louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02696772: Effect of 24 h Severe Energy Restriction on Appetite Regulation and Ad-libitum Energy Intake
Official title: Effect of 24 h Severe Energy Restriction on Appetite Regulation and Ad-libitum Energy Intake in Lean Males and Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deficiency; Calorie
Lead sponsor: Loughborough University
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2016-03-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Long term maintenance of weight loss is generally poor, which is at least partly due to increased feelings of hunger associated with restricting what can be eaten. Intermittent severe energy restriction is a novel dietary strategy that requires individuals to consume a very-low energy diet for 1-4 days per week, allowing normal feeding patterns to be adopted on the other days in the week. However, the effect of a consuming a very-low energy diet on appetite regulation, which might represent a key marker of long-term adherence to dieting, has not been determined. This study aimed to assess the effects of severely restricting energy intake for 24 h on markers of appetite regulation, energy balance and metabolism compared to an adequate energy trial.


Eligibility criteria: Inclusion Criteria:

* non-smoker, not currently dieting, weight stable for \>6 months (self-reported), no known history of cardiovascular or renal disease.

Exclusion Criteria:

* food allergies, dislike or intolerance of study foods and drinks, irregular eating patterns, use of medication that could influence hormone concentrations, excessive alcohol consumption (\>4 units/day), intensive training schedule (\>10 h/week)

Primary outcomes:
measure: Ad-libitum energy intake
timeFrame: 48 hours
measure: Subjective appetite
timeFrame: 48 hours
measure: Plasma acylated Ghrelin
timeFrame: 24 hours
measure: Plasma active glugagon-like peptide 1
timeFrame: 24 hours
Secondary outcomes:
measure: Plasma insulin
timeFrame: 24 hours
measure: Plasma glucose
timeFrame: 24 hours
measure: Plasma Non-esterified Fatty acids
timeFrame: 24 hours
measure: Energy expenditure
timeFrame: 24 hours
measure: Fat oxidation
timeFrame: 24 hours
measure: carbohydrate oxidation
timeFrame: 24 hors
Other outcomes:
Locations:
Study officials:
References:
citation: Clayton DJ, Burrell K, Mynott G, Creese M, Skidmore N, Stensel DJ, James LJ. Effect of 24-h severe energy restriction on appetite regulation and ad libitum energy intake in lean men and women. Am J Clin Nutr. 2016 Dec;104(6):1545-1553. doi: 10.3945/ajcn.116.136937. Epub 2016 Nov 2.
Clinical trial NCT04508972: The VOICE-COVID-19
Official title: Voice-based Identification of Clinical Features Requiring Emergent Action in Patients With Suspected COVID-19 Infection (VOICE-COVID) I and II Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: COVID-19
Alexa Device
Voice-based technologies
Screening
Safety
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Amazon Web Services (AWS) Canada
First posted: 2020-08-11
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any employees or patients entering the Heart Failure clinic at the McGill University Health Center

Brief summary: The VOICE-COVID study will evaluate the concordance of screening for symptoms of COVID-19 using a voice based device (Amazon Alexa) compared to manual screening by a study coordinator for individuals entering the Cardiology/Heart Failure clinic at the McGill University Health Centre.

Detailed description: This study is an open-label, prospective, cross-over randomized study.

VOICE-COVID I: All individuals entering the Heart Failure (HF) Clinic of the McGill University Health Center will be asked to participate. A poster with instructions to ask the participants (employees or patients) to speak with the Amazon Alexa device. The participant will remain 6 feet away from the device. The Amazon Alexa will ask the survey questions. A study coordinator will then ask the same questions along with some additional questions about Amazon Alexa usability. VOICE-COVID II: A second cohort of 52 people will be then randomized to be screened for symptoms of COVID-19 with an Amazon Alexa or a coordinator. We will study the correlation between the Alexa response and the response to the study coordinator using K-squared statistic tests and screening question concordance.

Eligibility criteria: Inclusion Criteria:

* Adults \>=18 yrs who is entering the HF clinic
* Speaks either English or French

Exclusion Criteria:

* None

Primary outcomes:
measure: Correlation between data captured using Amazon Alexa compared to manual (human) collected data.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
measure: Self reported Likert scale on comfort in using the Amazon Alexa device
timeFrame: Day 1
Locations:
city: Montreal
country: Canada
facility: Muhc-Rimuhc
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Abhinav Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01580072: Telemonitoring of Patients With COPD in Carinthia
Official title: REgions of Europe WorkiNg toGether for HEALTH (Renewing Health)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive (COPD)
Lead sponsor: Landeskrankenanstalten-Betriebsgesellschaft
Sponsor class: INDUSTRY
Collaborators: name: European Commission
First posted: 2012-04-18
Enrollment: 65
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluation whether the introduction of large-scale telemonitoring of patients with COPD produces benefits in terms of reduced hospital readmissions, improved health related quality of life and health status. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.


Eligibility criteria: Inclusion Criteria:

* COPD 3 or 4
* Be able to use the system provided
* Life expectancy \> 12 months

Exclusion Criteria:

Primary outcomes:
measure: Health Related Quality of Life as Measured by the Short-Form 36 Version 2 Questionnaire; The Short Form (36) Health Survey is a 36-item, Patient-reported Survey of Patient Health. The SF-36 is a Measure of Health Status.
timeFrame: 12 months
measure: Number of Inpatient Stays
timeFrame: 12 months
Secondary outcomes:
measure: Number of Bed Days for Hospitalised Patients
timeFrame: 12 months
measure: Number of Primary Care Visits
timeFrame: 12 months
measure: Number of Specialist Visits
timeFrame: 12 months
measure: Number of Consultations of Emergency Doctor
timeFrame: 12 months
measure: All Cause Mortality
timeFrame: 12 months
measure: COPD Assessment Test CAT (Carinthia)
timeFrame: 12 months
measure: St. George's Respiratory Questionnaire SGRQ (Carinthia)
timeFrame: 12 months
measure: BODE Index (Carinthia)
timeFrame: 12 months
Other outcomes:
Locations:
city: Kötschach
country: Austria
facility: LKH Laas
state: Carintha
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt
state: Carinthia
city: Villach
country: Austria
facility: LKH Villach
state: Carinthia
Study officials:
References:
Clinical trial NCT03357172: Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation
Official title: Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Allogeneic Hematopoietic Stem Cell Transplantation
Keywords: Immune recovery
Immunomodulatory cells
GVHD
GVL
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study concerns donors and patients receiving allogeneic stem cell haematopoietic transplantation. The aim of the study is to analyse HSC graft content in immune effector T (naive, memory, activated, exhausted) and immunoregulatory cell subtypes (Tregs, iNKT, MDSC) and correlate the results with post-transplant immune reconstitution of those different cell subtypes and clinical events (graft-versus-host-disease, relapse, infections). An ancillary study will focus on the impact of microbiota dysbiosis on post-transplant immune response and regulatory cell subsets.


Eligibility criteria: Inclusion Criteria:

* patient of the Nancy CHRU, for whom a CSH allograft is planned. or
* hematopoietic stem cell donors received at Nancy's CHRU for the duration of the research

Exclusion Criteria:

* Positive HIV
* active hepatitis B or C infection

Primary outcomes:
measure: Proportions of regulatory immune cells in peripheral blood.
timeFrame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Secondary outcomes:
measure: Occurrence of graft versus host (GVH) reaction after allografting of CSH
timeFrame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
measure: Incidence of relapse
timeFrame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
measure: Incidence of infections
timeFrame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
measure: Progress-free survival
timeFrame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
measure: Overall survival
timeFrame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: CHRU de Nancy
Study officials:
References:
Clinical trial NCT03402672: AWAITS: A Web-based E-health Application for Active Illicit Opioid Users
Official title: A Web-based E-health Application for Active Illicit Opioid Users Providing Information About Overdose and Infection Risk Factors and Encouraging HCV/HIV Testing and Medication Assisted Treatment Seeking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
IV Drug Usage
Overdose
Drug Addiction
Substance Use Disorders
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to:

1. assess how participants like the AWAITS e-health application as measured by their feedback on the intervention
2. test the impact of AWAITS on knowledge about opioid overdose and risk-reduction strategies.
3. assess the proportion of participants who accept a list of local treatment providers
4. test the impact of AWAITS on interest in being tested for HCV/HIV.

Detailed description: The pre-post study of AWAITS will: 1) assess the acceptability of AWAITS as measured by participant feedback about the intervention; 2) test the impact of AWAITS on knowledge about opioid overdose, as measured by the OOTAS; 3) assess the proportion of participants who accept a list of local MAT treatment providers; and 4) test the impact of AWAITS on interest in being tested for HCV/HIV.

The acceptability of AWAITS will be assessed with a feedback form which includes questions about how helpful the intervention was (scale of 1-4), what the patient liked most and least about the intervention, and any suggestions for improving it. The average (and standard deviation) for the rated helpfulness of the intervention will be derived and the qualitative data about what they liked most and least about the intervention and suggestions for improvement will be tabulated. Pre-/post-changes in the percent of correct knowledge assessment items (i.e., about overdose and MAT) and interest in HCV/HIV testing will be analyzed using a Wilcoxon signed-rank test. The proportion of participants accepting a list of local MAT treatment providers will be calculated.

Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age
2. Not enrolled in MAT per self-report
3. Self-reports illicit opioid use

Exclusion Criteria:

3. Does not acknowledge reviewing "Information Sheet for Research" within REDCap

Primary outcomes:
measure: 3 sections of the OOTAS (signs of overdose, how to respond to an overdose, and MAT)
timeFrame: Day 1
Secondary outcomes:
measure: Feedback on AWAITS
timeFrame: Day 1
measure: Acceptance of list of MAT providers
timeFrame: Day 1
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Addiction Sciences Division
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Theresa Winhusen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02020772: Coordinating Teams in Primary Health Care.
Official title: Coordination Between General Practitioners and Physical Therapists in Primary Health Care for Musculoskeletal Pain: Effect on Sick Leave and Referral to Specialist Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Diseases
Keywords: primary health care
Physical Therapy Specialty
General Practitioners
General Practice
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2013-12-25
Enrollment: 969
Sex: ALL
Minimum age (years): 21
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients who suffer from musculoskeletal pain often have more than one diagnosis. These patients mostly have to wait a long time for the doctor's examination and treatment, and they also often have a sick leave for a long period of time. The investigators expect that treatment and follow-up by an coordinating interdisciplinary team can improve these patients opportunity to function, increase their quality of life, and decrease their pain. The purpose of this study is to investigate if use of a coordinating interdisciplinary team in primary health care will result in reduced sick leave compared with practice as usual, and give fewer referrals to specialized health services and private rehabilitation centers. Research data will be obtained from the patients journals, questionnaires, and clinical examinations..


Eligibility criteria: Inclusion Criteria:

* patient in one of the participating general practices
* musculoskeletal complaints in 3 years before start of this study
* informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: change in sick leave
timeFrame: 3 years
measure: referrals to specialist care
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stjørdal
country: Norway
facility: Stjørdal Legesenter
city: Trondheim
country: Norway
facility: Persaunet Legesenter
city: Trondheim
country: Norway
facility: Rosten Legesenter
city: Trondheim
country: Norway
facility: Sjøsiden Legesenter
Study officials:
affiliation: Norwegian University of Science and Technology
name: Siv Mørkved, prof phd
role: STUDY_DIRECTOR
References:
citation: Garnaes KK, Morkved S, Salvesen O, Tonne T, Furan L, Gronhaug G, Vasseljen O, Johannessen HH. What factors are associated with health-related quality of life among patients with chronic musculoskeletal pain? A cross-sectional study in primary health care. BMC Musculoskelet Disord. 2021 Jan 22;22(1):102. doi: 10.1186/s12891-020-03914-x.
Clinical trial NCT01953172: Health Status and Quality of Life in the Elderly
Official title: Exploratory, Double-blind, Randomized, Placebo Controlled Study of AMP-886 in the Elderly
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Quality of Life
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: Sprim Advanced Life Sciences
First posted: 2013-09-30
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study is designed to investigate the effect of AMP886 (alpha-tocotrienol) on health status and quality of life measures, cognitive functioning, oxidative stress, inflammation markers and other symptoms effects on skin, sleep and vision in the elderly.


Eligibility criteria: Inclusion Criteria:

* Males and females 65-85 years old
* ECOG Performance score 0 to 1
* Body mass index 22-30 kg/m2
* Body weight \>60 kg
* Habit to consume standard breakfast like toast, bread, butter/margarine, eggs, bacon, cereals with milk
* Comply with protocol and likely to be compliant with prescribed product

Exclusion Criteria:

* Renal insufficiency or failure at screening
* Current or previous positive documented history of any chronic inflammatory state including chronic infection, arthritis, or collagen vascular disorder.
* Comorbid medical conditions
* Use of prescription medication for chronic conditions
* Use of hormone replacement therapy (with the exception of levothyroxine)
* Uncontrolled hypertension
* Use of hemostatic agents
* Hemorrhagic disorder and/or coagulation disorder
* Clinically important bleeding within 90 days prior to screening visit
* Fat malabsorption syndromes
* Constipation and/or abdominal pain/discomfort that require dietary supplements or medical therapy
* History of smoking within 1 year prior to visit 1.

Primary outcomes:
measure: Effects on health status and quality of life
timeFrame: up to 24 weeks
measure: Effects on health status and quality of life
timeFrame: up to 24 weeks
measure: Effects on health status and quality of life
timeFrame: up to 24 weeks
measure: Effects on health status and quality of life
timeFrame: up to 24 weeks
measure: Effects on health status and quality of life
timeFrame: up to 24 weeks
measure: Effects on health status and quality of life
timeFrame: up to 24 weeks
measure: Effects on health status and quality of life
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Whipps Cross Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: Manchester
country: United Kingdom
facility: Central Manchester Hospital
Study officials:
affiliation: Unilever Research and Development
name: C Verhoeven, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01888172: Weight Watchers Online
Official title: Weight Watchers Online
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: WW International Inc
name: University of Tennessee
First posted: 2013-06-27
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct a randomized controlled trial to compare the weight losses produced by the Weight Watchers Online program (WWO) and WWO plus the Philips ActiveLink physical activity system, over a 1-year period, compared to a control group.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 27 and 40 kg/m2
* All ethnic groups will be recruited
* English speaking
* Have access to the Internet via a computer, and basic computer skills

Exclusion Criteria:

* Report health problems that make weight loss or unsupervised exercise unsafe or unreasonable
* Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire
* Are currently pregnant or breastfeeding, or intend to become pregnant in the next 12 months
* Are planning to move outside of the state within the next 12 months
* Report any cognitive or physical limitations that preclude use of a personal computer
* Have participated in a study conducted by the WCDRC or UT in the past 2 years
* Have followed a commercial weight-loss program within the previous 6 months or who are currently following a commercial weight loss program
* Weight loss of ≥ 5% of initial body weight in the last 6 months
* History of clinically diagnosed eating disorder excluding Binge Eating Disorder.
* Previous surgical procedure for weight loss
* Currently taking weight loss medication
* Treatment of cancer within the last 6 months

Primary outcomes:
measure: Change in body weight, measured in kilograms
timeFrame: 3, 6, 9, and 12 months after randomizaiton
Secondary outcomes:
measure: Engagement with the electronic intervention system
timeFrame: 3, 6, 9, and 12 months after randomization
measure: Blood pressure
timeFrame: 3, 6, 9, and 12 months after randomization
Other outcomes:
Locations:
city: Providence
country: United States
facility: Miriam Hospital Weight Control & Diabetes Research Center
state: Rhode Island
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
Study officials:
References:
citation: Thomas JG, Raynor HA, Bond DS, Luke AK, Cardoso CC, Foster GD, Wing RR. Weight loss in Weight Watchers Online with and without an activity tracking device compared to control: A randomized trial. Obesity (Silver Spring). 2017 Jun;25(6):1014-1021. doi: 10.1002/oby.21846. Epub 2017 Apr 24.