louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04396275: The Effect of Navy Beans and Yellow Peas on Satiety in Children
Official title: The Effect of Cooked Whole Navy Beans and Yellow Peas on Short-term Satiety and Food Intake in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food
Eating
Satiety
Physical Comfort
Keywords: Pulses
Satiety
Food intake
Appetite
Beans
Peas
Lead sponsor: Mount Saint Vincent University
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 53
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The frequent consumption of pulses is associated with multiple cardiometabolic benefits in adults including a lower risk for overweight and obesity. However, it remains unclear whether these effects are mediated through the short-term mechanisms, including enhanced satiety and reduced food intake (FI), or through the long-term metabolic effects triggered by regular consumption of pulses. The objective of this study is to investigate the short-term effect of cooked pulses served in the amount similar to their recommended serving of 175ml (3/4 cup) on food intake in 12-14y children, and gastrointestinal comfort over 2-hours. The secondary objective is to evaluate how children perceive the sensory characteristics of the meals made with the whole pulses.


Eligibility criteria: Inclusion Criteria:

* Healthy boys and girls born at full-term
* do not receive any medications

Exclusion Criteria:

* Food sensitivities or allergies
* Dietary restrictions
* Health problems
* Learning, emotional or behavioral problems.

Primary outcomes:
measure: Food intake
timeFrame: 120 min
measure: Subjective appetite
timeFrame: 0-120 min
measure: Subjective feeling of physical comfort
timeFrame: 0-120 min
Secondary outcomes:
measure: Subjective perception of food palatability (pleasantness)
timeFrame: 0, 120 min
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Mount Saint Vincent University
state: Nova Scotia
Study officials:
affiliation: Mount Saint Vincent University
name: Bohdan Luhovyy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03085875: POWERMOM, A Healthy Pregnancy Research Community
Official title: POWERMOM, A Healthy Pregnancy Research Community
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Weight Change, Body
Health Problems in Pregnancy
Behavior
Keywords: Weight Change
Healthy Pregnancy
Physiologic Sensors
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 100000
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women, 16 years or older, who currently live in the United States, and own a smartphone.

Brief summary: This study will take advantage of the open source framework of ResearchKit developed by Apple to bring research directly to participants. Using the ResearchKit platform as well as a stand alone app available for Android and HTML, it makes it easier to enroll large numbers of participants and carry out real-world health research to answer questions important to a broad population.

Detailed description: * Eligibility determined, Individuals enrolled and consented to join study
* Short Intake Survey (demographic and baseline health information collected)
* Health History Survey (two days after participant enrolls in the study)
* Survey questions about current health and medical history will be sent to participants weekly. If participants had a prenatal visit during the week, a few additional questions will be asked.
* Twins / Multiples survey will begin appearing when a participant indicates they are having more than one baby
* Participants can submit home measurements of, weight and blood pressure as frequently as they want through HealthKit.
* Pregnancy outcome variables. (Miscarriage, stillbirth, birth of healthy baby, or pregnancy ended) will also be asked weekly.
* If the baby is born, questions about labor and delivery, as well as weight, size and birth date of the baby will be asked. A reminder to fill out the outcome survey will be given 4 weeks after a user's due date.

Eligibility criteria: Inclusion Criteria:

* Adults, 16 years of age or older
* Pregnant women or within 8 weeks postpartum
* Currently live within the United States
* Own, and comfortable using, a smartphone or tablet

Exclusion Criteria:

• Inability to consent

Primary outcomes:
measure: Improve our understanding of healthy pregnancy weight gain for all women.
timeFrame: Up to 46 weeks.
measure: Improve our understanding of how different factors impact pregnancy complications.
timeFrame: Up to 46 weeks.
measure: Improve our understanding how different factors impact the birth of the baby.
timeFrame: Up to 46 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Research Translational Institute
state: California
Study officials:
affiliation: The Scripps Research Institute
name: Lase Ajayi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01481675: Diabetes Resolution and Hormone Changes After BPDLL and LSG
Official title: Resolution of Diabetes and Hormonal Changes Following Biliopancreatic Diversion Long Limbs and Laparoscopic Sleeve Gastrectomy. A Comparative Prospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: biliopancreatic diversion
sleeve gastrectomy
diabetes mellitus
weight loss
ghrelin
PYY
GLP-1
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twelve patients with diabetes mellitus type 2 and BMI\> 50kg/m2 will undergo BPDLL and 12 patients with diabetes mellitus type 2 and BMI 40-50kg/m2 will undergo LSG

Brief summary: To evaluate and compare prospectively the effects of Biliopancreatic Diversion Long Limb (BPDLL) and Laparoscopic Sleeve Gastrectomy (LSG) on resolution of diabetes mellitus type 2.

Detailed description: Twelve patients with diabetes mellitus type 2 (DM 2) and body mass index (BMI)\> 50kg/m2) will undergo BPDLL and 12 twelve patients with DM 2 and BMI 40-50 kg/m2 will undergo LSG. The patients will be evaluated before and 1, 3 and 12 months after surgery with an oral glucose tolerance test. The investigators aim to investigate the effects of surgery on diabetes resolution, hypertension, dyslipidemia, and also on fasting, and glucose-stimulated insulin, glucagon, ghrelin, peptide-YY and glucagon-like peptide-1 (GLP-1) responses during during an oral glucose tolerance test (OGTT). Resolution of diabetes mellitus will be evaluated according to the criteria of American Diabetes Association with an OGTT. The effects on appetite and satiety will be also evaluated with the use of visual analog scores.

Eligibility criteria: Inclusion Criteria:

* BMI\>50kg/m2 to undergo BPDLL
* BMI 40-50kg/m2 to undergo LSG
* Diabetes mellitus type 2

Exclusion Criteria:

* Chronic medical illness
* Psychiatric illness
* Substance abuse
* Previous gastrointestinal surgery

Primary outcomes:
measure: Diabetes resolution at 12 months after surgery
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Weight loss at 12 months after surgery
timeFrame: 12 months after surgery
measure: Changes of GLP-1 response to glucose
timeFrame: 12 months after surgery
measure: Changes in ghrelin levels
timeFrame: 12 months after surgery
measure: Changes in PYY response to glucose
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Rion
country: Greece
facility: University Hospital of Patras
state: Achaia
city: Rion
country: Greece
facility: University Hospital of Patras
state: Achaia
Study officials:
affiliation: University of Patras
name: Theodore Alexandrides, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Patras
name: Fotis Kalfarentzos, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00337675: Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED)
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-06-16
Enrollment: 1771
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).


Eligibility criteria: Inclusion Criteria:

* Patients aged 6 months to 5 years with episodic (periodic) asthma

Exclusion Criteria:

* Patients who are not in otherwise good health
* Patients who have persistent asthma (continual asthma symptoms)

Primary outcomes:
measure: Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period
timeFrame: 1-year treatment period
Secondary outcomes:
measure: Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode
timeFrame: 1 Year
measure: Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes
timeFrame: 1 Year
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Valovirta E, Boza ML, Robertson CF, Verbruggen N, Smugar SS, Nelsen LM, Knorr BA, Reiss TF, Philip G, Gurner DM. Intermittent or daily montelukast versus placebo for episodic asthma in children. Ann Allergy Asthma Immunol. 2011 Jun;106(6):518-26. doi: 10.1016/j.anai.2011.01.017. Epub 2011 Mar 4.
Clinical trial NCT01533675: A Comparison Study of the Tensile Strength of Sutures Used in Dermatologic Surgery on the Day of Suture Removal, Following Wound Care With Two Different Products
Official title: A Comparison Study of the Tensile Strength of Sutures Used in Dermatologic Surgery on the Day of Suture Removal, Following Wound Care With Two Different
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sutured Wounds
Keywords: suture, tensile strength, wound care, saline, hydrogen peroxide, skin closure, wounds, wound healing, wound cleansing, antiseptics
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sutures are an integral part of surgery and available materials are diverse, as are the options for post-procedure care. Both saline and hydrogen peroxide are commonly used cleansing agents. This study aims to compare the effect of saline and hydrogen peroxide on the tensile strength of 4-0 nylon sutures following removal from a cutaneous surgical wound.


Eligibility criteria: Inclusion Criteria:

* Subject is willing to comply with the informed consent procedures
* Subject's wound is on the body or scalp
* Subject will be able to come to the clinic for suture removal on day 14

Exclusion Criteria:

* Subject is less than 18 years of age
* Subject's wound was not closed with 4-0 nylon sutures
* Subject's wound is on the face
* Subject plans to apply other topicals to the area under study
* Subject's suture is removed before or after day 14

Primary outcomes:
measure: Tensile strength of 4-0 nylon sutures
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
state: Florida
Study officials:
References:
citation: Snyder CC. On the history of the suture. Plast Reconstr Surg. 1976 Oct;58(4):401-6. doi: 10.1097/00006534-197610000-00001. No abstract available.
citation: Hochberg J, Meyer KM, Marion MD. Suture choice and other methods of skin closure. Surg Clin North Am. 2009 Jun;89(3):627-41. doi: 10.1016/j.suc.2009.03.001.
Clinical trial NCT01082575: Oxygen Monitoring of Patients After Surgery on the Hospital General Care Floor
Official title: Oxygen Saturation Monitoring in the General Care Floor (GCF): An Observational Study of Repetitive Reductions in Airflow
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disordered Breathing
Keywords: Post Op Patients
Continuous Pulse Oximetry Monitoring
Major Surgery
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2010-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital Patients

Brief summary: The pain medication given after major surgery may cause some patients to stop breathing for periods of time especially at night time. An oxygen monitor may reflect this abnormal breathing pattern. This is an observational study of 100 post-operative patients who will be monitored with a pulse oximeter for a minimum of two nights and a maximum of five nights to determine the prevalence of this abnormal breathing pattern.

Detailed description: No further details necessary or available.

Eligibility criteria: Inclusion Criteria:

* Age of 18 years or older
* Discharge from the post-anesthesia care unit (PACU) to the GCF after any of the following major surgeries: bariatric surgery, major orthopedic surgery (e.g., total hip replacement), major general surgery (e.g., bowel resections, open cholecystectomy), and major gynecological surgery (e.g., radical hysterectomy)

Exclusion Criteria:

* Pre-existing central neurological disease, including but not limited to recent traumatic brain injury, stroke, and neurodegenerative disease
* Ongoing use of mechanical ventilation or continuous positive airway pressure in the GCF

Primary outcomes:
measure: Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert.
timeFrame: 5 days
Secondary outcomes:
measure: Number of Participants With Adverse Events (AE) Caused by no Breathing
timeFrame: Five Nights
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Fort Worth
country: United States
facility: Texas Health Research & Education Institute
state: Texas
Study officials:
affiliation: Medtronic - MITG
name: Roger Mecca, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00355875: The Effect of Oxygen Exposure During Newborn Resuscitation on Lung Injury
Official title: Oxygen Exposure During Newborn Resuscitation and Pulmonary Oxidative Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Oxidative Pulmonary Injury
Keywords: newborn
preterm
resuscitation
oxidative injury
protein carbonyl
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Equipment loan from Masimo Corp.
First posted: 2006-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 23
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypothesis: In this feasibility study, hyperoxemia, as approximated by transcutaneous hemoglobin saturation with oxygen (Sp02), at the time of birth will cause sustained pulmonary oxidative stress as demonstrated by elevation of pulmonary protein carbonyl. Furthermore, this oxidative stress will be directly proportional to the imposed oxygen-burden during resuscitation at the time of birth.

This study will give us information regarding the magnitude of protein carbonyl elevation in the preterm infant. With these results we will be able to 1. establish the technique for the running or protein carbonyl assays and 2. calculate an appropriate sample size for a future randomized control trial.

Detailed description: Immediately prior to birth, preterm infants (\<= 32 weeks gestation) will be randomized to one of three groups: 1. Low Oxygen Burden (LOB) - initiation of resuscitation with 21% 02, II. Moderate Oxygen Burden (MOB) - initiation of resuscitation with 100% 02 and III. High Oxygen Burden (HOB) - 100% 02 used for the entire resuscitation. A pulse oximetry monitor will be connected to a probe on the infant's hand to measure the transcutaneous hemoglobin saturation with oxygen (Sp02). Adjustments to the inspired oxygen concentration will be made every 15 seconds for infants in the LOB and MOB groups to achieve a target Sp02 range of 85-92%. Resuscitation will otherwise proceed as per standard of care. The intervention will end upon arrival in the neonatal intensive care unit.

Eligibility criteria: Inclusion Criteria:

* \<=32 weeks gestation
* inborn
* require intubation

Exclusion Criteria:

* lethal anomalies
* cyanotic congenital heart disease
* known hemoglobinopathy
* risk factors for persistent pulmonary hypertension

Primary outcomes:
measure: protein carbonyl concentration in the tracheal aspirate on day 1
Secondary outcomes:
measure: protein carbonyl concentration in the tracheal aspirate on day 3
measure: protein carbonyl concentration in the tracheal aspirate on day 7
measure: protein carbonyl concentration in the tracheal aspirate on day 14
measure: protein carbonyl concentration in the tracheal aspirate on day 21
measure: protein carbonyl concentration in the tracheal aspirate on day 28
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Canada
state: Alberta
Study officials:
affiliation: University of Calgary
name: Yacov Rabi, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02940275: Population Research of Sublingual Microcirculation Data of Patients With Systemic Diseases
Official title: Population Research of Sublingual Microcirculation Data of Patients With Systemic Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Diabetes Mellitus
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 156
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with systemic diseases

Brief summary: This is an observational clinical study, patients with systemic diseases will be enrolled according to the inclusion and exclusion criteria. Patients will received the examination of sublingual microcirculation by using incident dark field video microscope (Cytocam，Braedius Battery Powered Transilluminator). The microcirculation data includes total small vessel density, perfused small vessel density, microvascular flow index, and heterogeneity index. The patients will be divided into right groups according to their systemic diseases as follows: group 1 hypertension (60 patients), group 2 diabetes mellitus (60), group 3 hypertension and diabetes mellitus (60), group 4 end stage renal disease with hemodialysis (60), group 5 kidney transplant recipients (60), group 6 coronary artery disease (60), and group 7 peripheral arterial occlusive disease (60).


Eligibility criteria: Inclusion Criteria:

* Patients aged from 20 to 79 years old
* BMI ranged from 18.5 to 27 kg/m2
* Presence of one of the condition

  * Diagnosed hypertension \> 6 months, without other systemic diseases
  * Diagnosed diabetes mellitus \> 6 months, without other systemic diseases
  * Diagnosed with both hypertension and diabetes mellitus \> 6 months, without other systemic diseases
  * Diagnosed with end stage renal disease \> 6 months
  * Received renal replacement therapy \> 6 months
  * Diagnosed with coronary artery disease \> 6 months
  * Diagnosed with peripheral arterial occlusive diseases \> 6 months

Exclusion Criteria:

* Diagnosed with sepsis, major trauma, or admission to ICU within one month
* Body temperature higher than 37.5 ℃ or lower than 35.5 ℃
* Any on of the following condition
* Asthma
* Chronic obstructive pulmonary disease
* Endocrine diseases
* Hematological disorders
* Uncured cancer
* Chronic uncured infection
* Other major disease with limited daily activity
* Non-native speakers

Primary outcomes:
measure: Perfused small vessel density of sublingual small vessels measured by Cytocam
timeFrame: Once at enrollment
Secondary outcomes:
measure: Total small vessel density of sublingual small vessels measured by Cytocam
timeFrame: Once at enrollment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: