Breath pH
timeFrame: baseline and 21 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Childrens Center
state: Georgia
Study officials:
affiliation: University of Virginia
name: W G Teague, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02837705: Therapeutic Antibodies Against Prion Diseases From PRNP Mutation Carriers
Official title: Therapeutic Antibodies Against Prion Diseases From PRNP Mutation Carriers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prion Diseases
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 213
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female carriers of a mutation in the Prion protein gene of any age and their wild type siblings.

Brief summary: The human Prion diseases can be classified into sporadic, acquired and inherited forms. Inherited forms usually manifest in higher age so there have to be factors preventing Prion propagation in young mutation carriers. Antibodies against the flexible tail of Prions have been shown to be protective in mice. The investigators intend to screen mutation carriers and controls for the presence of Prion autoantibodies.


Eligibility criteria: Inclusion Criteria:

* Relatives of patients of genetic Prion diseases
* Obtained informed consent

Exclusion Criteria:

* No informed consent

Primary outcomes:
measure: Anti-Prion protein autoantibody levels
timeFrame: Baseline, up to 90 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Memory and Aging Center
state: California
city: Graz
country: Austria
facility: Medical University Graz
city: Göttingen
country: Germany
facility: University Medical Center Göttingen
city: Pardés H̱anna Karkur
country: Israel
facility: CJD Foundation Israel
city: Milano
country: Italy
facility: Istituto di Ricerche Farmacologiche
city: Bratislava
country: Slovakia
facility: Slovak Medical University
city: Zürich
country: Switzerland
facility: Institute of Neuropathology
Study officials:
References:
citation: Frontzek K, Carta M, Losa M, Epskamp M, Meisl G, Anane A, Brandel JP, Camenisch U, Castilla J, Haik S, Knowles T, Lindner E, Lutterotti A, Minikel EV, Roiter I, Safar JG, Sanchez-Valle R, Zakova D, Hornemann S, Aguzzi A; THAUTAN-MC Study Group. Autoantibodies against the prion protein in individuals with PRNP mutations. Neurology. 2020 Oct 6;95(14):e2028-e2037. doi: 10.1212/WNL.0000000000009183. Epub 2020 Feb 25.
Clinical trial NCT01250405: Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients
Official title: Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2010-11-30
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The primary objective is to determine whether reduction of serum calcium concentration by cinacalcet leads to reduction of mean blood pressure adjusted c-fPWV. The secondary objectives are to study the effects of calcium reduction on 1) carotid-radial PWV (c-rPWV), 2) common carotid artery (CCA) biomechanics, 3) pulse wave profile and cardiac function.


Eligibility criteria: Inclusion Criteria:

* chronic (\> 3 months) hemodialysis population of \> 18 years old
* PTH \> 300 ng/L
* corrected Ca \> 2.10 mmol/L
* stable hypertensive drugs (\> 1 month)
* stable doses of phosphate binders and dialysis calcium concentration
* palpable femoral pulse
* systolic BP of 90-180 mmHg
* expected survival of \> 6 months

Exclusion Criteria:

* hemodialysis \> 3 years
* acute infection
* history of myocardial infarction or stroke within the past 3 months
* inability to consent
* intolerance to cinacalcet
* inadequate birth control

Primary outcomes:
measure: Arterial stiffness
timeFrame: Arterial stiffness with be measured after 1 week with placebo and after 1 week with cinacalcet
Secondary outcomes:
measure: Ventricular function
timeFrame: Ventricular function with be measured after 1 week with placebo and after 1 week with cinacalcet
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Karine Marquis
state: Quebec
Study officials:
affiliation: Laval University
name: Mohsen Agharazii, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poulin A, Bellemare PL, Fortier C, Mac-Way F, Desmeules S, Marquis K, Gaudreault V, Lebel M, Agharazii M. Acute effects of cinacalcet on arterial stiffness and ventricular function in hemodialysis patients: A randomized double-blinded crossover study. Medicine (Baltimore). 2017 May;96(21):e6912. doi: 10.1097/MD.0000000000006912.
Clinical trial NCT01988805: Gene Polymorphism Study of Normal Individual Inflammasome Genes
Official title: Immunological Characterization of Blood and Inflammasome Gene Segment Polymorphism Analysis of Normal Healthy Individuals
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Healthy Individuals
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal volunteers.

Brief summary: This study is intended to collect blood from healthy individuals to investigate whether variations in immune-related (inflammasome) genes affect how the immune cells found in the blood can help fight infections and prevent diseases.


Eligibility criteria: Inclusion Criteria:

1. Healthy with no chronic or acute illnesses, or taking medication which in the opinion of the PI would impact the analyses being conducted.
2. At least 18 years or older.
3. Are capable of reading, understanding and providing written informed consent.

Exclusion Criteria:

1. Non-English speaking.
2. Individuals under 18 years old.
3. Woman who believe they are or may be pregnant. (Based on self reporting. Pregnancy testing will not be conducted for the purposes of this study)
4. Individuals experiencing acute or chronic illnesses which in the opinion of the PI would impact the analyses being conducted.
5. Currently taking prescription or over the counter medication which in the opinion of the PI would impact the analyses being conducted.
6. Individual has donated blood more than twice in the last week or the amount to be drawn will exceed the maximum allowance in the last 8 weeks.

Primary outcomes:
measure: analyze their ability to respond to exogenous challenges by changing the production of proteins, the expression of genes and their ability to migrate and ingest materials
timeFrame: one visit
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Davis Heart & Lung Research Institute
state: Ohio
Study officials:
References:
Clinical trial NCT03305705: Effect of Iron on Cerebral Dopamine Receptor Density in Non-anaemic Premenopausal Women With Low Ferritin and Fatigue
Official title: Double-Blind, Single-Center Interventional Trial To Evaluate The Effect Of Intravenous Iron Versus Placebo On Cerebral Dopamine Receptor Density In Non Anaemic Premenopausal Women With Low Ferritin Levels And Fatigue
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fatigue
Iron-deficiency
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the effect of intravenous iron substitution in non-anaemic premenopausal women with iron deficiency on:

* Changes in the cerebral Dopamine (DA) receptor density after iron substitution, shown by brain PET
* Reduction of fatigue and other neuropsychological symptoms after iron supplementation


Eligibility criteria: Inclusion Criteria:

* Healthy female subjects, Age \> 18 years, premenopausal, regularly menstruating
* BMI 18-25 kg/m2
* Serum ferritin level \< 15 μg/ml, Hb \> 120 g/L
* Adequate contraception during the study period
* Fatigue determined as 2 or more points in the basic questionnaire for fatigue
* Informed consent

Exclusion Criteria:

* Day-night shift work
* 11 or more points in the BDI
* No psychiatric disease (as assessed by neuropsychiatric assessment)
* 15 or more points in the ISI
* Known hypersensitivity to iron carboxymaltose, iron sucrose or iron sulfate
* Intake of iron preparations during the last 8 weeks before the start of the trial protocol
* Pregnancy or lactation
* Any cardiovascular or pulmonary disease
* Acute or chronic infection/inflammation or malignancy
* Other obvious physical or psychiatric causes for fatigue (known mental disorders, e.g. depression)
* Chronic intake of concurrent medication (especially antipsychotic drugs), except oral contraceptives. Sporadic intake of NSAID or paracetamol, e.g. in the case of a common cold or sporadic headaches is allowed.
* CRP \> 10 mg/L
* TSH out of normal range
* Any concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients.
* Participation in any other therapeutic trial within the previous month
* Known History of HIV/HBV/HCV

Primary outcomes:
measure: Dopamine (DA) receptor density
timeFrame: 6 weeks
Secondary outcomes:
measure: Fatigue
timeFrame: 6 weeks
measure: Fatigue
timeFrame: 6 weeks
measure: Neuropsychological symptoms
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Albina Nowak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00571805: Study of Varencline Effects on Cigarette Smoking Reward and Craving During a Model of Brief Quit Attempt
Official title: Placebo-controlled Study of Varenicline Effects on Nicotine Withdrawal Followed by a Test of Smoking Topography, Reward, and Reinforcement
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Nicotine Dependence
Keywords: cigarette
craving
reward
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2007-12-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Study of varenicline 2.0 mg/day treatment for 2 weeks with smoking test done in laboratory on Day 8 and a 1 week quit attempt from Day 8-14.


Eligibility criteria: Inclusion Criteria:

* At least 10 cigarettes/day
* Interest in quitting smoking
* Willgness to comply with overnight smoking abbstiennce period followed by lab smoking test

Exclusion Criteria:

* Pregnancy
* Axis I psychiatric disorder which require treatment with psychoactive medication and would make study compliance difficult.
* Clinically significant medical condition in opinion of study clinician
* Drug or alcohol dependence inlast 12 months
* Use of other smoking cessation medications ot treatment progams in last 2 months

Primary outcomes:
measure: Smoking reward
timeFrame: laboratory test
Secondary outcomes:
measure: 1 week abstinence induced craving and reward
timeFrame: Day 8, 9, 11 and 14 questionaires
Other outcomes:
Locations:
city: New York
country: United States
facility: VA New York Harbor Healthcare System, MHAD clinic
state: New York
Study officials:
affiliation: NYU Langone Health
name: Malcolm Reid, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02477605: Clinical Comparison of 27+® and 23-gauge ULTRAVIT® 7500 Cpm Vitrectomy Outcomes
Official title: Clinical Comparison of 27+® and 23-gauge ULTRAVIT® 7500 Cpm Vitrectomy Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitreoretinal Disease
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-06-23
Enrollment: 137
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the treatment day change between immediate postoperative and immediate preoperative intraocular pressure (IOP) between 27-gauge and 23-gauge vitrectomy instruments.

Detailed description: Required follow-up for this study is 3 months post treatment.

Eligibility criteria: Inclusion Criteria:

* Willing and able to provide informed consent and attend all required study visits;
* Requires vitrectomy in at least one eye;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Previous vitrectomy or glaucoma surgery;
* Planned treatment requires scleral buckling, combined procedures (eg, cataract surgery), silicone oil, and expansive gas other than sterile air;
* Treated with topical IOP lowering medication(s) at any time from baseline assessment to time of surgery;
* Pregnant or planning to become pregnant during the course of the trial;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Change in Intraocular Pressure (IOP) on Operative Day
timeFrame: Day 0 preoperative, Day 0 postoperative
Secondary outcomes:
measure: Mean Conjunctival Edema Score at Week 1
timeFrame: Week 1 post operative
measure: Mean Post-operative Pain Rating at Day 1
timeFrame: Day 1 post operative
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon, A Novartis Division
name: Clinical Manager, Surgical, GCRA
role: STUDY_DIRECTOR
References:
Clinical trial NCT05578105: Prevalence and Genetic Alternation of Autoimmune Polyglandular Syndrome Type II in Taiwan
Official title: Prevalence and Genetic Alternation of Autoimmune Polyglandular Syndrome Type II in Taiwan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autoimmune Polyendocrine Syndrome Type II
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 650
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We study patients with autoimmune polyendocrine syndrome type II

Brief summary: Autoimmune polyendocrine syndrome (APS) is an autoimmune disease involving at least two endocrine organ. It is classified into type I and type II diseases. Among them, APS type II is more common. It is diagnosed when two of the three following diseases are diagnosed in the same patient, including type 1 diabetes mellitus, autoimmune thyroid disease, and primary adrenal insufficiency. In this study, we will observe the epidemiology, clinical characteristics, and genetic variants of APS II in Taiwan.


Eligibility criteria: Inclusion Criteria:

* Patients visited NTUH during 2006-2021, and had at least two of the three diseases: type 1 DM, primary adrenal insufficiency, and autoimmune thyroid disease.

Exclusion Criteria:

* Patients aged less than 20 years old

Primary outcomes:
measure: Rates of endocrine organs involved
timeFrame: 2022/1/1 ~ 2026/12/31
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Shyang-Rong Shih, MD, PhD
role: STUDY_DIRECTOR
References: