louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05211531: Walk With a Doc: Enhanced Recovery Walking Program for Surgical Inpatients and Wellness Program for Surgical Residents
Official title: Walk With a Doc: Enhanced Recovery Walking Program for Surgical Inpatients and Wellness Program for Surgical Residents
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Complication of Surgical Procedure
Resident Physicians
Keywords: Resident physician wellness
Post-operative walking program
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
First posted: 2022-01-27
Enrollment: 50
Sex: ALL
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: Minimally invasive surgery patients who are admitted and undergo surgery at a single tertiary care center.

Brief summary: Program studying the number of steps post-operative patients need to take to prevent post-operative complications. Also studying surgical resident wellness program that provides extra time to ambulate with inpatients.

Detailed description: Program studying the number of steps post-operative patients need to take to prevent post-operative complications. Patients receive a pedometer while inpatient to measure their daily steps, which is recorded in the electronic medical record.

Eligibility criteria: Inclusion Criteria:

* Post-operative surgical patient with an over 24 hour post-operative stay in the hospital
* Safe to ambulate with/without assistance

Exclusion Criteria:

* Unable to ambulate
* Bedbound

Primary outcomes:
measure: Total number of steps
timeFrame: From index surgery to initial post-operative office visit, up to 3 weeks
measure: 30 day Post-operative complications
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMASS Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: UMASS Memorial Healthcare
name: Richard Perugini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01952431: Measurement and Evaluation of Total Lung Capacity (TLC) in the Field of Pulmonary Functional Testing (PFT)
Official title: Measurement and Evaluation of Total Lung Capacity (TLC) in the Field of Pulmonary Functional Testing (PFT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TLC in Patients With and Without Respiratory System Disease
Keywords: Total Lung Capacity
Lead sponsor: PulmOne Advanced Medical Devices, Ltd.
Sponsor class: INDUSTRY
First posted: 2013-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: A comparative study to test the efficacy of a novel device - the MiniBoxPFT, in measuring TLC (total lung capacity) compared to TLC measured by standard body plethysmography using the ZAN 500. The study will be conducted as a prospective two-arm, open, randomized comparative study.

Detailed description: This study is a prospective, multi-centered, randomized, comparative study designed to demonstrate substantially equivalence performance of the proposed device, the PulmOne MiniBoxPFT, to its predicate device, the ZAN500, for the measurement of total lung capacity (TLC).

Eligibility criteria: Inclusion Criteria:

1. Subject is at least 18 years of age.
2. Subject is cooperative and capable of following instructions.
3. Healthy subjects:

   1. Never smokers.
   2. No known history of respiratory, cardiovascular, hepatic, renal or metabolic disease.
   3. BMI \< 35.
   4. No persisting respiratory symptoms during the last 12 months. (e.g., dyspnea, chronic cough, wheezing or phlegm).
   5. No history suggesting upper respiratory infection during the three weeks prior to testing.
4. Patients with known disease affecting the respiratory system, with previous documentation of obstructive, restrictive, or mixed obstructive plus restrictive ventilatory abnormality.

Exclusion Criteria:

1. Subjects who are unable to satisfactorily perform routine, full lung function testing(due to non-compliance or claustrophobia).
2. Subjects unable or unwilling to give informed consent.
3. Subjects who have performed any significant physical activity during 1 hour prior to the Study.
4. Patients with a tracheostomy.
5. Pregnant women.

Primary outcomes:
measure: Total Lung Capacity (TCL)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam University Medical Center
Study officials:
affiliation: Rambam University Medical Center
name: Mordechai Yigla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02299531: Effects of Portion Size and Energy Density of a Single Meal in Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Behaviors
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-11-24
Enrollment: 131
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study investigates the effect of varying both energy density and portion size of all foods at lunch on preschool children's intake. The foods used in this study are commercially-available, commonly-consumed foods with typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of energy density and portion size on preschool children's intake at a meal composed of foods typically served to this population.


Eligibility criteria: Inclusion Criteria:

* Children must be enrolled in participating childcare centers.

Exclusion Criteria:

* Allergy or intolerance to any of the foods or beverages served.

Primary outcomes:
measure: Food and energy intake (Food weight (grams) and energy (kcal)
timeFrame: Once a week for four weeks
Secondary outcomes:
measure: Meal energy density (Energy density (kcal/g)
timeFrame: Once a week for four weeks
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Barbara J Rolls, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kling SM, Roe LS, Keller KL, Rolls BJ. Double trouble: Portion size and energy density combine to increase preschool children's lunch intake. Physiol Behav. 2016 Aug 1;162:18-26. doi: 10.1016/j.physbeh.2016.02.019. Epub 2016 Feb 12.
Clinical trial NCT05156931: Exploration of Patient Self-medication Practices During and After Cancer in France
Official title: Exploration of Patient Self-medication Practices During and After Cancer in France: Cross-sectional Observational Study With Online Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Self-medication
Keywords: cancer
self-medication
quality of life
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 681
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients contacted by cancer patient's association

Brief summary: The purpose of this study is to assess the patient self-medication practices during and after cancer in France, using an online questionnaire

Detailed description: Patients will be contacted by email from patient's associations. Patients will be informed of the objectives of the study and will be free to answer or not to the online questionnaire.

Eligibility criteria: Inclusion Criteria:

* Past or active cancer

Exclusion Criteria:

* Speaking French
* Not living in France

Primary outcomes:
measure: Self-medication
timeFrame: day 1
Secondary outcomes:
measure: Class of products used in self-medication
timeFrame: day 1
measure: Indication for self-medication
timeFrame: day 1
measure: Origin of self-medication products
timeFrame: day 1
measure: Perception of adverse effects and drug-drug interaction related to self medication
timeFrame: day 1
measure: QLQ-C30 questionnaire
timeFrame: day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
References:
Clinical trial NCT01346631: The Paleolithic Diet and Male Factor Infertility
Official title: The Impact of a Paleolithic Diet on Sperm Parameters for Men Suffering From Male Infertility
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Male Infertility
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2011-05-03
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective studies concerning diet and male fertility are lacking. Observational studies suggest that a diet rich in fruits, vegetables and meats may be associated with higher sperm counts. The investigators wanted to see if a "paleolithic diet" consisting of meat, fish, fruits vegetables and nuts and lacking grains, legumes and dairy products can improve sperm counts.


Eligibility criteria: Inclusion Criteria:

* men with male infertility
* willingness to make dietary change for three months
* willingness to be blinded to sperm test results until the end of the experiment

Exclusion Criteria:

* High fever or abdominal or scrotal surgery during three months prior to intervention
* Change in diet, drinking or smoking habits in three months prior to intervention
* regular consumption of more than two servings of alcohol a day
* background ailment preventing dietary change

Primary outcomes:
measure: Sperm Parameters
timeFrame: 3 months
Secondary outcomes:
measure: Biomedical Indexes
timeFrame: 3 months
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
References:
Clinical trial NCT05296031: Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex
Official title: Randomized Trial Comparing Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex in Critical Limb Ischemia and Treatment of Lesions in Femoral and Popliteal Arteries"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Diseases
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
Primary purpose: TREATMENT

Brief summary: Randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia.


Eligibility criteria: Inclusion Criteria:

Critical limb ischemia RC 4-6

Lesions in superficial femoral artery and popliteal artery (p1 -p2)

Target vessel 4-8mm

At least I 1 vessel runoff to the foot

Age \>18 years

Exclusion Criteria:

Pregnancy

Patient disapproval

Age \<18 years

Primary outcomes:
measure: Freedom from TLR (Target Lesion Revascularization)
timeFrame: 6 months
measure: Freedom from TLR (Target Lesion Revascularization)
timeFrame: 12 months
measure: Freedom from TLR (Target Lesion Revascularization)
timeFrame: 24 months
measure: Open (functioning and not stenosed) vascular reconstruction (Primary Patency)
timeFrame: 12months
measure: Open (functioning and not stenosed) vascular reconstruction (Primary Patency)
timeFrame: 24 months
measure: Event Free Survival
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03427931: CGM Use in Islet Transplant Recipients
Official title: Continuous Glucose Monitoring in Islet Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Islet Transplantation
Type1 Diabetes Mellitus
Keywords: Type 1 Diabetes Mellitus
Islet Transplantation
Continuous Glucose Monitor (CGM)
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2018-02-09
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A study assessing glucose variability in subjects with Type 1 Diabetes who have had islet transplant.

Detailed description: Subjects who have an Islet Transplantation may have several outcomes including time when insulin is not required followed in some cases by additional insulin for glucose control as patients get further away from transplantation. It is unclear what role automated insulin delivery systems will have in addressing glucose variability in this group of patients who may have some amount of islet function. As a precursor to understanding ways in which automated insulin delivery systems may need to be adapted, we propose to gather data on glucose variability and insulin regimens in individuals who have undergone an islet transplantation.

Eligibility criteria: Inclusion Criteria:

* Type 1 Diabetes Mellitus
* Recipient of Islet Transplantation
* Age 18 or older
* Females, not currently know to be pregnant
* Demonstration of proper mental status and cognition for the study
* Understanding and willingness to follow the protocol and informed consent form
* Access to the internet and willingness to upload data during the study, including use of personal laptop

Exclusion Criteria:

* Pregnancy and intent to become pregnant during trial
* Use of acetaminophen (such as Tylenol)
* Current enrollment in another intervention clinical trial that affects glucose variability

Primary outcomes:
measure: Percentage Time in Range 70-180 mg/dL by CGM
timeFrame: 28-90 days
Secondary outcomes:
measure: Percentage Time in Range <70 mg/dL by CGM
timeFrame: 28-90 days
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Center for Diabetes Technology
state: Virginia
Study officials:
affiliation: University of Virginia
name: Sue A Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02276131: Human Factors and Home Use Study of the Vigilant Diabetes Management Application
Official title: Human Factors and Home Use Study of the Vigilant Diabetes Management Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: InSpark Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Virginia
First posted: 2014-10-28
Enrollment: 61
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: A human factors and home use study to assess whether subjects with diabetes and their caregivers can understand feedback received from the Vigilant Diabetes Management Application about their blood glucose patterns and whether the decisions made in response to device feedback are made in accordance with the intended use.


Eligibility criteria: Inclusion Criteria:

* Persons with diabetes mellitus testing blood glucose 3 or more times per day
* Clinicians who see diabetes patients

Exclusion Criteria:

* Admission for diabetic ketoacidosis in the 6 months prior to enrollment
* A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
* Patients who are not willing to share their glucose meter data, or do not perform the tasks asked of them and follow instructions for the study will be excluded
* Pregnancy

Primary outcomes:
measure: Adequate understanding of algorithmic feedback based on surveyed responses (Measure: units on a scale)
timeFrame: 1 month home use
measure: Successful completion of frequent and risk-related tasks (Measure: Percent of tasks successfully completed)
timeFrame: Controlled in-office testing for up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Virginia
name: Stacey Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01506531: Silo Versus Primary Closure for Gastroschisis
Official title: Bedside Silo Versus Attempted Operative Closure for Gastroschisis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroschisis
Keywords: gastroschisis
silo
primary closure
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2012-01-10
Enrollment: 38
Sex: ALL
Minimum age (years): 5
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to scientifically evaluate two different closure strategies for gastroschisis to determine if there is a difference in the two approaches.

Detailed description: The hypothesis is that there is no difference between bedside silo placement and operative closure in return of bowel function, ventilator dependence, or length of stay.

The primary outcome variable between the two techniques will be length of hospitalization. The likely variables will be length of time to meet discharge criteria, length of hospitalization, time to full feedings, time on mechanical ventilation and total hospital charges.

Eligibility criteria: Inclusion Criteria:

* Infants with gastroschisis

Exclusion Criteria:

* Born prior to 34 weeks estimated gestational age
* Another congenital anomaly influencing the respiratory status, gastrointestinal status, or the length of hospitalization and recovery.
* Inability to get parental permission before treatment.

Primary outcomes:
measure: Length of hospitalization
timeFrame: 1-6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital and Clinics
name: Shawn D St. Peter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00174031: Prevalence and Profiles of Sports Injury in Taiwanese Adolescent Baseball Players
Official title: Prevalence and Profiles of Sports Injury in Taiwanese Adolescent Baseball Players
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sports Injury
Keywords: baseball
injury
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 800
Sex: MALE
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: To investigate prevalence and profile of sports injury in Taiwanese adolescent baseball players in a longitudinal study.


Eligibility criteria: Inclusion Criteria:

* Taiwanese adolescent baseball players

Exclusion Criteria:

* Who are not willing to join this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School and Graduate Institute of Physical Therapy, NTU, Taiwan
Study officials:
affiliation: School and Graduate institute of Physical Therapy, National Taiwan University
name: Hsing-Kuo Wang, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02342431: Comparison of a Patient Warming System Using a Forced-air, Non-compressible Under-body Mattress Versus a Regular Forced-air Underbody Mattress System During Pediatric Cardiac Catheterization
Official title: Comparison of a Patient Warming System Using a Forced-air, Non-compressible Under-body Mattress Versus a Regular Forced-air Underbody Mattress System During Pediatric Cardiac Catheterization
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hypothermia
Keywords: Thermoregulation
Pediatric Anesthesia
Cardiac Catheterization
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-01-21
Enrollment: 0
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a comparison of a patient warming system using a forced-air, non-compressible under-body mattress (Möck \& Möck, Hamburg, Germany) versus a regular forced-air underbody mattress system during pediatric cardiac catheterization in 40 patients.

The hypothesis is, that the non-compressible mattress provides better warming with less incidence of perioperative hypothermia (Core temperature \< 36 °C) and faster warming slope (°C / time). The study is prospective, randomized, controlled and single-blinded.

Inclusion criteria will be pediatric patients \< 1 year of age without fever or a treatment of therapeutic hypothermia.


Eligibility criteria: Inclusion Criteria:

* Pediatric patient scheduled for cardiac catheterization (diagnostic and/or interventional)\< 1 year old

Exclusion Criteria:

* fever or therapeutic hypothermia

Primary outcomes:
measure: Incidence of hypothermia
timeFrame: during surgery (1 - 6 hours)
Secondary outcomes:
measure: Core Temperature Slope
timeFrame: during surgery (1 - 6 hours)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Oliver Kimberger, PD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03561831: Effect of Anaesthesia on ER Stress in Cancer Patients
Official title: Evaluation the Effects of Anaesthetic Agents on Endoplasmic Reticulum Stress During Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoplasmic Reticulum Stress
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 53
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Investigate the change in endoplasmic reticulum stress after cancer surgery according to different anaesthetics including propofol and sevoflurane.

Detailed description: We hypothesize propofol and sevoflurane based anesthesia would show different pattern of endoplasmic reticulum stress after cancer surgery in patients with cancer

Eligibility criteria: Inclusion Criteria:

- patients with cancer

Exclusion Criteria:

* age under 19 years old
* allergy history to propofol or sevoflurane
* history of previous cancer

Primary outcomes:
measure: Change in endoplasmic reticulum stress
timeFrame: baseline, postoperative 1 hours and 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Seong-Hyop Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References: