louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06067126: Post-delivery Maternal-offspring Obesity and Metabolic Risk After a Prepregnancy Weight-loss Intervention
Official title: PrepareD: Examining Post-Delivery Maternal-offspring Obesity and Metabolic Risk After a Prepregnancy Weight-loss Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight
Obese
Metabolic Disorders
Postpartum
Keywords: Wellness/Behavior Change
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Penn State University
First posted: 2023-10-04
Enrollment: 154
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants for PrepareD will be recruited from the pool of women who consented to participate in the Prepare trial \[NCT02346162\]. The investigators expect to re-enroll around 180 Prepare mother-offspring pairs in the PrepareD study.

Brief summary: The goal of PrepareD is to examine whether the prepregnancy weight-loss intervention administered during the Prepare trial \[NCT02346162\] has an influence in the postnatal period. PrepareD is a cohort study (no intervention) that will address new specific aims through one in-person visit with mothers and children, dietary recalls, actigraphy, and the use of medical record weights. The goal is to collect data when the child is 3 years old. However, due to the COVID-19 pandemic, the investigators expanded the data collection window in order to collect data up to when the child is 5 years old. The investigators hypothesize that intervening on women before pregnancy is the key to breaking the multigenerational cycle of obesity.


Eligibility criteria: Inclusion Criteria:

* Mother must be a Prepare \[NCT02346162\] participant who has experienced a viable pregnancy during the Prepare trial
* Child must be the first viable offspring born to a Prepare participant after consent into the Prepare study

Exclusion Criteria: None

Primary outcomes:
measure: Child body mass index (BMI) from birth up to 5 years of age
timeFrame: Birth up to 5 years of age
measure: Mother postpartum weight retention (PPWR) in pounds at 5 weeks and 1 year postpartum
timeFrame: 5 weeks and 1 year after delivery
Secondary outcomes:
measure: Healthy Eating Index (HEI) score for mother and child
timeFrame: At study visit, when child is 3-4 years of age
measure: Daily activity level for mother and child
timeFrame: At study visit, when child is 3-4 years of age
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
Study officials:
affiliation: Kaiser Permanente
name: Erin S LeBlanc, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02082626: Study of Eribulin in Children With Cancer to Determine Safety
Official title: A Phase I Study of Eribulin, a Novel Microtubule Inhibitor, in Children With Refractory or Recurrent Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pediatric Cancer
Solid Tumors
Lymphoma
Keywords: Phase I
Pediatric
Cancer
Lymphoma
Eribulin
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 3
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study for children with cancer with no curative treatment options. The investigators will be giving eribulin, a new chemotherapy agent, for the first time to children. This study is designed to determine a safe dose the investigators can give to children in larger studies. The investigators will be monitoring the children on this study for the safety of the treatment and levels of eribulin in the blood after treatment. The investigators will also study the effect of the agent on the cancer.

Detailed description: This is a phase I study of eribulin, a novel tubulin inhibitor in children with relapsed and refractory solid tumors including lymphoma. Dose escalation will be performed in a classic 3+3 design starting with 75% of the adult maximum tolerated dose (MTD). Pharmacokinetics will be done on each patient. Primary endpoint will be the pediatric MTD.

Eligibility criteria: Inclusion Criteria:

* Age: ≤ 21 years of age at the time of study enrollment
* Diagnosis: refractory or recurrent solid tumors, including lymphomas, except those with CNS tumors or known CNS metastases
* Disease Status: measurable or evaluable disease
* Adequate organ function as defined in protocol

Exclusion Criteria:

* Pregnant or breastfeeding

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: 1 year
Secondary outcomes:
measure: Pharmacokinetics of eribulin in children with cancer
timeFrame: 8 days after first dose
measure: Tumor expression of BRCP and ABCB1
timeFrame: 1 year
measure: Tumor response
timeFrame: 2 years
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Jimmy Everest Center for Cancer and Blood Disorders in Children
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Rene Y McNall-Knapp, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma
name: Amanda Linz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00353626: Gait Evaluation of Experienced Below Knee Amputees
Official title: Gait Evaluation of Experienced Post Traumatic Below Knee Amputees
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputations, Traumatic
Keywords: Amputation
trans tibial
prosthesis
motion analysis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-07-18
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trans tibial amputees without pain or complaints about stump or prosthesis,using their prosthesis more than 3 months.

Brief summary: Post traumatic amputees with an experience of over 3 months of prosthesis use at home, without any known difficulty using the prosthesis and without stump pathology, using no assistive devices, will be examined in a 3 D computerized gait laboratory. Kinematic and kinetic parameters of gait will be obtained.


Eligibility criteria: Inclusion Criteria:

* Post traumatic trans tibial amputees
* No stump pathology
* No assistive devices
* No technical difficulty

Exclusion Criteria:

* Vascular or DM background
* Stump pathology
* Gait difficulties
* Assistive device

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Motion analysis Laboratory, Sheba Medical Center
name: Uri Givon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03481426: The Effect of Workplace Interventions on the Treatment of Low-back Pain
Official title: Workplace Interventions Supporting Employees to Continue at Work: Participatory Actions Organized by OH Physiotherapist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Keywords: musculoskelelal disorder
occupational health service
Lead sponsor: Finnish Institute of Occupational Health
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 107
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: The study evaluates the effect of workplace interventions on work ability promotion among workers with back problems. The half of participant will receive Information, advice and guidance for back problems in addition to participatory workplace actions organized by Occupational Health Physiotherapist. The other half will receive only Information, advice and guidance without workplace intervention.

Detailed description: Musculoskeletal symptoms, especially back pain, account for the majority of days lost.

In order to enhance the health and working careers of people with MSD, it is important that work can be arranged in such a way that they can remain in work life despite MSD.In the field of work ability promotion, various stakeholders; the worker, employer, professionals in occupational health services (OHS) interact to optimize actions and practices to prevent absences from work and promote remaining at work. This study aims to investigate participatory working practices and modles of co-operation among OHS and workplaces.

Eligibility criteria: Inclusion Criteria:

* Back pain for at least two weeks or frequently occuring periods within the past 12 months

Exclusion Criteria:

* Back problems with forcoming surcical operation

Primary outcomes:
measure: work ability
timeFrame: through study completion, up to 12 months
Secondary outcomes:
measure: intensity of pack pain
timeFrame: through study completion, up to 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Finnish Institute of Occupational Health
Study officials:
affiliation: Finnish Institute of Occupational Health
name: Erja Sormunen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01496326: Osteoarthritis Topical Treatment
Official title: A Pilot Study to Compare the Efficacy and Safety of a Novel 10% Ibuprofen Formulation Versus Placebo Alone Applied to the Knee in Patients With Painful Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Osteoarthritis
knee pain
Lead sponsor: BioChemics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-21
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 2a clinical trial performed to evaluate the efficacy of a topical treatment of ibuprofen compared to the use of a placebo topical treatment.

A multi-center, double-blinded, randomized placebo controlled study. Study length: 14 days Dosing twice daily (b.i.d.)


Eligibility criteria: Main Inclusion Criteria:

* Male or female patients aged at least 40 years.
* Primary osteoarthritis in a single knee joint, grade II/III based on the Kellgren and Lawrence classification system.
* Radiographic evidence consistent with osteoarthritis carried out within 6 months before screening.
* pain is currently not adequately controlled with a simple analgesic or an NSAID OR would necessitate treatment, but is not yet treated.

Main Exclusion Criteria:

* Concomitant presence of another type of continuous pain that is more severe in intensity in comparison with the osteoarthritis target joint pain
* Osteoarthritis causing significant pain in any joint other than the identified knee, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at visit 1 for any other painful joint concerned.
* Female patients who are pregnant or breast-feeding.

Primary outcomes:
measure: Visual Analogue Scale (VAS) Pain scale
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Schaffhausen
country: Switzerland
city: St. Gallen
country: Switzerland
city: Zürich
country: Switzerland
city: Zürich
country: Switzerland
city: Zürich
country: Switzerland
facility: Rheumaklinik und Institut für Physikalische Medizin Universitätsspital
Study officials:
affiliation: BioChemics, Inc.
name: Stephen Carter, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Varadi G, Zhu Z, Blattler T, Hosle M, Loher A, Pokorny R, Frey D, Carter SG. Randomized clinical trial evaluating transdermal Ibuprofen for moderate to severe knee osteoarthritis. Pain Physician. 2013 Nov-Dec;16(6):E749-62.
Clinical trial NCT03680326: Intravitreal Anti-vascular Endothelial Growth Factor Administration and Its Influence on Vitreomacular Interface- and Retinal Morphology in Eyes With Neovascular Age-related Macular Degeneration
Official title: Influence of Intravitreal Anti-vascular Endothelial Growth Factor Administration on Vitreomacular Interface- and Retinal Morphology in Eyes With Neovascular Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitreomacular Interface
Lead sponsor: Hospital Hietzing
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 43
Sex: ALL
Minimum age (years): 66
Maximum age (years): 98
Standard ages: OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: treatment-naive patients with neovascular AMD

Brief summary: Purpose:

To assess the influence of intravitreal anti-vascular endothelial growth factor (anti-VEGF) administration on vitreomacular interface- and retinal morphology in eyes with neovascular age-related macular degeneration (AMD) and to identify morphological markers potentially influencing disease prognosis.

Methods:

43 patients (51 eyes) with treatment naïve neovascular AMD subsequently treated with Bevacizumab 1.25mg (in 0.05ml of solution) were monitored until month 12 of follow-up. Following a loading dose of 3 monthly intravitreal anti-VEGF injections, patients were treated as-needed \[pro re nata (PRN)\]. Functional and morphological changes were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT).

Detailed description: This retrospective study included 43 treatment-naive patients (51 eyes) with neovascular AMD over the course of 12 months. Patients were treated with a loading dose of 3 initial monthly anti-VEGF injections (Bevacizumab 1.25mg in 0.05ml of solution-Avastin®) and were followed monthly until year 1. Re-treatment was performed if needed (pro re nata-PRN) as previously reported.

Eligibility criteria: Inclusion Criteria:

- diagnosis of treatment-naive neovascular AMD

Exclusion Criteria:

* any treatment with other anti-VEGF agents than Bevacizumab in the follow-up period
* any other diseases leading to macular edema
* prior vitrectomy
* uveitis
* retinal or corneal laser surgery
* high myopia (\>6dpt)
* preceding eye trauma

Primary outcomes:
measure: visual acuity
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01015326: Development of Dermatology-related Quality of Life Assessment in Patients Treated With Epidermal Growth Factor Receptor (EGFR) Inhibitors
Official title: Development of a Functional Assessment of Side-effects to Therapy (FAST) Questionnaire to Assess Dermatology-Related Quality of Life in Patients Treated With EGFR Inhibitors: The FAST-EGFR Inhibitors: The FAST-EGFRI and Development of an Investigator Grading System: The Skin and Eye Reactions to Inhibitors of EGFR (SERIES) Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Toxicities
Keywords: EGFRI
HRQL
Quality of Life
Development of a standardized HRQL instrument for anti-EGFR therapy induced
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with an EGFRI and referred to a specialized dermatology clinic for skin rash management.

Brief summary: Epidermal Growth Factor Receptor Inhibitors (EGFRI) are associated with skin toxicities. Clinical experience suggests that skin toxicities interfere with health related quality of life (HRQL) and may interfere with treatment adherence. No systematic investigations of EGFRI-associated dermatologic toxicities and impact on HRQL have been reported. No patient-reported outcome measures exist to capture the unique concerns of oncology patients who experience EGFRI-associated dermatologic toxicities.

The purpose of this study is to develop a patient-reported outcomes measure to assess dermatologic-related symptoms burden and health-related quality of life among patients receiving an EGFRI, and to develop a grading system for EGFRI-associated dermatologic toxicities.


Eligibility criteria: Inclusion Criteria:

* Undergoing anti-EGFR cancer therapy
* Over 18 years old

Exclusion Criteria:

* Unable to complete the questionnaire
* Unable to follow instructions or give consent

Primary outcomes:
measure: Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL)
timeFrame: at time of questionnaire
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Dennis P West, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00445926: Evaluation of the H1-coil Deep TMS in the Treatment of Negative Symptoms and Cognitive Deficit in Schizophrenia
Official title: Deep TMS With the H Coils as a Novel Strategy for the Treatment of Negative Symptoms of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2007-03-09
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study evaluates the feasibility of using a 4 week stimulation protocol with the deep TMS H-coils for the treatment of negative symptoms and cognitive deficit in schizophrenia patients


Eligibility criteria: Inclusion Criteria:

* DSM IV Diagnosis of Schizophrenia
* PANNS Negative \> 21

Exclusion Criteria:

* risk factors for convulsions
* PANNS positive \> 24

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: Shalvata MHC
Study officials:
affiliation: Shalvata MHC
name: Eiran V Harel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01232426: A Randomized Controlled Trial of the Treatment of Mallet Fractures
Official title: A Randomized Controlled Trial of the Treatment of Mallet Fractures: Conservative Versus Operative Using One Meniscus Arrow®
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mallet Fracture
Lead sponsor: Conmed Linvatec Benelux
Sponsor class: OTHER
First posted: 2010-11-02
Enrollment: 84
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: Intra-articular fractures at the dorsal base of the distal phalanx of the hand are usually referred to as Mallet fractures. Treatment of Mallet fractures remains controversial. Although no differences in clinical results are reported between conservative treatment and operative treatment, operative treatment is suggested for fractures involving more than 30% of articular surface. There are many different operative techniques, all with specific disadvantages. The investigators hypothesis is that operative treatment of Mallet fractures with one Meniscus Arrow® has a better outcome than conservative treatment with a Mallet splint.


Eligibility criteria: Inclusion Criteria:

* avulsion fracture involving more than 30% of articular surface

Exclusion Criteria:

* (sub)luxation of the distal phalanx
* patients with a Mallet fracture developed 3 weeks or more prior to presentation
* patients with a Mallet fracture with failure of conservative treatment

Primary outcomes:
measure: Extension deficit
timeFrame: 1 year
measure: extension deficit
timeFrame: 1 year
Secondary outcomes:
measure: wound healing disturbances
timeFrame: 1 year
Other outcomes:
measure: nail deformaties
timeFrame: 1 year
Locations:
city: Tilburg
country: Netherlands
facility: st. Elisabeth Hospital
state: Noord-Barbant
city: Breda
country: Netherlands
facility: Amphia Hospital
state: Noord-Brabant
city: Eindhoven
country: Netherlands
facility: Catharaina Hospital
state: Noord-Brabant
city: Tilburg
country: Netherlands
facility: Twee Steden Hospital
state: Noord-Brabant
city: Haarlem
country: Netherlands
facility: Kennemer Gasthuis Hospital
state: Noord-Holland
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Hospital
Study officials:
References:
citation: Nelis R, Wouters DB. Is the use of biodegradable devices in the operative treatment of avulsion fractures of fingers, the so-called mallet finger advantageous? A feasibility study with meniscus arrows. Open Orthop J. 2008 Nov 3;2:151-4. doi: 10.2174/1874325000802010151.
Clinical trial NCT04696926: Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve
Official title: Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve: a Single-center Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Aortic Valve Disease
Keywords: severe aortic stenosis
severe aortic regurgitation
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 170 consecutive patients who underwent an aortic valve replacement with an Edwards Intuity TM bioprosthesis at La Timone Hospital, Marseille, France, were prospectively included between July 2012 and June 2015 and were followed for 5 years.

Brief summary: Objectives:

This report presents 5-year outcomes of the rapid-deployment Edwards Intuity TM valve in a single-center prospective study.

Methods:

All consecutive patients who underwent an aortic valve replacement with an Edwards Intuity TM bioprosthesis at La Timone Hospital, Marseille, France, were prospectively included between July 2012 and June 2015 and were followed for 5 years. The primary outcome was overall mortality at 5 years.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients implanted by the Intuity TM bioprosthesis
* For severe aortic valve stenosis or severe aortic regurgitation
* Including reoperation and combined surgery
* Between July 2012 and June 2015

Exclusion Criteria:

* absence of patient's authorization for anonymous publication of their clinical data for research purposes

Primary outcomes:
measure: 5-year overall mortality
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
References: