louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02496936: Acute Effects of Fats on Satiety and Energy Needs
Official title: Acute Effects of Fats on Satiety and Energy Needs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Energy Expenditure
Appetite
Satiety
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2015-07-14
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the acute effect of dietary fat on satiety and energy metabolism.

Detailed description: The influences of specific dietary fat sources on satiety, appetite and energy utilization remains unclear; evidence is lacking on whether responses vary according to acute intake. The researchers will use a controlled setting to determine whether the source of dietary fat is related to perceived satiety, satiety hormone responses, and energy expenditure by conducting experiments to evaluate short term (acute) effects.

Eligibility criteria: Inclusion Criteria:

* body mass index between 18.0-34.9 kg/m2
* free of major diagnosed, untreated medical conditions
* controlled hypertension
* non-smoking or use of other tobacco products, including e-cigarettes
* not taking steroid-based medications
* not planning to or currently attempting to gain or lose weight
* willing to comply with study demands
* use of oral contraceptives
* low intake of long chain omega 3 fatty acids

Exclusion Criteria:

* diagnosed eating disorders
* diabetes (blood sugar ≥ 126 mg/dl)
* hypertension (systolic ≥ 160 mmHg or diastolic \> 100 mmHg)
* diagnosed cardiovascular, pulmonary, skeletal and metabolic disease
* currently pregnant or planning to become pregnant, or lactating
* taking medications known to affect appetite, blood lipids, body composition, body weight, or food intake (appetite control drugs, steroids, antidepressants)

Primary outcomes:
measure: Acute effect of fat intake on energy expenditure as determined by metabolic rate
timeFrame: Incremental Area Under the Curve (iAUC) of metabolic rate from 0 to 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Matthew Picklo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02418936: Development and Clinical Application of Two New Genetic Deafness Gene Diagnostic Kit
Official title: Development and Clinical Application of Two New Genetic Deafness Gene
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Waardenburg Syndrome
Large Vestibular Aqueduct Syndrome
Keywords: Waardenburg syndrome
Large vestibular aqueduct syndrome
Diagnosis
copy number variation
Multiplex polymerase chain reaction
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who are diagnosised Waardenburg syndrome or large vestibular aqueduct syndrome.

Brief summary: The purpose of this study is to develop and applicate two new genetic deafness gene diagnostic kit for Waardenburg syndrome and large vestibular aquduct syndrome.

Detailed description: 1. For the pathogenic gene of Waardenburg syndrome and large vestibular aqueduct syndrome, based on the second-generation sequencing technology, the investigators develop multiplex PCR system for these two hereditary deafness gene diagnostic kit.
2. Using CNVplex high-throughput gene copy number detection technology to analyse Warrdenburg syndrome pathologic gene. CNVs analysis for Warrdenburg deafness syndrome develop special testing system / kit achieve SNP / CNVs detected simultaneously, as a supplementary means of genetic testing in clinical deafness.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Waardenburg syndrome
* Clinical diagnosis of large vestibular aqueduct syndrome

Exclusion Criteria:

* Could not be able to exsanguinate

Primary outcomes:
measure: the positive rate of WS diagnosis
timeFrame: two years
Secondary outcomes:
measure: the positive rate of LVAS diagnosis
timeFrame: two years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital
state: Hunan
Study officials:
References:
Clinical trial NCT02411136: A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Multi-dose Administration in Subjects With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-04-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. All subjects will receive 4 weekly doses of study drug over a 3 week period, and then will be followed for an additional 28 weeks, for total study duration of 31 weeks.


Eligibility criteria: Inclusion Criteria:

* Men and women between the ages of 18 and 65 years old
* Diagnosis of SLE
* Stable disease; defined as no change in SLE therapy within the previous 30 days. Up to 5 mg/day incremental changes of prednisone therapy is allowed during the 30 days prior to randomization
* SLE disease duration of at least 1 year, as diagnosed by a physician

Exclusion Criteria:

* Current renal disease
* Signs or symptoms of viral or bacterial infection within 30 days of enrollment
* Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere the study evaluation, completion and/or procedures per the investigator's discretion
* Administration of more than 10 mg/day prednison (or equivalent) in the 30 days prior to randomization

Primary outcomes:
measure: Incidence of treatment emergent adverse events
timeFrame: up to 31 weeks
measure: Incidence of abnormal clinically significant vital signs
timeFrame: up to 31 weeks
measure: Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
timeFrame: up to 31 weeks
measure: Incidence of abnormal clinically significant ECG results
timeFrame: up to 31 weeks
Secondary outcomes:
measure: Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax
timeFrame: up to 31 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Stohl W, Merrill JT, Looney RJ, Buyon J, Wallace DJ, Weisman MH, Ginzler EM, Cooke B, Holloway D, Kaliyaperumal A, Kuchimanchi KR, Cheah TC, Rasmussen E, Ferbas J, Belouski SS, Tsuji W, Zack DJ. Treatment of systemic lupus erythematosus patients with the BAFF antagonist "peptibody" blisibimod (AMG 623/A-623): results from randomized, double-blind phase 1a and phase 1b trials. Arthritis Res Ther. 2015 Aug 20;17(1):215. doi: 10.1186/s13075-015-0741-z.
Clinical trial NCT03614936: Study of a Simplified Geriatric Evaluation Performed by Oncologists Prior to Cancer Treatment by Radiotherapy or Chemotherapy in Subjects Aged 70 Years or Older With Inoperable Squamous Cell Cancer of the Head and Neck
Official title: Study of a Simplified Geriatric Evaluation Performed by Oncologists Prior to Cancer Treatment by Radiotherapy or Chemotherapy in Subjects Aged 70 Years or Older With Inoperable Squamous Cell Cancer of the Head and Neck
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inoperable Squamous Cell Cancer of the Head and Neck
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 800
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 70 years of age or older with ENT carcinoma

Brief summary: Use by Oncologists of Validated Geriatric Assessment Tools: G8 Screening Test and Certain Tests for Thorough Geriatric Evaluation


Eligibility criteria: Inclusion Criteria:

* Subject aged 70 or over
* Carrier of squamous cell carcinoma of the head and neck, locally advanced undergoing treatment by radiotherapy or metastatic / recurrence not accessible to treatment curative locoregional under treatment with chemotherapy.
* Patient likely to be eligible for ELAN-RT or ELAN-FIT or ELAN-UNFIT trials.
* Patients affiliated to a social security scheme

Exclusion Criteria:

* Person deprived of liberty or under guardianship,
* Presence of a neuro-psychological condition, family, social, or geographical, which may hinder the smooth running of the study.
* Patient expressing opposition to participation in this study

Primary outcomes:
measure: Completion rate
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val De Marne
Study officials:
affiliation: Centre Antoine Lacassagne
name: Joel GUIGAY, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05628636: AC-OLE-01-VA Tolerability Study in Healthy Participants Under Different Dosing Conditions
Official title: A Phase 1, Open-label Study to Evaluate the Tolerability of 21 Days of Treatment With the AC-OLE-01-VA Formulation of Tricaprilin Under Different Dosing Conditions in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Cerecin
Sponsor class: INDUSTRY
First posted: 2022-11-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is an open-label, 3-arm study to compare tolerability of three different titration and dosing schedules of the AC-OLE-01-VA formulation of tricaprilin.

Following a screening of up to 28 days, eligible participants will be initially randomised to one of 2 arms (Arm 1 or Arm 2). Arms 1 and 2 will be completed in advance of Arm 3 with all subsequent participants allocated to Arm 3.


Eligibility criteria: Inclusion Criteria:

* Participants who are overtly healthy (in the opinion of the Investigator) as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
* Body weight ≥45 kg and body mass index (BMI) within the range 18.0 - 32.0 kg/m2 (inclusive).

Exclusion Criteria:

* History of, or current gastrointestinal (GI) conditions constituting a risk when taking the study treatment; or interfering with the interpretation of data, based on the Investigator's judgement.
* Participants on a ketogenic diet, low-fat diet or actively using medium chain triglycerides, ketone esters, or other ketogenic products within 3 months prior to screening.

Primary outcomes:
measure: Ratings of discomfort of the adverse events nausea, dyspepsia, abdominal pain, abdominal distension, diarrhoea
timeFrame: 21 days
measure: Incidence of adverse events
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Newstead
country: Australia
facility: RDC Clinical
state: Queensland
Study officials:
References:
Clinical trial NCT03885336: Couples Dynamics and Smoking Cessation
Official title: Interpersonal Mechanisms of Smoking Relapse in Romantic Couples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Smoking Cessation
Cessation, Smoking
Smoking Behaviors
Smoking, Cigarette
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2019-03-21
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants may live through the United States.

Brief summary: This study is about investigating smoking and attempts to quit smoking in couples. Participation will help determine better treatment efforts for couples who want to quit smoking. All study procedures will be conducted remotely, allowing couples to interact with study personnel through zoom.


Eligibility criteria: Inclusion Criteria:

* Couples must be in a relationship for more than 6 months with no plans to separate or move in the next 30 days.
* Participants must smoke at least 5 cigarettes per day for at least the past 2 years.

Exclusion Criteria:

* English non-fluency.
* Currently pregnant, nursing, or intend to become pregnant within the next 6 months.

Primary outcomes:
measure: Cigarette Craving
timeFrame: Throughout study completion, an average of 28 days
measure: Confidence in Quit Attempt
timeFrame: Throughout study completion, an average of 28 days
measure: Mood
timeFrame: Throughout study completion, an average of 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Matthew Kirkpatrick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01863836: Study on the Influence of Fluoroscopy in the Diagnosis of Peripheral Lung Lesions With Endobronchial Ultrasound Guidance
Official title: Randomized Trial of Fluoroscopy Use for Radial Endobronchial Ultrasound-guided Biopsy of Peripheral Lung Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Pulmonary Lesions
Keywords: Radial endobronchial ultrasound
Peripheral lung lesion
Fluoroscopy
Lung cancer
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 133
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 purpose of this study is to determine whether the use of fluoroscopy improves the diagnostic yield of peripheral pulmonary lesions' biopsy guided by radial endobronchial ultrasound (with the use of a guide sheath).

Detailed description: See above

Eligibility criteria: Inclusion Criteria:

* Consecutive patients referred for the bronchoscopic diagnosis of peripheral pulmonary lesions at the Institut Universitaire de Cardiologie et de Pneumologie de Québec(not visible endobronchially)
* Adults over the age of 18

Exclusion Criteria:

* Therapeutic anticoagulation
* Antiplatelet therapy other than aspirin
* Known hemorrhagic diathesis
* Acute respiratory failure
* Pregnancy
* Inability to provide informed consent

Primary outcomes:
measure: Diagnostic yield
timeFrame: Upon production of pathology results, usually within 2 weeks after the test
measure: Sensitivity and specificity
timeFrame: Upon completion of ancillary or confirmatory tests, usually within 2 months after the test
Secondary outcomes:
measure: Lesion localization
timeFrame: Immediate (during the test)
measure: Procedure duration
timeFrame: During the test
measure: Complications
timeFrame: Immediately during the test and up to 4 hours after the test
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval
state: Quebec
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Antoine Delage, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01446536: Effect of Quality Improvement Tools in Congestive Heart Failure (CHF)
Official title: Decreased Readmissions and Improved Quality of Care With Use of Inexpensive Checklist in Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Quality
Improvement
Lead sponsor: St. Joseph Mercy Oakland Hospital
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Hypothesis: Quality Improvement tools like "Heart Failure Discharge Checklist" which emphasizes on proper education to patients, ensure appropriate dose titration and counselling improve outcome in congestive heart failure (CHF).


Eligibility criteria: Inclusion Criteria:

* Patients admitted to SJMO with principal diagnosis of acute decompensated heart failure

Exclusion Criteria:

* Age less than 18 years
* Pregnant women

Primary outcomes:
measure: Readmissions
timeFrame: 6 months
measure: Dose titration
timeFrame: patients were followed during the time of hospital stay, average of 5 days
Secondary outcomes:
measure: Medications prescribed
timeFrame: patients were followed during their hospital stay from admission to discharge, on an average of 5 days
Other outcomes:
Locations:
city: Pontiac
country: United States
facility: St. Joseph Mercy Oakland Hospital
state: Michigan
Study officials:
affiliation: St. Joseph Mercy Oakland Hospital
name: Abhijeet Basoor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00804518: Effect of Exercise on Heart Function in Healthy Elderly People
Official title: Aerobic Interval Training Reduces and Compensates Age Related Decline in Cardiac Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diastolic Dysfunction
Keywords: Aging
Diastolic dysfunction
Systolic function
Exercise
Echocardiography
tissue Doppler imaging
Cardiac function
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 45
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effect of aerobic interval training on left- and right ventricular diastolic- and systolic function on healthy, sedate people over 70 years. The old sedate cohort will be compared to young, sedate subjects also performing aerobic interval training and old master athletes without intervention.

Detailed description: Aging is associated with a reduced diastolic and systolic function of the heart. Earlier studies have shown that physical exercise can improve both systolic and diastolic function. However the impact on age-related cardiac function is to some extent conflicting. The use of different training intensities will impact on the cardiac result. We have in earlier studies shown aerobic interval training at 90 % of maximal heart rate (4x4 minutes) to have more impact on cardiac function, endothelial function and maximal oxygen uptake compared to moderate intensity.

To our knowledge the effect of aerobic interval training on cardiac function has not been studied in an old, sedate group before.

Eligibility criteria: Inclusion Criteria:

* over 70 years, healthy
* not exercising more than twice per week

Exclusion Criteria:

* chronic illness
* chronic use of any medication
* regular smoking
* metabolic or cardiovascular diseases

Primary outcomes:
measure: Improvement of left and right ventricular early diastolic tissue velocity at rest and sub maximal exercise ,e'.
timeFrame: 12 weeks
Secondary outcomes:
measure: Improvement of left and right ventricular systolic tissue velocity function at rest and sub maximal exercise, S'.
timeFrame: 12weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Ntnu/Dmf/Isb
state: Sør-Trøndelag
Study officials:
affiliation: National Taiwan Normal University
name: Charlotte Bjork Ingul, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Molmen HE, Wisloff U, Aamot IL, Stoylen A, Ingul CB. Aerobic interval training compensates age related decline in cardiac function. Scand Cardiovasc J. 2012 Jun;46(3):163-71. doi: 10.3109/14017431.2012.660192. Epub 2012 Feb 20.
Clinical trial NCT00197418: Second Line Therapy for the Cure of Helicobacter Pylori (H. Pylori) Infection
Official title: Dual Therapy With High-Dose of Rabeprazole and Amoxicilline Versus Triple Therapy With Rabeprazole, Amoxicilline and Metronidazole as the Second Line Therapy for the Cure of H. Pylori Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Helicobacter Infections
Gastritis
Gastric Ulcer
Duodenal Ulcer
Keywords: H. pylori infection
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Proton pump inhibitors (PPIs) are mainly metabolized in the liver by CYP2C19, one of the cytochrome P450 isoenzymes, which shows a genetic polymorphism associated with enzyme activities. The most essential role of a PPI in H. pylori eradication therapy is to make antibiotics more stable and bioavailable in the stomach by raising intragastric pH to neutral levels.

Most patients who have failed in the eradication of H. pylori infection by triple therapy with a PPI, amoxicillin (AMPC) and clarithromycin (CAM) at standard doses have extensive metabolizer (EM) genotypes of CYP2C19 and/or are infected with CAM-resistant strains of H. pylori.

Four-times daily dosing of a PPI could achieve complete gastric acid inhibition. Dual therapy with 4-times daily dosing of a PPI and AMPC could yield sufficient re-eradication rates in patients with EM genotype of CYP2C19.

Metronidazole (MNZ)-based re-eradication therapy, such as triple PPI/AMPC/MNZ therapy, also achieved high eradication rates and has been recommended as the second line therapy in Japan. But carcinogenic actions of MNZ have been unclear.

The purpose of this study is to compare the re-eradication rates of H. pylori infection by the dual high-dose PPI/AMPC therapy and triple PPI/AMPC/MNZ therapy, and to validate the efficacies of these re-eradication regimens as second line eradication therapies.


Eligibility criteria: Inclusion Criteria:

* Patients with H. pylori infection

Exclusion Criteria:

* Patients without H. pylori infection

Primary outcomes:
measure: Which treatment yields the higher re-eradication rate of H. pylori infection
Secondary outcomes:
measure: Side effects
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
state: Shizuoka
Study officials:
affiliation: Hamamatsu University
name: Naohito Shirai, MD., PhD
role: STUDY_CHAIR
References: