louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06525753: Weaning is Winning? (WeWin Study)
Official title: Weaning is Winning? (WeWin Study): Are Parenteral Nutrition (PN) Graduates Growing Up Healthy?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intestinal Failure
Parenteral Nutrition
Keywords: Quality of Life
Pediatric
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Erasmus University Medical Center (Erasmus MC) - Sophia Children's Hospital
First posted: 2024-07-29
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parenteral Nutrition graduates, i.e.: patients weaned off Parenteral Nutrition at time of inclusion for at least 1 year, with a history of intestinal failure, defined as dependence on supplemental PN support for a minimum of 60 days within a 74 consecutive day interval and followed by the Group for Improvement of Intestinal Function and Treatment (GIFT) team (SickKids) or IF team (Erasmus MC) as an outpatient.

Brief summary: We propose a multicenter prospective study on pediatric patients with intestinal failure (IF) who weaned off parenteral nutrition (PN).

Detailed description: Children with IF depend on PN. This is associated with frequent and various complications such as metabolic bone disease, micronutrient deficiencies and abnormal body composition. Due to advancements in care, many patients with IF are able to wean off PN; they are so called PN graduates. It is currently not well known how often complications do occur after weaning off PN, and which patients are at highest risk of developing these complications.

Eligibility criteria: Inclusion Criteria:

* Parenteral Nutrition graduates for at least 1 year, with a history of intestinal failure.
* Age \<18 years at time of inclusion.

Exclusion criteria:

* No consent provided.

Primary outcomes:
measure: Complications
timeFrame: From 1 year after weaning off PN to 18 years of age
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
Clinical trial NCT03374553: MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Official title: A Prospective, Open, Multicentre Clinical Trial Analysing the Effectiveness and Safety of MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Angle Glaucoma
Lead sponsor: iSTAR Medical
Sponsor class: INDUSTRY
First posted: 2017-12-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 26 patients enrolled into first arm, when enrolment completed, an additional 26 patients enrolled into second arm
Primary purpose: TREATMENT

Brief summary: The study will evaluate the efficacy and safety of MINIject 636 and IOP lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.

The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
* Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System.
* Glaucoma not adequately controlled

Exclusion Criteria:

* Diagnosis of glaucoma other than open angle glaucoma
* Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System.
* Neovascular glaucoma in the study eye
* Prior glaucoma surgery in the study eye
* Clinically significant corneal disease
* Patients with poor vision

Primary outcomes:
measure: Reduction in medicated diurnal IOP
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Clínica Oftalmológica del Caribe
city: Hyderabad
country: India
facility: Maxivision Eye Hospital
state: Telangana
city: Panama city
country: Panama
facility: Panama Eye Center
Study officials:
affiliation: iSTAR Medical
name: Zubair Hussain, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02790853: Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders
Official title: Multimodal Imaging for Surveillance of Patients With Oral Potentially Malignant Disorders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Dysplasia
Lip and Oral Cavity Carcinoma
Oral Disorder
Premalignant Lesion
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-06-06
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This early phase I trial studies how well multimodal imaging works for surveillance in patients with oral potentially malignant disorders. New types of imaging devices may help doctors decide if a lesion in the mouth is pre-cancerous or cancerous.

Detailed description: PRIMARY OBJECTIVES:

I. To compare standard white light examination to multimodal imaging for detection of high grade dysplasia and carcinoma during follow-up examinations of patients with oral potentially malignant disorders (OPMD).

SECONDARY OBJECTIVES:

I. To determine qualitative and quantitative diagnostic assessment of patients who agree to undergo imaging and have images of sufficient quality.

II. To compare expression of molecular biomarkers to results from white light examination, multimodal imaging and pathologic assessment in a subset of patients who have invasive biopsies or resection.

III. To compare cytologic results from brush biopsy specimens to white light examination and multimodal imaging results.

OUTLINE:

Participants undergo PS2.1/PS3 imaging and high-resolution microendoscope imaging with proflavine hemisulfate applied to the mucosa. Patients also undergo brush biopsy and incisional biopsy. Procedures are repeated every 3-4 months for 2 years.

After completion of study treatment, patients are followed up at 30 days.

Eligibility criteria: Inclusion Criteria:

* Subjects who are willing to participate.
* Adult subjects with: a. clinically evident oral premalignant lesion (OPL) or suspicious oral mucosal lesion. or b. pathologic diagnosis of dysplasia or c. history of resected oral cancer or d. oral potentially malignant disorder (OPMD) or e. history of tobacco and/or alcohol exposure.
* Ability to understand and willingness to sign a written informed consent document (ICD).

Exclusion Criteria:

* Known allergy to proflavine or acriflavine.
* Pregnant females.

Primary outcomes:
measure: Detection of high grade dysplasia and carcinoma
timeFrame: Up to 2 years
Secondary outcomes:
measure: Diagnostic assessment
timeFrame: Up to 2 years
measure: Biomarker analysis
timeFrame: Up to 2 years
measure: Cytologic results
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ann Gillenwater
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03377153: The Effects of Hesperidin and Flaxseed on Biochemical Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Disease
Official title: Evaluation of the Effects of Hesperidin and Flaxseed Supplementation on Hepatic Enzymes, Inflammatory Factors, Lipid Profile, Blood Glucose, Insulin Sensitivity, and Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Alcoholic Steatohepatitis
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effects of Hesperidin and flaxseed supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to contol group or 2 capsules Hesperidin and 30 gram flaxseed for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.


Eligibility criteria: Inclusion Criteria:

- Age of 18 to 70 years

* Body Mass Index (BMI) between 25-40
* Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion Criteria:

* Diabetes
* Taking any kind of antibiotics two weeks before recruitment
* History of alcohol consumption
* pregnancy or lactation
* Professional athletes
* Other liver disease (viral/etc)
* Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E
* A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
* History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty
* Following program to lose weight in recent 3 mo
* A history of hypothyroidism or Cushing's syndrome

Primary outcomes:
measure: liver fibrosis
timeFrame: 12 weeks
Secondary outcomes:
measure: body mass index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
Study officials:
References:
Clinical trial NCT03941353: Care Pathways for Benchmarking on Fragile Hip Fractures Rapid Recovery
Official title: Care Pathways for Benchmarking on Fragile Hip Fractures Rapid Recovery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality Improvement
Hip Fractures
Lead sponsor: European Pathway Association
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2019-05-07
Enrollment: 298
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient admitted with a proximal femur fracture

Brief summary: The aim of this project is to build an international community of centers of excellence in the care for Fragile Hip Fracture Rapid Recovery patients. These centers of excellence will benchmark and share their expertise and experiences based on clinical and managerial data. In project is designed in five different phase:

Phase 1: literature review: identifying relevant key interventions and indicators Phase 2: expert panel: expert panel for teams, management and policy makers Phase 3: data collection: collection managerial data through retrospective patient record analysis on clinical indicators Phase 4: statistical data analysis: data input, validation and statistical analysis Phase 5: feedback and knowledge sharing: feedback report with anonymous benchmarking and knowledge sharing of the results.


Eligibility criteria: Inclusion Criteria:

* Trauma related non-elective admission for hip fracture;
* Minimum age of 65 years;
* The following hip fractures are included: Femoral neck, femoral head, trochanteric and subtrochanteric fractures;
* Discharged or deceased before May 30th of 2019

Exclusion Criteria:

* Hip fracture is not the main reason for admission to emergency room;
* Additional ipsilateral fractures;
* Hip fracture resulting from in-hospital fall that occurred in the hospital where the patient receives hip fracture care.

Primary outcomes:
measure: Performance on quality indicators at patient level (Quality of Care and patient satisfaction) for patients admitted with a fragile hip fracture.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
References:
Clinical trial NCT01726153: A Pilot Trial of an Individualized Web-Based Condom Use Intervention
Official title: A Pilot Randomized Control Trial (RCT) of an Individualized Condom-HIM Web-based Intervention for Condom USe Among HIV+ Gay Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Condom Use
HIV+ gay males
Intervention
Tailored
On-line
Internet
Web-based
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2012-11-14
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy of an online intervention in increasing condom use among HIV+ gay males.


Eligibility criteria: Inclusion Criteria:

1. are HIV-seropositive,
2. Men who are having sex with men,
3. engaging in unprotected anal intercourse with a partner who is serostatus negative or unknown
4. age 18 years and older,
5. ability to read English
6. have access to a computer and internet.

Exclusion Criteria:

-

Primary outcomes:
measure: Change from Baseline in participants self-efficacy in condom use at 2-weeks post-intervention
timeFrame: baseline and 2-weeks post intervention
Secondary outcomes:
measure: Change from Baseline in participants intention to use condoms at 2-weeks post-intervention
timeFrame: Baseline and 2-weeks post intervention
Other outcomes:
measure: Change from Baseline in participants condom use at 2-weeks post-intervention Condom Use
timeFrame: baseline and 2-weeks post intervention
Locations:
city: Toronto
country: Canada
facility: Ryerson University
state: Ontario
Study officials:
affiliation: Ryerson University and Centre hospitalier de l'Universite de Montreal (CHUM)
name: Joyal Miranda, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miranda J, Cote J, Godin G, Blais M, Otis J, Gueheneuc YG, Fadel G, Barton L, Fowler S. An Internet-Based Intervention (Condom-Him) to Increase Condom Use Among HIV-Positive Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2013 Oct 16;2(2):e39. doi: 10.2196/resprot.2723.
Clinical trial NCT01921153: An Environmental Intervention to Encourage Healthy Food Choices
Official title: Encouraging Healthy Food Choices With an Environmental Intervention in Military Dining Facilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Health Knowledge, Attitudes, Practice
Lead sponsor: United States Army Research Institute of Environmental Medicine
Sponsor class: FED
First posted: 2013-08-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to test effectiveness of an environmental intervention designed to encourage healthy food intake during meals. It is hypothesized that fruit, vegetable, whole grain, lean protein, and low-fat dairy consumption will increase during the intervention. It is also hypothesized that nutrition knowledge, attitudes, and behaviors will change as a result of the intervention. The findings from this study will provide insight into the applicability of this intervention in military dining facilities.

Detailed description: Previous studies attempting to increase consumption of healthy foods in military dining facilities have had mixed results, and alternative approaches need to be considered. The present intervention was designed with the results of previous studies in mind, and as such, does not focus on labeling only healthy food choices. Instead, the present intervention aims to encourage consumption of nutritionally well-balanced meals using an environmental cue in military dining facilities.

Eligibility criteria: Inclusion Criteria:

* Military member or government civilian employee
* Normally eat in military dining facility at least 1 day per week.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Change in dietary intake
timeFrame: Participants will be followed for 6-12 weeks
Secondary outcomes:
measure: Change in nutrition knowledge
timeFrame: Measured at beginning and end of the 6-12 week study.
measure: Change in nutrition attitudes and behaviors (composite)
timeFrame: Measured at the beginning and end of the 6-12 week study.
Other outcomes:
Locations:
city: Natick
country: United States
facility: Natick Soldier Systems Center Dining Facility
state: Massachusetts
Study officials:
affiliation: United States Army Research Institute of Environmental Medicine
name: Tracey J Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01150253: Effect of a Probiotic on Grass Pollen Allergic Rhinitis Subjects
Official title: Double Blind Randomised Comparison of Two Preparations, One Enriched in Probiotics and One Without Probiotics (Placebo) in Grass Pollen Allergic Rhinitis Patients, Using a Nasal Provocation Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2010-06-24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Intervention model: CROSSOVER

Brief summary: Various studies in animals and humans have shown a potential beneficial effect of probiotics consumption on allergy. However, few studies exist that document their efficacy for upper airways allergies such as allergic rhinitis. The objective of this study is to investigate the effect of short-term oral administration of a Lactobacillus paracasei on a nasal provocation test (NPT) with grass pollen, performed out of pollen season. Adult volunteers with allergic rhinitis are enrolled in a randomized, double-blind, placebo-controlled study, based on two 4-weeks cross-over periods of product consumption (probiotic-fermented milk versus placebo), separated by a washout period of 6-8 weeks. Objective and subjective clinical parameters of NPT as well as systemic and nasal immunological parameters are compared between the two treatment periods.


Eligibility criteria: Inclusion Criteria:

* age 18 to 35 years
* history of allergic rhinitis to grass pollen confirmed by either a positive skin prick test (wheal diameter \>3 mm) or specific IgE for grass pollen (\>0.35 kU/L) as titrated by UniCAP 100 (Pharmacia Diagnostics, Uppsala, Sweden) and no history of perennial rhinitis
* a nasal reaction threshold of 10'000 standardized quality units (SQs)/ml grass pollen or less at the screening phase

Exclusion Criteria:

* any medical condition that could influence the study (pregnancy, viral or bacterial airway infection, active allergic rhinitis)
* uncontrolled asthma (peak expiratory flow \<20% of volunteer's best personal value)
* treatment with antihistamine or antibiotic treatment less than two weeks before enrolment or during the trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: François Spertini, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wassenberg J, Nutten S, Audran R, Barbier N, Aubert V, Moulin J, Mercenier A, Spertini F. Effect of Lactobacillus paracasei ST11 on a nasal provocation test with grass pollen in allergic rhinitis. Clin Exp Allergy. 2011 Apr;41(4):565-73. doi: 10.1111/j.1365-2222.2011.03695.x.
Clinical trial NCT03521453: PEPPER : PErcePtion of Pre-anesthesia Visit With or Without Robot
Official title: PEPPER : PErcePtion of Pre-anesthesia Visit With or Without Robot
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Satisfaction, Personal
Anesthesia
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2018-05-11
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients scheduled for a pre-Anesthesia visit during the study period (for orthopedic, general, urologic, ophthalmologic surgeries or for endoscopic examination under anesthesia).

Brief summary: Pre-anesthesia visit for scheduled surgery is mandatory by law in France. During this visit, patients should be informed of the different available technics of anesthesia (i.e. general or loco-regional) and of their own risks .

Nowadays, many informations are given through written paper and leaflets, just before the consultation. In addition, patients need usually to wait for the doctor. This time may be used to give information, and new information's support, such as videos, may be used.

The aim of this study is to evaluated if a robot (PEPPER), who is able to answer to patients and to give informations, may increase the satisfaction of patients having a pre anesthesia visit for a scheduled surgery.

Detailed description: Before- after observational study.

All adult patients (age≥18 yrs) coming for a pre-anesthesia visit will be proposed to fulfill a questionnaire regarding their satisfaction and the quality of information they received.

* in the first period, patients will receive paper informations before the anesthesia visit.
* in the second period, they will have the same paper informations but a robot PEPPER will also stand in the waiting room and propose to the patients to give them informations about anesthesia, patients journey, risks, blood transfusion etc...

Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled for a pre-Anesthesia visit during the study period

Exclusion Criteria:

* Refusal to answer the questionnaire
* unable to answer the questionnaire (not speaking french...)

Primary outcomes:
measure: Patients satisfaction about the pre-anesthesia visit
timeFrame: 1 hour
Secondary outcomes:
measure: quality of information
timeFrame: 1 hour
measure: quality of information about risks
timeFrame: 1 hour
measure: annoying of waiting
timeFrame: 1 hour
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: University Hospital, Angers
name: sigismond Lasocki, MD, PhD
role: STUDY_CHAIR
References: