louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05173376: SEP and the Impact of Portion Size on Daily Energy Intake
Official title: Socioeconomic Position and the Effect of Portion Size Reduction: a 1-day Dietary Behaviour Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Eating Behavior
Obesity
Keywords: portion size
socio-economic position
eating behaviour
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: European Research Council
First posted: 2021-12-29
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Reducing food portion size is a potential strategy to reduce energy intake. There is some evidence to suggest that individuals with lower socioeconomic position (SEP) intend to eat more from larger portions, suggesting that the effect of portion size on food intake might vary by SEP. However, no study has tested this by measuring actual food intake. This study examines whether reductions to the portion size of components of a main meal will reduce daily energy intake, and whether and how socioeconomic position (higher vs lower) moderates the portion size effect.

In a crossover experiment, participants will be served all meals in the lab on two separate days, with the portion size of main meal components at lunch and dinner manipulated (i.e. smaller on one day vs larger on the other day). All other foods offered are identical. Food intake from the portion-manipulated lunch and dinner, as well as all other meal components (breakfast, dessert, seconds, snacks) will be measured, and any additional food consumed by the participant will be measured using self-report, giving total daily energy intake (kcal).

Detailed description: See attached protocol document.

Eligibility criteria: Inclusion Criteria:

* Female
* UK (United Kingdom) residents, aged 18 or over
* Fluent in English
* willing to consume the test foods
* Self report liking of test foods
* BMI between 22.5 - 32.5kg2

Exclusion Criteria:

* taking medication which affects appetite
* currently pregnant
* history of eating disorders
* currently on a diet to lose weight
* food allergies, intolerances or specific dietary requirements (including being vegetarian or vegan)
* participated in 2018 Mood Study
* currently participating in another study where meals are provided

Primary outcomes:
measure: Daily energy intake
timeFrame: 24 hours after intervention administered
Secondary outcomes:
measure: Appetite
timeFrame: 24 hours after intervention administered
measure: Moderate-vigorous physical activity
timeFrame: 24 hours after intervention administered
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: University of Liverpool
Study officials:
affiliation: Study Principle Investigator
name: Eric Robinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05377476: Investigation of the Effects of Motor Imagery and Action Observation in People With Multiple Sclerosis
Official title: Investigation of the Effects of Motor Imagery and Action Observation on Walking, Fatigue, and Muscle Oxygenation in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Motor Imagery
Action Observation
Walking
Fatigue
Muscle Oxygenation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Bandırma Onyedi Eylül University
First posted: 2022-05-17
Enrollment: 48
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: It was planned to examine the effects of motor imagery and action observation applied in addition to standard rehabilitation in individuals with Multiple Sclerosis on walking, fatigue, and muscle oxygenation.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65
* A definitive diagnosis of MS by a neurologist according to the 2017 McDonald Criteria
* Expanded Disability Status Scale (EDSS) score of 4.0 and below (it is determined routinely by the physician during the examination)
* Not having an attack in the last 3 months
* A minimum score of 4 in each motor imagery ability (internal visual imagery, external visual imagery, and kinesthetic imagery) on the Movement Imagery Questionnaire-3 (MIQ-3)

Exclusion Criteria:

* cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score of less than 24
* Having another musculoskeletal, cardiovascular, pulmonary, metabolic, or neurological disease severe enough to preclude participation in the study.
* Having severe vision and hearing problems

Primary outcomes:
measure: 6 Min Walking Test
timeFrame: 6 week
Secondary outcomes:
measure: Timed Up and Go Test
timeFrame: 6 week
measure: Multiple Sclerosis Walking Scale-12
timeFrame: 6 week
measure: RehaGait® (Hasomed, Magdeburg, Germany) Gait Analysis
timeFrame: 6 week
measure: Fatigue Severity Scale
timeFrame: 6 week
measure: Measurement of Muscle Oxygenation
timeFrame: 6 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Bandırma Onyedi Eylül University
name: Melike Sumeyye Ozen, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02380976: Phase 1 Clinical Trial of DW340 and DW330SR + DW1030 Co-administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-05
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, single-dose, crossover Phase I Study to investigate the relative bioavailability of DW340 and DW330SR + DW1030 co-administration in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Age at screening visit only 20 healthy men over the age of 40 years or less
* Screening visit, BMI measurement is more than 19 kg/m2 who are below 27 kg/m2
* Screening vist, 90 mmHg ≤ SBP ≤ 140 mmHg, 50 mmHg ≤ DBP ≤ 90 mmHg
* Fully understand the purpose of trial, test drug and follow the instructions of the trial, Those who voluntarily written consent that ability and decision to participate during the entire period of the test

Exclusion Criteria:

* Those with a clinically significant history or character; Liver, kidney, digestive, respiratory, musculoskeletal, endocrine, neuropsychiatric, blood • tumor type, cardiovascular disease
* Those with Gastrointestinal diseases that may affect the absorption of the IND or history of surgery
* Those who have a clinically significant history of hypersensitivity to drug and food
* Those with genetic problems, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption
* Within 60 days those taking the other clinical trial drug
* Within 30 days those who take the drug metabolizing enzyme induction and inhibition drugs or prescription drugs
* Within 30 days those who take food abnormally, that may affect ADME of drug
* Within 60 days those who donate whole blood, within 30 days those who donate blood partially, receive transfusion
* Within 14 days those who take OTC drug
* Those who showing positive for drug abuse concerns in urine drug testing
* Those who drink excessive alcohol or have history of alcoholism
* Heavy smoker
* and so on

Primary outcomes:
measure: Cmax of DW330SR
timeFrame: 9 days
measure: Cmax of DW340
timeFrame: 9 days
measure: Cmax of DW1030
timeFrame: 9 days
measure: AUClast of DW330SR
timeFrame: 9 days
measure: AUClast of DW340
timeFrame: 9 days
measure: AUClast of DW1030
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01260376: Effect of Pharmacological Anti-lipolysis on FFA and VLDL-TG Metabolism Before and During Exercise
Official title: Effect of Pharmacological Anti-lipolysis on FFA and VLDL-TG Metabolism Before and During Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Obesity
Keywords: VLDL-TG
Metabolism
Exercise
Free Fatty Acids
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2010-12-15
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate free fatty acid and VLDL-TG metabolism before and during exercise with and without pharmacological antilipolysis by the niacin antagonist Acipimox. Main focuses will be VLDL-TG and free fatty acid metabolism as well as expression of membrane proteins in fat- and muscle biopsies.

Detailed description: Insulin resistance in liver and skeletal muscle is of central pathogenic significance in the development of type 2 diabetes. The molecular connections are unresolved but high levels of free fatty acids and triglyceride is probably involved. Diabetic subjects and to a lesser extent obese subjects have increased triglyceride levels, this could be due to an abnormal turnover of VLDL-TG. It is not yet investigated whether VLDL-TG kinetics changes during pharmacological antilipolysis. Using the aseptic ex-vivo labeling technique (developed in our laboratories) we will investigate this issue in sedentary healthy men. After a 3 hour basal period subjects will exercise on a bike for 60 minutes at 60% of VO2max. In both basal and exercise period one muscle and one fat biopsy will be obtained, further blood samples will be drawn to examine FFA and VLDL-TG metabolism etc..

This new knowledge will contribute to the understanding of metabolic disorders like type 2 diabetes and obesity.

Eligibility criteria: Inclusion Criteria:

- healthy, untrained males

Exclusion Criteria:

* medication
* history of malignancy, alcohol abuse or drug abuse
* participation in isotope trials in the last 6 months

Primary outcomes:
measure: Effects of exercise and antilipolysis on FFA and VLDL-TG kinetics
timeFrame: 6 hour investigation day
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: University Hospital of Aarhus, Norrebrogade
city: Aarhus
country: Denmark
facility: University Hospital of Aarhus, Norrebrogade
Study officials:
affiliation: University Hospital of Aarhus
name: Soren Nielsen, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00498576: Melatonin and Adiponectin in Hypertensive Kidney Transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Kidney Transplant
Keywords: hypertension
kidney transplant
melatonin
adiponectin
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-07-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: group1- patients from the kidney transplant unit, sheba medical center group2- patients from hypertension unit,sheba medical center

Brief summary: Recently we have shown that melatonin secretion is impaired in rats with metabolic syndrome. We have also demonstrated that exogenic melatonin supplementation can improve blood pressure profile in nondipper patients.

The aim of this study is to find whether there is a difference between melatonin secretion in hypertensive kidney recipients versus "normal" hypertensive patients. Secondly, to ask if there is any correlation between melatonin secretion and adiponectin levels.


Eligibility criteria: Inclusion Criteria:

* hypertension
* kidney transplantation ( group 1)
* good renal function

Exclusion Criteria:

* diabetes mellitus
* cancer
* renal failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-gan
country: Israel
facility: Sheba Medical Center
Study officials:
name: Avshalom Leibowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04774276: Protocol in Reeducation Occupational Therapist in Coronary Patients
Official title: Protocol in Reeducation Occupational Therapist in Coronary Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Coronary Artery Disease
Keywords: occupational therapy
quality of life
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease (CAD) needed a cardiac rehabilitation protocol

Brief summary: The quality of life, linked to physical, social and mental performance in people with coronary heart disease represents the primary goals in terms of rehabilitation. This is often developed to meet the expected performance standard in order to give the person effective autonomy. However, is the occupational balance always evaluated? and this management adapted? Does occupational therapist, expert in autonomy and independence in multiple illnesses and disabilities, has a major role to play in cardiac rehabilitation? This area of expertise and the application of occupational therapy to coronary patients seems appropriate, if not necessary. However, there are few scientific studies on the need to include occupational therapy within cardiac rehabilitation protocols.

Detailed description: The occupational therapy goals are in line with the theoretical objectives of coronary rehabilitation. At present, there is a lack of data on the benefits of coronary occupational therapy rehabilitation.

Goals : Evaluation of the quality of life of coronary heart patients who have benefited from cardiac rehabilitation optimized by secondary occupational therapy sessions:

Evaluation of aerobic and anaerobic performance of coronary heart patients who have benefited from cardiac rehabilitation optimized by occupational therapy sessions.

Evaluation of aerobic and anaerobic performance of coronary heart patients who have benefited from cardiac rehabilitation optimized by occupational therapy sessions.

Eligibility criteria: Inclusion Criteria:

* Coronary artery disease
* Included in the cardiac rehabilitation protocol in Saint Etienne university hospital

Exclusion Criteria:

* Patients who not perform all sessions of the cardiac rehabilitation protocol

Primary outcomes:
measure: Short Form (SF-36) questionnaire score
timeFrame: week 5
Secondary outcomes:
measure: Strength of biceps muscle (Kg)
timeFrame: week 5
Other outcomes:
measure: 6 minutes walk test (TM6)
timeFrame: week 5
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU ST ETIENNE
name: DAVID HUPIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04650776: Non-invasive Prediction of Thermal Strain in Healthy Male Adults
Official title: Single-centre Experimental Evaluation of Methods for Reliable Non-invasive Prediction of Thermal Strain in Healthy Male Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heat Stress
Lead sponsor: Empa, Swiss Federal Laboratories for Materials Science and Technology
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: This is primarily an experimental study investigating methods of temperature measurement / heat strain detection. In the calibration study, there are different skin temperature sensor types, and in the prediction study there are different methods for determining heat strain, including conventional methods (rectal, gastro-intestinal), the development of a prediction model, and an index based on heart rate variability.


Eligibility criteria: Inclusion Criteria:

* Apparently healthy males
* aged 18-45 y
* regularly participate in sport, exercise, or equivalent physical activity on a weekly basis.

Exclusion Criteria:

* Known injuries or illnesses that may affect safe participation. These include injuries or illnesses involving (but not limited to):
* cardiovascular, renal, or gastrointestinal tract
* heat or exercise intolerance
* acute infections,
* immunological diseases (including asthma)
* psychiatric disorders.
* Participants must not be currently or previously on cardiovascular-related medication and must not be taking psychotropic medication (last 60 days).

Primary outcomes:
measure: Core body temperature
timeFrame: 90 minutes
measure: Predicted core body temperature
timeFrame: 90 minutes
measure: ECG-based heat strain index
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: St.Gallen
country: Switzerland
facility: Empa
state: SG
Study officials:
affiliation: Empa, Swiss Federal Laboratories for Materials Science and Technology
name: Simon Annaheim, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04666376: Assessing the Technique of Ovarian Tissue Cryopreservation by Vitrification in Vietnam
Official title: Vitrified Ovarian Tissue in Cancer Patients: Assessing the Technique in Vietnam
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Tissue Cryopreservation
Vitrification
Lead sponsor: Mỹ Đức Hospital
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 43
Sex: FEMALE
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Ovarian tissue cryopreservation (OTC) is a new approach on fertility preservation for young female patients with cancer. It is now used by many IVF centers in the world. However, this is the first study which OTC by vitrification is carried on and assessed the effectiveness of the technique.

Detailed description: Ovaries from all less than 45 year-old breast cancer patients who undergo oophorectomy by laparoscopy after treated with chemotherapy will be enrolled to the study. Pieces of cortex of each patient will divide into two groups. Group 1 is fresh fragments (control group) and group 2 is vitrified group. Ovarian tissues in group 2 will be vitrified or warmed with medium and devices of Ova-kit type M (Kitazato, Japan).

Cortex fragments of each group will have:

* Follicle survival evaluation by Neutral red staining
* Histological evaluation by Hematoxylin and Eosin staining
* Evaluation relative Growth Differentiation Factor 9 (GDF-9) and Caspase-3 gene expression by real-time Polymerase chain reaction (PCR).

Comparison of data collected from 2 groups will be carried on to evaluate the effectiveness of the technique before applying this technique for cancer patients in Vietnam.

Eligibility criteria: Inclusion Criteria:

* Ovaries from all less than 45 year-old breast cancer patients who undergo oophorectomy by laparoscopy after treated with chemotherapy

Exclusion Criteria:

* The volume of ovaries is less than 2/3 of normal 3cm (L) x 2.5cm (H) x 1.5cm (W) ovary.

Primary outcomes:
measure: Rate of Survivable follicle
timeFrame: After 4 hours stained by Neutral red
Secondary outcomes:
measure: Rate of Healthy follicle by histological analysis
timeFrame: Immediately after tissue stained by Hematoxylin and Eosin
measure: The relative expression ratio ( R ) of genes in follicles
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: My Duc Hospital
Study officials:
affiliation: Hope Research Center
name: Tuong M Ho, MD, MCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03743376: The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients
Official title: The HIV Functional Cure Potential of UB-421: A Phase II, Randomized, Open-label, Controlled, 48 Week, Proof of Concept Study, to Evaluate the Safety of UB-421 in Combination With Standard Antiretroviral Therapy (ART) and the Efficacy of HIV Reservoir Reduction as Compared With ART Alone in ART Stabilized HIV-1 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV-1 Infection
Lead sponsor: United BioPharma
Sponsor class: INDUSTRY
Collaborators: name: National Taiwan University Hospital
name: Taipei Veterans General Hospital, Taiwan
name: Taoyuan General Hospital
name: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Kaohsiung Veterans General Hospital.
First posted: 2018-11-16
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluate the safety of UB-421 in combination with standard antiretroviral therapy (ART) and the efficacy of HIV reservoir reduction as compared with ART alone in ART stabilized HIV-1 patients


Eligibility criteria: Inclusion Criteria:

1. HIV-1 sero-positive
2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
3. HIV-1 plasma RNA level below 50 RNA copies/mL .

Exclusion Criteria:

1. Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may confound evaluation and treatment for HIV-1.
2. Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.
3. Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.
4. History of anaphylaxis to other mAbs.
5. Any vaccination within 8 weeks prior to the first dose of assigned drug.
6. Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to the first dose of assigned drug.
7. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.

Primary outcomes:
measure: treatment related TEAEs
timeFrame: 48Weeks
Secondary outcomes:
measure: the change of immune profiles
timeFrame: 16Weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: