louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06343597: Volume Outcome Relationships and Effects
Official title: Volume Outcome Relationships and Effects of Adjuvant and Neoadjuvant Therapy in Mortality in Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Cancer
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The purpose of the study is to evaluate the outcomes of esophageal cancer resection in patients in high volume (more than 5 esophagectomy performed per year) and low volume (less than 5 esophagectomy performed per year) hospital facilities.

Brief summary: This is a retrospective analysis to assess if high-volume hospital facilities experience greater or lesser rates of incidence in patients with esophageal cancer than low-volume facilities.

Detailed description: This is a retrospective analysis to assess if high-volume hospital facilities experience greater or lesser rates of incidence in patients with esophageal cancer than low-volume facilities.

The relationship between volume and outcomes has been proven in pancreatic cancer. Similar to pancreatic cancer, esophageal cancer historically has a bad prognosis. Esophageal cancer is typically asymptomatic, resulting in an advanced stage at the time of diagnosis. Additionally, it also has a significantly high morbidity and mortality. Therefore, it is crucial to determine volume-outcome relationships in esophageal cancer. This study aims to elucidate what these findings may entail by evaluating the impact that the volume-outcome relationship has on treatment assessment in esophageal cancer patients.

The purpose of the study is to evaluate the outcomes of esophageal cancer resection in patients in high volume (more than 5 esophagectomy performed per year) and low volume (less than 5 esophagectomy performed per year) hospital facilities. Furthermore, this paper will assess the outcomes of neoadjuvant and adjuvant therapy in esophageal cancer.

Eligibility criteria: Inclusion Criteria:

* esophageal cancer

Exclusion Criteria:

* No esophageal cancer

Primary outcomes:
measure: Esophageal Cancer resection in patients in high volume (more than 5 esophagectomy performed per year) and low volume (less than 5 esophagectomy performed per year) hospital facilities
timeFrame: through study completion, up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richardson
country: United States
facility: Methodist Richardson Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Dhiresh Jeyarajah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03259997: Efficacy of Probiotics on Physical Performance
Official title: Efficacy of Probiotics on Physical Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Performance
Lead sponsor: Probi AB
Sponsor class: INDUSTRY
First posted: 2017-08-24
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Efficacy of probiotics on physical performance


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18 to 40 years, at the time of signing the informed consent form
* Provides signed and dated informed consent form
* Engaged in competitive sports and regularly training
* Non-anemic, iron-deficient
* Willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

* Use of probiotics
* Use of iron supplementation
* Use of ascorbic acid (Vitamin C) supplementation
* Hypersensitivity to any of the ingredients in the investigational product (IP)

Primary outcomes:
measure: Metabolic response at standardized workloads during ergometer cycling
timeFrame: 4,8 and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Idrottsmedicinska enheten, Umeå universitet
Study officials:
affiliation: Umeå University
name: Michael Svensson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02109497: Phase 1 Study to Determine the Effects of PBT2 on the Pharmacokinetic Profile of Caffeine
Official title: A Phase 1, Single Centre, Open Label, Two-period Study in Healthy Volunteers to Determine the Effect of PBT2 on the Pharmacokinetics of Caffeine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pranabio
Sponsor class: UNKNOWN
First posted: 2014-04-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of caffeine and the effects that PBT2 has on the metabolism of caffeine in healthy volunteers.

Detailed description: This study will be conducted with all participants receiving a dose of caffeine 100 mg on Day 1 followed by a 7 day washout period before commencing 5 consecutive days of PBT2 250 mg from Day 8 to 12 and a second dose of caffeine 100 mg on Day 12. Pharmacokinetic samples will be collected during after each dose of the study drugs, along with safety monitoring assessments.

Eligibility criteria: Inclusion Criteria:

* Healthy males or females with a BMI between 19 and 30kg/m2
* No clinically significant abnormalities

Exclusion Criteria:

* Exposure to medications/drugs that interfere with metabolism of PBT2 including drugs that inhibit or induce CYP1A2
* Use of caffeine-containing beverages, supplements or alcohol
* Significant history of depression or other psychiatric illness
* Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion
* Unable to swallow capsules or tablets

Primary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of Caffeine After a Dose of PBT2 250mg
timeFrame: prior to dose on Day 1 and 12 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48 hours post each dose.
Secondary outcomes:
measure: Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Event
timeFrame: Up to 19 days after first dose of caffeine
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Centre for Clinical Studies - Nucleus Network
state: Victoria
Study officials:
affiliation: Prana Biotechnology
name: Caroline Herd
role: STUDY_DIRECTOR
References:
Clinical trial NCT03730597: Glenosphere Size and Scapular Notch in RSA, Prospective Randomized Study
Official title: Influenze of Glenosphere Size in Scapular Notch Development. Randomized Study Comparing 42 to 38 ECC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Shoulder Arthroplasty
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 95
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized study
Primary purpose: PREVENTION

Brief summary: Scapular notch can be reduced by using bigger glenospheres but in some patients it cannot be implanted because of small size. If small size of glenosphere is used then scapular notch may increase. To improve that situation, eccentricity has been added to some glenospheres to increase glenoid overhanging. The objective is to assess if eccentricity can avoid scapular notch as effectively as bigger glenospheres.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing reverse shoulder prosthesis because of rotator cuff disordes andacute fractures

Exclusion Criteria:

* patients with previous surgery
* patients with deltoid deficiency
* patients with acute infection

Primary outcomes:
measure: scapular notch development
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05320497: Transparent Cap-assisted SpyGlass for Biliary Stricture
Official title: Application of Transparent Cap-assisted Digital Cholangioscopy (SpyGlassTM) for Biliary Stricture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bile Duct Stricture
Endoscopic Retrograde Cholangiopancreatography
Biliary Disease
Biliary Tract Neoplasms
Keywords: Bile Duct Stricture
ERCP
Choledochoscopy
Transparent Cap
Biliary biopsy
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a before-after study. Transparent cap SpyGlass and standard SpyGlass were performed on the same patient successively.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The transparent cap-assisted endoscope has the function of fixing field of view and increasing visual space. It has been widely used in gastrointestinal examination and treatment. In this study, the investigators intend to apply transparent cap-assisted choledochoscopy to endoscopic biliary tract exploration and biopsy to investigate whether transparent cap-assisted choledochoscopy can improve operability, visual field clarity, and biopsy accuracy.

Detailed description: Recently, endoscopy has become more widely used in clinical practice. A straightforward method of improving mucosal visualization involves attachment of a transparent cap to the end of the endoscope. It has been widely used in gastrointestinal examination and treatment.This is a before-after study. In patients with suspected bile duct stricture, tandem ERCP combined with SpyGlass choledochoscopy procedures were carried out on the same day in random order, first without a transparent cap and then with a cap (without-to-with), or first with a cap and then without a cap (with-to-without). The differences in maneuverability, visual field clarity and biopsy accuracy of choledochoscopy with and without transparent cap were recorded to explore the application prospect of transparent cap assisted choledochoscopy.

Eligibility criteria: Inclusion Criteria:

* The indications for ERCP.
* Written informed consent

Exclusion Criteria:

* Underlying bleeding disorder
* The platelet count less than 50×10\^9/L
* Serious cardio-pulmonary, hepatic or renal disease
* Intolerance to ERCP
* Other high-risk conditions or disease (such as massive ascites, etc.)
* Pregnancy

Primary outcomes:
measure: The clearness of visual field
timeFrame: Immediately
measure: Intubation rates of bile duct ends, cystic duct openings, and left and right hepatic duct bifurcations
timeFrame: Immediately
Secondary outcomes:
measure: Biopsy accuracy
timeFrame: 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of Chinese PLA General Hosptial
state: Beijing
Study officials:
affiliation: Beijing 302 Hospital
name: Yan Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01696097: The Effects of Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure Regulation in Middle Aged and Older Adults
Official title: The Effects of Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure Regulation in Middle Aged and Older Adults (S31)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Dyslipidemias
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 19
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the source of dietary protein (pork or chicken/fish) as a part of the DASH diet affects blood pressure control in adults with high blood pressure.

Detailed description: High blood pressure is a major risk factor for heart disease and stroke and affects 50 million people in the United States. Making healthy food choices, such as those in the DASH (Dietary Approaches to Stop Hypertension) Diet, has been shown to improve blood pressure control in people with high blood pressure. The purpose of this study is to determine if the source of dietary protein (pork or chicken/fish) as a part of the DASH diet affects blood pressure control in adults with high blood pressure.

Eligibility criteria: Inclusion Criteria:

* male or female
* age 40-75
* BMI 25-40 kg/m2
* systolic blood pressure 120-160 mm Hg
* diastolic blood pressure \<100 mm Hg
* non-diabetic, no acute illness
* not following vigorous exercise program
* urinary continence

Exclusion Criteria:

* age \<40 or \>75
* BMI \<25 or \>40 kg/m2
* systolic blood pressure \<120 or \>160 mm Hg
* diastolic blood pressure \>100 mm Hg
* diabetic, acute illness
* following vigorous exercise program
* urinary incontinence
* current smoker

Primary outcomes:
measure: Change in blood pressure
timeFrame: After 6 weeks of following DASH diet
Secondary outcomes:
measure: Change in blood lipids
timeFrame: After 6 weeks of following DASH diet
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayne W Campbell, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sayer RD, Wright AJ, Chen N, Campbell WW. Dietary Approaches to Stop Hypertension diet retains effectiveness to reduce blood pressure when lean pork is substituted for chicken and fish as the predominant source of protein. Am J Clin Nutr. 2015 Aug;102(2):302-8. doi: 10.3945/ajcn.115.111757. Epub 2015 Jun 10.
Clinical trial NCT03344497: Animated Video Consultation for Reducing Pre-Operative Anxiety in Outpatient Dermatologic Surgery
Official title: Animated Video Consultation for Reducing Pre-Operative Anxiety in Outpatient Dermatologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatology/Skin - Other
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate whether the addition of an animated skin surgery educational video to conventional in-person surgery consultation will help reduce pre-operative anxiety in patients awaiting outpatient skin surgery.

Detailed description: This will be an randomized controlled pilot study. Subjects will be randomized to either receive an animated video along with conventional consultation OR receive a conventional consultation only. Pre-operative anxiety will be assessed.

Eligibility criteria: Inclusion Criteria:

1. Male and female, at least 18 years of age
2. Subjects scheduled to undergo outpatient skin surgery
3. Subjects able to comprehend and read the English language.

Exclusion Criteria:

1. Subjects unable to or unwilling to comply with the study procedures
2. Subjects unable to speak or read the English language.

Primary outcomes:
measure: Pre-operative anxiety levels assessed via questionnaire
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona - Banner University Medicine Dermatology
state: Arizona
Study officials:
References:
Clinical trial NCT01361997: Isopropyl Alcohol Against Chlorhexidine - Isopropyl Alcohol as Antiseptics to Prevent Hemoculture's Contamination
Official title: Comparative Study of 70% Isopropyl Alcohol Against 2% Chlorhexidine- 70% Isopropyl Alcohol as Antiseptics to Prevent Hemoculture's Contamination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infectious Diseases
Keywords: Antiseptics
Hemoculture contamination
Anti-infecting agents, local
Lead sponsor: Universidad de Guanajuato
Sponsor class: OTHER
First posted: 2011-05-27
Enrollment: 1102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determinate if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemocultures, compared with 2% chlorhexidine in 70% isopropyl alcohol.

Detailed description: The develop of contaminants in blood cultures is a problem of great impact to health institutions and patients, as they represent a waste of resources, and additionally increases the patient's hospital stay. The principal source of contaminant is the bacteria in the skin flora, so the greatest way to improve the sensibility of this test is to do an optimal skin antisepsis. It has been reported that 2% chlorhexidine gluconate in 70% isopropyl alcohol is superior that other skin disinfectants, and that 70% isopropyl alcohol has a high efficacy reducing the presence of bacteria on the skin, so both antiseptics are good options for skin antisepsis.

Eligibility criteria: Inclusion Criteria:

* Patients with suspected blood stream infection.
* Patients allocated in admission, hospitalization and intensive care units.

Exclusion Criteria:

* Patients with a single peripheral hemoculture.

Primary outcomes:
measure: Determine if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemoculture, compared with 2% chlorhexidine in 70% isopropyl alcohol.
timeFrame: 120 hours
Secondary outcomes:
measure: Determine the rate of contamination of each antiseptic used.
timeFrame: 1 year
measure: Description of the most frequent bacterial contaminants.
timeFrame: 1 year
Other outcomes:
Locations:
city: Leon
country: Mexico
facility: University of Guanajuato School of Medicine
state: Guanajuato
Study officials:
affiliation: Universidad de Guanajuato
name: Alejandro E. Macias, M. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02154997: The Effect of Different Food Products on Post Prandial Blood Glucose in Pregnant Woman With Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes
Type 2 Diabetes
Gestational Diabetes
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2014-06-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women perticapting in this study will be from the high risk pregnancy clinic of hadassah Ein Kerem.

Brief summary: During pregnancy nutrition demands change and the pregnant woman needs to adjust her food intake and take into consideration the corrected daily recommendations for micro and macro nutrients. Pregnant woman tend to suffer from hyperemesis and this affects their food choice.

Amongst pregnant women with Diabetes the glucose balance is extremely important during pregnancy. Glucose balance is a result of correct nutrition and an exact amount of insulin. This delicate balance requires from the pregnant women an ability to perform correct carbohydrate count.

Hyperglycemia has already been proven to affect the fetus and the neonatal outcomes. Hypoglycemia may also have a negative effect but the main danger is immediate harm to the mother and therefore to the fetus. For those reasons glucose balance is crucial and demands delicate synchronization of nutrition and insulin therapy.


Eligibility criteria: Inclusion Criteria:

* age 18-45
* women who suffer from type 1 diabetes, type 2 diabetes or gestational diabetes
* Do not suffer from any intestinal disease
* Accept to sign a consent form

Exclusion Criteria:

* over age of 45
* under age of 18
* suffer from any intestinal disease
* do not accept to sign a consent form

Primary outcomes:
measure: Post prandial blood glucose levels
timeFrame: The outcome will be measured at various time points during a 120 min OGTT: Fasting, 30, 60, 90 and 120 min
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem
Study officials:
affiliation: Hebrew Universtity
name: Ram Weiss, Md PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebrew University
name: Karen J Hershkop, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebrew University
name: Limor Marko, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05376397: Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)
Official title: Addressing Intersectional Stigma: Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Depressive Symptoms
Anxiety Symptoms
Emotion Regulation
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Thrive Social Services
name: Positive Impact Health Centers
name: National Institute of Mental Health (NIMH)
First posted: 2022-05-17
Enrollment: 34
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary goal of this study is to test a minority stress model of psychological health outcomes for Black sexual minority men (BSMM) while using and not using a novel intervention named THRIVE 365. THRIVE 365 combines mHealth and institutional support elements to provide four areas of support for BSMM: 1) Promote HIV and psychological health knowledge and motivation; 2) Foster a sense of community and positive social connections among BSMM; 3) Connect clients to BSMM-affirming healthcare, including HIV treatment and mental healthcare; 4) Provide resources for housing, transportation, and other economic empowerment. To examine the effects of the intervention, we will utilize a 14-day daily diary study to capture daily intervention engagement, HIV and psychological health outcomes, coping, and experiences of racial and sexual minority stressors. We will first examine main associations between intervention engagement and HIV (antiretroviral treatment use) and psychological health (depressive symptoms, anxiety symptoms, emotion regulation difficulties outcomes) outcomes, then consider how intervention engagement affects coping and attenuates the impacts of racial and sexual minority stressors during the 14 day period.


Eligibility criteria: Inclusion Criteria:

* 16 years old or older ;
* Identifying as masculine
* Identifying as Black/African American
* Reporting being attracted to and/or sexually active with men;
* Able to complete all procedures in English.
* Mobile access to the internet in order to complete the once-daily survey procedures.

Exclusion Criteria:

* evidence of unstable, unmanaged, or serious psychiatric symptoms that could be made worse by participation;
* evidence of gross cognitive impairment that would interfere with successful completion of study procedures.

Primary outcomes:
measure: Antiretroviral (ART) Medication Use
timeFrame: 24 Hours
measure: Depressive Symptoms
timeFrame: 24 Hours
measure: Anxiety Symptoms
timeFrame: 24 Hours
measure: Emotion Regulation
timeFrame: 24 Hours
Secondary outcomes:
measure: Coping
timeFrame: 24 Hours
Other outcomes:
Locations:
city: Newark
country: United States
facility: Devin English
state: New Jersey
Study officials:
affiliation: Rutgers School of Public Health
name: Devin English, PhD
role: PRINCIPAL_INVESTIGATOR
References: