louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06922513: Clinical Feasibility of Mobile App-Based Self-Management for Breast Cancer-Related Lymphedema
Official title: Clinical Feasibility of Mobile App-Based Self-Management for Breast Cancer-Related Lymphedema
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer Related Lymphedema
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study evaluates a newly developed service that provides personalized self-management guidance based on evidence-based arm circumference measurements and resulting volume changes. The research aims to determine whether this digital solution is practical and acceptable for patients while identifying any unexpected challenges during implementation, ultimately establishing its potential for clinical integration into lymphedema care.


Eligibility criteria: Inclusion Criteria:

* Between 18 and 70 years of age
* Diagnosed with breast cancer-related unilateral upper limb lymphedema
* Possessing an Android or iOS smartphone
* Voluntarily deciding to participate and providing written consent after receiving a detailed explanation of this study

Exclusion Criteria:

* Diagnosed with malignant lymphedema due to metastasis or recurrence
* Having severe comorbidities (underlying diseases, neuromusculoskeletal disorders, cognitive, mental, or visual impairments, etc.) that make it difficult to use the application and participate in exercise interventions

Discontinuation Criteria:

* Development of serious complications or cancer metastasis/recurrence during the study period
* Occurrence of a serious illness unrelated to study participation
* Failure to follow the instructions of the study physician
* Voluntary withdrawal from the study or development of circumstances preventing participation

Primary outcomes:
measure: Usability and Acceptability
timeFrame: Baseline, Month 3, Month 6
measure: SUS
timeFrame: Baseline, Month 3, Month 6
Secondary outcomes:
measure: TTM (Transtheoretical Model)
timeFrame: Baseline, Month 3, Month 6
measure: LYMQOL
timeFrame: Baseline, Month 3, Month 6
measure: EQ-5D-5L
timeFrame: Baseline, Month 3, Month 6
measure: self-efficacy
timeFrame: Baseline, Month 3, Month 6
measure: upper arm use
timeFrame: Baseline, Month 3, Month 6
measure: ICF (International Classification of Functioning, Disability, and Health)
timeFrame: Baseline, Month 3, Month 6
measure: COPM
timeFrame: Baseline, Month 3, Month 6
measure: Smart Measuring Tape
timeFrame: Baseline, Month 3
measure: Perometer
timeFrame: Baseline, Month 3, Month 6
Other outcomes:
measure: GPAQ
timeFrame: Baseline
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Republic of Korea
Study officials:
References:
Clinical trial NCT00523913: A Study Of BRL49653C For The Treatment Of Type 2 Diabetes
Official title: Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus -Long-term Study of Rosiglitazone Maleate-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes mellitus;
diabetes;
rosiglitazone
Avandia;
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-09-03
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the safety of BRL49653C administrated for 52 weeks


Eligibility criteria: Inclusion Criteria:

- Patients with type 2 diabetes mellitus managed by diet therapy or one antidiabetic agent (sulfonylurea or alpha glucosidase inhibitor) will be candidates for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function.

Exclusion Criteria:

- Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.

Primary outcomes:
measure: The safety profile (adverse events, laboratory parameters and other observations) of BRL49653C administered for 52 weeks will be evaluated.
timeFrame: 52 Weeks
Secondary outcomes:
measure: The efficacy profile (HbA1c, FPG and Insulin) of BRL49653C administered for 52 weeks will be evaluated.
timeFrame: 52 Weeks
Other outcomes:
Locations:
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: This study has not been published in the scientific literature.
Clinical trial NCT06723613: Exercise Program to Increase Breast Milk
Official title: Effect of Exercise Program to Increase Breast Milk on Breastfeeding Self-efficacy, Breastfeeding Success and Breast Milk Quantity: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Behavior
Breastfeeding, Exclusive
Breast Milk Expression
Keywords: Breastfeeding Self-Efficacy Scale
Breastfeeding problems
Breast Milk Quantity
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, the effects of an exercise program aimed at increasing breast milk on breastfeeding self-efficacy, breastfeeding success, and breast milk quantity will be evaluated.

Detailed description: The research is a randomized controlled trial. The research will be conducted with 122 mothers who are in their 8th week postpartum and have healthy babies. Mothers in the exercise group will be given 1 hour (60 minutes) of exercise to increase breast milk three times a week for 6 weeks. The control group will be given routine breastfeeding education. Data will be collected using a sociodemographic form, Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), LATCH- Breastfeeding Charting system, IMDAT: a tool for assessing the level of maternal milk intake scale.

Eligibility criteria: Inclusion Criteria:

* Those who are over 18 years old,
* Who gave birth at term pregnancy (38-42 weeks),
* Who have a healthy baby,
* Who are between 8 weeks postpartum.

Exclusion Criteria:

* Those with diagnosed mental illness (e.g., antidepressants, antianxiety or antipsychotic medications),
* Those with chronic systemic illnesses,
* Those with physical illnesses that may prevent them from exercising,
* Those with any postpartum complications (hemorrhage, postpartum infection, mastitis, thromboembolic disease or postpartum psychiatric disorder).

Primary outcomes:
measure: Comparison of mothers' sociodemographic characteristics with survey before intervention
timeFrame: 3 months
measure: Comparison of mothers' Breastfeeding Self-Efficacy Scale averages by groups
timeFrame: 3 months
measure: Comparison of mothers' LATCH- Breastfeeding Charting system averages by groups
timeFrame: 3 months
measure: Comparison of mothers' IMDAT: a tool for assessing the level of maternal milk intake averages by group.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Seyhan Çankaya
Study officials:
References:
Clinical trial NCT06909513: Impact of Travel Neck Pillow Use on Neck Comfort and Mobility After Thyroidectomy
Official title: Effects of Travel Neck Pillow Usage on Cervical Comfort, Pain,Stiff Neck and Cervical Range of Motion After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Total Thyroidectomy
Keywords: Cervical comfort
Postoperative neck pain
Neck stiffness
U-shaped Travel neck pillow
Cervical mobility
Nursing care
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the effectiveness of U-shaped travel neck pillow use in improving cervical comfort, reducing neck pain and stiffness, and enhancing cervical range of motion in adults undergoing total thyroidectomy surgery. It is the first randomized controlled trial in Turkey to examine the use of a travel neck pillow as a non-pharmacological intervention during the immediate postoperative period (day 0).

The study will be conducted at Erciyes University Gevher Nesibe Hospital between December 5, 2024 and June 5, 2025. Participants will be randomly assigned to either the pillow group or the control group. Those in the pillow group will use a U-shaped neck pillow for the first 24 hours after surgery while at rest.

Outcomes will be assessed using the Visual Analog Scale (VAS) for pain and comfort, the McGill Pain Questionnaire for pain localization and intensity, and goniometric measurements of cervical range of motion. Data will be collected preoperatively and at 24 hours postoperatively.

This study is expected to provide clinical evidence supporting the use of travel neck pillows to improve postoperative comfort and mobility, offering a simple and cost-effective nursing intervention for thyroidectomy recovery.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo elective total thyroidectomy

Classified as ASA physical status I or II

Aged 18 years or older

No communication impairments

Willing to participate and provide informed consent

Exclusion Criteria:

* Patients with a previously diagnosed condition in the cervical spine region prior to surgery

Patients who have previously undergone thyroidectomy

Primary outcomes:
measure: Assessment of Patient Comfort Using the Visual Analog Scale (VAS)
timeFrame: The scale was filled in the baseline
Secondary outcomes:
Other outcomes:
measure: Assessment of Pain Using the Visual Analog Scale (VAS)
timeFrame: The scale was filled in the baseline
measure: McGill Pain Questionnaire
timeFrame: The scale was filled in the baseline
measure: Cervical Spine Range of Motion Assessment
timeFrame: The scale was filled in the baseline
Locations:
city: Kayseri
country: Turkey
facility: Erciyes Üniversitesi
state: Talas
Study officials:
References:
Clinical trial NCT02225613: Spa Rehabilitation After Cruciate Ligament Injury in Sportsmen
Official title: Comparison Between Two Rehabilitation Programs (Conventional and Aquatic) After Cruciate Ligament Injury in Sportsmen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cruciate Ligament Injury
Balance Control
Keywords: Cruciate ligament injury
Balance control
Rehabilitation
Spa therapy
Sport
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2014-08-26
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee cruciate ligament injury is a common injury (15 000 per year in France) which concerns young sportsmen. Consequences are limitation in physical and sporting activities and at work.

Main objective: to compare water and traditional rehabilitation after cruciate ligament injury reconstruction in terms of kinematics of recovery and of proprioceptive abilities development.

Detailed description: Secondary objectives: to compare algo-functional and sport, social and job come back date between both groups.

Multicentric randomised trial comparing two therapy protocols in knee cruciate ligament injury.

After surgery, 2 weeks rehabilitation; 3 weeks conventional rehabilitation (group 1) or rehabilitation in water (group 2).

Data will be collected at inclusion (before surgery), 2 weeks, 1 month, 2 months and 6 months after surgery.

Eligibility criteria: Inclusion Criteria:

* Adults,
* 18-49 years,
* indication of knee anterior cruciate ligament reconstruction.

Exclusion Criteria:

* other recent lower limb sprain,
* history of neurological disease (stroke, central or peripheral degenerative disease),
* psychtrope or antihypertensive drugs,
* aquatic activities contra-indication (cutaneous).

Primary outcomes:
measure: Posturography composite score
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Nancy University Hospital
state: Lorraine
Study officials:
References:
citation: Peultier-Celli L, Mainard D, Wein F, Paris N, Boisseau P, Ferry A, Gueguen R, Chary-Valckenaere I, Paysant J, Perrin P. Comparison of an Innovative Rehabilitation, Combining Reduced Conventional Rehabilitation with Balneotherapy, and a Conventional Rehabilitation after Anterior Cruciate Ligament Reconstruction in Athletes. Front Surg. 2017 Nov 7;4:61. doi: 10.3389/fsurg.2017.00061. eCollection 2017.
Clinical trial NCT03699813: ROTEM Versus aPTT/PT in Pediatric Surgery
Official title: Use of Rotational Thromboelastometry (ROTEM) in Pediatric Perioperative Medicine and Its Comparison With Standard Coagulation Tests aPTT/PT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation Defect; Bleeding
Keywords: ROTEM, PT, aPTT
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 45
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients who underwent surgical scoliosis correction

Brief summary: Hemocoagulation management in perioperative bleeding is nowadays based on standard coagulation testing: activated partial thromboplastin time (aPTT), prothrombin time (PT), fibrinogen, D-dimers, platelets. An interest about viscoelastic coagulation testing methods is rising - use of rotational thromboelastometry (ROTEM) is mentioned in the newest European guidelines for hemostasis management. ROTEM has more advantages then standard tests. However, both tests have only grade 1C recommendation, and most of trials have been done on adults. The goal of the study is to compare a relationship between standard tests and ROTEM in pediatric patients in perioperative period to find out which test has better correlation with clinical status, to compare therapeutic strategies and time necessary for gain both of tests and to compare the difference in blood loss and blood products consumption in group treated by ROTEM versus standard tests. Reduced blood loss and amount of blood products transfusion is expected to be found in ROTEM group, representing lowering risk for the patient, all due to early evaluation of hemocoagulation and targeted therapy guided by ROTEM.

Detailed description: Pediatric patients who underwent spine surgery (under 18 years old) will be recruited in our study.

Retrospective data will be analysed from these patient who underwent scoliosis surgery before ROTEM implementation to daily practice and after ROTEM implementation do daily practice in our department.

Time to available results of ROTEM versus aPTT/PT tests will be compared. Blood loss and blood products used in these both groups will be analysed and compared between 2 groups.

Eligibility criteria: Inclusion Criteria:

• pediatric patients after surgical correction of scoliosis

Exclusion Criteria:

• patients older than 18 years

Primary outcomes:
measure: analysing blood loss during surgery
timeFrame: 3 years
Secondary outcomes:
measure: analysing blood transfusion units consumption
timeFrame: 3 years
measure: time to results of tests
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
citation: Jonas J, Durila M, Malosek M, Maresova D, Stulik J, Barna M, Vymazal T. Usefulness of perioperative rotational thrombelastometry during scoliosis surgery in children. J Neurosurg Spine. 2020 Jan 24;32(6):865-870. doi: 10.3171/2019.11.SPINE191137. Print 2020 Jun 1.
Clinical trial NCT02610413: Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Hypertension Receiving Bevacizumab for Breast Cancer
Official title: Exploratory Next Generation Sequencing to Identify Causative Variants for Bevacizumab-Induced Hypertension From Breast Cancer Study E5103 Germline DNA Samples
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2015-11-20
Enrollment: 354
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer enrolled on E5103 with or without hypertension

Brief summary: This research trial studies whole exome sequencing in finding causative variants in germline deoxyribonucleic acid (DNA) samples from patients with hypertension receiving bevacizumab for breast cancer. Studying samples of germline DNA in the laboratory from patients with hypertension receiving bevacizumab for breast cancer may help doctors learn about changes that occur in DNA and identify biomarkers related to hypertension.

Detailed description: PRIMARY OBJECTIVES:

I. To identify, using next generation sequencing, rare variants of large effect size that impact the risk of hypertension in patients from the clinical trial Eastern Cooperative Oncology Group (ECOG)-5103 (E5103).

OUTLINE:

Previously collected germline DNA samples are analyzed via whole exome sequencing.

Eligibility criteria: Inclusion Criteria:

* European American patients with deoxyribonucleic acid (DNA) available and designated case or control
* Patients who developed grade 3-4 bevacizumab-induced hypertension during their treatment with bevacizumab
* Patients who did not develop hypertension following a full course of treatment with bevacizumab

Primary outcomes:
measure: Identification of rare coding variants of large effect that predict the risk of bevacizumab-induced hypertension
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Eastern Cooperative Oncology Group
state: Massachusetts
Study officials:
affiliation: Eastern Cooperative Oncology Group
name: Bryan P Schneider
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05683613: Watering of the Eyes Following Uneventful Phacoemulsification Cataract Surgery
Official title: Watering of the Eyes Following Uneventful Phacoemulsification Cataract Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Watery Eyes
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50_ 80 year old Patients with age related cataract with no watery eyes subjected for phacoemulsification cataract surgery

Brief summary: An observational study aiming to assess the incidence and possible causes of post phacoemulsification watery eye.

Detailed description: This study will be conducted on patients who will undergo cataract extraction at Sohag university hospitals to evaluate the incidence of watery eyes in patients after phacoemulsification by one week , one month and three month.

* Study Design: observational study.
* Inclusion Criteria:

Patients with age-related cataract.

* Exclusion Criteria:

  1. patients with watering of eyes or ocular surface diseases or watering of the eyes .
  2. patients with previous ocular surgeries.
  3. patients with glaucoma, uveitis, corneal or retinal pathologies.
* Preoperative Evaluation:

Each patient will be subjected to the following:

Detailed history taking and full ophthalmological examination. Fluorescein dye disappearance test. Syringing and probing. Schirmer's test. Tear break up time test. Measurement of punctal diameter by AS-OCT.

* Operative procedures:

  1. regional anesthesia.
  2. phaco technique : stop and shop.
  3. cumulative dissipated energy (CDE ) \&fluid flow.
* Follow-up regimen: will be as follows:

  1. patients will be examined after surgery on: 1st postoperative week, 1st month, 3rd month.
  2. The following will be recorded for each patient:

     1. symptoms of watery eyes, visual acuity, IOP, slit lamp examination.
     2. dye disappearance test.
     3. Schirmer's test.
     4. tear break up time test.
     5. anterior segment OCT.

Eligibility criteria: Inclusion Criteria:

* patients with age related cataract.

Exclusion Criteria:

* patients with watering of the eyes or ocular surface disease.

  * patients with previous ocular surgeries .
  * patients with glaucoma, uveitis, cornealor retinal pathologies.

Primary outcomes:
measure: Assess the incidence and possible causes of post phacoemulsification watery eye.
timeFrame: Five months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00674713: Effect of Acupuncture on Postoperative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cholelithiasis
Keywords: Patients undergoing laparoscopic cholecystectomy for cholelithiasis
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2008-05-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to investigate if P6 acupuncture made after induction of general anaesthesia might be effective for the prevention of PONV as ondansetron and if the acupuncture-ondansetron combination could enhance single therapy efficacy in patients undergoing laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* Patients ASA I-II scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria:

* Patient's refusal
* Patients with history of carpal tunnel syndrome or eczema at P6 point
* Pregnant patients
* Female patients in a phase of the menstrual cycle other than premenstrual, nausea and vomiting within 24 hours before anaesthesia
* Known allergy to anti-inflammatory drugs, opioids and ondansetron.
* Patients with a pre-existing chronic pain disorder or with a gastrointestinal disease.

Primary outcomes:
measure: postoperative nausea and vomiting
timeFrame: 24 postoperative hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of Sacred Heart
Study officials:
affiliation: Catholic University of Sacred Heart
name: Germano De Cosmo, MD
role: PRINCIPAL_INVESTIGATOR
References: