louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04786691: How do You Take Your Coffee Before Anesthesia
Official title: How do You Take Your Coffee Before Anesthesia: A Randomized Controlled Crossover Study Comparing Gastric Emptying With Black Coffee vs Coffee With Cream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Aspiration
Fasting
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized Controlled Crossover
Primary purpose: BASIC_SCIENCE

Brief summary: Undergoing anesthesia requires patients to fast pre-operatively to allow the stomach to empty and prevent aspiration pneumonia but patients are allowed to drink "clear" liquids up to 2 hours before surgery. Clear liquids are defined as water, carbonated sodas, black coffee or tea without milk or sugar, and juices without pulp. Many Americans prefer to take their coffee with half and half or coffee creamer rather than black. This study will determine whether the addition of a small amount of cream to coffee makes any difference to the volume in the stomach after 2 hours.

This study will use healthy volunteers as study participants. Each participant will participate in the study 3 times with at least 2 days in between. We will use a bedside ultrasound machine to measure their stomach content volume at baseline and then they will consume one of 3 different prepare drinks - black coffee, coffee with half and half, or coffee with non-dairy coffee creamer. After 2 hours, we will scan their stomach again and measure stomach content volume and compare it to the first measurement. The participants will repeat this two more times on different days so that they would have had a chance to consume all three prepared coffee drinks in a random order.


Eligibility criteria: Inclusion Criteria:

* Age between 18-65

Exclusion Criteria:

* Diabetes mellitus
* Delayed gastric emptying
* Previous gastric surgery
* Lactose intolerance
* Current pregnancy
* Consumption of solid/liquids in 6 hours prior to commencement of ultrasound study

Primary outcomes:
measure: Difference Between Gastric Volume Post Coffee Consumption Compared to the Baseline Gastric Volume
timeFrame: Baseline 6 hours after fasting and 2 hours after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Jessica Yeh, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02886091: Observational Study of Keloids Scars Treated by Shaving and Cryosurgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Keloids Scars
Keywords: Keloids
Shaving
Ears
Cryosurgery
Hypertrophic scars
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Keloids scars

Brief summary: Treatment of keloids scars is difficult and controversial. These keloids have a functional and aesthetic impact. A lot of treatment are described with a lot of relapses and aggravation. Authors report outcomes of the treatment with shaving and cryosurgery


Eligibility criteria: Inclusion Criteria:

* keloids scars
* treatment of shaving and cryosurgery

Exclusion Criteria:

* immunosuppressive therapy
* chemotherapy

Primary outcomes:
measure: size scar
timeFrame: Inclusion and one years after
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU de Brest
name: Alexandra Trimaille
role: STUDY_DIRECTOR
References:
Clinical trial NCT03497091: Retrospective Review of Amino Acid Formula Use at a Children's Center
Official title: Retrospective Review of Amino Acid Formula Use at a Children's Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children Requiring Amino Acid-based Formula Tube Feeding
Enteral Feeding Intolerance
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-04-13
Enrollment: 23
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population studied retrospectively will be children in a pediatric feeding center consuming an amino acid-based enteral fomula and meeting the inclusion/ exclusion criteria.

Brief summary: This is a retrospective review of data documented in medical records.

Detailed description: This is a retrospective review of data documented in medical records of patients consuming an amino-acid based enteral formula at a pediatric care facility in the United States.

Eligibility criteria: Inclusion Criteria:

* Consuming or with a history of consuming an amino acid-based formula

Exclusion Criteria:

* Medical records lacking information on consumption of an amino acid-based formula

Primary outcomes:
measure: Documented indication for formula use
timeFrame: Up to 12 months before formula switch
Secondary outcomes:
measure: Body weight
timeFrame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
measure: Length/height
timeFrame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
measure: Formula volume consumption
timeFrame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
measure: Stool frequency
timeFrame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
measure: Stool consistency
timeFrame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
measure: Vomiting
timeFrame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Children's Center for Rehabilitation Hospital
state: Oklahoma
Study officials:
affiliation: Société des Produits Nestlé (SPN)
name: Krysmaru AraujoTorres, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03464591: Cardiac Speckle Tracking Myocardial Strain Balance
Official title: Cardiac Speckle Tracking Myocardial Strain Balance Method: a New Method to Evaluate the Effect of Pulmonary Hypertension on the Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Hypertension
Echocardiography
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 30
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: From 2007 to date, 18-80 year old patients with mean pulmonary arterial pressure ≥25mmHg measured by right heart catheterization

Brief summary: The investigators intend to evaluate the function of left heart and right heart and the motion balance between four chambers of the heart by speckle tracking technique during the follow-up of patients with pulmonary hypertension, and explore the relationship between the balance and prognosis of patients.

Detailed description: Pulmonary hypertension is a fatal disease with progressive progressive vascular resistance that leads to the loss of right heart function. Right heart failure is the cause of death in most patients with end-stage pulmonary hypertension, and right heart function is also an important factor in determining the prognosis of patients.

Echocardiography speckle tracking technology is a noninvasive technique for evaluating global and local cardiac function by tracking myocardial ultrasonic spots through computer image analysis technology and quantifying myocardial deformation.

The investigators intend to evaluate the function of left heart and right heart and the motion balance between four chambers of the heart by speckle tracking technique during the follow-up of patients with pulmonary hypertension, and explore the relationship between the balance and prognosis of patients.

Eligibility criteria: Inclusion Criteria:

Diagnosed with pulmonary hypertension by right cardiac catheterization The patient is between 18-80 years of age The date of diagnosis was from 2007 to 2017

Exclusion Criteria:

Cardiomyopathy Severe complications Pregnancy Atrial fibrillation, or other irregular heart rhythm Poor ultrasonic image quality

Primary outcomes:
measure: outcome
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
affiliation: RenJi Hospital, School of Medicine, Shanghai Jiaotong University
name: Shen Jieyan, PhD
role: STUDY_CHAIR
affiliation: RenJi Hospital, School of Medicine, Shanghai Jiaotong University
name: Shen Xuedong, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03338491: Addiction Risk: Mindset Induction Effect on Brief Intervention
Official title: Research Group RISKDYNAMICS, Sub-Project 8, Work Package 1, Study 2 (Student Sub-study): Addiction Risk: The Influence of Mindset Induction on the Effect of a Brief Intervention to Reduce Alcohol Use
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alcohol Drinking in College
Lead sponsor: University of Konstanz
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Brief Interventions (BI) based on Motivational Interviewing are effective to reduce alcohol use. In this study the investigators test the hypothesis that that an open Mindset increases the positive effects of BI.

University students take part in a voluntary screened for risky alcohol use. All students with risky alcohol use are eligible to the study and all receive the WHO's ASSIST-linked BI.

Participants receive a brief Mindset induction prior to receiving BI. They are are randomly assigned to either the induction of an open or a closed mindset according to the Mindset theory of action phases (Gollwitzer \& Keller (2016). Mindset Theory. In: V. Zeigler-Hill, T.K. Shackelford (eds.), Encyclopedia of Personality and Individual Differences. New York: Springer).

The investigators measure the change in alcohol-related risk perception, treatment motivation and real alcohol drinking after the Brief Intervention in relation to the mindset induced before receiving the intervention.


Eligibility criteria: Inclusion Criteria:

* student status at University of Konstanz
* risky alcohol use in past 12 months

Exclusion Criteria:

* acute psychosis, acute suicidality, illiteracy

Primary outcomes:
measure: Questionnaire on Alcohol-related Risk Perception
timeFrame: 4 weeks
measure: Alcohol Time-line Follow Back
timeFrame: 4 weeks
Secondary outcomes:
measure: SOCRATES
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: University of Konstanz, Psychotherapy Outpatient Clinic
Study officials:
affiliation: University of Konstanz
name: Michael Odenwald, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02108691: Effect of Intake of Glycin Max (L.) Merr. Peel Extract on Body Fat and Body Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Glycin max (L.) Merr. peel extract on decrement of body fat. The investigators measured decrement of body fat parameters , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure.


Eligibility criteria: Inclusion Criteria:

* Males and females 19-65 years old
* BMI(body mass index) ≥ 25 kg/m\^2 or WC(Waist Circumference) ≥ 90(men), WC ≥ 85(women)
* Able to give informed consent

Exclusion Criteria:

* Significant variation in weight(more 10%) in the past 3 months
* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.

Primary outcomes:
measure: Changes in Body Fat Mass
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in Percent Body Fat
timeFrame: 8 weeks
measure: Changes in Weight
timeFrame: 8 weeks
measure: Changes in BMI(Body Mass Index)
timeFrame: 8 weeks
measure: Changes in LDLc
timeFrame: 8 weeks
measure: Changes in Non-HDLc
timeFrame: 8 weeks
measure: Changes in LDLc/HDLc
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University
Study officials:
References:
Clinical trial NCT02315391: Protein Nutrition for Muscle Hypertrophy in Older Adults
Official title: Efficacy of Isolated Whey and Micellar Whey Protein (+/- Citrulline) to Stimulate Protein Synthesis in 'Healthy' and 'Anabolically Resistant' Elderly Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Elderly Muscle
Anabolically Resistant Elderly Muscle
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-12-11
Enrollment: 30
Sex: MALE
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective is to determine the effect of reduced activity on the stimulation of myofibrillar FSR with protein feeding in the elderly.

Detailed description: The primary objective is to determine the effect of reduced activity on the stimulation of myofibrillar FSR with protein feeding in the elderly

Eligibility criteria: Inclusion Criteria:

* Must habitually complete a minimum of 5000 steps per day
* Having obtained informed consent
* Non-obese
* Non-smoker

Exclusion Criteria:

* Aged \>80 years
* Inability to comply with study procedures
* Currently participating or having participated in another infusion trial during last 12 months
* Any acute or chronic llness
* History of neuromuscular problems
* Medications known to affect protein metabolism
* Individuals who complete fewer than 5000 steps per day
* Individuals who have metal implants

Primary outcomes:
measure: Change in myofibrillar fractional synthetic rate (FSR)
timeFrame: one day and 2 weeks
Secondary outcomes:
measure: change in non-myofibrillar fractional synthetic rate (FSR)
timeFrame: baseline and one day of feeding
measure: Capillary dilatation and blood flow
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University
name: Stuart Philips, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03471780: Evaluation of Transperineal US in Labour
Official title: The Importance of Transperineal US in Labour
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Labor Long
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
First posted: 2018-03-21
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * pregnant women in labour
* Full term

Brief summary: Assessment of progress of labour is an important step in decision making of obstetricians

Detailed description: delayed progress of labour resemble an annoying problem to obstetrician so noninvasive diagnostic methods can play an important role in implementing a guidelines to follow patients in labour as transperineal US .

Eligibility criteria: Inclusion Criteria:

* pregnant women in labour
* Full term

Exclusion Criteria:

* pregnant ladies not in labour
* Preterm labour

Primary outcomes:
measure: the number of participants who will deliver by normal delivery
timeFrame: within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05077280: A Study of Concurrent Stereotactic Body Radiotherapy With Opdualag in Metastatic Uveal Melanoma
Official title: A Phase II Study of Concurrent Stereotactic Body Radiotherapy With Relatlimab and Nivolumab in Patients With Metastatic Uveal Melanoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Uveal Melanoma
Keywords: metastatic
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with relatlimab and nivolumab for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years

Detailed description: Metastatic uveal melanoma has no standard therapy, but there is evidence that both radiation therapy and immunotherapy may be helpful and may be synergistic. This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with Opdualag (nivolumab 480mg and relatlimab 160mg) for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases, limiting the total dosage to 700cc's of normal liver to \<15Gy. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years. Objectives are to determine the safety and tolerability, and iRECIST will be used to determine responses.We will treat up to 50 patients.

Eligibility criteria: Inclusion Criteria:

* measurable metastatic uveal melanoma.
* No concomitant therapy.
* Prior PD1 or tebendafesp allowed.
* Performance status 0-1.
* No active Hepatitis B.
* No known HIV infection.
* WBC\>2000, ANC\>1500, Hgb \>8.
* Creatinine \< 3 x ULN.
* AST \& ALT \< 2.5 x ULN Bilirubin \< 2 x ULN.
* Albumin \>2.9

Exclusion Criteria:

* Liver tumor volume \> 50%.
* Active CNS metastases.
* Pregnancy.
* Prior therapy with Opdualag or relatlimab
* Certain autoimmune diseases.
* Previous liver embolization or radiation.
* Use of systemic steroids

Primary outcomes:
measure: safety and tolerability of the therapy
timeFrame: 5 years
Secondary outcomes:
measure: Response rate
timeFrame: 5 years
Other outcomes:
measure: Progression-free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center Research Institute
state: California
Study officials:
affiliation: California Pacific Med Center Research Inst.
name: David R Minor, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03669380: Superior Mesenteric Artery Dissection
Official title: Isolated Superior Mesenteric Artery Dissection With Concomitant Vascular Aberrancy: Extremely Rare Cases and Clinical Implications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Diseases
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between Oct. 2011 and Jan. 2018, a total of 57 consecutive patients with SISMAD were included in this study.

Brief summary: This study investigate CT images of patients with spontaneous isolated superior mesenteric artery dissection (SISMAD). The investigators also further analyze the CT morphological differences between different options, aiming to determine "alarming CT character" during initial conservative treatment.

Detailed description: 57 Patients with SISMAD from Oct 2011 to Jan 2018 in investigator's hospital were included in this research. The investigators collected relevant clinical data and further investigated the CTA characters of both true lumen and false lumen. SMA angle, distance between entry site of dissection and SMA root were also measured.

Eligibility criteria: Inclusion Criteria:

* SMA dissection

Exclusion Criteria:

* SMA dissection combined with aortic or other visceral arteries
* Trauma related SMA dissection

Primary outcomes:
measure: Diameters of true lumen
timeFrame: up to 6 months
measure: the distance between dissection and SMA root
timeFrame: up to 6 months
measure: the angle between SMA root and abodominal aorta
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Lei Dou, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04535180: Sarcopenia and Osteoporosis in the Patients With Hemophilia
Official title: Sarcopenia and Osteoporosis in the Patients With Hemophilia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Hemophilia
Osteoporosis, Osteopenia
Hemophilic Arthropathy
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemophilia adult patients

Brief summary: Hemophilia is a bleeding disorder and repeated joint bleeding leads to hemophilic arthropathy. Among patients with hemophilia, vitamin D deficiency and hemophilic arthropathy have been associated with osteoporosis in several clinical studies.There is no data on the prevalence of osteoporosis in hemophilia patients in Taiwan or Asia. To the best of our knowledge, no previous studies have reported the prevalence of sarcopenia and correlation with osteoporosis in hemophilia adult patients. This study will investigate the prevalence and corelation of sarcopenia and low BMD in patients with hemophilia.

patients in Taiwan. The study will estimate the prevalence of sarcopenia and body composition in the hemophilia population and compared baseline demographic and clinical characteristics between the non-sarcopenia and sarcopenia individuals, with particular emphasis on the overlap with osteoporosis and hemophilic arthropathy.


Eligibility criteria: Inclusion Criteria:

* Hemophilia patients

Exclusion Criteria:

* History of total hip arthroplasty
* History of instrumentation in lumbar spine

Primary outcomes:
measure: Sacropenia
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
References: