louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01822626: Pediatrician-lead Motivational Counselling to Control BMI in Overweight Children: a RCT in Primary Care
Official title: Pediatrician-lead Motivational Counselling to Control BMI in Overweight Children: a RCT in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: overweight
obesity
children
BMI
counseling
pediatrician
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2013-04-02
Enrollment: 372
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Obesity is one of the leading causes of morbidity and mortality in the industrialised world. Evidence is growing that early life nutrition can play a role in behavioural and cognitive problems in children and adolescents and is well documented that being overweight and obese during childhood can have short- and long-term physical and psycho-social health implications.

This is an individually randomised trial to evaluate the efficacy of a family pediatrician-lead counselling intervention in reducing the BMI of over-weight children aged 4-7 years old. As secondary objectives the investigators evaluate the effect of the counselling on dietary behaviours and physical activity.

The investigators targeted the intervention to overweight children, while obese children were referred to specialised care. The counselling targeted diet, physical activity, and sedentary behaviours.


Eligibility criteria: Inclusion Criteria:

* overweight children with BMI percentile between 85° and 94°
* 4-7 years old
* resident in Reggio Emilia Province
* assisted by the pediatrician at least for 12 months

Exclusion Criteria:

* metabolic pathologies and all pathologies related with obesity
* family in pre-contemplation stage

Primary outcomes:
measure: BMI variation from baseline
timeFrame: 12 months
Secondary outcomes:
measure: Physical Activity behaviors variations
timeFrame: 12 months
measure: Diatary behaviors variations
timeFrame: 12 month
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Local Health Authority of Reggio Emilia
Study officials:
affiliation: Primary Care Program, Local Health Authority of Reggio Emilia, Italy
name: Anna Maria Davoli
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davoli AM, Broccoli S, Bonvicini L, Fabbri A, Ferrari E, D'Angelo S, Di Buono A, Montagna G, Panza C, Pinotti M, Romani G, Storani S, Tamelli M, Candela S, Giorgi Rossi P. Pediatrician-led motivational interviewing to treat overweight children: an RCT. Pediatrics. 2013 Nov;132(5):e1236-46. doi: 10.1542/peds.2013-1738. Epub 2013 Oct 21.
Clinical trial NCT01565226: Capnography in Neonates Ventilated With High Frequency Ventilation: Prospective, Observational Multi-Center Study
Official title: Capnography in Neonates Ventilated With High Frequency Ventilation: Prospective, Observational Multi-Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubated Neonates That Require High Frequency Ventilation
Keywords: Capnography
CO2
neonates
High Frequency ventilation (HFV)
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2012-03-28
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates

Brief summary: * This will be an observational study. Respiratory data will be recorded using Capnostream20p. There will be no use in the recorded data for the medical care of the patients. Other clinical data will be captured in the CRF. Similar study is currently conducted in Bnai Zion MC since 2008. Thirty four (34) patients have been recruited without any adverse events.
* During the study the medical team will capture in the CRF the following: Blood gas and distal capnography values at time of sampling, ventilator settings at time of sampling.
* Changes made in the ventilation parameters, blood gas time and results, concomitant treatment (e.g. suction) and concomitant medication (respiratory related e.g. surfactant), vital signs all these will be retrieved from the patient's medical charts.


Eligibility criteria: Inclusion Criteria:

* Intubated neonates with double-lumen ETT (Uncuffed Tracheal Tube, Mallinckrodt Inc., Chih, Mexico)
* Neonates that their respiratory condition requires HFV
* Neonates expected to have at least 3 pairs of distal capnography measurements and blood gas samplings.

Exclusion Criteria:

* Intubated neonates with single-lumen ETTs
* Neonates who are ventilated with conventional ventilation
* Any significant medical condition which, at the investigator's discretion, may interfere with the study.

Primary outcomes:
measure: Evaluate the feasibility of measuring distal capnography on HFV and to assess its correlation and agreement with PaCO2 in infants ventilated with HFV in a prospective study.
timeFrame: August 2012 - February 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka MC
city: Haifa
country: Israel
facility: Bnai Zion MC
city: Jerusalem
country: Israel
facility: Shaare Zedek MC
Study officials:
affiliation: Bnai Zion MC, Haifa Israel
name: Amir Kugelman, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06685926: The Impact of Supermicrosurgery Intervention on Patients with Lower Extremity Lymphedema Using Groin-Only Approach Lymphaticovenous Anastomosis
Official title: Groin-Only Lymphaticovenous Anastomosis for Lower Extremity Lymphoedema: a Retrospective Cohort Propensity-Score Matched Analysis of a Novel Supermicrosurgical Concept
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema
Lymphedema of Leg
Keywords: propensity score matching
LVA
supermicrosurgery
lymphaticovenous anastomosis
lymphovenous bypass
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 189
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study employs a propensity score-matched analysis to compare the treatment outcomes, focusing on percentage volume reduction between the conventional multi-incision lymphaticovenous anastomosis (LVA) technique and the novel single groin incision LVA technique in patients with unilateral lower extremity lymphoedema.

Detailed description: Lymphaticovenous anastomosis (LVA), a surgical technique that connects lymphatic vessels (LVs) to adjacent veins, has demonstrated efficacy in alleviating lymphedema by enabling the drainage of stagnant lymphatic fluid.

Conventional LVA treatment for lower extremity lymphoedema (LEL) has favored distal, multiple incisions in the lower leg due to the denser and more superficial distribution of LVs and recipient veins in the distal regions.

Based on the recent advancement in the understaning of lymphosomes and the role of antegrade lymph flow, a shift to more proximal LVA around the groin region for LEL could be theoretically advantagous, but its clinical efficacy compared to conventional distal LVA remains underexplored.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with lymphatic-related diseases to the lower extremity
* Patients who is undergoing LVA for unilateral lower-limb lymphedema.

Exclusion Criteria:

* Primary lymphedema
* Bilateral lower limb lymphedema
* History of previous treatment for lymphedema (LVA, vascularized lymph node transfer (VLNT), liposuction, or excisional therapy such as the Charles procedure) - Those that were lost to follow-up.
* Patients who recieved both LVA to the groin site and non-groin site.

Primary outcomes:
measure: Volume change after LVA
timeFrame: 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT03256526: 6-week Safety and PD Study in Adults With NAFLD
Official title: A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PARALLEL- GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-alcoholic Fatty Liver Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-08-22
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY, SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS WILL BE ASSESSED IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE


Eligibility criteria: Inclusion Criteria:

* BMI at least 28 kg/m2
* Type 2 diabetes and/or metabolic syndrome

Exclusion Criteria:

* Liver disease
* Type 1 diabetes
* Recent heart attack or stroke
* Inability to have an MRI scan

Primary outcomes:
measure: Percent Change From Baseline in Whole Liver Fat at Week 6
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Day 77 (28-35 days post last dose)
measure: Number of Participants With Post-dose Vital Signs Data Meeting Categorical Criteria
timeFrame: Baseline up to Day 56 (Week 8)
measure: Number of Participants With Post-dose ECG Data Meeting Categorical Criteria
timeFrame: Baseline up to Day 56 (Week 8)
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline up to Day 56 (Week 8)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Stand-Up MRI of Miami
state: Florida
city: Orange City
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd.
state: Ohio
city: Chattanooga
country: United States
facility: WR-ClinSearch LLC
state: Tennessee
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Richmond
country: United States
facility: National Clinical Research, Inc
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Kazierad DJ, Chidsey K, Somayaji VR, Bergman AJ, Birnbaum MJ, Calle RA. Inhibition of ketohexokinase in adults with NAFLD reduces liver fat and inflammatory markers: A randomized phase 2 trial. Med. 2021 Jul 9;2(7):800-813.e3. doi: 10.1016/j.medj.2021.04.007. Epub 2021 Apr 27.
Clinical trial NCT06123026: Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion
Official title: Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Lactation Suppressed
Second Trimester Abortion
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare breast symptoms (lactation, engorgement, etc) of individuals who undergo a procedure for second trimester of pregnancy loss between 16 weeks and 20 weeks gestational age. The participants will be randomly placed in two groups, one with a placebo tablet and one with medication called "cabergoline" which are taken immediately after their procedure. Researchers will compare groups to see if there are any significant differences in breast symptoms.


Eligibility criteria: Inclusion Criteria:

* pregnant individuals seeking termination of pregnancy after 16w0d gestation and up to 19w6d gestation. this includes management of intrauterine demises
* ages 18 to 50
* con provide informed consent in English

Exclusion Criteria:

* Age under 18 or above 50
* gestational ages before 16 weeks 0 days or after 20 weeks 0 days
* unable to provide written consent in English
* hypertensive disorder
* uncontrolled hypertension or known hypersensitivity to ergot derivatives
* History of cardiac valvular disorders
* history of pulmonary fibrosis
* documented bipolar schizophrenia
* documented allergy to medication, including lactose intolerance (placebo pill involves lactose)

Primary outcomes:
measure: breast symptoms
timeFrame: 3 days post procedure and two weeks post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT04847726: Contrast-enhanced Ultrasound With Perfluorobutane and Sulfur Hexafluoride for Hepatocellular Carcinoma
Official title: Perfluorobutane-enhanced Ultrasound as a Diagnostic Tool for Hepatocellular Carcinoma in Individuals With High Risk: Intraindividual Comparison With Sulfur Hexafluoride-enhanced Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: HCC
Contrast-enhanced ultrasound
Perfluorobutane
Sulfur hexafluoride
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study participants underwent contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride. The diagnostic performance will be compared intra-individually.
Primary purpose: DIAGNOSTIC

Brief summary: Intra-individual comparison of diagnostic performance of CEUS With perfluorobutane and sulfur hexafluoride for HCC in high-risk Individuals, and their role in the diagnostic algorithm of HCC.

Detailed description: The investigators would compare the diagnostic performance for HCC at high-risk individuals between both USG contrast agents.

Eligibility criteria: Inclusion Criteria:

* high-risk for HCC (liver cirrhosis, chronic hepatitis B)
* treatment-naive hepatic nodule (\>= 1cm) on preceding CT, MR or ultrasound

Exclusion Criteria:

* severe cardiopulmonary dysfunction
* pregnancy
* refusal to enroll study

Primary outcomes:
measure: Diagnostic accuracy for HCC: non-inferiority test
timeFrame: up to 3 months
Secondary outcomes:
measure: Diagnostic performance of perfulorobutane enhanced USG using different definition of washout
timeFrame: up to 3 months
Other outcomes:
measure: Role of perfluorobutane enhanced USG in EASL diagnostic algorithm of HCC
timeFrame: up to 3 months
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang HJ, Lee JM, Yoon JH, Yoo J, Choi Y, Joo I, Han JK. Sonazoid versus SonoVue(R) for Diagnosing Hepatocellular Carcinoma Using Contrast-Enhanced Ultrasound in At-Risk Individuals: A Prospective, Single-Center, Intraindividual, Noninferiority Study. Korean J Radiol. 2022 Nov;23(11):1067-1077. doi: 10.3348/kjr.2022.0388. Epub 2022 Sep 30.
Clinical trial NCT00123526: Workplace-Sponsored Diet and Exercise Program to Reduce Obesity
Official title: Active Living and Healthy Diet at the Workplace
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Cardiovascular Diseases
Heart Diseases
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-07-25
Enrollment: 899
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the effectiveness of an environmental worksite intervention to reduce obesity among hospital employees.

Detailed description: BACKGROUND:

Obesity is a significant public health problem in the United States, prompting policy makers and researchers to call for action against the epidemic. Obesity and associated health conditions affect all age groups and both genders, yet disproportionately affect racial and ethnic minorities. Health consequences of obesity include high blood pressure, high cholesterol, hyperinsulinemia, type 2 diabetes, heart disease, stroke, gallbladder disease, arthritis, sleep disturbances, breathing problems, and certain types of cancer. Hospitals are important worksite environments that employ large numbers of people in diverse job categories from diverse educational and socioeconomic backgrounds.

DESIGN NARRATIVE:

The purpose of this study is to promote weight loss among those who are overweight and obese, and prevent weight gain among those of normal weight through an environmental intervention targeted to all employees at six hospitals in central Massachusetts. The hospitals will be matched according to size, and within each matched pair randomly assigned to either the intervention or control group. The intervention will promote active living, in which physical activity is incorporated into each participants' daily routine. Participants will also follow a healthy diet, characterized by higher intakes of fruits, vegetables, fish, poultry, legumes, and whole grains. Participants will consume less high fat foods and refined grains, and reduce their total caloric intake through smaller portion sizes.

Eligibility criteria: Inclusion criteria:

* Works at least 20 hours per week at a participating hospital
* Speaks English or Spanish

Exclusion criteria:

* Works at only one hospital within the participating hospital system

Primary outcomes:
measure: Body mass index
timeFrame: Measured at Months 12 and 24
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Stephenie Lemon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04018326: Loss to Follow-up in PDR Patients
Official title: Causes and Clinical Impact of Loss to Follow-up in Patients With Proliferative Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Keywords: loss to follow-up
proliferative diabetic retinopathy
diabetic retinopathy
panretinal photocoagulation
intravitreal injections
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 467
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who had developed PDR in one eye. Patients were allocated to receive PRP, IVIs of anti-VEGF, or a combination of both procedures.

Brief summary: This study determined the clinical impact and causes of loss to follow-up (LTFU) from the patients' perspective in individuals with proliferative diabetic retinopathy (PDR) who received panretinal photocoagulation (PRP) and/or intravitreal injections (IVIs) of anti-vascular endothelial growth factor (VEGF).

This prospective cohort study included 467 patients with PDR who received PRP and/or IVIs of anti-VEGF between May 2013 and June 2018. LTFU was defined as missing any follow-up visit for any interval exceeding 6 months, provided that patients eventually resumed care. Main outcome measures include rates and causes of LTFU.


Eligibility criteria: Inclusion Criteria:

* included treatment-naïve patients who had developed PDR in one eye with a best corrected visual acuity (BCVA) ranging from 20/22 to 20/69, as determined by the Snellen equivalent. Patients were allocated to receive PRP, IVIs of anti-VEGF, or a combination of both procedures.

Exclusion Criteria:

1. patients receiving follow-up ophthalmic care for their PDR with or without interventions at any other medical care provider during the observation period, as declared by the patients at any follow up visit.
2. patients LTFU who did not resume follow-up until the end of the observation period.
3. patients needing PPV at first presentation or having additional retinal pathology. 4) patients receiving their treatment procedure during December 2017 or having vitreous hemorrhage that failed to clear up by June 2018 but still ineligible candidates for PPV.

Primary outcomes:
measure: Final BCVA
timeFrame: "through study completion, an average of 1 year",
measure: Final UCVA
timeFrame: "through study completion, an average of 1 year",
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Abdelmotaal H, Ibrahim W, Sharaf M, Abdelazeem K. Causes and Clinical Impact of Loss to Follow-Up in Patients with Proliferative Diabetic Retinopathy. J Ophthalmol. 2020 Feb 8;2020:7691724. doi: 10.1155/2020/7691724. eCollection 2020.
Clinical trial NCT05514626: Three-dimensional (3D) Holographic Display for Ultrasound-Guided Structural Heart Disease Procedures
Official title: Three-dimensional (3D) Holographic Display for Ultrasound-Guided Structural Heart Disease Procedures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Structural Cardiac Defects
Lead sponsor: RealView Imaging
Sponsor class: INDUSTRY
First posted: 2022-08-24
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to Fifty (50) patients undergoing elective procedures which use 3D echocardiography for treatment of structural heart disease.

Brief summary: This study is intended to evaluate the use of the holographic display of 3D images acquired during ultrasound based cardiac procedures and to assess the clinical use of the HOLOSCOPE-i, in providing 3D spatial understanding to the clinician performing the procedure. Patients scheduled to undergo an elective procedure in the Cardiac Catheterization Laboratory which use 3D echocardiography (ECHO) as part of the procedure will be enrolled to this study. In addition to the standard of practice imaging using ultrasound, patients anatomical structures will be evaluated using a 3D holographic system. The patients will complete their participation in the study, at the end of the procedure. No follow-up is required and patients will continue their routine medical care following the procedure.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18
* Patients are scheduled to undergo an elective procedure in the Cardiac Catheterization Laboratory which use 3D echocardiography (ECHO) as part of the procedure.

Exclusion Criteria:

* Denial of informed consent
* Any contraindications to three-dimensional echocardiographic imaging.

Primary outcomes:
measure: HOLOSCOPE-i is of clinical use for ultrasound based cardiac procedures
timeFrame: During procedure
Secondary outcomes:
measure: HOLOSCOPE-i provides an intuitive understanding of the spatial relationship of the anatomy
timeFrame: During procedure
measure: HOLOSCOPE-i provides an intuitive understanding of the spatial relationship between the tool and the anatomy
timeFrame: During procedure
measure: Satisfaction with the use of the HOLOSCOPE-i under intra-procedural conditions
timeFrame: During procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian
state: New York
Study officials:
References: