louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03009916: Bileacid Malabsorption and GLP-1 Secretion
Official title: Bileacid Malabsorption and GLP-1 Secretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bileacid Malabsorption
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to examine the influence of BAM on postprandial GLP--1 secretion and glucose homeostasis, both with and without bile acid sequestration.


Eligibility criteria: Inclusion Criteria:

* Northern European origin
* Normal haemoglobin
* Age above 18 years and below 70 years
* Informed and written consent
* BMI \> 23 kg/m2 and \< 35 kg/m2
* Normal fasting plasma glucose (FPG) \< 6.5 mM) and glycated haemoglobin (HbA1c) \< 48 mmol/mol

Exclusion Criteria:

* Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>2 times normal values) or history of hepatobiliary disorder
* Gastrointestinal disease (except BAM), previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
* First-degree relatives with diabetes
* Nephropathy (serum creatinine \>150 µM and/or albuminuria
* Treatment with medicine that cannot be paused for 12 hours
* Hypothyroidism or hyperthyroidism
* Treatment with oral anticoagulants
* Active or recent malignant disease
* Any treatment or condition requiring acute or sub-acute medical or surgical intervention
* Lack of effective birth control in premenopausal women
* Any condition considered incompatible with participation by the investigators

Primary outcomes:
measure: GLP-1
timeFrame: 240 min
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Center for Diabetes Research, Gentofte Hospital
Study officials:
References:
Clinical trial NCT05733416: Intensive Cancer Screening After Cryptogenic Stroke
Official title: Intensive Cancer Screening After Cryptogenic Stroke (INCOGNITO) Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Occult Cancer
Keywords: cryptogenic stroke
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Brain Canada
name: Heart and Stroke Foundation of Canada
name: Canadian Stroke Consortium (CSC)
First posted: 2023-02-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The INCOGNITO Pilot Trial is a single centre pilot prospective randomized open-label blinded endpoint (PROBE) trial to assess the feasibility of a full-scale randomized trial to determine whether an occult cancer screening strategy of FDG PET/CT in addition to usual care increases the number of occult cancers diagnosed after screening compared to usual care cancer screening alone in patients with cryptogenic stroke.


Eligibility criteria: Inclusion Criteria:

* adults ≥18 years
* presenting to the Ottawa Hospital Stroke Prevention Clinic or the Ottawa Hospital Neurovascular Unit with a first cryptogenic ischemic stroke after advanced evaluation as per American Heart Association guidelines and Saver approach (maximum 3 months after stroke)
* patient or delegate willing and able to provide informed consent.

Exclusion Criteria:

* contraindications to FDG PET/CT (pregnancy or unable to lie still in bed for 20 minutes)
* active cancer or previous cancer diagnosis (other than basal or squamous cell carcinoma of the skin)

Primary outcomes:
measure: Participant Recruitment
timeFrame: Over 12 months
Secondary outcomes:
measure: Eligibility Rate
timeFrame: Over 12 months
measure: Consent Rate
timeFrame: Over 12 months
measure: Retention Rate
timeFrame: Over 24 months
measure: Study Completion Rate
timeFrame: Over 24 months
measure: Adherence Rate
timeFrame: Over 24 months
Other outcomes:
measure: Screening time frame
timeFrame: Over 24 months
measure: Reasons for participation
timeFrame: Over 24 months
measure: Usual care cancer screening strategies
timeFrame: Over 24 months
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT01787916: 52 Week Trial of Liraglutide in Type 1 Diabetes
Official title: Cross-over, Double-blind, Unicentric, 52 Week Trial of Liraglutide in Type 1 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
overweight
insulin
liraglutide
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2013-02-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To our knowledge, no trial has specifically studied the effect of liraglutide combined with a basal/bolus insulin regimen in type 1 diabetes in a cross-over, double-blind, unicentric model. Moreover, the potential impact of a glucagon-like peptide-1 agonist on measures of abdominal fat (assessed by CT scan), insulin sensitivity (assessed by the gold standard euglycemic-hyperinsulinemic clamp) and satiety sensations have not been evaluated in this population.

Hypothesis Overweight participants with type 1 diabetes on liraglutide/insulin treatment will present improved glucose control with decreased HbA1c, decreased fasting and mean weekly glucose concentrations and glycemic excursions as well as increased insulin sensitivity compared to participants on placebo/insulin treatment. Participants with liraglutide/insulin treatment will also present improved endothelial function, lower body weight, central adipose tissue assessed by CT scan and higher satiety sensations assessed by visual analogue scales.

Detailed description: Participants will be submitted to this double-blind cross-over protocol of 52-week use of liraglutide/placebo.

Eligibility criteria: Inclusion Criteria:

* type 1 diabetes non smoker BMI superior or equal to 25 diabetes duration superior or equal to 5 years

Exclusion Criteria:

* diabetic complication HbA1c superior or equal to 8.5% cancer acute or chronic pancreatitis

Primary outcomes:
measure: Assessment of Changes in Glycemic Control by HbA1c.
timeFrame: Measure changes in HbA1c at 24 and 52 weeks from baseline
Secondary outcomes:
measure: Assessment of Changes on Adipose Tissue
timeFrame: Measure changes in the composite at 24 and 52 weeks from baseline
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: CHU de Québec
Study officials:
affiliation: CHU de Québec
name: Stanley John Weisnagel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Québec
name: Martin D'Amours, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dube MC, D'Amours M, Weisnagel SJ. Beyond glycaemic control: A cross-over, double-blinded, 24-week intervention with liraglutide in type 1 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):178-184. doi: 10.1111/dom.13063. Epub 2017 Sep 6.
Clinical trial NCT06657716: Heidelberg Engineering ANTERION Software Comparison Study
Official title: The Heidelberg Engineering ANTERION Software Comparison Precision and Agreement Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eyes With Normal Anterior Segment
Eyes With Abnormal Anterior Segment
Lead sponsor: Heidelberg Engineering GmbH
Sponsor class: INDUSTRY
First posted: 2024-10-24
Enrollment: 60
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Normal Anterior Segment
* Abnormal Anterior Segment

Brief summary: This study is conducted to compare the the investigational device ANTERION with software version 1.5 against the ANTERION with software version 1.2.4 (cleared version)


Eligibility criteria: Inclusion Criteria Normal Anterior Segment

1. Age 22 years or older
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
3. Able to fixate
4. Eye(s) with normal anterior segment

Exclusion Criteria Normal Anterior Segment

1. Active infection or inflammation in the study eye
2. Insufficient tear film or corneal reflex
3. Physical inability to be properly positioned at the study devices or eye exam equipment
4. Rigid contact lens wear 2 weeks prior to imaging
5. Soft lenses worn within one hour prior to imaging
6. Cataract grade ≥1.5

Inclusion Criteria Abnormal Anterior Segment

1. Age 22 years or older
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
3. Able to fixate
4. Eye(s) with abnormal anterior segment (including cataract grade ≥ 1.5)

Exclusion Criteria Abnormal Anterior Segment

1. Active infection or inflammation in the study eye
2. Insufficient tear film or corneal reflex
3. Physical inability to be properly positioned at the study devices or eye exam equipment
4. Rigid contact lens wear 2 weeks prior to imaging
5. Soft lenses worn within one hour prior to imaging

Primary outcomes:
measure: Central Cornea Thickness
timeFrame: Through study completion, an average of 1 day
measure: Thinnest Point Thickness
timeFrame: Through study completion, an average of 1 day
measure: Lens Thickness
timeFrame: Through study completion, an average of 1 day
measure: Anterior Chamber Depth
timeFrame: Through study completion, an average of 1 day
measure: Axial Length
timeFrame: Through study completion, an average of 1 day
Secondary outcomes:
measure: Adverse Events Rate
timeFrame: Through study completion, an average of 1 day
Other outcomes:
Locations:
city: Wilmar
country: United States
facility: Fischer Eye Laser Center
state: Minnesota
Study officials:
affiliation: Fischer Laser Eye Center
name: Jeffrey Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01344616: Reducing Preterm Births in Underserved Pregnant Women
Official title: Reducing Preterm Births in Underserved Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Preterm Birth
Low Birth Weight <2500 Grams
Verylow Birthweight <1500 Grams
Keywords: computer-based behavioral support
Lead sponsor: PHCC LP
Sponsor class: INDUSTRY
First posted: 2011-04-29
Enrollment: 482
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 48
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Timely screening and management of modifiable conditions can reduce preterm births, yet providing effective prenatal risk management systems to meet the unique needs of medically underserved populations is complex. If the proposed system proves to be effective in reducing preterm births it can improve maternal and child quality of life as well as reduce the economic burden of preterm births in the U.S.

Detailed description: The primary aim of this proposal is to test the efficacy of a clinic-based, computer-assisted intervention system to significantly reduce preterm births in high-risk populations. This system will: (1) assess a pregnant woman's unique risks in six modifiable areas associated with increased risks of preterm birth including smoking cessation, poor nutrition, domestic violence, maternal depression and stress, urinary and reproductive tract infections and substance use; (2) provide her with tailored advice and action planning tools on reducing her risks; (3) provide her certified nurse midwife or physician with information related to her assessed risks and counseling suggestions tailored for her needs, and \[(4) promote effective referrals to, and successful linkages with community-based support organizations.\] Because preterm birth rates are much higher for underserved African American women, we are proposing to focus the intervention with this population.

Eligibility criteria: Inclusion Criteria: Study inclusion criteria include:

1. age 16-48 years,
2. 1st trimester of pregnancy,
3. race/ethnicity (non-Hispanic Black, or English-speaking Hispanic Black), and 4) a self-reported completion of grade 6 or higher.

Exclusion Criteria: Exclusion criteria include:

1. a medical condition or risk to the pregnancy that the physician or nurse midwife determines serious and a reason for exclusion, and
2. a literacy level of \< grade 6. No prior experience using a computer is needed. -

Primary outcomes:
measure: Birthweight
timeFrame: 9 months
Secondary outcomes:
measure: Gestational Weight
timeFrame: 9 months
Other outcomes:
Locations:
city: Pueblo
country: United States
facility: PHCC LP
state: Colorado
Study officials:
References:
Clinical trial NCT00385216: Nicotine as an Adjuvant Analgesic for Third Molar Surgery
Official title: Effect of Nicotine on Pain After Third Molar Extraction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Crowding
Keywords: Third Molar
Pain
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2006-10-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Third molar surgery is complicated by pain and swelling for several days after surgery. Non-steroidal antiinflammatory drugs have been useful in combination with opioids for treatment. Nicotine has antiinflammatory and pain relieving properties. We will use nicotine or placebo as a nasal spray before surgery to determine whether nicotine affects pain or inflammation.

Detailed description: This is a randomized double blind cross-over study. In each of two sittings, the third molars on one side of the mouth are removed. In one sitting the subject will receive a nicotine nasal spray (3mg) and in the other placebo. VAS and narcotic utilization will be compared within patients.

Eligibility criteria: Inclusion Criteria:

* over 18
* 4 molars to be removed

Exclusion Criteria:

* pregnant
* lactating
* chronic pain
* narcotic use
* asthma
* ex-smokers

Primary outcomes:
measure: Pain Reported by Patient
timeFrame: Up to 1 day
Secondary outcomes:
measure: Heart Rate
timeFrame: 5 days
measure: Systolic Blood Pressure
timeFrame: 5 days
measure: Diastolic Blood Pressure
timeFrame: 5 days
measure: Difference in Amount of Nausea Reported
timeFrame: 5 days
measure: Difference in Number of Hydrocodone 5 mg Acetaminophen 325 mg Tablets Taken After Surgery
timeFrame: 5 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Pamela Flood, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03345316: Study of FFI-1010 in Pediatric Kidney Disease
Official title: Safety and Usability Evaluation Study of FFI-1010 Single Administration for Children Under 18 Years Old With Kidney Disease (Phase III Study).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Children Under 18 Years Old With Kidney Disease
Lead sponsor: Fuji Yakuhin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 60
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is revealing that the ratio of creatinine clearance (Ccr) to inulin clearance (Cin) measuring at the same time is more than 1.2.


Eligibility criteria: Inclusion Criteria:

* Kidney disease patients requiring exact evaluation of kidney function
* eGFR: \>=30 and \<=89 mL/min/1.73m\^2

Exclusion Criteria:

* Edema on the day before start of study treatment
* Oliguria on the day before start of study treatment
* Dehydration on the day before start of study treatment
* Infection or inflammatory disease before administration
* History of epilepsy or organic brain disorder
* History of, clinically significant cardiac, hematologic, hepatic and pancreatic disease

Primary outcomes:
measure: Ratio of Cin to Ccr measuring at the same time
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Fuji Yakuhin Investigational sites
Study officials:
References:
citation: Uemura O, Ishikura K, Kamei K, Hamada R, Yamamoto M, Gotoh Y, Fujita N, Sakai T, Sano T, Fushimi M, Iijima K. Comparison of inulin clearance with 2-h creatinine clearance in Japanese pediatric patients with renal disease: open-label phase 3 study of inulin. Clin Exp Nephrol. 2022 Feb;26(2):132-139. doi: 10.1007/s10157-021-02133-5. Epub 2021 Sep 25.
Clinical trial NCT04035616: Probiotics in Elderly Patients With Medical Conditions
Official title: Evaluation of the Efficacy of Probiotics in Treating Constipation in Elderly Patients With Multiple Chronic Co-morbidities: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Constipation
Multi-Core Disease
Keywords: microbial cell preparation
Hexbio®
probiotics
elderly
chronic medical conditions
constipation,
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The subjects received either the probiotics or a placebo.
Primary purpose: TREATMENT

Brief summary: Study of efficacy of probiotic in older patients with multiple co-morbidites and constipation

Detailed description: Background and aims:

Probiotics are known to have a beneficial effect on the management of constipation. Thus, the current study objective was to evaluate the impact of a microbial cell preparation (MCP) (Hexbio®; comprising Bifidobacterium and Lactobacillus strains) on stool frequency, consistency, and constipation-related symptoms in elderly patients with multiple chronic medical conditions.

Eligibility criteria: Inclusion Criteria:

-clinical diagnosis of constipation

Exclusion Criteria:

* Parkinson's disease,
* spinal cord lesions
* post radiation strictures
* on calcium supplements of greater than 1,500 mg per day
* immune-deficiency
* critical illness

Primary outcomes:
measure: changes in stool output frequency
timeFrame: 7 days
measure: changes in stool consistency
timeFrame: 7 days
Secondary outcomes:
measure: patients' perceptions of an improvement in their constipation-related symptoms 1
timeFrame: 7 days
measure: patients' perceptions of an improvement in their constipation-related symptoms 2
timeFrame: 7 days
measure: patients' perceptions of an improvement in their constipation-related symptoms 3
timeFrame: 7 days
measure: patients' perceptions of an improvement in their constipation-related symptoms 4
timeFrame: 7 days
Other outcomes:
Locations:
city: Kuala lumpur
country: Malaysia
facility: Universiti Kebangsaan Malaysia Medical Faculty
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: National University of Malaysia
name: hayati Yaakup, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghafar MYA, Yaakup H, Ali RAR, Shah SA. Evaluation of the Efficacy of Probiotics (MCP(R) BCMC(R) Strains) Treating Constipation in Elderly Patients with Multiple Chronic Co-Morbidities: A Randomized Control Trial. J Nutr Health Aging. 2020;24(10):1066-1072. doi: 10.1007/s12603-020-1494-1.
Clinical trial NCT05199116: National Registry of Cardiovascular Surgery in Argentine
Official title: National Registry of Cardiovascular Surgery in Argentine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Surgery
Lead sponsor: Sociedad Argentina de Cardiología
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years of age who underwent CCV according to the inclusion criteria.

Brief summary: The National Registry of Cardiovascular Surgery in Argentina is a registry of patients undergoing cardiovascular surgery that involves the entire country with the ultimate aim of determining the results of said surgery throughout the country.

Detailed description: It is an observational registry with selective inclusion of patients who undergo certain cardiovascular surgeries, where the pre-surgical status will be analyzed, the determinants during surgery and the postoperative evolution of said patients will be evaluated

Eligibility criteria: Iinclusion Criteria:

Over 18 years

Myocardial revascularization surgery

Valvular surgeries

Ascending Aortic Surgery

Type A Aortic Dissection Surgery

Combined surgery

Exclusion Criteria:

Cardiovascular surgery for congenital pathologies

Peripheral vascular surgery

Cardiovascular surgery secondary to trauma

Thoracic and abdominal aorta pathology

Other surgeries

Primary outcomes:
measure: National Registry of Cardiovascular Surgery
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Sociedad Argentina de Cardiología
state: Caba
Study officials:
References: