louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02394236: Aerobic Exercise and Oxygen Uptake Efficiency Slope in Coronary Artery Disease
Official title: Continuous vs. Interval Exercise Training on Oxygen Uptake Efficiency Slope in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: exercise training
Lead sponsor: Hospital TotalCor
Sponsor class: OTHER
First posted: 2015-03-20
Enrollment: 35
Sex: ALL
Minimum age (years): 49
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thus, the purpose of the present study was to evaluate the effects of continuos exercise training (CET) and interval exercise trainining (IET) on oxygen uptake efficiency slope (OUES) in patients with coronary artery disease.

Detailed description: The oxygen uptake efficiency slope (OUES) is a submaximal index that incorporates cardiovascular, peripheral and pulmonary factors that determine ventilatory response to exercise. There is scarce information about the effects of the mode and intensity of exercise training on OUES in patients with coronary artery disease.

Eligibility criteria: Inclusion Criteria:

* stable coronary artery disease diagnosed by coronary angiography

Exclusion Criteria:

* unstable angina pectoris,
* complex ventricular arrhythmias,
* pulmonary congestion and
* orthopaedic or neurological limitations to exercise

Primary outcomes:
measure: The oxygen uptake efficiency slope
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05371236: Spiritual Health Scale in Chinese Pediatric Cancer Patients
Official title: Development and Validation of the Spiritual Health Scale in Chinese Pediatric Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child
Keywords: cancer
spiritual health
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: children with cancer

Brief summary: Pediatric cancer patients experience spiritual concerns such as meaningless, hopeless of life, fear of death and losses at all stages of illness. The availability of a valid and reliable instrument that accurately assesses the level of spiritual health among pediatric cancer patients is crucial before any appropriate interventions to solve their spiritual concerns can be appropriately planned and evaluated.

Detailed description: The study aimed to adapt the 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-being Scale (FACIT-Sp-12) scale and validate it in Chinese pediatric cancer patients.

A two-phase sequential method design will be used. Phase I will use a descriptive qualitative approach to understand pediatric cancer patients' opinions related with spiritual issues and experience. At least 12 participants are expected to be interviewed. The results of the qualitative study will be used to compare with the items of the original scale, and emerging themes will be used to generate new items. Phase Ⅱ will translates and adapt the scale based on the result of Phase I. Further, the adapted version of the scale will be validated among 200 pediatric cancer patients.

Eligibility criteria: Inclusion Criteria:

* age 8-17 years old,
* diagnosed with any type of cancer who were treated at these sites at any point after their diagnosis,
* knowing about condition and prognosis of their disease,
* their parents agree to sign the informed consent form,
* able to communicate with Chinese and read Chinese.

Exclusion Criteria:

* younger than age 8-17 years old
* cancer survivors

Primary outcomes:
measure: The adapted spiritual well-being scale of the Functional Assessment of Chronic Illness Therapy-12 (FACIT-Sp-12) for pediatric cancer patients
timeFrame: past senven days
measure: The Chinese version of the center for epidemiology studies depression scale for children (CES-DC)
timeFrame: past seven days
measure: Pediatric quality of life inventory 3.0 cancer module (PedsQL 3.0 Cancer Module)
timeFrame: past seven days
measure: Socio-demographic and clinical characteristics
timeFrame: on that day filling out questionnaire
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Ka Yan Ho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02404636: Alcohol Diet and Drug Use Preceding Alcoholic Hepatitis
Official title: Alcohol Diet and Drug Use Preceding Alcoholic Hepatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis, Alcoholic
Lead sponsor: University Hospital Birmingham
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (aged over 18 years) admitted to Queen Elizabeth Hospital Birmingham, UK

Brief summary: ADDUP is an observational study of patients with alcoholic hepatitis. A structured interview is used to quantitatively estimate:

1. Alcohol use
2. Dietary intake
3. Drug use (legal and illegal)

in the weeks preceding onset of acute alcoholic hepatitis. After interview patients are followed up for 12 months with regard to response to therapy and survival.

The study is intended to explore potential precipitants of alcoholic hepatitis.


Eligibility criteria: Inclusion Criteria:

* acute alcoholic hepatitis
* aged over 18 years
* able to give informed consent

Exclusion Criteria:

* evidence of other acute or chronic liver disease
* episode of alcoholic hepatitis in 6 months before admission
* severe hepatic encephalopathy
* delirium

Primary outcomes:
measure: Changes in alcohol intake, dietary intake or drug use before illness
timeFrame: 1 month
Secondary outcomes:
measure: Survival after admission (Brief structured interview)
timeFrame: 12 months
measure: Response to treatment (Brief structured interview)
timeFrame: 1 week
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
state: West Midlands
Study officials:
References:
Clinical trial NCT02851836: Attachment Image Data Set Validation in Adolescent
Official title: Validation of an Attachment Picture Set in School-adolescent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotion Dysregulation
Keywords: attachment
adolescent
picture
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 133
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: this study aims to validate a picture data set that particularly activates the attachment process and that could be used in attachment studies.

Detailed description: Pictures have been chosen to represent several emotions: distress, comfort, complicity and neutral.

Eligibility criteria: Inclusion Criteria:

* adolescent going to high school not hospitalized

Exclusion Criteria:

* mental retardation non comprehension of french visual deficit

Primary outcomes:
measure: mean score of valence in the SAM (self assessment manikin system)
timeFrame: at inclusion
Secondary outcomes:
measure: mean score of arousal in the SAM (self assessment manikin system)
timeFrame: at inclusion
measure: mean score of dominance in the SAM (self assessment manikin system)
timeFrame: at inclusion
measure: emotional categorization of the picture
timeFrame: at inclusion
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Besancon
state: Doubs
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Lauriane Vulliez-Coady, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szymanska M, Monnin J, Noiret N, Tio G, Galdon L, Laurent E, Nezelof S, Vulliez-Coady L. The Besancon Affective Picture Set-Adolescents (the BAPS-Ado): Development and validation. Psychiatry Res. 2015 Aug 30;228(3):576-84. doi: 10.1016/j.psychres.2015.04.055. Epub 2015 Jun 20.
Clinical trial NCT04292236: The Effect of Food Supplements on Food Intake and Gut Hormone Levels
Official title: The Effect of Food Supplements on Food Intake and Gut Hormone Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Endocrine; Obesity
Appetite; Perverted
Keywords: Nutrient
Anorexigenic hormone
Calorific Intake
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double blinded, randomised, crossover, placebo controlled.
Primary purpose: TREATMENT

Brief summary: When a meal is eaten, nutrients activate the release of hormones from the bowel into the blood stream. Normally there is a large amount of hormone released, which tells the brain that an individual is full and to stop eating. When people gain weight and become overweight or obese, these hormone signals are reduced, resulting in these people eating more and gaining more weight. This study is investigating mechanisms which may break this cycle by using particular nutrients to restore reduced hormone levels.


Eligibility criteria: Inclusion Criteria:

* Obese but otherwise healthy volunteers,
* body mass index (BMI) of 30-40 kg/m2
* agreement to consume scheduled meals
* ability to understand the study information sheet and instructions in English and able to provide informed consent.

Exclusion Criteria:

* Not meeting any of the exclusion criteria above.
* Major gut surgery
* Major health problems
* Taking medication for diabetes

Primary outcomes:
measure: Effect on appetite and satiety ratings
timeFrame: Study day 1 and study day 2 (following meal intake at breakfast and lunch)
Secondary outcomes:
measure: Effect on gut hormone levels
timeFrame: Study day 1 and study day 2 with samples taken every 30 min
measure: Effect on satiety scores
timeFrame: Study day 1 and study day 2 (following meal intake at breakfast and lunch)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Queen Mary University of Queensland
Study officials:
affiliation: Queen Mary University of London
name: Madusha Peiris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peiris M, Aktar R, Reed D, Cibert-Goton V, Zdanaviciene A, Halder W, Robinow A, Corke S, Dogra H, Knowles CH, Blackshaw A. Decoy bypass for appetite suppression in obese adults: role of synergistic nutrient sensing receptors GPR84 and FFAR4 on colonic endocrine cells. Gut. 2022 May;71(5):928-937. doi: 10.1136/gutjnl-2020-323219. Epub 2021 Jun 3.
Clinical trial NCT06939036: Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )
Official title: A Multicentre, Open-label, Phase I/II Study Investigating the Safety, Tolerability, and Preliminary Efficacy of 225Ac-SSO110 in Participants With Extensive Stage Small Cell Lung Cancer (ES-SCLC) or Merkel Cell Carcinoma (MCC) Receiving Standard of Care (SoC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Small Cell Lung Cancer Extensive Stage
Merkel Cell Carcinoma
Keywords: actinium
225Ac
actinium-225
SSO110
SSO120
gallium
68Ga
gallium-68
radiopharmaceutical
MCC
Merkel Cell carinoma
ES-SCLC
Extensive Stage Small Cell Lung Cancer
radioligand
somatostatin receptor 2
JR11
sstr2-antagonist
Lead sponsor: Ariceum Therapeutics GmbH
Sponsor class: INDUSTRY
First posted: 2025-04-22
Enrollment: 50
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: This study aims to determine safety, tolerability, recommended phase 2 dose (RP2D), and preliminary antitumor activity of 225Ac-SSO110 with standard of care (SoC) therapy in patients with somatostatin receptor 2 expressing (SSTR2+) extensive-stage small cell lung cancer (ES-SCLC) and recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).


Eligibility criteria: Key Inclusion Criteria:

Signed Informed Consent Form and willing to comply with all study procedures.

Participants with ES-SCLC (defined as Stage IV per NCCN guidelines Version 1.2024) or recurrent locally advanced or metastatic MCC (per NCCN guidelines Version 1.2024) documented by histology or cytology.

Participants eligible to receive immune checkpoint inhibitor (CPI) monotherapy at the start of treatment with 225Ac-SSO110 or patients already on CPI monotherapy for 7 weeks.

ECOG performance status of 0 or 1. Life expectancy of at least 6 months.

Positive 68Ga-SSO120 scan (Investigator-assessed) during screening.

Key Exclusion Criteria:

Participants with unstable spinal cord compression.

Any previous systemic radioligand therapy or extensive radiotherapy.

Participants receiving or planned to receive consolidative chest radiation.

History of primary immunodeficiency, transplantation or CAR-T cell therapy.

Major surgical procedure except diagnostic biopsy within 28 days prior to enrolment or scheduled to have major surgery during the study.

Inadequate organ or marrow function.

Primary outcomes:
measure: Part 1: Safety, tolerability, RP2D of 225Ac-SSO110 in combination with SoC
timeFrame: 42 days
measure: Part 2: Safety, tolerability, and preliminary anti-tumor activity of 225Ac-SSO110 in combination with SoC at RP2D
timeFrame: 42 days
measure: Part 1 & 2: Safety and tolerability of 68Ga-SSO120
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Biogenix Molecular
state: Florida
Study officials:
References:
Clinical trial NCT03534336: Behavioral Economics-Based Online Lifestyle Balance Program
Official title: Behavioral Economics-Based Online Lifestyle Balance Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Reduction
Health Knowledge, Attitudes, Practice
Keywords: Weight Reduction
Health Literacy
Financial Incentives
Lifestyle Change
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 710
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 3-arm RCT (Control, Incentive for Weight Loss, Incentive for Education) stratified by Gender.
Primary purpose: TREATMENT

Brief summary: The objective of this project is to design a Behavioral Economics Based Online Lifestyle Balance Program that employs behavioral economics to engage and motivate adherence to an Internet-based program. The investigators compare the effects of two financial incentives on inducing weight loss: a direct financial incentive for weight loss and a financial incentive for health literacy.

Detailed description: This project investigates whether participants in an online weight loss program can be induced to achieve weight loss using financial incentives. The study is a 3-arm randomized controlled trial (RCT) stratified by gender. The goal is to examine how overweight individuals respond to two different types of financial incentives. The first type of incentive, incentive for weight loss (IW), is a cash award of approximately $150 given for achieving 5% weight loss over 12 weeks. The second type of incentive, incentive for education (IE), is a $150 award for passing quizzes that test the participants' health literacy about weight loss and the techniques required for maintaining a healthy lifestyle. The investigators compare the effectiveness of IW to IE in promoting weight loss in overweight individuals and investigate whether the two incentives work equally well for men and women.

Eligibility criteria: Inclusion Criteria:

* BMI between 23 and 33
* Age between 40 and 60 years old

Exclusion Criteria:

* History of diabetes
* History of significant cardiovascular disease
* Family history of atherosclerosis
* High blood pressure
* Significant lung disease

Primary outcomes:
measure: Weight Loss at the end of the weight loss program (at Week 13)
timeFrame: At week 13 of the RCT.
Secondary outcomes:
measure: Weight Loss at the end of the post-intervention period (Week 25)
timeFrame: At week 25 of the RCT.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore
Study officials:
References:
Clinical trial NCT01463436: The Effect of Soy Isoflavone Supplementation on Endothelial Function
Official title: Study of Soy Isoflavone 100 mg/Day in Postmenopausal Women to Elaborate the Effect of Soy Isoflavone in Endothelial Function and to Reduce Oxidative Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Disease
Osteoporosis
Keywords: endothelial function
postmenopausal
soy isoflavone supplementation
osteoporosis
Lead sponsor: Trisakti University
Sponsor class: OTHER
First posted: 2011-11-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 47
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized double blind controlled trial was conducted to evaluate the effect of daily supplementation with soy isoflavone 100 mg/day for 12 months on 182 postmenopausal women aged 47 to 60 years at subdistrict South Jakarta Indonesia. The study hypothesis was supplementation soy isoflavone 100 mg/day for 6 and 12 months can increase endothelial function.

Detailed description: The subject were randomized to the intervention group receiving tablets consisting of 100 mg soy isoflavone and calcium carbonate 500 mg and the control group receiving 500 mg calcium carbonate for 1 year. This study was carried out 13 months(13 x 28 days).

There were three outcome measure from this study; vascular cell adhesion molecule-(VCAM-1), nitric oxide (NO) and malonyldialdehyde (MDA). The outcome measure will be assessed at three times; before soy isoflavone supplementation / the beginning of study,post supplementation 6 months and 12 months. The outcome will be measured change from baseline in the level of VCAM-1, NO and MDA.

Eligibility criteria: Inclusion Criteria:

* healthy postmenopausal women
* natural cessation 1-10 years
* body mass index \<=35 kg/m2
* not receiving medication and supplement in the previous 6 months

Exclusion Criteria:

* has chronic or terminal disease
* severe psychosis

Primary outcomes:
measure: the changes levels of endothelial function marker in blood after 13 months supplementation
timeFrame: 13 months
Secondary outcomes:
measure: the changes levels of osteoporosis parameter after 6 months supplementation
timeFrame: 6 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Trisakti University
state: DKI Jakarta
Study officials:
affiliation: Trisakti University
name: Pusparini Sunarno, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hall WL, Rimbach G, Williams CM. isoflavones and endothelial function. Nutrion Research Review 18:123-131, 2005. Vincent A,Fitzpatrick LA. soy Isoflavone: are they useful in menopause? Mayo clinic Proceeding 75:1171-1184, 2000
Clinical trial NCT04298736: Bariatric Surgery vs. Lifestyle Modification for NASH
Official title: Bariatric Surgery vs. Lifestyle Modification: Effects Against Nonalcoholic Steatohepatitis Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NASH - Nonalcoholic Steatohepatitis
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 50
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: Randomized Controlled Trial comparing the effects of Bariatric Surgery vs. Lifestyle modification on NASH resolution.

Detailed description: Patients with biopsy-proven NASH will be randomized to either bariatric surgery or lifestyle interventions. After 1-year follow-up a liver biopsy will be done to evaluate NASH resolution

Eligibility criteria: Inclusion Criteria:

* BMI between 30 and 45
* with biopsy-proven NASH
* with or without type 2 diabetes
* that fit for bariatric surgery.

Exclusion Criteria:

* borderline NASH ou cirrhosis;
* alcohol consumption (\> 20 g/day for men and \> 10 g/day for women, for the last 2 years);
* other hepatic diseases (such as viral hepatitis, autoimmune hepatitis, drug-induced hepatic disease, Wilson's disease, hemochromatosis);
* HIV infection;
* unable to provide informed consent;
* previous foregut or bariatric surgery;
* malignancy;
* patients that unfit for bariatric surgery.

Primary outcomes:
measure: NASH resolution
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Guilherme S Mazzini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06096636: National Survey of Young Adult Nutrition
Official title: National Survey of Young Adult Nutrition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight or Obesity
Keywords: Healthy Weight
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: Texas A&M University
First posted: 2023-10-24
Enrollment: 1123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The researchers aim to have the analyses be as nationally-representative as possible on certain criteria. To do so, there are goals for the number of participants belonging to 20 demographic profiles. The 20 demographic profiles will be based on sex assigned at birth (male, female), education (no college, some college +), and race/ethnicity (non-Hispanic white, non-Hispanic Black, non-Hispanic Asian, Hispanic, and non-Hispanic other). Using the 2019 American Community Survey, a nationally representative survey of adults in the United States, we have identified what proportion of 18- to 24-year-olds fall into each of the 20 demographic profiles. Taking these proportions, we will incorporate a 15% oversample of Black, Asian, and Hispanic individuals.

Brief summary: The purpose of this research is to better understand how people's background, habits, and other factors influence their diets and health.

Detailed description: The purpose of this study is to provide further insight into the correlates and predictors of young adults' eating habits, with particular emphasis on sociodemographics, reproductive health, and food upbringing.

Eligibility criteria: Inclusion Criteria:

* U.S. citizens
* Current, full-time, non-institutionalized residents of the United States
* Access to a computer with internet access

Exclusion Criteria:

* Non-U.S. citizens
* Non-resident of the United States
* No access to a computer with internet access

Primary outcomes:
measure: Diet quality
timeFrame: Baseline
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: Julie Hess, PhD
role: PRINCIPAL_INVESTIGATOR
References: