louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04511299: Impact of Fish Oil-enriched Lipid Emulsion on Fatty Acid and Inflammatory Response in Infants After Surgery
Official title: Impact of Fish Oil-enriched Intravenous Lipid Emulsion in Parenteral Nutrition of Phospholipid Fatty Acid Composition and Inflammatory Response in Infants After Gastrointestinal Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: Parenteral nutrition
Interleukin-1b
Interleukin-8
Lipid emulsion
Lead sponsor: Dr. Soetomo General Hospital
Sponsor class: OTHER_GOV
First posted: 2020-08-13
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aim to compare the impact of fish oil-enriched intravenous lipid emulsion to standard Intravenous lipid emulsion on fatty acid composition and inflammatory response (IL-1β and IL-8 levels) in infants after gastrointestinal surgery. Our hypothesis is the fish oil-enriched intravenous lipid emulsion can improve the fatty acid composition and lower the inflammatory response.

Detailed description: This study is conducted in infants post gastrointestinal surgery that requires parenteral nutrition for at least 3 days. Subjects are classified into two groups. Group 1 received standard IVFE and group 2 received ω-3-enriched IVFE. The type of intravenous standard and omega-3-enriched fat emulsion used in this study are Lipofundin 20% and SMOFlipid 20%, respectively, both administered for three consecutive days after surgery (72 hours) in 1-4 gram/kilogram/day dosing. The inflammatory response (IL-1β and IL-8 levels) and fatty acid composition are checked from blood plasma. Blood examination is done before the surgery and 3 days after the surgery.

Eligibility criteria: Inclusion Criteria:

* willing to participate in this study (through informed consent)
* undergo gastrointestinal surgery
* get parenteral nutrition for at least 3 days

Exclusion Criteria:

* chronic diseases
* allergic to fish, egg, soy and/or nut proteins

Primary outcomes:
measure: Fatty Acids Composition
timeFrame: 3 days (before surgery and after surgery)
measure: Inflammatory response
timeFrame: 3 days (before surgery and after surgery)
Secondary outcomes:
measure: Hemoglobin
timeFrame: 3 days (before surgery and after surgery)
measure: Leukocyte
timeFrame: 3 days (before surgery and after surgery)
measure: C reactive Protein
timeFrame: 3 days (before surgery and after surgery)
measure: Albumin
timeFrame: 3 days (before surgery and after surgery)
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Dr. Soetomo General Hospital
Study officials:
affiliation: Dr. Soetomo General Hospital
name: Meta H Hanindita
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01590199: Evaluate Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs
Official title: Extension Study to the "Open-label Phase I Study Evaluating the Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs - The COOPERATE-1 Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neuroendocrine Tumors
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-05-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate long-term safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic NET patients, who who have not progressed during 12 months of combination therapy with pasireotide LAR and everolimus


Eligibility criteria: Inclusion and Exclusion Criteria:

Patients eligible for inclusion in this extension study have to meet all of the additional inclusion criteria:

* The patient must provide a signed Informed Consent Form (ICF) for the extension study prior to any study related procedures
* Completion of the whole treatment period of 15 months (3 months monotherapy with either pasireotide LAR or everolimus followed by a 12 months combination of pasireotide LAR/everolimus) in the CSOM230F2102 study
* No tumor progression during 12 months of combination therapy with pasireotide LAR and everolimus (checked via radiologically assessment).

No intolerable toxicity during combination therapy with pasireotide LAR and everolimus

Primary outcomes:
measure: Number of Participants with Adverse Events and Serious Adverse Enents as a Measure of Safety and Tolerability
timeFrame: up to 4 years
measure: Number of Participants with abnormal laboratory and ECG results as a Measure of Safety and Tolerability
timeFrame: up to 4 years
Secondary outcomes:
measure: investigator-assessed progression free survival (PFS)
timeFrame: up to 4 years
measure: best overall response
timeFrame: up to 4 years
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02920099: Adaptation and Validation of a Nutrition Literacy Assessment Instrument
Official title: Adaptation and Validation of a Nutrition Literacy Assessment Instrument
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dietary Habits
Keywords: Nutrition literacy
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-09-30
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University of Kansas Medical Center (KUMC) students

Brief summary: The purpose of this study is to develop a tool to help researchers better understand what diet information people know and what skills they use to make diet choices.


Eligibility criteria: Inclusion Criteria:

* Able to speak and read English
* Have 1 or more of the following diseases: diabetes, hyperlipidemia, hypertension, and/or overweight/obesity

Exclusion Criteria:

* Visual acuity insufficient to read the testing instrument
* Cognitive impairment
* Weight \> 500 pounds

Primary outcomes:
measure: Change in Nutrition Literacy Assessment Instrument (NLAI) responses
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Heather Gibbs, PhD, RD, LD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00674999: Use of Amnion on Partial Thickness Burns
Official title: Project Title The Treatment of Partial Thickness Burns: Treated Amnion Versus Currently in Use Topical Medications
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Burn
Keywords: Burn
Partial thickness burn
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2008-05-08
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if Amnion, used on partial thickness burn injuries would provide an improvement in rate of healing, pain control and scarring as compared to standard medical treatments.


Eligibility criteria: Inclusion Criteria:

* Partial thickness burn injury.
* \>2% burn injury.
* Ages 0-100 years.

Exclusion Criteria:

* Patients not expected to survive

Primary outcomes:
measure: Length of time to 95% healing of treated burn wounds
timeFrame: Assessment daily until 95 % healed
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Measured at hospital discharge
measure: Incidence of infection
timeFrame: Measure daily until complete wound healing
measure: Amount of daily pain until wound is healed with different treatments.
timeFrame: Daily until wound is completely healed.
measure: Amount of scaring with different treatments
timeFrame: From injury to 2 years post burn
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: David N Herndon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04707599: Telephone Reminder to Increase Appointment Rates
Official title: Reducing the Rate of Missed Appointments in an Outpatient Substance Use Treatment Clinic in Norway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reminder Systems
Substance-Related Disorders
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2021-01-13
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Quasi-experimental with an OFF-ON design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Missed appointments to outpatient substance use treatment are common and costly and can have a negative effect on the health of patients.

In this quasi-experimental study, the investigators used an on-off design to examine whether a reminder "plus" intervention (telephone call from therapist before first appointment) would increase attendance and improve cancellation and rebooking practices. Secondary outcomes included satisfaction with treatment and intention to complete the treatment program.


Eligibility criteria: Inclusion Criteria:

* Newly referred patient
* \> 18 years
* Diagnosis: Substance related disorder

Exclusion Criteria:

* Patients who are unable to understand or score the survey due to cognitive or language barriers

Primary outcomes:
measure: Attendance rate
timeFrame: Up to 10 treatment sessions, estimated average timeframe = 3 months
Secondary outcomes:
measure: Dropout rate
timeFrame: Up to 10 treatment sessions, estimated average timeframe = 3 months
measure: Cancellation / rebooking rate
timeFrame: Up to 10 treatment sessions, estimated average timeframe = 3 months
Other outcomes:
measure: Treatment satisfaction
timeFrame: First week
measure: Intention to complete treatment
timeFrame: First week
Locations:
city: Arendal
country: Norway
facility: Addiction Unit - Sørlandet Hospital
state: Agder
city: Kristiansand
country: Norway
facility: Addiction Unit - Sørlandet Hospital
state: Agder
Study officials:
affiliation: Sørlandet Hospital
name: John-Kåre Vederhus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallefoss LJ, Gabrielsen KB, Haugland SH, Clausen T, Vederhus JK. Effects of a brief pre-admission telephone reminder on no-show and dropout rates in substance use disorder treatment: a quasi-experimental study. Subst Abuse Treat Prev Policy. 2022 Aug 23;17(1):61. doi: 10.1186/s13011-022-00489-9.
Clinical trial NCT02049099: A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care
Official title: A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Haemophilia A
Haemophilia B
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
First posted: 2014-01-29
Enrollment: 1658
Sex: MALE
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients with a diagnosis of ICD10: haemophilia A D66.9 or haemophilia B D67.9.

Brief summary: To describe the current treatment practice during 12 months for previously treated patients diagnosed with haemophilia A or haemophilia B.

Detailed description: The study population consists of patients with a diagnosis of ICD10: haemophilia A D66.9 or haemophilia B D67.9.

Eligibility criteria: Inclusion Criteria:

* Male patients with severe or moderate haemophilia A or haemophilia B.
* Treatment with Factor VIII/Factor IX products initiated at least 24 months before inclusion in the study.
* Informed consent is obtained from the patient or patient's legal representative (as applicable according to legal regulation).

Exclusion Criteria:

* Confirmed positive inhibitor test detected in the past 24 months.

Primary outcomes:
measure: Total dose (IU) issued of Factor VIII during a 12 month period
timeFrame: - 12 month to Day 0
measure: Total dose (IU) issued of Factor IX during a 12 month period
timeFrame: - 12 month to Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Swedish Orphan Biovitrum Investigational Site
city: Montpellier
country: France
facility: Swedish Orphan Biovitrum Investigational Site
city: Nantes
country: France
facility: Swedish Orphan Biovitrum Investigational Site
city: Bonn
country: Germany
facility: Swedish Orphan Biovitrum Investigational Site
city: Leipzig
country: Germany
facility: Swedish Orphan Biovitrum Investigational Site
city: Firenze
country: Italy
facility: Swedish Orphan Biovitrum Investigational Site
city: Milano
country: Italy
facility: Swedish Orphan Biovitrum Investigational Site
city: Vicenza
country: Italy
facility: Swedish Orphan Biovitrum Investigational Site
city: Barcelona
country: Spain
facility: Swedish Orphan Biovitrum Investigational Site
city: Madrid
country: Spain
facility: Swedish Orphan Biovitrum Investigational Site
city: Stockholm
country: Sweden
facility: Swedish Orphan Biovitrum Investigational Site
city: Manchester
country: United Kingdom
facility: UKHCDO
Study officials:
affiliation: Swedish Orphan Biovitrum AB (publ)
name: Stefan Lethagen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01337999: Human Epididymis Protein 4 in Normal Menstruating Women
Official title: Human Epididymis Protein 4 in Normal Menstruating Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Premenopausal Women
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2011-04-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ovulating women recruited from local college campuses, doctor's offices and hospitals.

Brief summary: The purpose of this study is to determine if Human Epididymis Protein 4 (HE-4) levels vary during the menstrual cycles in ovulatory women. HE-4 is a sensitive serological marker that is elevated in certain ovarian and endometrial cancers and can aid in the diagnosis of these malignant conditions. In order to optimize the utility of HE4 as a tumor marker in premenopausal women, its expression in the normal menstrual cycle needs to be characterized. We hypothesize that HE-4 levels do not vary in the menstrual cycle.


Eligibility criteria: Inclusion Criteria:

* women age 18-45 years old
* regular menstrual cycles (every 25-35 days)
* normal BMI (19-25)
* no hormonal contraception in the two menstrual cycles prior to enrollment

Exclusion Criteria:

* pregnancy
* pelvic mass

Primary outcomes:
measure: HE-4 level
timeFrame: 5 times during menstrual cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island, Division of Reproductive Endocrinology & Infertility
state: Rhode Island
Study officials:
affiliation: Women and Infants Hospital of Rhode Island
name: Beth Plante, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anastasi E, Granato T, Marchei GG, Viggiani V, Colaprisca B, Comploj S, Reale MG, Frati L, Midulla C. Ovarian tumor marker HE4 is differently expressed during the phases of the menstrual cycle in healthy young women. Tumour Biol. 2010 Oct;31(5):411-5. doi: 10.1007/s13277-010-0049-1. Epub 2010 May 20.
citation: Moore RG, McMeekin DS, Brown AK, DiSilvestro P, Miller MC, Allard WJ, Gajewski W, Kurman R, Bast RC Jr, Skates SJ. A novel multiple marker bioassay utilizing HE4 and CA125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecol Oncol. 2009 Jan;112(1):40-6. doi: 10.1016/j.ygyno.2008.08.031. Epub 2008 Oct 12.
citation: Lambert-Messerlian G, Plante B, Eklund EE, Raker C, Moore RG. Levels of antimullerian hormone in serum during the normal menstrual cycle. Fertil Steril. 2016 Jan;105(1):208-13.e1. doi: 10.1016/j.fertnstert.2015.09.033. Epub 2015 Oct 23.
Clinical trial NCT02325999: Endoscopic Submucosal Dissection Combine With Laparoscopic Regional Lymph Node Dissection for Early Gastric Cancer
Official title: Endoscopic Submucosal Dissection Combine With Laparoscopic Regional Lymph Node Dissection:a New Therapy for Early Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Early Gastric Cancer
Keywords: Endoscopic Submucosal Dissection
Laparoscopic Regional Lymph node Dissection
early gastric cancer
Disease-free survival
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 200
Sex: ALL
Standard ages: CHILD
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 Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection for early gastric cancer can improve Disease-free survival ？

Detailed description: Patients with early stage of gastric cancer(T1a/T1bN0M0,NCCN2014.V1) will depart into two group randomized double-blind, then experimental group accept Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection ,and control group accept Endoscopic Submucosal Dissection only.The follow-up time is from operation to recrudescence.

Eligibility criteria: Inclusion Criteria:

* cT1a：ulcer（+）and lesion diameter\>3cm and differentiated type. Any ulcer and lesion diameter d\>2cm and poorly differentiated type.
* cT1b: Submucosal injection (+)

Exclusion Criteria:

* metastasis
* recrudescence

Primary outcomes:
measure: DFS
timeFrame: Five years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: The capital health research and development of special
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Shu-tian ZHANG
role: STUDY_CHAIR
References:
Clinical trial NCT02964299: Mandibular Advancement Bite Block Efficacy Observational Study
Official title: Mandibular Advancement Bite Block Efficacy Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Obstruction
Keywords: Gastrointestinal endoscopy
Moderate sedation
Airway management
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2016-11-16
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ASA class I or II patients admitted for routine upper gastrointestinal endoscopy

Brief summary: The purpose of this study is to compare the effect of mandibular advancement bite block to standard bite block for prevention of hypoxemia, intervention events and adverse effects during endoscopic examinations.

Detailed description: During endoscopic examinations, especially upper gastrointestinal, bile duct, or bronchoscopic examinations, the endoscope need to be placed through the mouth. A bite block is used to protect vulnerable endoscope and protect patient's teeth. During sedative endoscopic exams, respiratory depression, apnea or upper airway obstruction will occur under the influence of the sedative medications. Serious adverse events may occur such as hypoxemia. A nasal airway, Larson's maneuver, jaw thrust or chin lift may be needed to open airways.

Mandibular advancement devices has been widely used in treating obstructive sleep apnea. A modified bite block that provides mandibular advancement could provide entry inlet of endoscope as well as provide mandibular advancement to provide patent airway during sedative endoscopy. In this study, we group the patients into test group using mandibular advancement bite block and a control group using standard bite block. After anesthetic induction, gastric endoscopy was performed. Degree of upper airway obstruction will be evaluated and recorded. Differences between the two groups will be evaluated.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist class I or II
* Patients undergoing routine upper gastrointestinal endoscopy under sedation

Exclusion Criteria:

* Baseline oxygen saturation \< 90%
* Known difficult airway
* Oral or facial surgery history
* BMI \> 35
* patients with gastroparesis or gastrointestinal bleeding
* anticipated exam time \> 30 minutes

Primary outcomes:
measure: Area under curve of 95% oxygen desaturation
timeFrame: up to 30 minutes
Secondary outcomes:
measure: number of rescue interventions: chin lift, jaw thrust, insertion of nasal airway or mask-bag ventilation
timeFrame: up to 30 minutes
measure: Adverse events: partial or complete airway obstruction, or apnea
timeFrame: up to 30 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Anesthesiology, Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Wei-Nung Teng, MD
role: PRINCIPAL_INVESTIGATOR
References: