louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01641055: A Study of the Effects of Fish Protein Intake on Glucose Regulation in Overweight and Obese Adults.
Official title: A 8 wk Study to Compare the Effects of Proteins Various Fish Species (Salmon, Herring, Cod) and Milk on Glucose Regulation in Overweight and Obese Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: BlueProtein
name: NutriMar
First posted: 2012-07-16
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the possible health benefits of intake of proteins from salmon, herring, cod and milk on glucose tolerance in overweight and obese adults. Overweight and obese subjects often have reduced glucose tolerance, and previous findings from a study on cod proteins suggested that glucose tolerance was improved.

Detailed description: Participants receive 2.5g protein per day for 8 weeks as tablets.

Eligibility criteria: Inclusion Criteria:

* BMI above 27 kg/m2
* healthy

Exclusion Criteria:

* fasting blood glucose above 7 mM
* medication that affects blood glucose, lipids and inflammatory status
* pregnancy or breastfeeding
* allergies to fish or milk
* intentional weight loss and large fluctuation in body weight
* a high consumption of fish
* an extreme diet
* use of fish oil, n-3 or multivitamin supplements

Primary outcomes:
measure: Glucose regulation
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in serum insulin, insulin C-peptide, non-esterified fatty acids, lipids, adiponectin, leptin and fatty acid composition
timeFrame: 8 weeks
measure: Changes in serum and urine concentrations of amino acids and their metabolites
timeFrame: 8 weeks
measure: Changes in serum concentrations of vitamins
timeFrame: 8 weeks
measure: Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Institute of Medicine, University of Bergen
Study officials:
affiliation: University of Bergen
name: Oddrun A Gudbrandsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hovland IH, Leikanger IS, Stokkeland O, Waage KH, Mjos SA, Brokstad KA, McCann A, Ueland PM, Slizyte R, Carvajal A, Mellgren G, Remman T, Hogoy I, Gudbrandsen OA. Effects of low doses of fish and milk proteins on glucose regulation and markers of insulin sensitivity in overweight adults: a randomised, double blind study. Eur J Nutr. 2020 Apr;59(3):1013-1029. doi: 10.1007/s00394-019-01963-0. Epub 2019 Apr 10.
Clinical trial NCT03095755: Ischemic Conditioning as an Intervention to Improve Motor Function in Chronic Stroke
Official title: Ischemic Conditioning as an Intervention to Improve Motor Function in Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Marquette University
First posted: 2017-03-30
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will test whether an intervention called ischemic conditioning can improve paretic leg motor function in chronic stroke subjects.

Detailed description: This study will study ischemic conditioning (IC) as an intervention to improve motor function post-stroke. IC is a well studied, well tolerated intervention which has been shown to improve regional blood flow, motor neuron excitability and muscle function in multiple patient groups and in young, healthy subjects. Because IC targets three physiological systems which are all affected by stroke, the investigators hypothesize that repeated bouts of IC will result in improved motor function of the paretic leg.

Eligibility criteria: Inclusion Criteria:

1. be between the ages of 18-85
2. able to give informed consent
3. be ≥ 6 months post diagnosis of unilateral cortical stroke and
4. have residual leg paresis.

Exclusion Criteria:

1. chronic low back or hip pain
2. substance abuse
3. head trauma in last 6 months
4. neurodegenerative disorder
5. any uncontrolled medical condition
6. any condition where knee extension contractions are contraindicated
7. people who are unable to follow multi step commands.
8. people who cannot walk ≥ 10 ft without physical assistance.
9. history of major psychiatric disorder
10. participant has had a myocardial infarction in the last year
11. participant has uncontrolled hypertension
12. participant is unable to contract knee muscles

Primary outcomes:
measure: Leg Muscle Strength
timeFrame: Within 1 year of admission into the study
Secondary outcomes:
measure: Leg Muscle Fatigue
timeFrame: Within 1 year of admission into the study
measure: Brachial Artery Flow Mediated Dilation
timeFrame: Within 1 year of admission into the study
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Marquette University
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Matthew J Durand, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04837755: CORONA in the Saarland
Official title: CORONA in the Saarland
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid19
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All COVID-19 patients in the State of Saarland

Brief summary: The CORSAAR study is an observational, prospective study to investigate the natural biology of COVID-19

Detailed description: Patients with all forms of COVID-19 are included and followed up. Medical history, measurements and biomarkers are registered and collected at baseline, dung hospitalization and after discharge. In addition, patients with LONG-COVID-19 are recruited.

Eligibility criteria: Inclusion Criteria:

all form of COVID-19 including long-COVID-19

Exclusion Criteria:

-

Primary outcomes:
measure: Correlation of biomarkers with mortality and disease subgroups
timeFrame: 2 years after initial disease
Secondary outcomes:
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Saarland University
state: Saarland
Study officials:
References:
Clinical trial NCT06062355: Phase I Clinical Study of HRS-9815 for PET/CT Imaging in Patients With Prostate Cancer
Official title: Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics and Radiation Dosimetry of HRS-9815 for PET/CT Imaging in Patients With Prostate Cancer.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-02
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the the safety, pharmacokinetics, radiation dosimetry of HRS-9815 for PET/CT imaging in adult patients with prostate cancer.


Eligibility criteria: Inclusion Criteria:

1. Voluntary participation in this clinical trial, understanding of the study procedures and being able to sign the informed consent form in writing;
2. Male, age ≥18 years;
3. ECOG score 0 - 1;
4. Histologically confirmed adenocarcinoma of the prostate;

Exclusion Criteria:

1. Severe urinary incontinence, hydronephrosis, severe micturition dysfunction, etc. Note: Subjects with bladder outflow obstruction or urinary incontinence that can be controlled by the best available standard of care (including pads, drainage, etc.) are eligible to participate in the study.
2. Active syphilis infection.
3. Known allergy, hypersensitivity, or contraindication to the trial product or any component of its formulation.。
4. Active in other clinical studies or less than 4 weeks after the last dose in the previous clinical study at the time of the first dose.

Primary outcomes:
measure: Incidence and severity of AEs and SAEs,
timeFrame: up to 30 days follow-up
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: up to 1 days follow-up
measure: time to maximum plasma concentration (Tmax)
timeFrame: up to 1 days follow-up
measure: biological half-life (t1/2)
timeFrame: up to 1 days follow-up
measure: cumulative urinary excretion rate based on radioactivity;
timeFrame: up to 1 days follow-up
measure: Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs;
timeFrame: up to 1 days follow-up
measure: Mean standardized uptake value (SUVmean)
timeFrame: up to 1 days follow-up
measure: Maximum standardized uptake value (SUVmax),
timeFrame: up to 1 days follow-up
measure: Tumor-to-background ratio (TBR) [Time Frame: up to 1 days follow-up]
timeFrame: up to 1 days follow-up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04826055: Biliary Limb as a Percentage From the Small Intestine Rather Than Fixed Length in Loop Bypass Surgery for Morbid Obesity
Official title: tp Make the Length of the Biliary Limb as a Percentage From the Small Intestine Rather Than Fixed Length in Loop Bypass Surgery for Morbid Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Keywords: biliary limb length in bypass bariatric surgery
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 210
Sex: ALL
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: in all loop bypass bariatric procedure (mini gastric bypass \& single anastomosis sleeve jejunal bypass), biliary limb is fixed length. we do it as a percentage from total small intestine length rather than fixed length

Detailed description: in all loop bypass bariatric procedure (mini gastric bypass \& single anastomosis sleeve jejunal bypass), biliary limb is fixed length we count the length of small intestine and do it as a percentage from total small intestine length rather than fixed length

Eligibility criteria: Inclusion Criteria:

* obese patients with BMI more than 40 or more than 35 with comorbidity
* patients fit for laparoscopic surgery
* give approval to share in the study

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 50
* patients with BMI less than 35
* patient with previous upper abdominal surgery either for obesity or other diseases

Primary outcomes:
measure: effect on weight loss
timeFrame: one year
measure: effect on nutritional deficiency
timeFrame: 1 year
Secondary outcomes:
measure: operative time
timeFrame: 6 hours
measure: effect on obesity comorbidities
timeFrame: 1 year
measure: early complications
timeFrame: 30 days
measure: late complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of medicine
Study officials:
References:
Clinical trial NCT02215655: Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence
Official title: Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: phosphate binder adherence
autonomous motivation
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 150
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: Hyperphosphatemia in end-stage renal disease (ESRD) patients is a non-traditional risk factor for all-cause and cardiovascular mortality. Non-adherence to phosphate binders is as high as 74% in ESRD patients and has been shown to be most related to psychosocial factors including attitudes. There is limited data on the influence of attitudes and perceived autonomy support on phosphate binder adherence and these two psychosocial constructs can be positively influenced through the use of motivational interviewing skills to increase autonomous motivation. Furthermore, racial disparities are known to exist in ESRD however and there are still gaps, which exist in understanding the determinants of disparities in adherence in vulnerable patients with ESRD.

In this study, the investigators seek to determine the impact of motivational interviewing on phosphate binder adherence in diverse ESRD patients. The investigators will ask all the subjects to fill out surveys mainly regarding their attitudes; perceived providers' autonomy support and phosphate binder adherence. The investigators will administer motivational counseling to subjects in the intervention arm of the study, at baseline and 1 month after recruitment. The investigators will ask all the subjects to fill out the same surveys 2 months after recruitment and the investigators will compare subjects who underwent motivational interviewing to those who did not.


Eligibility criteria: Inclusion Criteria:

* Adults age 18 years or older
* Receiving phosphate binder therapy currently
* English speaking

Exclusion Criteria:

* Non- English speaking
* Known diagnosis of psychosis or dementia, limiting ability to provide informed consent
* Any medical condition that precludes participation in the study including deafness, dying etc.
* Initial Morisky Medication Adherence score greater than 6

Primary outcomes:
measure: change in subjects' adherence to phosphate binders
timeFrame: baseline and 2 months
Secondary outcomes:
measure: change in attitudes towards phosphate binder therapy
timeFrame: baseline and 2 months
measure: change in perceived providers' autonomy support towards phosphate binder therapy
timeFrame: baseline and 2 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Ebele M Umeukeje, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03272555: WILD 5 Wellness: A 30-Day Intervention
Official title: WILD 5 Wellness: A 30-Day Intervention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wellness
Anxiety
Depression
Cognitive and Executive Dysfunction
Lead sponsor: Beloit College
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition in First Year Beloit College students self-selected into a wellness focused first year initiative.

Detailed description: The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition in First Year Beloit College students self-selected into a wellness focused first year initiative. This program is called "WILD 5 Wellness: A 30-Day Intervention". Results for this study will be quantified through the use of standardized self-report questionnaires administered prior to and after students complete the WILD 5 program. Data will be collected to evaluate participants' adherence and response to each element of WILD 5, a 5-pronged 30-day wellness intervention. It is expected that this 30-day integrated, prescriptive, and trackable program will be found to be an efficacious wellness intervention for First Year Beloit College students.

Eligibility criteria: Inclusion Criteria:

* students 18 years of age or older
* students enrolled in First Year Initiative Course titled, "Habits of Mind, Habits of Body."

Exclusion Criteria:

* individuals who are pregnant or plan to get pregnant during the next 30 days
* students who are not enrolled in the First Year Initiative Course titled, "Habits of Mind, Habits of Body".

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
measure: Change in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
measure: Change in The HERO Wellness Scale
timeFrame: Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
measure: Change in World Health Organization-5 (WHO-5)
timeFrame: Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
measure: Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
timeFrame: Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
Secondary outcomes:
measure: The Post-Program Participant Questionnaire
timeFrame: Day 31+/- 5 days
Other outcomes:
Locations:
city: Beloit
country: United States
facility: Beloit College
state: Wisconsin
Study officials:
References:
Clinical trial NCT01618955: Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device
Official title: Phase 2, Multi-Center, Open-Label, Single-Dose, Single Arm, In-Clinic Study to Evaluate the Actual Human Use of Methotrexate Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device in Adult Patients With Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis (RA)
Lead sponsor: Antares Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-14
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate.

Detailed description: Primary objective:

- To assess the safe usability of the VIBEX MTX device for subcutaneous (SC) self-injection of methotrexate (MTX) in adult patients with rheumatoid arthritis (RA) after standardized training by site personnel and review of written instructions

Secondary objectives:

* To evaluate the reliability and robustness of the VIBEX MTX device
* To evaluate the safety and local tolerance of an SC self-injection of MTX using the VIBEX MTX device
* To evaluate the effectiveness and ease of use of the VIBEX MTX device patient education tools for SC self-injection

Eligibility criteria: Inclusion Criteria:

* Male or female patients \>18 years of age, diagnosed with Rheumatoid Arthritis

Exclusion Criteria:

* Pregnant females
* Any other clinically significant disease or disorder which, in the opinion of the investigator might put the subject at risk

Primary outcomes:
measure: Safe Usability of the VIBEX MTX Device for Subcutaneous (SC) Self-injection With Methotrexate (MTX) in Adult Patients With Rheumatoid Arthritis (RA) as Demonstrated by Successful Self-Injection
timeFrame: 24 hours
Secondary outcomes:
measure: Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools
timeFrame: 24 hours
measure: Safety of Vibex MTX Device
timeFrame: 24 hours
measure: Tolerance of Vibex MTX Device (Injection Site Pain Severity as Reported by Patient on VAS Scale - 0 mm = no Pain to 100 mm = Very Severe Pain)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
Study officials:
affiliation: Altoona Center for Clinical Research
name: Alan J Kivitz, MD;CPI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04339855: AI for Colorectal Polyp Detection in Endoscopy
Official title: Artificial Intelligence Combined With LCI for Colorectal Polyp Detection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Focus of the Study is to Evaluate a New Developed Deep-learning Computer-aided Detection System in Combination With LCI for Colorectal Polyp Detection
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ondergoing screeining or surveillance endoscopy

Brief summary: Linked color imaging (LCI) has shown its effectiveness in multiple randomized controlled trials for enhanced colorectal polyp detection. Most recently, artificial intelligence (AI) with deep learning through convolutional neural networks has dramatically improved and is increasingly recognized as a promising new technique enhancing colorectal polyp detection. Study aim was to evaluate a new developed deep-learning computer-aided detection (CAD) system in combination with LCI for colorectal polyp detection.


Eligibility criteria: Inclusion Criteria:

* Full endoscopy withdrawal videos with LCI of patients ondergoing screening or surveillance endoscopy

Exclusion Criteria:

* non adequate bowel preparation
* no full length withdrawal in LCI mode

Primary outcomes:
measure: Colorectal polyp detection rate in comparison to traditional detection rate
timeFrame: 2019-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Hospital Mainz
Study officials:
affiliation: Head of Interdisciplinary Endoscopy
name: Helmut Neumann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: