louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02469727: mHealth Intervention to Promote Cancer Survivors' Physical Activity
Official title: mHealth Intervention to Promote Cancer Survivors' Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Quality of Life
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2015-06-11
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Primary Goal is to conduct a 5-10 week randomized controlled trial (RCT) of the Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit mHealth app. The target population will be childhood cancer survivors 14-18 years old recruited from Seattle Children's Hospital. For the intervention group, peer influences will be engaged via a private, social network (e.g. a Facebook group) customized for survivors. Measurements will be completed (1) at baseline, prior to randomization, and (2) during the final week of the intervention period (follow-up measure). This study will provide initial proof of concept and allow for further customization of the intervention for childhood cancer survivors in anticipation of a future, larger proposal to study physical activity and related outcomes over a multi-year period.


Eligibility criteria: Inclusion Criteria:

* in remission for childhood cancer and previously treated for childhood cancer at Seattle Children's Hospital
* ≥1-year post-cancer therapy
* ambulatory without any known medical contraindications to participation
* able to complete surveys in English
* agree to install and share data from the FitBit smart phone app with the investigators

Exclusion Criteria:

* currently or previously used a wearable physical activity sensing device to improve physical activity

Primary outcomes:
measure: Post-intervention physical activity (measured by accelerometers)
timeFrame: up to week 10
Secondary outcomes:
measure: Post-intervention health related quality of life (measured by questionnaire)
timeFrame: up to week 10
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
Study officials:
References:
Clinical trial NCT02392273: A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil
Official title: A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Primary Headache Disorders
Keywords: migraine
cluster headache
primary headache
Ausanil
capsicum annuum
Lead sponsor: VR1 Corporation
Sponsor class: INDUSTRY
First posted: 2015-03-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in a Clinical headache practice (outpatient) with a diagnosis of a primary headache disorder.

Brief summary: This study is an observational study with the primary objective to assess the safety and tolerability of Ausanil in the treatment of primary headache disorders. The secondary objective is to assess headache pain, functional outcome, time loss to headache and patient satisfaction with Ausanil treatment.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 to 80 years
* Primary Headache disorder as per International Classification of Headache Disorders-11
* Ausanil naive
* Signed dated informed consent
* Females of childbearing potential must be using adequate contraception during study period.
* Willing and able to comply with registry requirements to document headache response

Exclusion Criteria:

* Known allergy to Ausanil or any of its ingredients
* Active bronchial asthma that in the opinion of the investigator would interfere with use of Ausanil
* Nasal obstruction due to any cause or extensive nasal surgery resulting in scarring or other such impact on nasal mucosa that might lead to heightened sensitivity to Ausanil in the opinion of the investigator.
* Pregnant or breast feeding females
* History of addictive behavior
* Any severe or chronic unstable medical or psychiatric condition
* Active nasal infection or inflammation
* Unable or unwilling to provide informed consent
* Suffer from atypical, basilar or hemiplegic migraine that is new onset or unstable.

Primary outcomes:
measure: Incidence of Adverse Events (all cause)
timeFrame: 8 weeks
measure: Incidence of Adverse Events causally related to Ausanil
timeFrame: 8 weeks
measure: Serious Adverse Events
timeFrame: 8 weeks
Secondary outcomes:
measure: Headache Response to Ausanil
timeFrame: 24 hours
measure: Functional Assessment
timeFrame: 24 Hours
measure: Patient satisfaction for Treatment
timeFrame: 24 hours
measure: Time Loss to headache
timeFrame: 24 hours
measure: Use of Rescue Medication
timeFrame: 24 hours
measure: Sting severity and duration
timeFrame: one hour
Other outcomes:
Locations:
city: Summit
country: United States
facility: Atlantic Health System/Overlook Medical Center Medical Arts Center
state: New Jersey
Study officials:
affiliation: Atlantic Health System
name: Seth Stoller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03731273: Compensation for Smaller Portion Sizes and Portion Size Normality
Official title: Compensation for Smaller Portion Sizes and Portion Size Normality: Two Laboratory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Portion Size
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: Medical Research Council
First posted: 2018-11-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Reducing food portion size is a potential strategy to reduce energy intake. However it is unclear at what point consumers compensate for reductions in portion size by increasing energy intake from other items. The investigators tested the hypothesis that reductions to food portion size will only result in significant compensatory eating when the reduced portion size is no longer visually perceived as 'normal'. In two within-subjects experiments, participants (Study 1: N = 45, M BMI = 26.9; Study 2: N = 37, M BMI = 26.9; 51% female) were served different sized portions of a lunchtime meal on three occasions: a 'large-normal', a 'small-normal', and a 'smaller than normal' portion. Both the reduction from 'large-normal' to 'small-normal' and from 'small-normal' to 'smaller than normal' portions represented the same change in food volume and energy content (84g, 77kcal Study 1; 98g, 117kcal Study 2). Participants were able to serve themselves additional helpings of the same food (Study 1), or dessert items (Study 2).


Eligibility criteria: Inclusion Criteria:

* general liking and willingness to consume the test foods in each study

Exclusion Criteria:

* food allergies, intolerances or specific dietary requirements (including being vegetarian or vegan)
* a history of eating disorders;

Primary outcomes:
measure: Meal energy intake
timeFrame: Immediate
measure: 'Compensatory' (additional) energy intake
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Ashleigh Haynes
state: Merseyside
Study officials:
References:
Clinical trial NCT05773573: Skeletal and Dental Changes with Hyrax-type Rapid Maxillary Expander Anchored to Permanent Versus Deciduous Molars
Official title: Comparison of Skeletal and Dental Changes with Hyrax-type Rapid Maxillary Expander Anchored to Permanent (6) Versus Deciduous Molars (V) in Growing Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Hypoplasia
Keywords: Orthodontic appliances
Orthodontic interceptive
Palatal expansion technique
Child
Dentition mixed
Tooth deciduous
Rapid maxillary expansion
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to compare the skeletal and dental maxillary expansion obtained with an Hyrax tooth-borne expander anchored either on the 2nd deciduous molars (V) or on the 1st permanent molars (6)

Detailed description: The aim of the study is to compare the skeletal and dental maxillary expansion obtained with an Hyrax tooth-borne expander anchored either on the 2nd deciduous molars (V) or on the 1st permanent molars (6).

The main objective is to compare at the skeletal level the distance between the cephalometric points, right jugal (RJ) and left jugal (JR) (maxillary base).

The secondaries objectives are performed at the dental level by measuring the distance between the maxillary first molars mesio-palatal cusp and the cuspids cups. Molar derotation is also assessed

Eligibility criteria: Inclusion Criteria:

* Patient coming to the dental clinic for a first orthodontic consultation in mixed dentition
* Patient aged 6 to 12 years
* Patient with a transverse maxillary deficiency requiring rapid maxillary expansion
* Presence of 1st permanent molars "6" and 2nd deciduous "V" molars with sufficient root length

Exclusion Criteria:

* Syndromic patients (all syndromes combined: cleft lip, etc.)
* Patient with V or 6 with decays (or with major root resorption)
* Patient with oral hygiene non compatible with orthodontic treatment
* Failure to obtain informed written consent
* No affiliation to a French national medical health system
* Patient with a legal protection measure

Primary outcomes:
measure: Difference in skeletal maxillary width before/ after rapid maxillary expansion
timeFrame: 6 months
Secondary outcomes:
measure: Difference of the inter-molar distance before/after
timeFrame: 6 months
measure: Difference of the inter-canine distance before/after
timeFrame: 6 months
measure: Difference in the amount of molar derotation (inter-molar angle) before/after
timeFrame: 6 months
measure: Inter-operator reproducibility
timeFrame: 1 month
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre de Soins Dentaires
Study officials:
References:
Clinical trial NCT04884373: Patient Satiety as an Indicator of Stomach Contents and Fluid Volume
Official title: Patient Satiety as an Indicator of Stomach Contents and Fluid Volume: an Observational Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasting
Hunger
Keywords: Ultrasonography
Gastric ultrasound
Lead sponsor: Imeldaziekenhuis
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adult patients scheduled for elective surgery that fit inclusion criteria

Brief summary: This research proposal aims to investigate the correlation between a) the hunger feeling as measured by a ten point scale and b) total gastric fluid volumes and content as measured with gastric PoCUS in fasted, healthy subjects \> 18 of age, scheduled for elective surgery.

Detailed description: An ultrasound exam will be performed before induction of anaesthesia. GUS results from selected patients will be systematically acquired and assessed following an algorithm (Appendix Ia). The ultrasound results will be collected on a standardized form (Appendix IIa). The technique is performed in the supine and right lateral decubitus position (Appendix Ib) and only by anesthesiologists with sufficient experience with ultrasound and the technique. The patient will be asked to indicate his/her satiety on a predetermined ten-point scale. Patient data and satiety score will be collected on a standardized form (Appendix IIb). The scanning anaesthesiologist is blinded to the result of the questionnaire.

Eligibility criteria: Inclusion Criteria:

* - Age ≥ 18 years
* Fasted according to national guidelines
* Elective surgery
* ASA physical status I-II
* Ability to assume both supine and right lateral decubitus position.
* Able to understand and to sign informed consent

Exclusion Criteria:

* - Previous esophagus and gastric surgery, hiatal hernia, gastric cancer.
* Pregnancy
* Failure of GUS (defined as failure to visualize the antrum)

Primary outcomes:
measure: the correlation between total gastric fluid volume in millilitres and a ten-point (0-10) satiety scale.
timeFrame: Before surgery
Secondary outcomes:
measure: the correlation between the Perlas grading scale ( 0,1,2) and a ten-point (0-10) satiety scale.
timeFrame: Before surgery
measure: the correlation between the type of gastric content ( no content, fluid content, solid content) and a ten-point (0-10) satiety scale
timeFrame: before surgery
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
Study officials:
affiliation: Imeldaziekenhuis
name: Peter Van de Putte, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01289873: Prevalence, Persistence, and Risk Factors for Oral Human Papillomavirus (HPV) Infections in College Women
Official title: Prevalence, Persistence, and Risk Factors for Oral HPV Infections in College Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-02-04
Enrollment: 1036
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female college students

Brief summary: The purpose of this study is to determine how common oral HPV infections are in college women. The investigators also will find out what risk factors are associated with having oral HPV infections. The investigators hypothesize that approximately 3% of women will have oral HPV, and that HPV will be associated with oral sexual behaviors and with smoking behaviors. Finally, for those women with oral HPV- the investigators will determine whether the infections are persistent (still present) at 3-, 6-, and 12-months after the initial diagnosis.


Eligibility criteria: Inclusion Criteria:

* Age \>=18 years
* Female
* Currently enrolled as a college student

Exclusion Criteria:

* Unable to provide an oral rinse sample
* Unable to complete survey
* Unable to provide contact information
* Already completed study.

Primary outcomes:
measure: Prevalence of oral HPV
timeFrame: at enrollment
Secondary outcomes:
measure: Persistence of oral HPV over 1 year of follow-up
timeFrame: 1 year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Student Health Care Center
state: Florida
Study officials:
affiliation: University of Florida
name: Robert L Cook, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01752673: The Visualization of Uncertainty in Clinical Diagnostic Reasoning for Pulmonary Embolism
Official title: The Visualization of Uncertainty in Clinical Diagnostic Reasoning for Pulmonary Embolism: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Diagnostic Uncertainty
Clinical Reasoning
Evidence Based Medicine
Visualization of Uncertainty
Keywords: randomized controlled study
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 24
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Medical reasoning is a form of inquiry that examines the thought processes involved in making medical decisions. When physicians are faced with patients' symptoms or signs, their thought processes follow either direct shortcuts to suspect a diagnosis or go into a deeper and more analytic process to reach a diagnosis. The second pathway is less prone to biases and errors. This study explores whether the use of an interactive visual display of probabilities of pulmonary embolism generated from positive or negative test results will increase the adherence to evidence based guidelines in the diagnosis of pulmonary embolism.


Eligibility criteria: Inclusion Criteria:

* Medical students, University of Calgary, in clerkship who finished at least 4 weeks of a block of medicine rotation at any hospital site.
* First year subspecialty or Internal Medicine residents.
* Practicing physicians in the subspecialties of Internal Medicine or Emergency Medicine.

Exclusion Criteria:

* Physicians in the subspecialty of Haematology or Respiratory

Primary outcomes:
measure: Concordance with medical diagnostic reasoning pathway for pulmonary embolism.
timeFrame: Paper-based clinical case scenarios were completed within 2 hour after either intervention.
Secondary outcomes:
measure: Time.
timeFrame: Paper-based clinical case scenarios were completed within 2 hour after either intervention.
Other outcomes:
measure: Survey.
timeFrame: Survey was completed within 2 hours after completion of either intervention.
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Ghazwan Altabbaa, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01569373: Analysis of Biomarkers for Acute Graft-versus-Host Disease (GVHD)
Official title: Analysis of Biomarkers for Acute Graft-versus-Host Disease (GVHD).
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Blood Stem Cell Transplant Failure
Keywords: Allogeneic stem cell transplant
Graft versus Host Disease
GVHD
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-04-03
Enrollment: 0
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: Patients who have undergone an allogeneic stem cell transplant being followed for post transplant care.

Brief summary: Samples of blood and urine will be analyzed for biomarkers to check their predictivity of Graft-versus-Host Disease (GVHD) outcomes.

Detailed description: To determine if serum biomarkers of inflammation correlate with onset and severity of acute GVHD, particularly GVHD of the gut.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older patients
* Undergoing allogeneic stem cell transplant

Exclusion Criteria:

None

Primary outcomes:
measure: Diagnosis of severe acute GVHD
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark Litzow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05691673: Upper Extremity Force-velocity Profile in Swimmers
Official title: The Effect of Training Periodization on the Upper Extremity Force-velocity Profile in Swimmers During a Macro Cycle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Extremity Injury
Keywords: swimming
performance
strength
plyometric
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health young swimmers in competitive club

Brief summary: The aim of this study was to measure the changes in the upper extremity force-velocity profile of young swimmers at different training periods during a training season

Detailed description: Tested at each experimental test time point (Baseline: E1, post-general preparation: E2, post-specific E3 and post-competition season: E4). To measure the upper extremity force-velocity parameters, the countermovement push-up test was performed using the force plate

Eligibility criteria: Inclusion Criteria:

* 15-18 age
* go to training regularly

Exclusion Criteria:

* upper extremity surgery in the last 1 year
* pain during the tests

Primary outcomes:
measure: The change in the parameters of the force (Newton) obtained from the force platform with countermovement push up from the baseline to the end of the season.
timeFrame: Baseline: E1, (week 0) post-general preparation: E2 (week 6), post-specific E3 ( week12) and post-competition season: E4 (week 16).
measure: velocity (m/s)
timeFrame: Baseline: E1, (week 0) post-general preparation: E2 (week 6), post-specific E3 ( week12) and post-competition season: E4 (week 16).
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT04858373: Characterizing Emmer Seeds and Flours, and Determining the Glycemic Effects of Emmer Breads
Official title: Characterizing the Technological Properties of Emmer Seeds, Flour, and Bread; and Determining the Effect of Emmer Breads on Glycemic Responses in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Potential Abnormality of Glucose Tolerance
Appetitive Behavior
Keywords: blood glucose
emmer bread
glycemic index
glycemic load
blood pressure
Lead sponsor: Agricultural University of Athens
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment
Primary purpose: OTHER

Brief summary: This study characterized emmer seeds, flours, and breads, and investigated the effects of emmer breads on the glycemic response

Detailed description: This study aimed to 1. describe the technological characteristics of emmer seeds, flours, and breads, 2. determine the glycemic index and glycemic load of two emmer breads, and 3. to investigate the effects of these breads on postprandial glycemic response in healthy subjects

Eligibility criteria: Inclusion Criteria:

* healthy
* non-smoking
* non-diabetic men and women
* body mass index (BMI) between 18 and 27 kg/m2

Exclusion Criteria:

* severe chronic disease (e.g. coronary heart disease, diabetes mellitus,kidney or liver conditions, endocrine conditions)
* gastrointestinal disorders
* pregnancy
* lactation
* competitive sports
* alcohol
* drug dependency

Primary outcomes:
measure: Capillary blood glucose responses
timeFrame: 2 hours
Secondary outcomes:
measure: Subjective appetite ratings
timeFrame: 2 hours
measure: Blood pressure
timeFrame: 2 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Agricultural University of Athens
state: Attica
Study officials:
affiliation: Agricultural University of Athens
name: Aimilia Papakonstantinou, PhD
role: PRINCIPAL_INVESTIGATOR
References: