louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02819037: Small Intestinal Bacterial Overgrowth Obese
Official title: Modification of Digestive Flora After Gastric Bypass : Pilot Study on Microbial Overgrowth Using Gas Chromatography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Bypass
Blind Loop Syndrome
Bacterial Overgrowth Syndrome
Chromatography, Gas
Keywords: Gastric bypass
Intestinal Bacterial Overgrowth Syndrome
Gas chromatography
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Santelys Association
First posted: 2016-06-30
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this research is to determine the incidence of microbial overgrowth of the small intestine before and after a gastric bypass. For this purpose, the study is based on the analysis of the expired hydrogen H2 with gas chromatography before surgery and at 1, 3, 6, 12, 18 and 24 months.


Eligibility criteria: Inclusion Criteria:

* Severe obesity (BMI\>35kg/m² with at least one comorbidity or BMI\>40kg/m² without comorbidity) and after medical care for at least 6 months
* Patient who will follow bariatric surgery by bypass gastric
* Social insurance affiliation
* Signature of the informed consent

Exclusion Criteria:

* Contraindication criteria for bariatric surgery (cognitive or mental severe disorders, severe and non-stabilized eating disorders, etc.)
* Chronic inflammatory bowel disease (Crohn's disease, hemorrhagic rectocolitis)
* Previous intestinal surgery
* Antibiotic periodicity treatment of less than 3 months
* Other diseases responsible for bacterial overgrowth
* Pregnancy or breastfeeding

Primary outcomes:
measure: Changes in expired hydrogen H2 concentration
timeFrame: change at baseline et up to 24 months
Secondary outcomes:
measure: Changes in digestive symptoms
timeFrame: change at baseline et up to 24 months
measure: Changes in intestinal transit
timeFrame: change at baseline et up to 24 months
measure: Changes in malabsorption
timeFrame: change at baseline et up to 24 months
Other outcomes:
Locations:
city: Arras
country: France
facility: Centre Hospitalier d'Arras
city: Douai
country: France
facility: Centre Hospitalier de Douai
Study officials:
affiliation: Centre Hospitalier Arras
name: Vincent Florent, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00384137: A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients
Official title: A Multicenter, Open, Single Sequence Crossover Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Stable Kidney Transplant Patients Converted From a Prograf® Based Immunosuppressive Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Transplantation
Keywords: Tacrolimus
Kidney Transplantation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-10-05
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable kidney transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.

Detailed description: Multicenter, open, single sequence crossover study. Subject Enrolment: Prograf® administered twice daily is replaced by Prograf as study medication, administered twice daily.

Six weeks Prograf-Treatment Phase to confirm compliance to regimen stability requirements (see Inclusion and Exclusion Criteria), and collection of data under Prograf treatment.

Conversion from Prograf (twice daily, morning \& evening dosing) total daily dose to MR4 once daily (only morning dosing) on a 1:1 (mg:mg) basis on Day 1.

Twelve weeks MR4-Treatment Phase with study assessments for safety and efficacy.

Eligibility criteria: Inclusion Criteria:

* Kidney transplant at least 12 months prior to enrollment.
* Prograf® dose remained unchanged for a minimum of 12 weeks prior to enrollment and tacrolimus whole blood trough level measurements were in the range of 5-15 ng/mL.

Exclusion Criteria:

* Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.

Primary outcomes:
measure: Creatinine clearance
timeFrame: 12 weeks
Secondary outcomes:
measure: Blood pressure, HbA1c, acute rejection
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bicetre
country: France
city: Freiburg
country: Germany
city: Regensburg
country: Germany
city: Maastricht
country: Netherlands
city: Rotterdam
country: Netherlands
city: Poznan
country: Poland
city: Szczecin
country: Poland
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Manchester
country: United Kingdom
Study officials:
affiliation: Astellas Pharma GmbH
name: Use Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT06386237: Nutritional Modulation of Cognition and Brain Activity
Official title: Nutritional Modulation of Learning and Decision Making and Their Underlying Neural Processes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nutrition, Healthy
Cognitive Change
Brain Activity
Lead sponsor: University of Vienna
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
First posted: 2024-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to investigate the effects of different meal interventions on cognition (i.e., learning and decision making) and brain activity in healthy participants.


Eligibility criteria: Inclusion Criteria:

* 18 to 40 years old
* fluent in German
* right-handed
* able to safely undergo MRI scanning
* BMI (Body-Mass-Index) between 18.5 and 29.9 kg/m2

Exclusion Criteria:

* current medication that might interfere with the processes studied
* any metabolic, gastrointestinal, cardiological, neurological, psychiatric or any recurring or chronic diagnoses
* drug use
* alcohol consumption \> 10 g/d for women and \> 20 g/d for men
* smoking
* shifted circadian rhythm (e.g. jetlag, shift work)
* vegan or vegetarian diet
* food intolerances
* females: hormonal contraception, pregnancy, lactation

Primary outcomes:
measure: Changes in cognition/behavior I
timeFrame: 3-4.5 hours (post-meal)
measure: Changes in cognition/behavior II
timeFrame: 3-4.5 hours (post-meal)
measure: Changes in brain activity
timeFrame: 3-4.5 hours (post-meal)
Secondary outcomes:
measure: Changes in metabolic parameters I
timeFrame: from baseline (prior meal) to approx. 4.5 hours after meal at several time points
measure: Changes in metabolic parameters II
timeFrame: from baseline (prior meal) to approx. 4.5 hours after meal at several time points
measure: Changes in metabolic parameters III
timeFrame: from baseline (prior meal) to approx. 4.5 hours after meal at several time points
measure: Changes in metabolic parameters IV
timeFrame: from baseline (prior meal) to approx. 4.5 hours after meal at several time points
measure: Changes in subjective affective state
timeFrame: from baseline (prior meal) to approx. 4.5 hours after meal at several time points
measure: Changes in experienced hunger
timeFrame: rom baseline (prior meal) to approx. 4.5 hours after meal at several time points
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University of Vienna
Study officials:
affiliation: University of Vienna
name: Stefan Schulreich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05996237: Older Adults' Readiness to Stop Prescribed Medications
Official title: Older Adults' Readiness to Stop Prescribed Medications with Guidance from Health Care Professionals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polypharmacy, Decision-making
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 108
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in the University of Pittsburgh Claude D. Pepper communty research registry.

Brief summary: Polypharmacy, regular use of 5+ prescribed medications, is common among older adults and potentially harmful. Patients differ in their concern about medications, comfort in raising questions about them, and trust and confidence in physician judgment. This pilot observational research will determine older adults' readiness to "deprescribe," that is, stop prescribed medications under physician guidance.

Detailed description: The purpose of this research is to assess readiness to deprescribe, that is, to determine how willing patients are to stop prescriptions that may no longer be necessary or may no longer have a favorable benefit-risk ratio. This readiness depends on many factors, including a patient's trust in a health care provider, how proactive patients are in seeking care, and patients' comfort in changing longstanding medical regimens.

The proposed two-wave survey research will use validated instruments and recruit from an older adult research registry to determine (i) readiness to deprescribe at baseline, (ii) correlates of such readiness, and (iii) effects of intercurrent illness and changing health on readiness to deprescribe at 6 months.

Specific aims:

1. Determine readiness to deprescribe among a sample of patients with 5+ prescriptions using validated scales.
2. Determine correlates of readiness to deprescribe. Patients differing in age, gender, race, education, and comorbidity may differ in willingness to stop prescribed medications.
3. Determine the effect of intercurrent illness on readiness to deprescribe. Over 6 months, we anticipate some patients will have a new onset of illness or hospitalization, or increasing levels of disability. We would like to determine if these changes in medical status affect readiness to deprescribe.

Eligibility criteria: Inclusion Criteria:

1. 65 years or older
2. Medical visit within past 6 months
3. Self-report of at least 5 regular medications for at least 4 weeks

Exclusion criteria:

1. Diagnosis of dementia or score \<=4 on Memory Impairment Screen
2. Hospitalization in prior 30 days with change in medications

Primary outcomes:
measure: Patient Motivation to Deprescribe
timeFrame: Change over 6 months
Secondary outcomes:
measure: Self-reported stopping/changing prescription medication
timeFrame: 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00746837: AZD5672 Absolute Bioavailability Study
Official title: A Phase I Study to Assess Absolute Bioavailability of AZD5672 at Steady-state in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: AZD5672
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to estimate the absolute bioavailability at steady state of 2 doses of AZD5672 (50 mg and 150 mg administered orally once daily)


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures.
* Females should not be of childbearing potential
* Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate
* Unsuitable venous access for intravenous studies
* Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer).

Primary outcomes:
measure: PK variables
timeFrame: Frequent sampling occasions during study periods
Secondary outcomes:
measure: Safety variables (adverse events, blood pressure, pulse, safety lab)
timeFrame: During the whole treatment periods
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Research Site
state: London
Study officials:
affiliation: AstraZeneca R&D, Charnwood, UK
name: Mark Layton, MD, PhD
role: STUDY_DIRECTOR
affiliation: PAREXEL Clinical Pharmacology Research Unit
name: Tania Hugo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01403337: Cardiac Remote Ischemic Preconditioning Before Elective Major Vascular Surgery
Official title: Cardiac Remote Ischemic Preconditioning Before Elective Major Vascular Surgery (CRIPES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Peripheral Arterial Disease
Keywords: peripheral arterial disease
myocardial infarction
Lead sponsor: Center for Veterans Research and Education
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 205
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: Vascular surgery is considered a high-risk operation with an anticipated risk of major cardiovascular complications in excess of 5%. The occurrence of a cardiovascular complication after surgery carries a long-term higher mortality risk. The main objective of this investigation is to reduce the proportion of patients having major cardiovascular complications during surgery through a clinical protocol of remote preconditioning that is safe, effective and reproducible.


Eligibility criteria: Inclusion Criteria:

* Eligible patients would be those undergoing elective major vascular surgery at the Minneapolis VA Medical Center for an expanding abdominal aortic aneurysm, obstructive carotid disease, and/or chronic limb ischemia during the study period. All patients must be ≥ 18 years of age and provide written informed consent.

Exclusion Criteria:

* Exclusion criteria include hypertensive crisis, acute coronary syndrome in the preceding 6 weeks, severe valvular heart disease, peripheral arterial disease of the upper extremities, manifested by a systolic blood pressure difference greater than 20 mmHg, pregnant women, patients unable to understand the consent process due to mental illness, advanced malignancy with limited life expectancy (\<1 year), and hemodialysis with a fistula in the upper extremity.

Primary outcomes:
measure: Troponin I elevation above the URL
timeFrame: Within 1 week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
Study officials:
affiliation: Minneapolis VA Medical Center and The University of Minnesota
name: Santiago A Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01015937: Effect of Turmeric on Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Nephropathy
Proteinuria
Keywords: diabetes
nephropathy
turmeric
serum IL8
serum TGFb
serumINF
urinary IL8
urine TGFb
Lead sponsor: Shaheed Faghihi Hospital
Sponsor class: OTHER
Collaborators: name: Shiraz University of Medical Sciences
First posted: 2009-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether turmeric is effective in improvement of diabetic nephropathy and in decrease in the amount of proteinuria and cytokine levels.

Detailed description: Diabetic nephropathy is leading cause of ESRF that many therapy recommended for it. In this study, we investigate effect of turmeric on diabetic nephropathy, thus we selected diabetic nephropathy patients and divided them into 2 groups. One group received turmeric + ACE inhibitor + Angiotensin II receptor blocker (ARB) and the second group received only ACE inhibitor + ARB.

Eligibility criteria: Inclusion Criteria:

* diabetic nephropathy
* more than 300 mg proteinuria/day
* age more than 18 years old

Exclusion Criteria:

* DM type 1

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Clinic
state: Fars
Study officials:
affiliation: Shiraz nephro-urology research center
name: maryam pakfetrat, assistant professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00356837: Diagnosing Extremity Fractures and/or Dislocations Using Ultrasound Presenting to the Emergency Department
Official title: Diagnosing Extremity Fractures and/or Dislocations Using Ultrasound in Adult Patients Presenting to the Emergency Department
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fractures
Dislocations
Lead sponsor: United States Army Institute of Surgical Research
Sponsor class: FED
First posted: 2006-07-26
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the efficacy of ultrasound in diagnosing the presence or absence of extremity fractures or dislocations.

Hypothesis: Can ultrasound be used as an accurate and effective method for determining the presence or absence of extremity fractures or dislocations? Is there a difference in amount of pain experienced prior to and after the ultrasound?

Detailed description: This prospective, multicenter cohort study. The sampling method will be a convenience sample of all adult patients presenting to the ED with symptoms concerning a fracture and/or dislocation of an extremity. Once a patient has been deemed an appropriate candidate for the study, written consent will be obtained from one of the Associate Investigators. Once consent has been obtained, a resident physician will perform the ultrasound examination on the affected extremity(s) and note their findings.

Eligibility criteria: Inclusion Criteria:

* clinical suspicion of a fracture and/or dislocation of an extremity
* Age Greater than 18 years
* English speaking
* able to give consent

Exclusion Criteria:

* Age less than 18 years, including emancipated minors
* Unstable patients with B/P below 90mmHg systolic
* Open, unstable, or suspected compound fracture
* Physician has reviewed X-Rays and made diagnosis before ultrasound could be done
* X-Rays will not be ordered
* Patient is pregnant
* Patient cannot give own consent
* English is not the patient's primary language

Primary outcomes:
measure: Faster diagnosis and sooner definitive treatment for extremity fractures or dislocations.
timeFrame: 1 hour
Secondary outcomes:
measure: Unnecessary evacuation in the pre hospital combat setting.
timeFrame: 2 hours
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: US Army Institute of Surgical Research
name: John G. McManus, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kirkpatrick AW, Brown R, Diebel LN, Nicolaou S, Marshburn T, Dulchavsky SA. Rapid diagnosis of an ulnar fracture with portable hand-held ultrasound. Mil Med. 2003 Apr;168(4):312-3.
Clinical trial NCT00332137: Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects
Official title: Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Health
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2006-06-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The muscarinic antagonist tolterodine is widely used treat urinary urge incontinence. Though acteylcholine is the primary excitatory neurotransmitter in the gastrointestinal tract, the phase III trials suggest that tolterodine infrequently causes constipation. Therefore, the objectives of this study are to assess if tolterodine affects the speed at which food travels through the stomach, intestines and colon (i.e., gastrointestinal and colonic transit) in healthy subjects.

Detailed description: The specific aims of this study are to test the hypotheses that the non-specific muscarinic antagonist tolterodine will not:- i) delay colonic transit and the proximal colonic emptying rate; ii) delay gastric emptying; nor iii) delay small intestinal transit compared to placebo in healthy subjects.

Eligibility criteria: Age 18-70 years old. Absence of gastrointestinal symptoms as characterized by bowel symptoms questionnaire and absence of significant anxiety or depression characterized by a hospital anxiety and depression questionnaire.

Able to understand and willing to sign informed consent. Females who are nonpregnant, nonlactating, and willing to use a clinically approved methods of contraception two weeks prior to Day 0 until 1 week after the last dose of study medication.

Primary outcomes:
measure: Colonic transit (as measured by GC24)
Secondary outcomes:
measure: Colonic transit (GC48)
measure: Ascending colon emptying t1/2
measure: Colonic filling at 6 hours, i.e. a surrogate marker of small bowel transit time
measure: Gastric emptying time (1, 2, 4 hours, thalf)
measure: Average number of stools per day before and during treatment
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References: