louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05106439: Intern Health Study: 2020 Cohort Micro-Randomized Trial
Official title: Intern Health Study: 2020 Cohort Micro-Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 2286
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization scheme
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of gamified competition (delivered through a smartphone) for improving the physical activity and sleep of medical interns.

Detailed description: Due to their high-stress workloads, medical interns tend to have lower sleep and decreased physical activity. The goal of this study is to evaluate the efficacy of gamified competition (delivered through a smartphone) for improving the physical activity and sleep of medical interns. During the study, they are teamed up by programs and institutions and competes with other teams, which aim to motivate them to have more physical activity and sleep duration during their internship year.

The primary aim of this study is to investigate whether introducing competition mechanisms into mobile health (mHealth) interventions can improve a medical intern's activity-related behavioral outcomes: daily step counts and sleep duration. The first secondary aim is to assess the time-varying competition effect on their behavioral outcomes. The second secondary aim is to evaluate how social cooperation (competing within the same institution or program) moderates the effect of competition on behavioral outcomes. The first exploratory aim is to assess the competition effect on study engagement and the second exploratory aim is to evaluate the competition effect on mental outcome, mood score.

Eligibility criteria: Inclusion Criteria:

* Medical intern during the 2020-2021 internship year
* Downloaded app, completed consent and filled out baseline survey prior to June 16th, 2020

Exclusion Criteria:

* None

Primary outcomes:
measure: Average daily step count
timeFrame: 7 days
measure: Average daily sleep minutes
timeFrame: 7 days
Secondary outcomes:
measure: Average daily mood score
timeFrame: 7 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan, Ann Arbor
state: Michigan
Study officials:
affiliation: University of Michigan
name: Srijan Sen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00357539: Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1 and 1.5% in 48 Healthy Volunteers
Official title: Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Eye Infections, Bacterial
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2006-07-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225.

Detailed description: The present phase I clinical trial was performed in order to investigate the ocular tolerance, safety and the ocular pharmacokinetics of a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Male or female aged from 18 to 45 years old;
* Written informed consent;
* Healthy volunteers (without any ocular symptom);
* Normal ocular examination in both eyes (corrected visual acuity (VA) \>= 6/10 - slit lamp examination without clinical relevant abnormalities - tear break-up time (BUT) \>= 10 seconds - lachrymal secretion in the Schirmer test \>= 10 mm in 5 minutes - lissamine green test total score \< 4).

Exclusion Criteria:

* Ocular trauma, infection or inflammation within the last 3 months;
* Conjunctival hyperaemia score \>= 2, watering score \>= 2, folliculo-papillary conjunctivitis score \>= 2, number of fluorescein-stained punctuations \>= 10;
* Blepharitis, conjunctivitis, uveitis;
* Ocular laser treatment within the last 3 months;
* Ocular surgery, including LASIK and PRK, within the last 12 months;
* Topical ocular treatment during the last month;
* Ocular antibiotics within the last 7 days;
* Medication during the study (except paracetamol and contraceptives).

Primary outcomes:
measure: Subjective ocular symptoms
measure: Objective ocular symptoms
Secondary outcomes:
measure: Systemic adverse events
measure: Ocular adverse events
measure: Ocular pharmacokinetic
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: Unité de Pharmacologie Clinique
Study officials:
affiliation: Unité de Pharmacologie Clinique - Clermont-Ferrand (France)
name: Claude DUBRAY, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05448339: Tumor Feeding Vessels Deprivation Combined With Tyrosine Kinase Inhibitor in Liver Transplantation
Official title: The Value of Tumor Feeding Vessels Deprivation Combined With Tyrosine Kinase Inhibitor in Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (1) age ≥18 years; (2) exceeding UCSF criteria; (3) absence of vascular invasion, nodal involvement, or extrahepatic metastases; (4) receiving TACE treatment or LTFVD treatment for downstaging purposes. Patients who underwent resection, LT, or any form of downstaging treatment prior to enrollment were excluded.

Brief summary: To investigate the value of tumor feeding vessels deprivation combined with tyrosine kinase inhibitor in liver transplantation. Patients are enrolled into two groups according to the downstaging therapy they undergo before transplantion.


Eligibility criteria: (1) age ≥18 years; (2) exceeding UCSF criteria; (3) absence of vascular invasion, nodal involvement, or extrahepatic metastases; (4) receiving TACE treatment or LTFVD treatment for downstaging purposes.

Primary outcomes:
measure: Underwent LT
timeFrame: January 2013 and December 2020
measure: Successful downstaging
timeFrame: January 2013 and December 2020
Secondary outcomes:
measure: AFP reduction of patients
timeFrame: January 2013 and December 2020
measure: Survival time of patients
timeFrame: January 2013 and December 2020
measure: Recurrence of patients
timeFrame: January 2013 and December 2020
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01592539: Skin Blood Flow in Patients With Type 1 Diabetes Mellitus Compared to Normal Controls
Official title: Skin Blood Flow in Patients With Type 1 Diabetes Mellitus Compared to Normal Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes,
Bone
Keywords: Type 1 Diabetes
Bone
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2012-05-07
Enrollment: 78
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Type 1 DM

Brief summary: The effects of high serum glucose on bone could be direct or could be indirect through its effects on the microvasculature. Previous studies by Rendell et al and Brugler et al have found significant differences in skin blood flow between diabetics and control. The investigators are proposing that blood flow measurements of the skin may be correlated with bone remodeling rates in iliac bone biopsies.


Eligibility criteria: Inclusion Criteria:

* Must have completed a previous study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Laura AG Armas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00934986: Natural Killer Cells Function in Patients With Chronic Lymphocytic Leukemia
Official title: Study of Natural Killer Cells Function in Untreated Patients With Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia
NK Cells
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2009-07-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Purpose:

The involvement of Natural Killer cells (NK) in the efficiency of the treatment in lymphoma and the beginning of new therapies based on function and activation of NK, justify an improvement of knowledge about the status of the population of NK (number, function, genic expression) in Chronic Lymphocytic Leukemia (CLL).

Detailed description: Method: prospective, monocentric, descriptive study

Primary objective:

Evaluation of the expression and function of receptors activator of NK cell (KIRs) in patients with CLL at stage A with therapeutic abstention, or stage B or C which require a treatment.

Secondary objectives:

Measure of the evolution of cytotoxic function of NK cells and theirs biomarkers of activation when the patient receives an immunochemotherapy with Rituximab/ Fludarabine/ Cyclophosphamide (RCF).

Verification, by analysis, of functions and biomarkers of the adaptive and innate immunity

Eligibility criteria: Inclusion Criteria:

* Diagnosis of CLL (Score of Matutes \>=4) with no history of treatment: Stade A of Binet, Or Stade B or C before the beginning of the treatment with RFC
* Patients who can undergo blood collection
* Patient aged 18 years and older
* Signed consent

Non inclusion Criteria:

* Patient with anemia: haemoglobin \< 9 g/dl
* Pregnancy, breast feeding
* Patient in an urgent situation, or unable to give a consent

Primary outcomes:
measure: Analysis of the surface expression of functional biomarkers of the NK cell, functional study, analysis of expression of transcription of values genes.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut PAOLI-CALMETTES
Study officials:
affiliation: Institut Paoli-Calmettes
name: Thérèse AURRAN-SCHLEINITZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04781439: The Effect of Early Switching From Intravenous to Oral Antibiotics Therapy
Official title: The Effect of Early Switching From Intravenous to Oral Antibiotics Therapy: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin and Subcutaneous Tissue Infection
Keywords: effectiveness
antibiotics
Lead sponsor: Gia Dinh People Hospital
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 210
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: To date, many studies showed the great benefits of switching from IV to PO antibiotics in some infectious diseases, especially skin and soft tissue, urinary tract, respiratory tract, gallbladder, and biliary tract infection. Higher level of evidence is necessary to confirm the benefit of early switching protocol in infectious condition management. Therefore, we conducted a clinical trial to investigate the effectiveness and cost of IV-to-PO antibiotic switch therapy in some surgical infection conditions.

Detailed description: Introduction: The benefit of early switching from intravenous (IV) to oral (PO)was raising from the last decade. This randomized clinical trial was to evaluate the effect of early switching from IV to PO antibiotics on the outcome of surgical patients at a public hospital.

Methods: Patients admitted for a therapeutic antibiotic to orthopedic and general surgery conditions were randomly assigned to three groups: control (non-switching), early switching (within 48-72 hours), and late switching (after 72 hours). The rate of effectiveness of each arm, length of hospital stay, length of IV antibiotics, and cost were recorded prospectively.

Eligibility criteria: Inclusion Criteria:

* on the second day of IV antibiotic
* no difficulties on taking oral medication
* clinical improvement

Exclusion Criteria:

* n/a

Primary outcomes:
measure: rate of effectiveness
timeFrame: 3 months
Secondary outcomes:
measure: length of hospital stay
timeFrame: 3 months
measure: length of IV antibiotics
timeFrame: 3 months
measure: cost of treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Gia Dinh people hospital
Study officials:
affiliation: Gia Dinh People Hospital
name: Dung Nguyen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01342939: Pathophysiological Implications of the Incretin Hormones in Maturity Onset of Diabetes of the Young (MODY)
Official title: Postprandial Secretion of of Incretin Hormones and Incretin Effect in Patients With Maturity-onset Diabetes of the Young (MODY)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maturity-onset Diabetes of the Young
Keywords: Monogenetic diabetes
Diabetes mellitus
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Steno Diabetes Center Copenhagen
First posted: 2011-04-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Genetically well-charaterized MODY2 and MODY3 patients at Hagedorn Research Institute/Steno Diabetes Center

Brief summary: The purpose of this study is to describe the incretin effect and postprandial incretin response in patients with MODY2 and MODY3 and a group of matched healthy subjects. In sulphonyl urea treated subjects the purpose is also to compare the incretin effect with and without treatment. In healthy subjects the purpose is also to investigate the incretin effect under increased levels of endogen incretin hormones.

Detailed description: Comparison of of insulin secretion (AUC) during the experimental days. Furthermore a comparison of GIP, GLP1 and glucagon responses as well as plasma glucose levels.

Eligibility criteria: Inclusion Criteria:

* Caucasians above 18 years
* BMI \> 19 kg/m2
* Negative pancreatic beta cell- and glutamate decarboxylase-65(GAD65)- autoantibodies
* Normal haemoglobin
* Normal bloodpressure
* Informed concent

Exclusion Criteria:

* Known liver disease or affected liver enzymes (ALAT/ASAT \>2 x upper normal limit)
* Nephropathy (see creatinine\> 130 μM and / or albuminuria)
* Treatment with medications that cannot be discontinued for 12 hours
* Any condition that the investigators feel would interfere with trial participation
* Pregnancy or lactation

Primary outcomes:
measure: Incretin effect
timeFrame: Within 1 year
Secondary outcomes:
measure: Plasma GLP1 response
timeFrame: Within 1 year
measure: Plasma GIP response
timeFrame: Within 1 year
measure: Plasma glucagon response
timeFrame: Within 1 year
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Diabetes Research Division, Gentofte University Hospital, Niels Andersens vej 65, opgang 40, 2.
Study officials:
affiliation: Diabetes Research Division, University Hospital Gentofte, Denmark
name: Signe H Østoft, MD, phd stud
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ostoft SH, Bagger JI, Hansen T, Hartmann B, Pedersen O, Holst JJ, Knop FK, Vilsboll T. Postprandial incretin and islet hormone responses and dipeptidyl-peptidase 4 enzymatic activity in patients with maturity onset diabetes of the young. Eur J Endocrinol. 2015 Aug;173(2):205-15. doi: 10.1530/EJE-15-0070. Epub 2015 May 7.
Clinical trial NCT01941186: A Family Centered Intervention to Promote Optimal Child Development
Official title: A Family Centered Intervention to Promote Optimal Child Development at the Interface of the Health System and Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Delays
Keywords: Children
Developmental Delays
Early Intervention (EI)
Patient Decision Aid (PDA)
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 64
Sex: ALL
Minimum age (years): 2
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a randomized controlled trial aimed at assessing the effectiveness of a patient decision aid (PDA) and text message reminder in promoting early intervention referral completion when infants and toddlers are identified with a developmental concern in the pediatric medical home. Subjects will be randomized to one of two study arms- (1) intervention (2) control condition. Subjects in the intervention arm will watch a video PDA and will receive a text message reminder approximately 7 to 14 business days after enrollment if they agree to the early intervention referral.


Eligibility criteria: Inclusion Criteria:

* Parent-child dyads in which the child is age 0 to 36 months screening positive for developmental concern and receiving care at a practice within Children's Hospital of Philadelphia Pediatric Research Consortium (PeRC).
* Caregivers able to give permission (informed consent).

Exclusion Criteria:

* Primary language other than English
* Children already enrolled in early intervention

Primary outcomes:
measure: Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups
timeFrame: Up to 1 year after randomization
Secondary outcomes:
measure: Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
timeFrame: Up to 7 days
Other outcomes:
measure: Parent Uncertainty About Early Intervention
timeFrame: Up to 7 days
measure: Parental Predisposition for Early Intervention
timeFrame: Up to 7 days
measure: Feasibility of the Patient Decision Aid
timeFrame: Up to 7 days
measure: Acceptability of the Patient Decision Aid for Early Intervention Referral
timeFrame: Up to 7 days
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Alexander Fiks, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Manuel Jimenez, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05696639: SMCV Assessment on Brain Swelling in Patients With SAH
Official title: Cerebral Venous Assessment on Brain Swelling in Patients With Aneurysm Subarachnoid Hemorrhage: Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aneurysm
Subarachnoid Hemorrhage
Brain Swelling
Lead sponsor: Shenzhen Baoan District People's Hospital
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an anterior communicating aneurysmal subarachnoid hemorrhage between January 2017 and December 2022 who underwent aneurysm embolization surgery, excluding patients with posterior communicating aneurysm, poor general condition or combined with pregnancy , malignant tumors.

Brief summary: Cerebral swelling is a major complication following aneurysmal subarachnoid hemorrhage.This study is a retrospective cohort aimed to predict the extent of brain swelling. Cerebral venous assessment can identify the risk of brain swelling and improve surgical outcomes.

Detailed description: Cerebral swelling is a major complication following aneurysmal subarachnoid hemorrhage (SAH).This study is a retrospective cohort aimed to predict the extent of brain swelling (BS). Cerebral venous assessment can identify the risk of cerebral swelling and improve surgical outcomes. This study is a retrospective cohort analysis. Cerebral venous angiography (CVA) will be adopted and the superficial middle cerebral vein (SMCVs) will be evaluated.

Eligibility criteria: Inclusion Criteria:

patients with anterior communicating aneurysm

Exclusion Criteria:

Hunt-Hess grade I- patients with posterior communicating aneurysm, poor general condition or combined with pregnancy , malignant tumors were excluded.

Primary outcomes:
measure: brain swelling
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Baoan People's Hospital
state: Guangdong
Study officials:
affiliation: The People Hospital of Shenzhen Baoan
name: JIangang Hu, Phd
role: STUDY_DIRECTOR
References: