louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05744050: The Impact of Food Reformulation on Energy Intake
Official title: The Impact of Food Reformulation on Energy Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Eating Behavior
Obesity
Lead sponsor: University of Liverpool
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Repeated measures
Primary purpose: PREVENTION

Brief summary: Food prepared outside of the home tends to have a high energy content, and high levels of nutrients of concern (sodium, fat, saturated fat and sugar), especially when compared to home-cooked food. A number of studies suggest that when energy density of a food is manipulated it has a linear effect on energy intake, because consumers tend to eat a constant weight of food. However, recent observational research suggested that up to approximately 1.5-2kcal/g, individuals are relatively insensitive to changes in energy density, and there is no indication of compensation through altering meal size. However, upwards of approximately 1.5-2kcal/g, the authors proposed that individuals compensate for increases in energy density by selecting and consuming smaller meal sizes.

The investigators aim to measure participant's consumption (in grams and kilocalories) of three meals at low, medium and high energy densities, and to measure later food intake to observe any evidence of later compensation in response to experimental condition

Detailed description: See attached protocol document.

Eligibility criteria: Inclusion Criteria:

* Currently reside in the United Kingdom
* Over the age of 18 years
* Fluent English speaker
* Like the test foods
* Have a BMI between the ranges of 18.5 and 35.

Exclusion Criteria:

* Pregnant/breastfeeding
* Partaking in a fast or other restrictive eating for religious reasons at time of participation
* Currently following a diet
* On medication that affects appetite
* Being a smoker
* Current or historic eating disorder
* Dietary restrictions/intolerances including:

  * Any allergies
  * Vegan/vegetarian
  * Gluten-free
  * Dairy-free
  * Sugar-free

Primary outcomes:
measure: Acute intake
timeFrame: 30 minutes after intervention administered
Secondary outcomes:
measure: Later intake
timeFrame: Up to 7 hours after intervention administered
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: University of Liverpool
state: Merseyside
Study officials:
affiliation: University of Liverpool
name: Eric Robinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01296750: Late Compared to Early Physiotherapy Following Knee Dislocation
Official title: A Randomized Clinical Trial Comparing Late Versus Early Physiotherapy Start Times Following Multi Ligament Reconstruction for Knee Dislocation (Co-LEAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Knee Dislocation
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2011-02-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A knee dislocation is an unusual and extremely serious injury and is defined as complete displacement of the tibia with respect to the femur, usually with disruption of 3 or more of the stabilizing ligaments. When the knee dislocates, there is often significant damage to the soft-tissues envelope surrounding the joint, including adjacent neurovascular structures. Not surprisingly, this injury is a profoundly debilitating, life-altering event, with the potential to necessitate career change in athletes and laborers alike. Current evidence indicates that operative management for these injuries is more effective at returning patients to pre-morbid range of motion (ROM) and activity than conservative management. Post operative rehabilitation programs for these patients must balance the need for stability of their surgical repair and knee ROM and functionality. Experimental data suggests that post-operative immobilization offers greater protection of the surgical reconstruction, whereas immediate, aggressive physiotherapy may be more effective at preventing arthrofibrosis stiffness. The investigators are proposing a randomized clinical trial comparing early physiotherapy (day one post op) versus immobilization for three weeks then initiation of physiotherapy. The physiotherapy progams will be identicalbe in all aspects except for progam initiation.


Eligibility criteria: Inclusion Criteria:

* Ambulation without aids in pre-morbid condition
* Multi-ligament knee injury with or without associated peri-articular fracture
* Operative management within three weeks of the injury

Exclusion Criteria:

* Poly-trauma with life-threatening injuries preventing rehabilitation
* Patients unable to comply with intensive rehabilitation
* Patients unable or unlikely to maintain follow-up

Primary outcomes:
measure: Need for knee manipulation at or within 6months of initial surgery.
timeFrame: 6 months
Secondary outcomes:
measure: Knee Range of Motion
timeFrame: 6 months
measure: Knee stability
timeFrame: 6 months
measure: Patient Reported Outcome
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
References:
citation: Hoit G, Rubacha M, Chahal J, Khan R, Ravi B, Whelan DB. Is There a Disadvantage to Early Physical Therapy After Multiligament Surgery for Knee Dislocation? A Pilot Randomized Clinical Trial. Clin Orthop Relat Res. 2021 Aug 1;479(8):1725-1736. doi: 10.1097/CORR.0000000000001729.
Clinical trial NCT06010550: Validating a Clinical Decision Support Tool for Stratifying Stroke Risk for Dizziness/Vertigo
Official title: Validating a Clinical Decision Support Tool for Stratifying Stroke Risk in Patients Presenting With Dizziness to the Emergency Department
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dizziness
Vertigo
Keywords: Dizzy
Vertigo
Stroke
Machine learning
Lead sponsor: Chiayi Christian Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
First posted: 2023-08-24
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who visit the emergency department.

Brief summary: This study aims to validate a machine learning model that stratifies the risk of stroke in patients who present to the emergency department with dizziness or vertigo.

Detailed description: This is a cross-sectional, hospital-based study, with no randomization procedure. Over a 21-month period, approximately 600 subjects will be enrolled. The study will assess the risk of stroke in each patient using a machine-learning model. To detect ischemic or hemorrhagic stroke, each patient will undergo a non-contrast brain magnetic resonance imaging study. The predictive performance of the machine-learning model will be evaluated in terms of accuracy, precision, recall, F1 score, and area under the receiver operating characteristics curve.

Eligibility criteria: Inclusion Criteria:

* Presenting to the emergency department with dizziness or vertigo
* Aged ≥ 20
* Dizziness or vertigo lasting for at least 1 hour and \< 7 days
* Persistent dizziness or vertigo at the time of the examination at the emergency department

Exclusion Criteria:

* Having 5 or more prior episodes similar in quality, intensity, and duration to the current symptoms, with at least one episode more than a year prior and one within the past year
* Having frank stroke-like symptoms or signs, such as hemiparesis, facial asymmetry, dysarthria, dysphasia, ataxia, gaze palsy
* Consciousness disturbance, Glasgow coma scale \< 13
* Severe dementia
* Recent stroke within 3 months
* Dizziness or vertigo thought to be the result of head injury, hypotension, medication/drug intoxication, hypoglycemia, electrolyte imbalance, anemia, hepatic encephalopathy, hydrocephalus, etc
* Concomitant head or neck trauma
* Severe degenerative cervical spondylosis
* Having contraindications to magnetic resonance imaging examination

Primary outcomes:
measure: Number of participants with stroke
timeFrame: Between 24 hours and 14 days after the emergency department visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ditmanson Medical Foundation Chia-Yi Christian Hospital
name: Sheng-Feng Sung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00454350: A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis
Official title: A Randomized , Open-Label, Cross-over, Pharmacokinetic Study of Doxercalciferol and Paricalcitol Following Multiple Intravenous Injections in Chronic Kidney Disease Subjects on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Secondary Hyperparathyroidism
Keywords: Hectorol (doxercalciferol injection)
Zemplar (paricalcitol injection)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-03-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will measure serum levels of the active Vitamin D compound that circulates in hemodialysis subjects treated with either doxercalciferol injection (Hectorol®) or Zemplar® (paricalcitol injection).


Eligibility criteria: Inclusion Criteria:

* The subject must be receiving hemodialysis three times per week for a minimum of three months.
* The subject must be receiving intravenous doxercalciferol or paricalcitol at each dialysis session (three times weekly) for a minimum of 12 weeks prior to Screening.
* At Screening Visit the subject's laboratory measurements must be within the following ranges: Serum iPTH measurement between 150-800 pg/mL; Corrected calcium measurement ≤ 10.5 mg/dL; Serum phosphorus measurement ≤ 7 mg/dL

Exclusion Criteria:

* Any ongoing use of over the counter or prescription vitamin D preparations except doxercalciferol or paricalcitol injection or multivitamins.
* History of heparin-induced thrombocytopenia.

Primary outcomes:
measure: Pharmacokinetic Study
timeFrame: 44 hour interval
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
state: Minnesota
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00672750: A Retrospective Review Of Outcomes Following Laparoscopic Myomectomy
Official title: A Retrospective Review Of Outcomes Following Laparoscopic Myomectomy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Laparoscopic Myomectomy
Keywords: laparoscopic
myomectomy
menorrhagia
pelvic pain
Lead sponsor: The Advanced Gynecologic Surgery Institute
Sponsor class: OTHER
First posted: 2008-05-06
Enrollment: 70
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Private patients of Dr Charles Miller who have undergone laparoscopic myomectomy since 1999

Brief summary: This will be a retrospective review of approximately 900 patients who have undergone laparoscopic myomectomy since 1999. patients will be contacted by phone and surveyed. All patients who have had laparoscopic myomectomy will be included. Only those not wishing to take part in the survey will be excluded. The data will then be compiled for statistical analysis , looking at pain, bleeding and subsequent fertility.

Detailed description: Patients will be called and surveyed using a survey tool. They will be asked about what factors lead them to have surgery and then was their issue resolved after surgery.

Eligibility criteria: Inclusion Criteria:

* All patients who are willing to be surveyed

Exclusion Criteria:

* Those patients who are not willing to answer the survey will be excluded

  * Those patients who are unable to be contacted( ie; moved) will be excluded

Primary outcomes:
measure: That patients who had pain prior to laparoscopic myomectomy will have less pain in 75% of the cases
timeFrame: since 1999
Secondary outcomes:
measure: That patients who had menorrhagia prior to laparoscopic myomectomy would see a reduction after surgery 75% of the time
timeFrame: since 1999
Other outcomes:
Locations:
city: Naperville
country: United States
facility: Advanced Gynecologic Surgery Institute
state: Illinois
Study officials:
affiliation: Advanced gynecologic surgery institute
name: Charles E Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02770950: Zushima Plaster for Treating Knee Osteoarthritis
Official title: Zushima Plaster for Patients in Knee Osteoarthritis: a Random, Positive Drug Controlled, Multi-center Clinical Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Knee Osteoarthritis
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Beijing Hospital of Traditional Chinese Medicine
name: Beijing Hospital
name: Beijing Jishuitan Hospital
name: Beijing Shijitan Hospital, Capital Medical University
name: Shanghai Municipal Hospital of Traditional Chinese Medicine
name: Gansu Provincial Hospital
name: General Hospital of Beijing Military Area
First posted: 2016-05-12
Enrollment: 396
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
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 further evaluate the clinical efficacy and safety of Zushima plaster for patients in knee osteoarthrosis post-marketing.


Eligibility criteria: Inclusion Criteria:

* Ages 40-75;
* Unilateral or bilateral knee OA, confirmed radiographically;
* Patients taking oral NSAIDs prior to the breakthrough period will be permitted;
* VAS pain score is or above 20mm.

Exclusion Criteria:

* Knee is swollen and hot;
* Allergic to any ingredient in Girald Daphne Bark Plaster (Girald Daphne Bark, Lithargite, Linseed oil, Red lead) ;
* Congestive Heart Failure and Edema;
* Advanced renal disease;
* Knee joint skin is burst or skin disease or allergies.

Primary outcomes:
measure: the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment
timeFrame: Week 2.
Secondary outcomes:
measure: the change of Patient's global assessment of disease activity from baseline to posttreatment
timeFrame: Week 2.
measure: the change of WOMAC Osteoarthritis Index from baseline to posttreatment
timeFrame: Week 2.
measure: the change of Short Form 36 Questionnaire (SF-36) score from baseline to posttreatment
timeFrame: Week 2.
measure: the change of Erythrocyte Sedimentation rate (ESR) from baseline to posttreatment
timeFrame: Week 2.
measure: the change of C-reactive protein (CRP) from baseline to posttreatment
timeFrame: Week 2.
measure: the change of knee musculoskeletal ultrasound (MSUS) from baseline to posttreatment
timeFrame: Week 2.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital
state: Beijing
Study officials:
affiliation: Rheumatology Department
name: Quan Jiang, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00697450: Observational Study on the Weight Effect of Insulin Detemir (Levemir®) in Type 2 Diabetics
Official title: Observational Study Evaluating the Body Weight Progress During the Treatment With Insulin Detemir (Levemir®) in Type 2 Patients, Previously Treated With Other Basal Insulins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 206
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: Type 2 diabetics

Brief summary: This study is conducted in Europe. Observational study evaluating the body weight progress during the treatment with insulin detemir (Levemir®) in Type 2 patients, previously treated with other basal insulins


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Current treatment with insulin NPH or glargine
* The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria:

* Current treatment with insulin detemir
* Previous enrolment in this study
* Hypersensitivity to insulin detemir or to any of the excipients.
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months

Primary outcomes:
measure: Weight effect
timeFrame: 12 months prior to and 12 months after detemir treatment.
Secondary outcomes:
measure: Improvement in FPG levels
timeFrame: 12 months prior and 12 months after detemir treatment
measure: Improvement in HbA1c levels
timeFrame: 12 months prior and 12 months after detemir treatment
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05286450: Non-compliance on Treatment Among Diabetic Students at Sohag University
Official title: Non-compliance on Treatment Among Diabetic Students at Sohag University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 153
Sex: ALL
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all the diabetic students in sohag university from different faculties

Brief summary: A cross-sectional study on diabetic students in Sohag University will be conducted to collect data about factors affecting compliance and adherence to diabetes treatment and its impact on development of complications.

Detailed description: Personal interviews with diabetic students through a questionnaire :

1. To determine factors affecting non compliance on treatment among diabetic students.
2. To detect relation between non compliance on treatment and development of complications.

Eligibility criteria: Inclusion Criteria:

* Diabetic students at Sohag University age from 17 to 25

Exclusion Criteria:

* Healthy students
* Students in other universities

Primary outcomes:
measure: Distribution of Participants Responses as Regards DSMQ Glucose Management Domain
timeFrame: 2 months
measure: Distribution of Participants Responses as Regards DSMQ Dietary Control Domain
timeFrame: 2 months
measure: Distribution of Participants Responses as Regards DSMQ Physical Activity Domain
timeFrame: 2 months
measure: Distribution of Participants Responses as Regards DSMQ Health Care Use Domain
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of medicine Sohag University
Study officials:
affiliation: Faculty of Medicine Sohag University
name: Samah W. Elkhayat, demonstrator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01738750: Laparoscopic Versus Open Appendectomy? Let the Patient Decide
Official title: Laparoscopic Versus Open Appendectomy? Let the Patient Decide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Keywords: surgical choice
cost of care
decision making
health care
health care cost
pediatric
children
appendicitis
patient satisfaction
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 100
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This protocol examines choice where it pertains to choosing between two standard methods for appendectomy, laparoscopic or open procedures, and the affect that "cost" of the appendectomy has upon choice.

Children admitted with a diagnosis of uncomplicated appendicitis will be consented to participate in a study in which the patient can choose between laparoscopic or open appendectomy procedures. Those that agree to review a consent form will be randomly placed into one of two groups. The two groups consist of one in which the consent form includes "cost information for each operative procedure" in the comparison between the procedures, and the other group receives a consent form that does not include "cost information for each operative procedure". Both groups also view a short, group specific, computerized presentation that describes each procedure.

The hypothesis is that those patients given a choice between two similar surgical procedures and are provided with "cost information" will more often choose the less expensive surgical procedure than those that do not have information related to the cost of the surgical procedures.


Eligibility criteria: Inclusion Criteria:

* acute appendicitis

Exclusion Criteria:

* age 18 or older
* imaging positive for perforation; ultrasound or CT scan
* pain for greater than 2 days
* children with a body mass index \> 95% for age and sex
* surgeon decision for non-equivalent procedure based on patient presentation

Primary outcomes:
measure: Choice Based on Cost
timeFrame: Outcome assessed prior to surgical procedure with data presented within 1 year
Secondary outcomes:
measure: Hospital/Operative Dollars
timeFrame: Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
Study officials:
affiliation: University of Utah
name: Eric Scaife, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Russell KW, Rollins MD, Barnhart DC, Mone MC, Meyers RL, Skarda DE, Soukup ES, Black RE, Molitor MS, Stoddard GJ, Scaife ER. Charge Awareness Affects Treatment Choice: Prospective Randomized Trial in Pediatric Appendectomy. Ann Surg. 2015 Jul;262(1):189-93. doi: 10.1097/SLA.0000000000000885.