louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04269941: Prognostic Factors Affecting Survival of Gastric GIST
Official title: Clinicopathological Characteristics and Prognostic Factors of Gastrointestinal Stromal Tumors Located in the Stomach in Tunisian Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric GIST
Lead sponsor: Université de Sousse
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 34
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There were 34 patients with the mean age of 58.2 years and male predominance. The disease was localized, locally advanced and metastatic in 26, 6 and 2 cases, respectively. Complete surgical resection was performed in 32 cases.

Brief summary: Gastrointestinal stromal tumor (GIST) is the most common non-epithelial mesenchymal tumor of the gastrointestinal tract. Surgical treatment is the only curative therapy for primary localized GIST. This study aimed to identify the clinicopathological characteristics of gastric GISTs and to study the predictive factors for recurrence in Tunisian patients.

Detailed description: The prognosis of gastric GIST depends on various tumor factors with the most important being the mitotic index and tumor necrosis. Imatinib therapy has revolutionized the treatment of advanced GIST.

They have been the subject of much controversy in terms of their histogenesis, classification, treatment and prognosis. GISTs are histologically similar to smooth muscle and nerve tumors such as leiomyomas, leiomyosarcomas or schwannomas. Currently they are well characterized with the recent discovery of the C-KIT gene mutation and the expression by tumor cells of the C-KIT protein.

Moreover, the discovery of this receptor is at the origin of the introduction of a "targeted therapy": an anti-tyrosine kinase molecule having revolutionized the therapeutic management of these tumors. However, the standard curative treatment of GIST remains complete surgical resection with negative margin from the tumor.

Eligibility criteria: Inclusion Criteria: patient having gastric GIST

-

Exclusion Criteria:

* patient operated for other gastric tumors

Primary outcomes:
measure: number of patients operated for gastric GIST
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: university of sousse
name: ALI BEN ALI, PROFESSOR
role: STUDY_DIRECTOR
References:
Clinical trial NCT03382119: Increased Liver Stiffness: A Study of Acoustic Radiation Force Impulse (ARFI) Elastography
Official title: Increased Liver Stiffness: A Study of Acoustic Radiation Force Impulse (ARFI) Elastography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Fibroses
Keywords: liver stiffness Fontan
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 2017-12-22
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will either be scheduled for a Stage 3 Fontan cardiac operation or have chronic liver disease caused by biliary atresia.

Brief summary: The goal of this study is to determine if ultrasound tools can be used to detect liver stiffness. Acoustic radiation force impulse (ARFI) elastography and backscatter will be used to see if they can detect liver stiffness in different populations of patients with liver disease.

The study is measuring liver stiffness in pediatric patients aged 2-5 years. Patients either have had a Fontan cardiac surgery or have liver disease.

Ultrasound scanning takes images of the liver and has much lower risks for patients. ARFI elastography and other tools can be used to measure liver stiffness.

Detailed description: If patients have liver congestion, reversing it could prevent liver fibrosis, which cannot be treated. Liver fibrosis has serious health risks and is associated with a higher chance of developing liver cancer later in life.

Subjects from two patient populations will be enrolled in order to test ultrasound technologies. A total of 30 subjects between 2-5 years of age will be enrolled.

1. 15 children with increased liver stiffness due to the Fontan operation
2. 15 children with increased liver stiffness caused by Biliary Atresia.

Eligibility criteria: Inclusion Criteria:

* Patients aged 2-5 years
* Children who are scheduled to have a Stage 3 Fontan cardiac operation (arm 1) AND Children who have chronic liver disease caused by biliary atresia (arm 2)
* Patient must be receiving care at the University of Michigan CS Mott Children's Hospital
* Parent/guardian must be willing to sign the study consent form

Exclusion Criteria:

* For arm 1 subjects: pre-existing evidence of chronic liver disease (as defined by chronic elevation (over 4 weeks) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or conjugated bilirubin to greater than two times the upper limit of normal
* For arm 1 subjects: evidence of overt liver nodularity by conventional US imaging or evidence of portal vein or hepatic vein thrombosis (clots) by US Doppler exam

Primary outcomes:
measure: Shear wave speed
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: C.S. Mott Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Frank DiPaola, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00203619: Capsule Endoscopy in Obscure GI Bleeding
Official title: An Economic Evaluation of Capsule Endoscopy for Obscure Gastrointestinal Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obscure Gastrointestinal Bleeding
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Heritage Foundation for Medical Research
name: Calgary Health Region
First posted: 2005-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to conduct a cost-effectiveness analysis of wireless capsule endoscopy in the investigation of patients with overt obscure gastrointestinal bleeding. To inform this analysis, a randomized controlled trial of capsule endoscopy compared with standard care will be conducted

Detailed description: The purpose of this study is to conduct a cost-effectiveness analysis of wireless capsule endoscopy in the investigation of patients with overt obscure gastrointestinal bleeding. To inform this analysis, a randomized controlled trial of capsule endoscopy compared with standard care will be conducted. Patients randomized 1:1.

Eligibility criteria: Inclusion Criteria:

1. Age 18 or older
2. Obscure overt GI bleeding
3. No cause for bleeding found on Gastroscopy and colonoscopy within 1 week of bleeding

Exclusion Criteria:

1. Known or suspected swallowing disorders
2. Known or suspected small bowel obstruction
3. Multiple comorbidities precluding surgery
4. Patients with implantable electromagnetic devices
5. Pregnant women

Primary outcomes:
measure: sf36
timeFrame: 48 weeks
measure: giqli
timeFrame: 48 weeks
measure: eq50
timeFrame: 48 weeks
measure: diagnostic yield
timeFrame: 48 weeks
Secondary outcomes:
measure: transfusions
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Robert J Hilsden, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00398619: A Study of the Effect of INCB013739 on Cortisone Reducing Enzyme Activity in Obese People Predisposed to Diabetes
Official title: A Double-blind, Placebo Controlled Pharmacodynamic Study of the Effect of INCB013739 on Systemic and Adipose Tissue 11βHSD1 Activity in Obese, Insulin Resistant Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insulin Resistance
Obesity
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2006-11-14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the investigational drug INCB013739 has an effect on systemic and adipose tissue 11-HSD1 activity in obese, insulin resistant subjects.

Detailed description: "Proprietary Information: Exploratory (Non-Confirmatory) Trial".

Eligibility criteria: Inclusion Criteria:

* Male and female subjects between 18 years and 65 years of age.
* BMI between 30 and 42 kg/m2, inclusive.
* FPG \<126 mg/dL

Exclusion Criteria:

* Meet criteria for diagnosis of diabetes mellitus at the screening evaluation, female subjects with a history of gestational diabetes are permitted.
* Are receiving oral antidiabetic agents within the 3 months prior to screening.

Primary outcomes:
measure: Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.
timeFrame: Serial collections at each visit
measure: Evaluation of change in cortisol laboratory values
timeFrame: Serial collections at each visit
measure: Assessment of ECGs, laboratory results and physical exams for adverse events
timeFrame: Measured from baseline through study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: Chula Vista
country: United States
state: California
Study officials:
affiliation: Incyte Corporation
name: William V Williams, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02877719: The Effect of Poverty on Psychological Well-being of Children
Official title: The Effect of Poverty and Income Disparity on the Psychological WellBeing of Hong Kong Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 1725
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Hong Kong Chinese pupils from Grades 5 and 6 of the elementary schools in Hong Kong

Brief summary: The aim of this study is to explore the impacts of poverty and income disparity on the psychological well-being of Hong Kong Chinese children.

Detailed description: It is well documented that poverty has a negative impact on the physiological well-being of children in the West. There is an imperative need for health care professionals to develop and evaluate interventions to promote the psychological wellbeing of children living in poverty. First, however, it is crucial to assess and understand how the impact of poverty, in particular the impact of income disparity, affects the psychological wellbeing of Hong Kong children before any intervention to promote it can be planned, developed, or evaluated. Unfortunately, while much public concern about poverty has concentrated on children's physical development, the impact of poverty and income disparity on their psychological well-being remains relatively underexplored. Because the cultural context in which they live is drastically different from that of Western children, the way that Chinese children view the nature and meaning of poverty, as well as their responses to it and to any psychosocial interventions, will in all likelihood differ considerably from those of Western children. Hence, the aim of this study is to explore the impacts of poverty and income disparity on the psychological well-being of Hong Kong Chinese children.

Eligibility criteria: Inclusion Criteria:

* Hong Kong Chinese pupils from Grades 5 and 6 of the elementary schools in Hong Kong
* be able to read Chinese and speak Cantonese
* had to live and go to school in the same district

Exclusion Criteria:

* Children with chronic illness or identified cognitive and learning problems

Primary outcomes:
measure: Levels of quality of life at baseline
timeFrame: baseline
Secondary outcomes:
measure: Levels of self-esteem at baseline
timeFrame: baseline
measure: Number of depressive symptoms at baseline
timeFrame: baseline
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Ho Cheung William Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ho KY, Li WH, Chung JO, Lam KK, Chan SS, Xia W. Factors contributing to the psychological well-being for Hong Kong Chinese children from low-income families: a qualitative study. Int J Ment Health Syst. 2016 Sep 8;10(1):56. doi: 10.1186/s13033-016-0088-0. eCollection 2016.
Clinical trial NCT01684319: Milk-induced Gastrointestinal Symptoms in Infants
Official title: Prospective, Randomized, Double Blind and Placebo Controlled Study With the Aim to Establish the Role of Milk Proteins in Gastrointestinal Diseases (GERD, Constipation and Colics) of Young Infants and to Determine the Diagnostic Value of Immunological Tests in These Pathologies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Symptoms in Young Infants
Keywords: Constipation
Gastroeosphageal reflux
Colics
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 120
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Various digestive manifestations are common in infants less than 6 months and have a significant impact on morbidity and quality of life of the family. In a prospective study on more than 2800 Italian infants followed by 0-6 months of life, it was determined that 55% of these children had gastrointestinal symptoms such as regurgitation (23%), colics (20%), constipation (17%) or poor weight gain (15%). However, these symptoms are not very accurate, and their cause is often difficult to determine. Frequently, the pediatrician will exclude cow's milk protein in infant feeding, but without a clear etiological diagnosis was asked. This measure causes significant additional costs through the use of extensively hydrolyzed milk specifically for children and involves an elimination diet of all foods containing cow's milk sometimes for several years. This can negatively influence the growth of the child.

If the involvement of milk in these pathologies is suggested by some early studies (35% for colics, 68% in constipation, 42% in gastroesophageal reflux), it is unclear in the current state of knowledge if these gastrointestinal symptoms are actually due to an "allergy" to milk. Moreover, there is no validated diagnostic test for non-IgE-mediated gut allergy. However, various tests have proven their effectiveness in the investigation of non IgE-mediated allergy (eg. LAT, patch tests) and will be used in this study.


Eligibility criteria: Inclusion Criteria:

* Infants 0-6 month old with at least one of the following symptoms : constipation, gastroesophageal reflux, colics

Exclusion Criteria:

* Prematurity
* exclusive breastfeeding
* Other cause for symptoms

Primary outcomes:
measure: Milk allergy in gastrointestinal diseases in young infants
timeFrame: 10 weeks
Secondary outcomes:
measure: Diagnostic tests
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Genève
country: Switzerland
facility: Département de l'enfant et de l'adolesent - Hôpitaux Universitaires de Genève
state: GE
Study officials:
affiliation: Hôpitaux Unversitaire de Genève
name: Philippe A Eigenmann, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04154319: HPV Vaccination Among Daughters of Latina Immigrants
Official title: HPV Vaccination Among Daughters of Latina Immigrants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Healthy Diet
Keywords: HPV vaccination
Healthy Eating
Latina immigrants
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 634
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group randomized trial
Primary purpose: PREVENTION

Brief summary: The overall goal of this study to promote HPV vaccine uptake among daughters of Latina immigrants between the ages of 9 and 12.

Detailed description: Objective: Implementation and examination of the efficacy of a culturally relevant, community-based HPV vaccination intervention among daughters of Latina immigrants 9-12 years of age in Alabama.

Methods: Group-randomized controlled trial evaluating two interventions: 1) promotion of HPV vaccination and 2) promotion of healthy eating using "place of residence" as the unit of randomization. Between May 2013 and October 2017, forty locations with 317 mother-daughter dyads were enrolled.

Eligibility criteria: Inclusion Criteria:

* Latina immigrant
* Resident of selected randomization unit (place of residence)
* 18 years of age and older
* At least one HPV unvaccinated daughter between the ages of 9 and 12

Exclusion Criteria:

-

Primary outcomes:
measure: HPV vaccination among 9-12yo daughters of Latina immigrants
timeFrame: 7 months
measure: Healthy eating among Latina immigrants and their 9-12 yo daughters
timeFrame: 7 months
measure: Appropriate nutrition label interpretation among Latina immigrants mothers and 9-'12yo daughters
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Scarinci IC, Hansen B, Kim YI. A Cluster-Randomized Controlled Trial to Evaluate a Community-Based Healthy Eating and Nutrition Label Interpretation Intervention Among Latinx Immigrant Mothers and Their Daughters. J Community Health. 2021 Apr;46(2):313-323. doi: 10.1007/s10900-020-00885-x.
Clinical trial NCT02392819: Effects on Metabolism and Cognitive Functions of a Commonly Used Commercial Food Supplement
Official title: Food Design for Improved Cognitive Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Blood Glucose Regulation
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Anti-Diabetic Food Centre
First posted: 2015-03-19
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This project evaluate effects of a commonly used food supplement on glucose metabolism and cognitive function.

Detailed description: The test product has previously been suggested to elicit beneficial effects on glucose metabolism and cognitive performance. The purpose with this study is to evaluate metabolic effects and effects on mood variables of the test product provided at breakfast. Test variables are determined at fating and postprandial a standardised breakfast. The results are compared with effects after a placebo product.

Eligibility criteria: Inclusion Criteria:

* age between 40-60 years, normal BMI, healthy, non-smokers

Exclusion Criteria:

* metabolic disorders or gastro- intestinal disease, intake of probiotics- or antibiotics during the last 2 weeks prior to the study.

Primary outcomes:
measure: blood glucose
timeFrame: 4 hours
Secondary outcomes:
measure: serum insulin
timeFrame: 4 hours
measure: Mood as measured by ratings on 100 mm visual analog scales( VAS rating scales)
timeFrame: 4 hours
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Food for Health Science Centre, Medicon Village
Study officials:
affiliation: Food for Health science Centre
name: Anne C Nilsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04562519: Salivary Flow Rate Response to Electrostimulation in HD Patients
Official title: Hyposalivation Response to TENS in HD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodialysis Complication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Xerostomia is a subjective complaint of dry mouth, whereas hyposalivation is an objective decreased of salivary flow. Hyposalivation was reported in 28.8 % of haemodialysis (HD) patients (Bruzda-Zwiech, 2014).

Detailed description: Stimulation of the salivary glands can be induced mechanically (for example, by chewing gum or acupressure) or through medications (such as pilocarpine, cevimeline, angiotensin-converting-enzyme inhibitors and angiotensin-receptor blockers) or by electrostimulation as transcutnaeous electrical nerve stimulation (TENS) (Bossola and Tazza, 2012).

Eighty HD patients (40 diabetics and 40 nondiabetics) will receive 20 minutes of TENS on skin over bilateral parotid gland, 3 times weekly for 3 weeks to investigate the hyposalivation response of diabetic and non diabetic HD patients to TENS.

Eligibility criteria: Inclusion Criteria:

* Eighty HD patients (40 diabetics and 40 non diabetics)
* HD at least from three month
* saliva flow less than or equal 0.15 millilitre per minute

Exclusion Criteria:

* pulmonary or cardiac disorders
* drugs to treat hyposalivation
* salivary glands inflammation, tumor, and autoimmune diseases.
* smokers and alcholics

Primary outcomes:
measure: 3-week response of salivary flow rate
timeFrame: immediately after the last session
Secondary outcomes:
measure: immediate response of saliva flow
timeFrame: immediately after the first session
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: Dokki
city: Giza
country: Egypt
facility: Cairo Unoversity
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References: