louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05238168: Evaluation of Digital Follow up of Preterm Infants
Official title: ePIPARI - Digital Follow-up of Preterm Infants During First Two Years
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Birth
Development Delay
Sensory Disorder
Growth Disorders
Family Relations
Keywords: Preterm infant
Digital follow up
Electronic health monitoring
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
name: University of Helsinki
First posted: 2022-02-14
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm infants treated in a neonatal intensive care unit and their parents.

Brief summary: The aim is to study how a digital follow up tool can identify the preterm born children and their families who need further support or clinical interventions

Detailed description: This study runs a digital follow up parallel to clinical follow up, up to 2 years of corrected age of the child. It evaluates the ability of the digital follow up tool to identify the problems in growth and health, eating and feeding, neurodevelopment and parental wellbeing which require further support or interventions. This study includes all infants born under 34 weeks of gestation in Turku University Hospital during years 2019-2022 and those preterm children born under 32 weeks of gestation who turn to 2 years during years 2019-2021.

Parent satisfaction about the digital follow up tool is asked at each time point and anonymously once per year. The follow up age points are the expected day of birth, 1 month, 2 months, 4 months, 8 months, 12 months, 18 months and 24 months after the expected birth date.

Eligibility criteria: Inclusion Criteria:

* Children born before 34 weeks fo gestation and their parents
* Clinical follow up at Turku University Hospital

Exclusion Criteria:

* Parents do not speak Finnish, Swedish or English

Primary outcomes:
measure: Ability to identify children and parents in need for further support/interventions questionnaire
timeFrame: 0-28 months
measure: Response rate
timeFrame: 0-28 months
Secondary outcomes:
measure: Parent satisfaction Questionnaire
timeFrame: 0-28 months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: NICU/Pediatrics
Study officials:
affiliation: Turku University Hospital
name: Liisa Lehtonen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01171768: The Expression of Serum Angiogenesis Marker in Patients Presenting With Hemoptysis
Official title: The Expression of Serum Angiogenesis Marker in Patients Presenting With Hemoptysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Lung Diseases
Hemoptysis
Keywords: Vascular endothelial growth factor
angiopoietin-2
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-07-28
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients visited Samsung Medical Center for the treatment of benign inflammatory disease such as bronchiectasis, aspergilloma, peumonia and post-tuberculosis destroyed lung

Brief summary: Vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) are major mediators of angiogenesis and are induced by tissue inflammation and hypoxia. While elevated serum VEGF levels have been reported in inflammatory lung diseases, especially with hemoptysis, there was no study to evaluate the Ang-2 levels in lung inflammatory diseases according to the presence of hemoptysis, inflammatory biomarker and hypoxia.


Eligibility criteria: Inclusion Criteria:

* patients visited Samsung Medical Center for the treatment of benign inflammatory disease such as bronchiectasis, aspergilloma, pneumonia and post-tuberculosis destroyed lung

Exclusion Criteria:

* patients with tumorous condition including lung cancer, vasculitis and the lung disease associated with collagen vascular disease on the point of enrollment

Primary outcomes:
measure: serum VEGF and Ang-2 level in lung inflammatory disease according to the presence of hemoptysis
timeFrame: up to 7 days after enrollment
Secondary outcomes:
measure: to investigate association between angiogenesis factors and other factors such as inflammatory biomarker and hypoxia.
timeFrame: up to 7 days after enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT05251168: PET Guided Bone Marrow Biopsy vs Trephine Bone Marrow Biopsy
Official title: Role of FDG PET/CT Guided Bone Marrow Biopsy vs. Conventional Bone Marrow Trephine Biopsy for Assessing the Bone Marrow Infiltration in Newly Diagnosed Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Bone Marrow Neoplasm
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2022-02-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treatment naïve patients of lymphoma who underwent FDG PET/CT for initial staging were recruited.

Brief summary: Newly diagnosed lymphoma patients were recruited for FDG PET/CT and PET/CT guided bone marrow biopsy. All the patients also underwent routine bone marrow sampling from the posterior superior iliac spine.

Detailed description: Newly diagnosed patients underwent FDG PET/CT for whole-body staging. All the PET/CT images were analyzed by a qualified nuclear medicine physician. The bone marrow FDG uptake was classified as negative, focal, multifocal and diffuse marrow uptake. A PET/CT guided metabolic bone marrow sampling from the FDG avid marrow-based lesion was done. However, patients with diffuse FDG avidity or no uptake in the marrow differed for PET-guided biopsy. All the patients underwent routine trephine bone marrow sampling. Bone marrow infiltration (final diagnosis) was established based on trephine bone marrow sampling and FDG PET/CT targeted bone marrow biopsy results in the present study. The results of both the biopsies were correlated with the final diagnosis.

Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed cases of lymphoma (both HL and NHL).
2. Hypermetabolic bone marrow lesions on staging 18F-FDG PET/CT, which are accessible for biopsy.
3. Aged between 18 -80 years.
4. Informed consent prior to the procedure.

Exclusion Criteria:

1. Previously treated/relapsed lymphoma.
2. Initiation of therapy (chemotherapy, radiation therapy) and/or hematopoietic growth factor injections before 18F-FDG PET/CT or BMTB.
3. Patients who underwent a prior BMTB to evaluate the role of BMI.
4. Patients with pre-existing bleeding diatheses like hemophilia, coagulopathy, INR \> 1.2 and platelet counts \< 50,000/mm3,
5. Patients who refuse to provide informed consent.
6. No 18F FDG avid skeletal lesions.
7. Pregnant/Lactating female patients.
8. Non-cooperative patients.

Primary outcomes:
measure: Comparison results of PET guided bone marrow biopsy with trephine bone marrow biopsy
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Department of Nuclear Medicine, PGIMER
state: Chandīgarh
Study officials:
References:
Clinical trial NCT00213668: Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates
Official title: Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Enteral Feeding
Keywords: glutamine
premature neonate
gastric emptying
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study investigates the effects of enterally supplied glutamine on gastric emptying, intestinal transit, age of total enteral nutrition and age at the end of hospitalisation. Forty neonates, aged at least 2 days and free of acute illness participate in a prospective, randomised, double-blind study. All are fed with parenteral and enteral nutrition enriched with glutamine (0.7 g/kg/per day, group 1) or isonitrogenous control (group 2). Gastric emptying is analysed by sequential measure of intragastric residue by diluted polyethylene glycol (PEG) 4000. Intestinal transit is analysed by Rouge Carmin test.


Eligibility criteria: Inclusion Criteria:

* Premature neonates aged 30-33 weeks of gestational age
* Aged at least 2 days and no more than 10 days
* Free of acute illness
* Written informed consent is obtained from the parent prior to enrolment.

Exclusion Criteria:

* Premature infants with respiratory (fraction of inspired oxygen \[FiO2\] \> 30%), or cardiovascular, liver, intestinal or acute diseases
* Premature infants with congenital syndrome

Primary outcomes:
measure: gastric emptying
timeFrame: at day 0, day 1, day 7 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product
Secondary outcomes:
measure: intestinal transit
timeFrame: at day 1 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product
measure: date and duration of arrest of nutrition if necessary
measure: age of total enteral nutrition
measure: age at the end of hospitalization
measure: variation of cholescystokinin and gastrin postprandial concentration
timeFrame: at day 0 and day 14
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU-Rouen
Study officials:
affiliation: CHU Rouen
name: Anne Mercier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06154668: Profiling of Circulating Immune Cells to Uncover Response Signatures to Anti-PD1 Immunotherapy in Melanoma Patients
Official title: Phenotypic, Functional, Metabolic and Transcriptomic Profiling of Circulating Immune Cells to Uncover Response Signatures to Anti-PD1 Immunotherapy in Melanoma Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Etablissement Français du Sang
First posted: 2023-12-04
Enrollment: 707
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: Patients with unresectable (stage III) or metastatic (stage IV) melanoma, followed at CHU Grenoble - Alpes in Dermatology deparment for diagnosis, follow-up or recurrence of melanoma, and treated with immune checkpoint blocker in curative or adjuvant setting.

Brief summary: Despite being standard of care, there are still many medical requirements related to immune checkpoint blocker based therapies such as identify patients susceptible to respond with the less adverse events, evaluate the clinical benefit of adjuvant treatment /risk of relapse and design new strategies for non-responder patients.

Thus, this project aims at understanding the impact of anti-PD1 on the immune system through investigation of the phenotypic, functional, metabolic and transcriptomic profiles of circulating DC subsets and effectors in response to anti-PD1 therapy in melanoma patients.

The primary objective of the study is to identify the biomarkers of response to anti-PD1 according to the type of patient before the start of the treatment.


Eligibility criteria: Inclusion Criteria:

* Patient with histologically confirmed melanoma (stage I, II, III or IV based on AJCC classification)
* Able to sign the informed collection consent for the retrospective part or to express their non-opposition to the research for the prospective part of the study

Exclusion Criteria:

* Subject under guardianship or subject deprived of freedom
* Persons benefiting from special protection (as defined in Articles L1121-5 and L1121-8 of the Public Health Code): minors, pregnant or breastfeeding women, adults protected by law (under guardianship, curatorship or deprived of liberty) and persons hospitalized without their consent (as defined in Articles L3212-1 and L3212-3 of the Public Health Code).
* ocular melanoma

Primary outcomes:
measure: Identification of biomarkers of response to anti6PD1 according to the type of patient before the start of treatment
timeFrame: 6 months
Secondary outcomes:
measure: identification of early biomarkers predictive of the response to anti-PD1
timeFrame: at each time point (3, 4 or 6 weeks)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
Study officials:
affiliation: CHU Grenoble Alpes
name: Julie Charles, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00308672: The Prevalence of Metabolic Syndrome and Its Associated Factors in an Urban City
Official title: The Study for the Prevalence of Metabolic Syndrome and Its Associated Factors in an Urban City- Comparison of Agreement for Prevalence of Metabolic Syndrome Among the WHO, NCEP ATP III and Taiwan Definitions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prediabetes
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2006-03-30
Enrollment: 3000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: The secondary objective is to evaluate the agreement between these criteria and the prevalence of concordant and discordant according to different criteria.

Detailed description: Up to now, there has been to uniform case definition for the metabolic syndrome. The World Health Organization and the Third Report of the National Cholesterol Education Program's Adult Treatment Panel (ATP III), and Bureau of Health Promotion, Taiwan proposed different criteria for the metabolic syndrome. Therefore, the secondary objective is to evaluate the agreement between these criteria and the prevalence of concordant and discordant according to different criteria. Three thousand persons will be randomly selected from resident of Taichung City. All the participants will fulfill a structured questionnaire. Blood pressure, anthropometric variables are measured. Biochemical markers are analyzed by a biochemical autoanalyzer. Kappa will be used to estimate the agreement between different criteria.

Eligibility criteria: Inclusion Criteria:

Residents aged 40 and over of Taichung City, Taiwan in October, 2004.

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung city
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: School of Medicine, China Medical Universtiy
name: Lin C Chieh, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00689572: New Medication Treatment for Stimulant Dependence
Official title: New Medication Treatment for Stimulant Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine Dependence
Keywords: cocaine dependence
cocaine abuse
cocaine
crack
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-06-03
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy of ondansetron compared with placebo in the treatment of cocaine dependence.

Detailed description: We propose to conduct a 9 week randomized, controlled clinical trial to evaluate the efficacy of ondansetron 4 mg twice daily compared with placebo (total N = 100/group × 2 groups = 200 individuals randomized, 400 total subjects will be consented), provided as an adjunct to manual-driven, structured CBT + BBCET in the treatment of cocaine dependence.

Eligibility criteria: Inclusion Criteria:

* Males and females who have given written informed consent.
* Ages 18 years and above and, must weigh at least 40 Kg and no more than 140 Kg.
* Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters.
* Current DSM-IV diagnosis of cocaine dependence.
* At least one positive urine drug screen for cocaine at screen or baseline prior to randomization.
* The pregnancy test for females at intake must be negative.
* Literacy in English and ability to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments.
* Answered an advertisement in the newspaper/radio/television, and expressing a wish to stop using cocaine.
* Willing to participate in behavioral treatments for cocaine dependence.

Exclusion Criteria:

Please contact site for additional information

Primary outcomes:
measure: Cocaine Use by Self-report
timeFrame: up to 9 weeks
measure: Cocaine Use by Urine Benzoylecgonine
timeFrame: up to 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Center for Addiction Research and Education
state: Virginia
city: Richmond
country: United States
facility: University of Virginia Center for Addiction Research and Education
state: Virginia
Study officials:
affiliation: University of Virginia
name: Nassima Ait-Daoud Tiouririne, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blevins D, Seneviratne C, Wang XQ, Johnson BA, Ait-Daoud N. A randomized, double-blind, placebo-controlled trial of ondansetron for the treatment of cocaine use disorder with post hoc pharmacogenetic analysis. Drug Alcohol Depend. 2021 Nov 1;228:109074. doi: 10.1016/j.drugalcdep.2021.109074. Epub 2021 Sep 24.
Clinical trial NCT04524572: The Role of a Motion Sensor With Accompanying Web Application on Step Counts, Energy Balance, and Metabolic Markers in Nurses
Official title: The Role of a Motion Sensor With Accompanying Web Application on Step Counts, Energy Balance, and Metabolic Markers in Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Cardiovascular Diseases
Keywords: cardiovascular disease
motor activity
woman
workplace
Delivery of health care
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this prospective randomized controlled trial is to explore the role of a motion sensor with accompany web application on step counts, energy balance, and metabolic markers in nurses. Additionally, eating behaviours, behavioural regulation in exercise, and mood states that may impact these parameters will also be examined.


Eligibility criteria: Inclusion Criteria:

* 1. Participant must be a registered nurse with the University of Ottawa Heart Institute;

  2. Participant must be 18 years of age or older;

  3. Participant must be able to walk unassisted;

  4. Participant is able and willing to provide informed consent.

Exclusion Criteria:

1. Participant is pregnant, lactating or planning to become pregnant during the study period;
2. Participant is unable to read and understand English;
3. Medical contraindications to exercise;
4. Already using a motion sensor device to track physical activity. -

Primary outcomes:
measure: Step counts
timeFrame: 6 weeks during observation and 6 weeks during intervention
Secondary outcomes:
measure: Body Mass (kg)
timeFrame: Screening (week 1), Observation (weeks 2-5), during the intervention (weeks 6-9), post study at week 26 and week 52
measure: Waist Circumference
timeFrame: Screening (week 1), Observation (weeks 2-5), during the intervention (weeks 6-9), post study at week 26 and week 52
measure: Fat mass
timeFrame: Screening (week 1), Observation (weeks 2-5), during the intervention (weeks 6-9), post study at week 26 and week 52
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
References:
citation: Brunet J, Black M, Tulloch HE, Pipe AL, Reid RD, Reed JL. Work-related factors predict changes in physical activity among nurses participating in a web-based worksite intervention: A randomized controlled trial. BMC Nurs. 2021 Nov 9;20(1):224. doi: 10.1186/s12912-021-00739-4.
citation: Brunet J, Tulloch HE, Wolfe Phillips E, Reid RD, Pipe AL, Reed JL. Motivation Predicts Change in Nurses' Physical Activity Levels During a Web-Based Worksite Intervention: Results From a Randomized Trial. J Med Internet Res. 2020 Sep 11;22(9):e11543. doi: 10.2196/11543.
Clinical trial NCT00170872: 6 Week Open-label Trial With Lumiracoxib 200mg o.d. in Primary Knee Osteoarthritis or Rheumatoid Arthritis
Official title: A 6 Week, Multicenter, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of Lumiracoxib 200mg o.d. in Patients With Primary Knee Osteoarthritis or Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Rheumatoid Arthritis
Keywords: Osteoarthritis
Rheumatoid Arthritis
Cox-2
lumiracoxib
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study tested the safety, tolerability and efficacy of lumiracoxib - a COX-2 inhibitor- in patients with primary knee osteoarthritis or rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Requirement of regular NSAID therapy
* With primary osteoarthritis of the target knee (by ACR Criteria) or with a diagnosis of rheumatoid arthritis (by ACR Criteria)

Exclusion Criteria:

* Evidence of active ulceration of the UGI tract within 6 months prior to the screening visit or history of active bleeding of the UGI tract within the previous 5 years. As well as with pyloric or duodenal obstruction or with history of gastrointestinal parasites.
* History of cardiac and cerebral thrombotic/ischemic diseases and/or events
* Patients taking additional NSAIDs (including COX-2 inhibitors) during the course of the study.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Assess safety and tolerability profile of lumiracoxib in comparison to baseline
Secondary outcomes:
measure: Demonstrate that lumiracoxib 200mg o.d. is effective in treating OA and pain due to RA with respect to overall OA/ RA pain intensity on a 0-100 mm Visual Analog Scale (VAS) after 6 weeks of treatment in comparison to baseline
measure: Assess efficacy of lumiracoxib compared to baseline with respect to a) overall OA/ RA pain intensity b) patient's and physician's global assessment of disease activity c) patient functional status
measure: Use of rescue medication
Other outcomes:
Locations:
Study officials:
affiliation: Sponsor GmbH
name: Novartis Pharma AG
role: STUDY_CHAIR
References: