louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06973265: Effects of Transcutaneous Electrical Nerve Stimulation on Breast Surgery
Official title: Effects of Transcutaneous Electrical Nerve Stimulation on Pain, Lymphedema, Upper Extremity Functions, and Quality of Life in Patients Undergoing Breast Surgery After Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Cancer Surgery
Transcutaneous Electric Nerve Stimulation
Keywords: pain
lymphedema
Mastectomy
Mobility Limitation
Quality of Life
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2025-05-15
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: TENS group and control group
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled trial was to evaluate the effects of transcutaneous electrical nerve stimulation (TENS) on postoperative pain, lymphedema development, shoulder range of motion, and quality of life in women undergoing breast cancer surgery after neoadjuvant chemotherapy. The main questions it aims to answer are:

Does TENS reduce postoperative pain? Does TENS prevent postoperative lymphedema? Does TENS increase postoperative shoulder range of motion? Does TENS improve postoperative quality of life? The researchers will compare the effects of TENS after breast surgery with a control group.

Participants will be assessed for pain, lymphedema development, and shoulder range of motion before surgery, on the first day after surgery, at the first month after surgery, and at the third month after surgery. Quality of life will be assessed before surgery, at the first month after surgery, and at the third month after surgery.


Eligibility criteria: Inclusion Criteria:

* Those whose primary cancer tissue is breast
* ASA classification is between I and III
* Having unilateral breast surgery

Exclusion Criteria:

* Those with cardiac problems and those using a pacemaker
* Pregnant
* Cognitively impaired
* Disruption of skin integrity in the TENS application area

Primary outcomes:
measure: Pain intensity
timeFrame: Until the end of 3 month
measure: Lymphedema severity
timeFrame: Until the end of 3 month
measure: Shoulder and arm mobility
timeFrame: Until the end of 3 month
Secondary outcomes:
measure: Upper extremity functions
timeFrame: Preoperative period, postoperative 1 month and postoperative 3 month
measure: Cancer Related Quality of Life
timeFrame: Preoperative period, postoperative 1 month and postoperative 3 month
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
References:
citation: Akutay S, Yuceler Kacmaz H, Ceyhan O. The healing power of transcutaneous electrical nerve stimulation: a systematic review on its effects after breast surgery. Support Care Cancer. 2025 Jan 13;33(2):90. doi: 10.1007/s00520-024-09129-3.
Clinical trial NCT01288365: The Impact of Exercise Training on Functional Capacity in Heart Failure
Official title: Impact of Exercise Training on Functional Capacity in Heart Failure Patients With Preserved Ejection Fraction.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: heart failure
preserved ejection fraction
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Clalit Health Services
name: Hadassah Medical Organization
First posted: 2011-02-02
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether exercise training will improve functional capacity in patients with heart failure and preserved ejection fraction.


Eligibility criteria: Inclusion Criteria:

* Clinical heart failure
* Preserved ejection fraction (\>50%)
* Stable clinically
* New York Heart Association Class II-III

Exclusion Criteria:

* Unable to exercise
* Other debilitating or unstable disease limiting length of life
* Implanted pacemaker

Primary outcomes:
measure: Change from baseline of peak oxygen uptake on graded exercise.
timeFrame: After 3 month exercise training
Secondary outcomes:
measure: Change from baseline of six minute walk
timeFrame: After 3 month exercise training
measure: Change from baseline of NYHA class
timeFrame: After 3 month exercise training
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
Study officials:
affiliation: Hadassah University Hospital
name: Israel Gotsman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01586065: Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes
Official title: Use of CGM in Adolescents With Poorly-controlled Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
adolescents
poor control
CGM
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2012-04-26
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if children and adolescents with poorly controlled type 1 diabetes will benefit from using a continuous glucose monitor (CGM), a device that can be used to check blood sugars.

Detailed description: Adolescents with type 1 diabetes, HbA1c ≥9% on insulin pumps were admitted to the clinical research center and a continuous glucose sensor was inserted. Sensor glucose (SG) values were compared to plasma glucose measured at least hourly using Yellow Springs Instrument's (YSI) glucose analyzer. SG rather than YSI was used for treatment decisions unless YSI was \<70 mg/dL or specific criteria indicating SG and YSI were very discordant were met.

Eligibility criteria: Inclusion Criteria:

* 12 to \<18 years old
* T1D for at least one year
* Treatment with insulin pump therapy
* A1c ≥9%
* Willingness to comply with study procedures

Exclusion Criteria:

* Current diabetic ketoacidosis
* Hypoglycemia unawareness
* Chronic use of medications that affect recognition of hypoglycemia (e.g., beta blockers)
* Chronic use of medications that mimic symptoms of high or low blood sugars (e.g., decongestants)
* Recent or frequent severe hypoglycemia (2 episodes in the last year; 1 episode in the last 6 months)
* Skin rashes or conditions that may affect CGM placement and wear

Primary outcomes:
measure: Number of High Glucose Correction Doses Administered.
timeFrame: 24 hrs
Secondary outcomes:
measure: Pre- and Post-meal (2-3 Hour) Glucose Levels
timeFrame: 24 hours
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
Study officials:
affiliation: Nemours Children's Clinic
name: Larry A Fox, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fox LA, Balkman E, Englert K, Hossain J, Mauras N. Safety of using real-time sensor glucose values for treatment decisions in adolescents with poorly controlled type 1 diabetes mellitus: a pilot study. Pediatr Diabetes. 2017 Jun;18(4):271-276. doi: 10.1111/pedi.12404. Epub 2016 Jul 20.
Clinical trial NCT06385665: The Effect of Appropriate Family Companionship on the Physical and Mental Health of Patients With Advanced Breast Cancer
Official title: The Effect of Appropriate Family Companionship on the Physical and Mental Health of Patients With Advanced Breast Cancer:A Real World Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 304
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to learn about companionship needs in breast cancer patients who are pathologically or cytologically diagnosed as cancer, are alive with the tumor, and have TNM clinical stage IV. The main questions it aims to answer are:

1. Patients with advanced breast cancer need family companionship
2. Analyze and study the reasons and factors that affect the physical and mental impact of effective family companionship on patients with advanced breast cancer Participants will be divided into a companion group and a non-accompaniment group. Patients in the companion group are given graded companion intervention methods. A comparison group: Researchers will compare a non-accompaniment group to see if the physical and mental impact of companionship on patients.


Eligibility criteria: Inclusion Criteria:

* Breast cancer patients who are pathologically or cytologically diagnosed as cancer
* TNM clinical stage IV

Exclusion Criteria:

* Terminal cancer patients who are mentally ill or confused and refuse to participate in the survey

Primary outcomes:
measure: Change from Baseline meatal state on GAD-7 at Week 48.
timeFrame: Baseline and Week 48
measure: Change from Baseline physical state on kps at Week 48.
timeFrame: Baseline and Week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study officials:
affiliation: Wuhan Union Hospital, China
name: Deyin Hu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00932165: Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin
Official title: Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin (Regulatory Post Marketing Commitment Plan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-03
Enrollment: 451
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A5991078 prescribes the Exemestane (Aromasin).

Brief summary: The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed description: All the patients whom an investigator prescribes the first Exemestane (Aromasin) should be registered.

Eligibility criteria: Inclusion Criteria:

* Subjects with postmenopausal breast cancer (including ovariectomy etc.).

Exclusion Criteria:

* Patients cannot be evaluated.For example, not administered Exemestane (Aromasin).

Primary outcomes:
measure: Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane
timeFrame: 24 weeks
measure: Number of Participants With Performance Status Score Based on Eastern Cooperative Oncology Group (ECOG) Factors Considered to Affect the Safety and/or Efficacy of Exemestane
timeFrame: 24 weeks
measure: Number of Participants With Adverse Drug Reaction
timeFrame: 24 weeks
measure: Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment
timeFrame: 24 weeks
measure: Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status
timeFrame: 24 weeks
Secondary outcomes:
measure: Number of Participants With Unexpected Adverse Drug Reaction
timeFrame: 24 weeks
measure: Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction
timeFrame: 24 weeks
measure: Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03413865: Telemedicine Clinic for Prostate Cancer Patients
Official title: A Pilot Study of a Nurse and Pharmacist Led OTN (Ontario Telemedicine Network) Based Clinic for Management of Prostate Cancer Patients on Oral Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer, Treatment-Related
Lead sponsor: Grand River Hospital
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This randomized, open label study will evaluate a nurse and pharmacist led clinic conducted remotely from Grand River Regional Cancer Centre at Grand River Hospital (GRRCC/GRH) using OTN teleconferencing as a platform for patients with prostate cancer receiving oral chemotherapy agents.


Eligibility criteria: Inclusion Criteria:

1. Male over 18 years of age with prostate cancer receiving oral treatment with abiraterone or enzalutamide.
2. Ability to provide consent to study.
3. Willingness to complete study questionnaires and a semi-structured exit interview.
4. Adequate command of the English language to complete study questionnaire and survey.
5. Access to technology to allow a link to the virtual telemedicine clinic. (excluding control group)
6. Willingness to participate in videoconference with pharmacist or nurse from their home environment. (excluding control group)

Exclusion Criteria:

1. Patients receiving oral anti-cancer therapy other than abiraterone and enzalutamide.
2. Patients lacking the technology at home to participate in the virtual telemedicine clinic. (excluding control group)

   -

Primary outcomes:
measure: Patient satisfaction with overall care
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Kitchener
country: Canada
facility: Grand River Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT02311465: A Randomized Study of Early Palliative Care
Official title: A Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Oncology Care Alone in Patients With Non-colorectal Gastrointestinal Malignancies.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Quality of Life
Keywords: Palliative Care
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 0
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: The purpose of this research study is to find out whether it is better to introduce cancer patients to the palliative care team at a later date when there is a specific issue or problem or to introduce cancer patients to the palliative care team when first diagnosed before any specific issue or problem occurs.

Detailed description: The investigators will conduct a one-year randomized, controlled study to evaluate the impact of an early, integrated palliative care services. The intervention will include comprehensive palliative care services delivered in conjunction with standard oncology care and patient friendly materials for high risk oncology patients. The investigators primary clinical endpoint will be health related quality of life, specifically focusing on measures of anxiety, depression, and well-being.

Secondary personalized palliative care outcomes are expected to include:

* Reduced deviations from care plan as captured in the medical record compared to the group who did not receive early, integrated palliative care services
* Reduced hospital utilization compared to the group who did not receive early, integrated palliative care services

Eligibility criteria: Inclusion Criteria:

* -Adults with newly diagnosed pancreatic, hepatocellular, esophageal, or stomach cancer
* Upcoming scheduled oncology clinic visit (2nd visit to the clinic) at Vanderbilt
* Ability to read and respond to questions in English
* Permission of oncology physician

Exclusion Criteria:

* -Receiving oncology care at non-Vanderbilt sites (to ensure appropriate follow-up)
* Participation in another clinical trial

Primary outcomes:
measure: Functional Assessment of Cancer Therapy: General (FACT-G) Health Related Quality of Life Questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: PROMIS Depression Scale
timeFrame: 1 year
measure: PROMIS Anxiety Scale
timeFrame: 1 year
measure: Hospitalizations
timeFrame: 1 year
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Gordon Bernard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03354065: Inmediate Feeding Tolerance in Acute Pancreatitis
Official title: Inmediate Feeding Tolerance in Patients With Mild and Acute Biliary Pancreatitis vs Early Feeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pancreatitis Due to Gallstones
Keywords: pancreatitis
mild
biliary
referring
Lead sponsor: Hospital Central "Dr. Ignacio Morones Prieto"
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 59
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: Determine tolerance of immediate oral intake (8 hours posterior to the beginning of treatment) against traditional management (early feeding at 48hr) in patients with mild acute pancreatitis of biliary origin.

Double blind, randomized clinical trial

Detailed description: The investigators included patients 15 - 85 years old, any sex. Diagnosis of mild acute pancreatitis according to the Ranson, APACHE II and BISAP.

Signed infromed consent to participate in the study. All participants had a hepatic and biliary ultrasound to determine the biliary etiology.

The investigators excluded patients with pancreatitis of nonbiliary etiology, pregnant, severe pancreatitis, cholangitis or choledocholithiasis demonstrated during the hospital stay or with other comorbidities.

Eligibility criteria: Inclusion Criteria:

Patients older than 15 years.

* Patients with a diagnosis of mild acute pancreatitis biliary.
* Patients who agree to enter the protocol.

Exclusion Criteria:

* Patients managed at another institution.

  * Patients with a diagnosis of pancreatitis of non-biliary etiology.
  * Patients with heart disease or lung disease.
  * Patients with organic failure.
  * Patients with pregnancy.
  * Patients with cholangitis.

Primary outcomes:
measure: Pancreatitis reactivation after oral Feeding
timeFrame: Measures at 24hours after the begining of the oral intake
measure: Pancreatitis reactivation after oral Feeding
timeFrame: Measures at 48hours after the begining of the oral intake
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Postgraduate office at UASLP
name: Juan F Hernandez
role: STUDY_CHAIR
References:
Clinical trial NCT01979965: Effect of Ranolazine on Valvular Disease in Patients With Pacemakers
Official title: Ranolazine Effects on Ischemic Mitral Regurgitation Severity in Patients With Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ischemic Mitral Regurgitation
Keywords: Mitral Regurgitation
cardiac resynchronization therapy
ranolazine
maximal medical therapy
ischemic cardiomyopathy
Lead sponsor: University Cardiology
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 50
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: The purpose of this study is to find out whether mitral regurgitation (or a leaky heart valve) caused by ischemic heart disease (decreased blood flow to heart muscle) will improve after administration of ranolazine.


Eligibility criteria: Inclusion Criteria:

* Ischemic cardiomyopathy AND
* Moderate or severe mitral regurgitation AND
* Cardiac resynchronization therapy (CRT) ≥ 3 months prior to enrollment AND
* Maximal Medical Therapy (ACE-Inhibitor, beta blocker, aldosterone antagonist, diuretic, aspirin, statin)

Exclusion Criteria:

* nonischemic cardiomyopathy
* active heart failure
* current ranolazine therapy
* congenital heart disease
* mechanical valve prostheses
* vegetation/endocarditis
* significant pulmonary disease
* peripheral vascular disease
* trivial or mild mitral regurgitation
* creatinine clearance \< 30 mL/min
* liver cirrhosis
* strong inhibitors of CYP3A (including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)
* strong inducers of CYP3A (including rifampin, rifapentine, phenobarbital, phenytoin, carbamazepine and St.John's wort)
* Strong P-glycoprotein inhibitors (including cyclosporine, verapamil, and quinidine)
* Initial QTc interval ≥ 440msec

Primary outcomes:
measure: effective regurgitant orifice by echocardiography
timeFrame: Day T = 90 days
measure: proximal isovelocity surface area by echocardiography
timeFrame: T = 90 days
Secondary outcomes:
measure: Seattle Angina Questionnaire
timeFrame: T = 0 days, and T = 90 days
measure: Rose Dyspnea Scale
timeFrame: T = 0 days, and T= 90 days
Other outcomes:
measure: Adverse Reactions
timeFrame: T = 90 day
Locations:
city: Knoxville
country: United States
facility: University Cardiology
state: Tennessee
Study officials:
affiliation: University Cardiology
name: Raj Baljepally, MD
role: PRINCIPAL_INVESTIGATOR
References: