louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05118464: Effect of Dual-Task Training on Pediatric Oncology Patients
Official title: Evaluation of the Effect of Dual-Task Training on Muscle Strength, Balance, and Gait in Pediatric Oncology Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: cancer
gait
postural balance
muscle strength
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 21
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is known that the treatment of children with cancer has negative effects on cognition, muscle strength, balance, and gait. Therefore, the aim of this study is to evaluate the effects of dual-task training, which is based on the principle of simultaneous performance of cognitive tasks and motor tasks, on muscle strength, balance, and gait.

Detailed description: With the increase in the incidence of cancer, the number of children who survived cancer is also increasing. Most studies on cancer survivors show that the disease and its treatment have side effects and long-term late effects on the musculoskeletal system, physical function, motor, and cognitive skills. Therefore, the aim of this study is to evaluate the effects of dual-task training, which is based on the principle of simultaneous performance of cognitive tasks and motor tasks, on muscle strength, balance, and gait. This study is planned to be the first study in which dual-task training is applied in children with cancer.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with pediatric cancer and inpatient and outpatient treatment in Hematology-Oncology Clinics for treatment,
* Able to walk alone without any walking aid,
* Children aged 6-18 will be included

Exclusion Criteria:

* Staying in an isolated room or at risk of infection (neutropenic, etc.),
* Any orthopedic or neurological disorder that may prevent walking;
* Having any mental disability that will prevent performing a cognitive task,
* Individuals with malignant hypertension or unstable heart disease (eg, congestive heart failure) will not be included in the study.

Primary outcomes:
measure: gait speed
timeFrame: 600 seconds
measure: balance
timeFrame: 300 seconds
measure: Muscle strength
timeFrame: 600 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Emel Taşvuran Horata
Study officials:
affiliation: AFSU
name: EMEL TAŞVURAN HORATA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02292264: Risk Factors and Complications of Ventral Hernia Repair
Official title: Risk Factors and Complications of Ventral Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Hernia
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 575
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent ventral hernia repair at the Surgical Department of Køge University Hospital in the timeperiod from 2009 - 2014.

Brief summary: The aim of this study is to evaluate risk factors and complications of ventral hernia repair. A retrospective study of journal files with patients undergoing ventral hernia repair, and an analyses of complications by use of the Clavien-Dindo classification of surgical complications.


Eligibility criteria: Inclusion Criteria:

* Surgically treated ventral hernia repair

Exclusion Criteria:

* All surgically treated patients are included

Primary outcomes:
measure: Identifying pre-operative risk factors by use of the Clavien Dindo classification.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Køge University Hospital
Study officials:
affiliation: Dept. of surgery, Køge University Hospital
name: Henrik Sjølander, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03033264: Labor Induction With Dinoprostone in Oppose to Cervical Ripening Balloon as a Factor of BMI.
Official title: A Comparison Between Labor Induction With Dinoprostone and a Cervical Ripening Balloon in Women With a BMI>30 as Oppose With a BMI<30.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induction of Labor
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women with a BMI\>30 and women with a BMI\<30 will be divided in a randomized controlled manor to 4 groups depending on the mode of labor induction and BMI value:

1. Dinoprostone in women with a BMI\>30.
2. Dinoprostone in women with a BMI\<30.
3. Cervical ripening balloon in women with a BMI\>30.
4. Cervical ripening balloon in women with a BMI\<30. The subjects will be followed until labor, and information regarding the success of induction, mode of delivery and time of delivery will be collected from patients' electronic files.

Detailed description: The study is a randomized controlled test in which women with a BMI\>30 and women with a BMI\<30 will sign an informed consent and then divided to 4 groups depending on the mode of labor induction and BMI value:

1. Dinoprostone in women with a BMI\>30.
2. Dinoprostone in women with a BMI\<30.
3. Cervical ripening balloon in women with a BMI\>30.
4. Cervical ripening balloon in women with a BMI\<30. All subjects participating in the study will be induced for obstetrical indications alone.

The subjects will be followed until labor, and information regarding the success of induction, mode of delivery and time of delivery will be collected from patients' electronic files.

The participants will finish participation in the study after delivery.

Eligibility criteria: Inclusion Criteria:

* Any pregnant woman at term with an obstetric indication for labor induction.

Exclusion Criteria:

* Previous cesarean section.
* Positive Oxytocin challenge test.
* Positive contraction stress test.

Primary outcomes:
measure: Mode of delivery
timeFrame: Up to 5 days.
Secondary outcomes:
measure: Time to delivery
timeFrame: Up to 5 days.
measure: Induction success.
timeFrame: Up to 5 days.
measure: Neonatal complications and outcome.
timeFrame: Up to 5 days.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: ROY LAUTERBACH, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05459064: Retrospective Data Collection on the Use of Motiva Flora TE in Breast Reconstruction
Official title: Retrospective Data Collection on the Use of Motiva Flora TE in Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Establishment Labs
Sponsor class: INDUSTRY
First posted: 2022-07-14
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient has had a complete tissue-expander based breast reconstruction with the Motiva Flora® TE .

Brief summary: The Motiva Flora® TE are intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and are not intended for use beyond six (6) months.

All Motiva Flora® TE's require periodic, incremental inflation with sterile saline for injection until the desired tissue amount is developed. After the desired volume, the expander is surgically removed and replaced with a long-term breast implant in the same space as the tissue expander.

The study collects retrospective data on the use of the Motiva Flora TE, from patients who had a tissue expander-based-breast reconstruction using the Motiva Flora® TE since market introduction in May 2020.


Eligibility criteria: Inclusion Criteria:

* Patient has completed a tissue expander-based breast reconstruction with the Motiva Flora® TE .
* Patient has been informed correctly according to to the applicable national and local regulations.

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Safety - adverse events
timeFrame: Until finalization of staged Breast reconstruction, approximately 6 months
measure: Safety - device deficiencies
timeFrame: Until finalization of staged Breast reconstruction, approximately 6 months
measure: Performance - succesful implant of long-term breast implant
timeFrame: Until finalization of staged Breast reconstruction, approximately 6 months
measure: Performance - surgeon satisfaction
timeFrame: Until finalization of staged Breast reconstruction, approximately 6 months
Secondary outcomes:
measure: Length of hospitalization
timeFrame: Until discharge from hospital after first surgery (Motiva Flora Tissue Expander), approximately 1-2 days
measure: Surgical difficulties- 1st surgery (Motiva Flora TE implantation)
timeFrame: Intraoperative
measure: Surgical difficulties - 2nd surgery (Long-term breast implant)
timeFrame: Intraoperative
measure: Concomitant treatments - 1st surgery
timeFrame: Intraoperative
measure: Concomitant treatments - 2nd surgery
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Dr Filip Stillaert
city: Madrid
country: Spain
facility: Fundacion Tejerina
Study officials:
References:
Clinical trial NCT03104764: Labial Frenulum Surgery - a Comparative Study of Conventional Scalpel and Er-Yag Laser Technique
Official title: Evaluation of Wound Healing and Patients´Experiences of Labial Frenulum Surgery - a Randomized, Controlled Comparative Study of Conventional Scalpel Technique and Er-Yag Laser Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labial Tie
Keywords: labial frenulum
surgery
scalpel technique
Er:YAG laser
Lead sponsor: Public Dental Health in Uppsala Region
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2017-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled, single-blind investigation
Primary purpose: TREATMENT

Brief summary: The aim of the study was to compare the outcome in terms of wound healing time, surgery time, bleeding and patient experience of the ectomy of frenulum when performed with laser technology versus conventional scalpel technique. A prospective, single-blind, randomized and controlled study was performed. Wound healing was assessed five and ten days after after surgery. The long-term outcome were assessed blinded by a dentist not earlier involved in the study.

Detailed description: Children referred to a pediatric clinic to surgically remove a labial frenulum were randomized to treatment with conventional scalpel or laser treatment technology after parents and children had given consent to participate. During the surgery the time required for the procedure and the amount of bleeding the different techniques caused were measured. Wound healing was assessed five and ten days after surgery by a clinical judgement and by analysing photos. Three months after surgery an independent dentist assessed the long-term outcome by a clinical examination. The patients´ view of the treatment were assessed directly after the surgery and five days, ten days and three months after the surgery.

Eligibility criteria: Inclusion Criteria:

* patients in need of frenulum labials surgery

Exclusion Criteria:

* patients with severe general diseases (ASA\>2)
* patients who required general anaesthesia for treatment

Primary outcomes:
measure: Wound healing
timeFrame: 0-3 months
Secondary outcomes:
measure: Patient experience
timeFrame: 0-3 months
measure: Time required for surgery
timeFrame: Intervention day
measure: Scar tissue formation
timeFrame: 3 months
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Public Dental Service, Vretgränd 9
Study officials:
References:
Clinical trial NCT00932464: Study Evaluating The Effect Of A High-Fat Meal On The Pharmacokinetics Of Neratinib
Official title: An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study To Determine The Effect Of A High-Fat Meal On The Relative Bioavailability And Pharmacokinetics Of A Single Dose Of The 240 mg Formulation Of Neratinib In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Puma Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is being conducted to see if neratinib is absorbed, distributed, or eliminated differently when administered in the fasting state versus after a high-fat meal.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women of nonchildbearing potential, age 18 to 50 years.

Exclusion Criteria:

* Any previous or current clinically significant medical condition or disease.

Primary outcomes:
measure: Pharmacokinetics as measured by AUC, Cmax, tmax, t1/2
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Biotechnology
name: Puma
role: STUDY_DIRECTOR
References:
Clinical trial NCT04508764: Implementation of the Families Accelerating Cascade Testing Toolkit (FACTT) for Hereditary Breast and Ovarian Cancer and Lynch Syndrome
Official title: Implementation of the Families Accelerating Cascade Testing Toolkit (FACTT) for Hereditary Breast and Ovarian Cancer and Lynch Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hereditary Breast and Ovarian Cancer
Lynch Syndrome
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Foundation for Barnes-Jewish Hospital
First posted: 2020-08-11
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research study is to learn how cancer care providers can help their patients communicate the need for genetic testing in families with inherited cancer syndromes.


Eligibility criteria: Inclusion Criteria:

* Documentation of HBOC or Lynch-associated "pathogenic/ likely pathogenic" mutation per American College of Medical Genetics and Genomics criteria (1)
* Diagnosis of one or more invasive cancers: epithelial ovarian, fallopian tube, primary peritoneal, breast, colorectal, endometrial
* Mutation listed in NCCN guidelines with at least Category 2A evidence for intervention
* Over the age of 18
* Psychological ability and general health that permits completion of study requirements and follow-up
* Willingness to complete follow-up surveys in person, electronically, or by telephone for up to 6 months

Exclusion Criteria:

-"Variant of undetermined significance," "likely benign" or "benign" variant per ACMGG criteria

Primary outcomes:
measure: Proband-reported cascade testing rates of first-degree relatives
timeFrame: From start of study through completion of 6 month follow-up (estimated to be 18 months)
measure: Number of primary barriers to genetic testing for first-degree relatives
timeFrame: From start of study through completion of 6 month follow-up (estimated to be 18 months)
measure: Family member-reported cascade testing rates
timeFrame: From start of study through completion of 6 month follow-up (estimated to be 18 months)
measure: Number of primary barriers to genetic testing for family members
timeFrame: From start of study through completion of 6 month follow-up (estimated to be 18 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Andrea Hagemann, M.D., MSCI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06439264: Assessing the Clinical Efficacy of Bentonite Clay Gel on Bone Regeneration in the Treatment of Intra-bony Defects: A Clinico-radiograph Study
Official title: Assessing the Clinical Efficacy of Bentonite Clay Gel on Bone Regeneration in the Treatment of Intra-bony Defects: A Clinico-radiograph Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Regeneration
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate osseous regeneration efficacy of bentonite gel with hydroxyapatite in comparison with hydroxyapatite incase of intrabony defects

The test group includes patients with intrabony defects where flap surgery is will be performed and bentonite clay gel with HA will be placed and in control group only HA is placed.

Detailed description: Experimental: Main treatment group bentonite with hydroxyaatite is added into the defect site.

Comparator: In patients allocated to control group,only hydroxyapatite is added.

Eligibility criteria: Inclusion Criteria:

1. Systemically healthy male and female patients of age \>18 years
2. two-walled or three-walled intrabony defects and
3. probing pocket depths (PPD) of ≥ 5mm.

Exclusion Criteria:

1. Medically compromised patients,
2. patients \<18 years of age,
3. pregnant women,
4. heavy smokers, and
5. patients who underwent radiotherapy or chemotherapy are excluded.

Primary outcomes:
measure: RVG
timeFrame: baseline , 3months,6months
measure: probing depth
timeFrame: baseline , 3months,6months
measure: clinical attachment level
timeFrame: baseline , 3months,6months
Secondary outcomes:
measure: 1. Assessment of plaque - according to Turesky modification of Quigley and Hein Plaque Index, 1970. 2. Assessment of Gingivitis - according to Loe H and Silness P, 1963.
timeFrame: baseline ,3months,6months
Other outcomes:
Locations:
city: Mahbūbnagar
country: India
facility: Svs Dental College
state: Telangana
Study officials:
References:
Clinical trial NCT06934564: De-Implementation of Low-value Testing in Patients Undergoing Low-Risk Surgery
Official title: De-Implementation of Low-value Testing in Patients Undergoing Low-Risk Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Lumpectomy
Laparoscopic Cholecystectomy
Inguinal Hernia Repair
Keywords: Preoperative testing
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Blue Cross Blue Shield of Michigan Foundation
First posted: 2025-04-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Using a stepped wedge cluster-randomized design, sixteen Michigan Value Collaborative (MVC)/Michigan Surgical Quality Collaborative (MSQC) sites in Michigan will implement a multi-level, multi-component de-implementation strategy and collect information on the use of unnecessary preoperative testing.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This trial aims to evaluate the effectiveness of a multi-level, multi-component de-implementation strategy to reduce unnecessary preoperative testing. Sixteen Michigan Value Collaborative (MVC)/Michigan Surgical Quality Collaborative (MSQC) sites in Michigan will implement several tools that have been proven to reduce unnecessary testing at a single site, including clinician education, a decision aid, audit and feedback on performance, and a pay-for-performance incentive. The researchers believe that, through the use of these strategies, there will be a significant reduction in unnecessary preoperative testing during the intervention.


Eligibility criteria: Site

Inclusion Criteria:

* Over 30% of testing rates on at least one of the three index procedures (breast lumpectomy, laparoscopic cholecystectomy, and inguinal hernia repair)

Exclusion Criteria:

* none

Surgical participants must be over 18 years old.

Primary outcomes:
measure: Number of tests within 30 days of surgery not associated with an emergency department visit
timeFrame: Within 30 days of surgery
Secondary outcomes:
measure: Number of unnecessary preoperative testing before low-risk surgery at MVC/MSQC sites not participating in the trial
timeFrame: Up to year 2, quarter 4
measure: 30-day episode-based spending
timeFrame: Up to Year 2, Quarter 2
measure: Number of unnecessary preoperative testing before low-risk surgery at trial sites
timeFrame: Up to year 2, quarter 4
measure: Number of intraoperative complications
timeFrame: Up to year 2, quarter 4
measure: Number of same-day case cancellations
timeFrame: Up to year 2, quarter 4
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan and other Michigan Surgical Quality Collaborative sites
state: Michigan
Study officials:
affiliation: University of Michigan
name: Lesly Dossett, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Hari Nathan, PhD
role: PRINCIPAL_INVESTIGATOR
References: