louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02464150: Gluten Challenge in Celiac Disease
Official title: Gluten Challenge in Celiac Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Celiac Disease
Keywords: gluten
antigen-specific T cells
transcriptome
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Stiftelsen Helse og Rehabilitering
name: Helse Sor-Ost
First posted: 2015-06-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Up till 30 participants with celiac disease on a glutenfree diet are asked to consume gluten containing cookies or bread for 3 days.

Questionnaires and sampling of blood is done before, during and after.

Detailed description: Before and 6 days after start of gluten challenge, blood samples will be collected and analysed by using HLA-tetramers to identify and purify CD4+ gluten-specific T cells by flow cytometry. T cells will undergo transcriptome analysis to get an insight in signalling of antigen-specific cells. Other cell populations like CD8+ T cells and γδ T cells will also be analyzed by flow cytometry.

Eligibility criteria: Inclusion Criteria:

* Celiac disease confirmed by biopsy
* Age 18 - 80 years
* Gluten free diet last 6 months
* Subject has received information and signed the informed consent form

Exclusion Criteria:

* Pregnant or breast feeding
* Probability of participant becoming pregnant (f.ex. by not using adequate sexual prevention by woman in fertile age)
* Drugs influencing immune system used last 3 months
* Current infectious disease of moderate or high severity
* Other chronic active intestinal disease
* Serious reaction on small amounts of gluten ingested

Primary outcomes:
measure: Transcriptome of gluten-specific T cells
timeFrame: Day 6
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo university hospital - Rikshospitalet
Study officials:
affiliation: Oslo University Hospital and University of Oslo
name: Knut EA Lundin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zuhlke S, Risnes LF, Dahal-Koirala S, Christophersen A, Sollid LM, Lundin KE. CD38 expression on gluten-specific T cells is a robust marker of gluten re-exposure in coeliac disease. United European Gastroenterol J. 2019 Dec;7(10):1337-1344. doi: 10.1177/2050640619874183. Epub 2019 Sep 7.
citation: Skodje GI, Sarna VK, Minelle IH, Rolfsen KL, Muir JG, Gibson PR, Veierod MB, Henriksen C, Lundin KEA. Fructan, Rather Than Gluten, Induces Symptoms in Patients With Self-Reported Non-Celiac Gluten Sensitivity. Gastroenterology. 2018 Feb;154(3):529-539.e2. doi: 10.1053/j.gastro.2017.10.040. Epub 2017 Nov 2.
citation: Sarna VK, Skodje GI, Reims HM, Risnes LF, Dahal-Koirala S, Sollid LM, Lundin KEA. HLA-DQ:gluten tetramer test in blood gives better detection of coeliac patients than biopsy after 14-day gluten challenge. Gut. 2018 Sep;67(9):1606-1613. doi: 10.1136/gutjnl-2017-314461. Epub 2017 Aug 4.
Clinical trial NCT03242850: Assuring Patient-centered Literacy Promotion for Underserved Children Study
Official title: Assuring Patient-centered Literacy Promotion for Underserved Children to Promote School Readiness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Literacy
Keywords: Reading
Text Messages
Video
Cognitive Development
Child Development
Infants
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2017-08-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study tests whether an enhanced primary cared based literacy promotion intervention consisting of a video and text message will increase shared reading occurrences between parents and children compared to the standard version.

Detailed description: This is a randomized controlled trial aimed at assessing the effectiveness of an enhanced intervention consisting of a video and a series of text messages in promoting shared reading between parents and children. Participants will be randomized to one of two study arms (1) the enhanced intervention consisting of a video in the waiting room, standard guidance on shared reading, and a series of text messages (2) regular care which includes standard guidance on shared reading. The primary outcome will be shared reading occurrences. Secondary outcomes will include receipt of intervention, measure of the cognitive home environment, developmental screening results, and measure of parent reading beliefs.

Eligibility criteria: Inclusion Criteria:

1. primary caregiver of a child age 6-15 months,
2. primary language English or Spanish,
3. cell phone ownership,
4. age ≥18 years,
5. willing to receive text messages, and
6. willing to accept randomization

Exclusion Criteria:

1. Individuals unable to provide consent
2. Individuals who do not meet inclusion criteria

Primary outcomes:
measure: Reading Recall
timeFrame: Visit 2 (approx. 6 months)
Secondary outcomes:
measure: Survey of Wellbeing of Young Children Milestones
timeFrame: Visit 2 (approx. 6 months)
measure: StimQ2 Read Scale / Parental Verbal Responsivity Scale
timeFrame: Visit 2 (approx. 6 months)
measure: Parental Reading Beliefs Inventory
timeFrame: Visit 2 (approx. 6 months)
measure: Receipt of intervention
timeFrame: Visit 2 (approx. 6 months)
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Eric B. Chandler Health Center
state: New Jersey
Study officials:
References:
citation: Jimenez ME, Crabtree BF, Hudson SV, Mendelsohn AL, Lima D, Shelton PA, Veras J, Lin Y, Pellerano M, Morrow L, Strom BL. Enhancing Reach Out and Read With a Video and Text Messages: A Randomized Trial in a Low-Income Predominantly Latino Sample. Acad Pediatr. 2021 Aug;21(6):968-976. doi: 10.1016/j.acap.2021.02.011. Epub 2021 Feb 19.
Clinical trial NCT00740350: Logan Basic During Pregnancy on Labor and Childbirth
Official title: Does the Logan Basic Protocol for Chiropractic Care During Pregnancy Reduce Labor Time and Increase the Ease of Labor and Childbirth?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Pregnancy
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2008-08-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if women who have chiropractic care, according to the Logan Basic Protocol for adjusting, during pregnancy have an easier, shorter labor and delivery as compared to women who haven't had chiropractic care during pregnancy.

Detailed description: This study will be designed to test if the Logan Basic Technique system of adjusting pregnant women can reduce labor time and increase the ease of labor and delivery as compared to the labor times reported by Kilpatrick and Laros in the obstetric literature. It is proposed that women who have regular chiropractic care throughout pregnancy or at least for the third trimester will have an easier labor and delivery as well as a shorter labor time than is reported in the literature.

Eligibility criteria: Inclusion Criteria:

* 20-24 weeks pregnant
* enrolled in a separate pre-natal care protocol with an outside provider
* a Logan College Student or member of the family of a Logan Student ("family" as defined by CCE designation)

Exclusion Criteria:

Primary outcomes:
measure: Post delivery interview/questionnaire
timeFrame: 2 weeks post delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan University, College of Chiropractic
state: Missouri
Study officials:
References:
Clinical trial NCT00098150: Follow-Up Study of Patients Previously Treated With Pimecrolimus Tablets for Atopic Dermatitis
Official title: A Follow-Up Study of Patients Previously Treated in a Core Study With Pimecrolimus Tablets for Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Keywords: Safety, atopic dermatitis, adverse event, SAE, extension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-06
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: This extension study is being conducted to collect post-treatment safety information on patients who previously participated in the core clinical trial.


Eligibility criteria: Inclusion Criteria:

* Consenting patients who participated in the core clinical trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01481350: Sildenafil for Post-capillary Pulmonary Hypertension in Patients Undergoing Cardiac Surgery
Official title: Phase 2 Use of Sildenafil for the Treatment of Post-capillary Hypertension in Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Hypertension
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 20
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: Pulmonary hypertension increases the perioperative risk in patients undergoing cardiac surgery for valvular heart diseases, especially in patients with a long life mitral valve disease. The present study wants to test the hypothesis that intravenous administration of sildenafil reduces pulmonary vascular resistances and afterload of the right ventricle.

Detailed description: Pulmonary hypertension represents an increased risk for perioperative patients undergoing cardiac surgery for valvular heart disease especially in patients with a long life mitral valve disease complicated by sever pulmonary hypertension, with high risk of developing post operative right ventricular failure during separation from cardiopulmonary by pass. A recent study showed that a single oral administration of sildenafil at the beginning of the cardiac intervention in patients undergoing valvular heart surgery complicated by pulmonary hypertension reduces pulmonary vascular resistances without inducing significant effects on systemic vascular resistances. The present study wants to test the hypothesis that intravenous administration of sildenafil reduces pulmonary vascular resistances and afterload of the right ventricle avoiding right ventricular failure. This should support weaning from cardiopulmonary by pass in patients undergoing cardiac surgery for valvular heart diseases associated to pulmonary hypertension.

Eligibility criteria: Inclusion Criteria:

* all patients undergoing valvular heart surgery associated to post capillary pulmonary hypertension with a mean pulmonary arterial pressure (mPAP)\>30mmHg or pulmonary vascular resistance (PVR)\>3Wu.

Exclusion Criteria:

* patients younger than 18 years old
* ischemic cardiomyopathy
* Ejection Fraction (EF)\<30%
* severe Chronic obstructive pulmonary disease (COPD) with oxygen and bronchodilators therapy
* chronic pulmonary disease, chronic renal failure on dialysis
* hepatic failure
* patients with orotracheal intubation and already admitted to the ICU before the intervention

Primary outcomes:
measure: reduced mechanical ventilation
timeFrame: seven days
Secondary outcomes:
measure: ICU length of stay
timeFrame: 28 days
Other outcomes:
Locations:
city: Turin
country: Italy
facility: San Giovanni Battista Hospital University of Turin
Study officials:
affiliation: San Giovanni Battista, Hospital University of Turin
name: Mauro Rinaldi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03561350: Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing
Official title: Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Neoplasms
Keywords: Microsatellite Instability
Circulating Tumor DNA
Colorectal Neoplasms
Lead sponsor: Shanghai Minimally Invasive Surgery Center
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 60
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: Patients hospitalized in Shanghai Minimally Invasive Surgery Center

Brief summary: The method to analyze the microsatellite instability (MSI) status by next-generation sequencing (NGS) has been established to assess the deficiency of DNA mismatch repair (MMR) system. The aim of our study is to evaluate the feasibility and reliability of this NGS method by testing the circulating tumor DNA (ctDNA) in blood sample of advanced colorectal cancer patients. If the result is positive, the MSI status could be easily learned without the acquisition of tissue samples.


Eligibility criteria: Inclusion Criteria:

* a biopsy proven histological diagnosis of colorectal carcinoma
* MSI status of tissue sample known by IHC or PCR method
* willing to participate and informed consent signed

Exclusion Criteria:

* history of other malignant tumors
* patients with inflammatory bowel disease
* patients with familial adenomatous polyposis
* patients treated by surgery or adjuvant treatment
* pregnant or lactating women

Primary outcomes:
measure: MSI status in blood sample
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Minimally Invasive Surgery Canter, Ruijin hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT04587050: Screening for HPV and Cervical Cancer in Young Women With Perinatally Acquired HIV
Official title: Screening for Human Papillomavirus and Cervical Cancer in Young Women With Perinatally Acquired HIV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Human Papillomavirus Infection
Cervical Cancer
Keywords: Cervical screening
HPV vaccination
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Public Health England
First posted: 2020-10-14
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women living with perinatally acquired HIV aged 18 years or older

Brief summary: This is a cross-sectional, observational study of high-risk HPV status, cervical cytology and HPV vaccine uptake and response in young women with perinatally acquired HIV.

Detailed description: This is an observational study of cervical cytology assessment, high risk human papilloma virus (hr-HPV) status, and HPV antibody titres amongst adult women living with perinatally acquired HIV infection (PaHIV). Eligible consenting participants will have two samples taken; firstly, a cervical sample tested for cytology and Hr-HPV with the Cepheid GeneXpert HPV; secondly serum will be assessed for hr-HPV serology. All women with PaHIV, vaccinated and unvaccinated for HPV, over the age of 18 years will be eligible and will be recruited into one of two cohorts: (1) sexually active women: full study, cervical and blood sampling or (2) non-sexually active women, blood sampling only (total n=80). Follow up for abnormal smear results or hr-HPV positivity will be arranged through colposcopy.

Eligibility criteria: Inclusion Criteria - Cohort 1:

* Perinatally acquired HIV aged 18+
* Sexually active
* Able to give informed consent

Inclusion Criteria - Cohort 2:

* Perinatally acquired HIV aged 18+
* Able to give informed consent

Exclusion Criteria - Cohort 1:

* Pregnancy
* Not sexually active
* Previous total abdominal hysterectomy
* Unable to give informed consent

Exclusion Criteria - Cohort 2:

* Unable to give informed consent

Primary outcomes:
measure: Prevalence of Abnormal Cervical Cytology
timeFrame: 1 year
Secondary outcomes:
measure: Prevalence of High Risk HPV by Subtype
timeFrame: 1 year
measure: Prevalence of CIN2+
timeFrame: 1 year
measure: HPV Serology (16/18)
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Tamara Elliott
role: STUDY_CHAIR
References:
Clinical trial NCT06603350: The Effect of Perioperative Factors on Postoperative Outcomes After Lung Transplantation
Official title: The Effect of Perioperative Factors on Postoperative Outcomes in Patients Undergoing Lung Transplantation: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Complications After Lung Transplantation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 200
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: Inclusion Criteria are adult patients undergoing lung transplantation Those undergoing retransplantation,multiple organ transplantation or refusal to participate will be excluded.

Brief summary: 1. Evaluate the influence of perioperative factors on postoperative outcomes in patients undergoing lung transplantation patients.
2. To evaluate the feasibility of using pulmonary ultrasound to identify lung complications such as atelectasis and pulmonary edema after lung transplantation
3. Observe the changes of perioperative inflammation and immune indexes after lung transplantation


Eligibility criteria: Inclusion Criteria:

Prosedure of lung transplantation, Aged more than 18 years old

Exclusion Criteria:

Secondary lung transplantation, multiple organ transplantation, refusal to participate

Primary outcomes:
measure: Postoperative pulmonary complications
timeFrame: 3 days after surgery
measure: Mortality
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Inflammatory index IL-6
timeFrame: 3 days after after surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT06178250: Placenta, Fetal Liver, Sectional Ductus Venosus Volumes Examined by Three-dimensional Ultrasound in the Second Trimester
Official title: The Role of Placenta, Fetal Liver, Sectional Ductus Venosus Volumes Examined by Three-dimensional Ultrasound in the Second Trimester in Predicting Gestational Diabetes Mellitus and Maternal-fetal Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
DUCTUS VENOSUS VOLUME
PLACENTA VOLUME
3D SONOGRAPHY
FETAL LİVER VOLUME
Keywords: GESTATİONAL DİABETES MELLİTUS
PLACENTA VOLUME
FETAL LİVER VOLUME
DUCTUS VENOSUS VOLUME
3D SONUGRAPHY
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 139
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 46 pregnant women diagnosed with gestational diabetes mellitus, 93 pregnant women with normal glycemic index
Primary purpose: OTHER

Brief summary: Investigators measured the placenta, fetal liver and ductus venosus volumes of pregnant women with GDM diagnosis and normal glycemic indices in the second trimester.Investigators aimed to correlate measurements with maternal/fetal outcomes and evaluate their success in predicting poor obstetric outcomes

Detailed description: GDM screening may not always be possible with OGTT performed in limited weeks of gestation. In addition, mid-trimester ultrasound scanning is done in all pregnancies. Therefore, measurement of placental volume and fetal liver volume may be an alternative method for the diagnosis of GDM. In order to predict GDM in the second trimester, the use of 3D sonography and VOCAL (Virtual Organ Computer Aided Analysis) technology in high-risk pregnant women and their cost-effectiveness rates should be investigated further. Multicenter randomized controlled studies with more patients are needed to be able to say more clearly.

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* diagnosed with GDM

Exclusion Criteria:

* multiple pregnancy
* congenital anomalies
* gestational hypertansion
* preeclampsia

Primary outcomes:
measure: Placenta volume in ultrasound
timeFrame: 10 months
measure: Fetal liver volume in ultrasound
timeFrame: 10 months
measure: Ductus venosus volume in ultrasound
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Nefise Nazlı YENIGUL
Study officials:
References: