louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00557791: Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (CARBON)
Official title: A Phase 3, Randomized, Double-masked, Parallel-assignment and Dose-finding Study of Intravitreal Bevasiranib Sodium, Administered Every 8 Weeks as Maintenance Therapy Following Three Injections of Lucentis® Compared With Lucentis® Monotherapy Every 4 Weeks in Patients With Exudative Age-Related Macular Degeneration (AMD).
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Age Related Macular Degeneration
Keywords: AMD
ARMD
Exudative Macular Degeneration
Bevasiranib
siRNA
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2007-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 50
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 compare the safety and effectiveness of three doses of intravitreal bevasiranib sodium as maintenance therapy for Age-Related Macular Degeneration following initiation of anti-VEGF therapy with three doses of Lucentis®.


Eligibility criteria: Inclusion Criteria:

* Patients must be age 50 years or older
* Patients must have predominantly classic, minimally classic or occult with no classic lesions secondary to Age Related Macular Degeneration.
* The study eye must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen equivalent).
* Patients must be willing and able to return for scheduled monthly follow-up visits for two-years.

Exclusion Criteria:

* Prior pharmacologic treatment for AMD in the study (patients can not have previously received Avastin®/Lucentis®, Macugen®, or any other anti-VEGF agents, steroid treatments, PDT, radiation treatment, or any experimental therapies for AMD in the study eye)
* Any intraocular surgery of the study eye within 12 weeks of screening
* Previous posterior vitrectomy of the study eye
* Advanced glaucoma or intraocular pressure above 22 mm Hg in the study eye despite treatment.

Primary outcomes:
measure: Primary efficacy measure: The proportion of patients at week 60 in each group with a successful visual acuity outcome (as defined as avoidance of a 3, or more, line loss in vision).
timeFrame: 60 weeks
Secondary outcomes:
measure: Time from tx initiation to 1st use of rescue
timeFrame: 60 weeks
measure: Distribution of change in VA from baseline to 60 weeks
timeFrame: 60 weeks
measure: Proportion of patients at week 60 with a 3, or more, line gain in vision
timeFrame: 60 weeks
Other outcomes:
Locations:
Study officials:
affiliation: SVP at Opko Health
name: Naveed Shams, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05662891: The Effect of Blood Flow Restriction Applied During Nordic Hamstring Exercise
Official title: The Effect of Blood Flow Restriction Applied During Nordic Hamstring Exercise on Neuromuscular Activation and Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Hamstring Injury
Keywords: blood flow restriction
nordic hamstring exercise
endothelial function
muscular activation
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled single-blind study
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of blood flow restriction applied during nordic hamstring exercise on neuromuscular activation and endothelial function.


Eligibility criteria: Inclusion Criteria: Ankle arm index above 0.9

-

Exclusion Criteria:

* Having chronic diseases such as coronary heart disease, kidney diseases, diabetes, uncontrollable hypertension
* Having a history of deep vein thrombosis
* Having a previous hamstring injury
* To smoke
* Having a Body Mass Index over 25
* Having a history of major surgery

Primary outcomes:
measure: Endothelial function
timeFrame: It was evaluated for the control and experimental extremities before exercise.
measure: Surface EMG
timeFrame: During exercise
measure: Endothelial function
timeFrame: It was evaluated for the control and experimental extremities 15 minutes after exercise. ( Outcomes were evaluated as acute.)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
state: Çankaya
Study officials:
References:
Clinical trial NCT06323291: Cancer Coaching and Remote Education for Self-Empowerment (CARES) Study
Official title: Cancer Coaching and Remote Education for Self-Empowerment (CARES) Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Pancreatic Cancer
Keywords: Pancreas
Pancreatic Cancer
Caregiver
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Canopy Cancer Collective
First posted: 2024-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This Pilot Study will evaluate a 12-week pilot program that offers digital health coaching for individuals with pancreatic cancer and their caregivers.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* Participant must have a pancreatic cancer diagnosis or be a caregiver such as a friend or spouse.
* Participant must be planning to receive treatment and/or care management at Moffitt Cancer Center.
* Participant must be able to speak and read English.
* Participant must be able to provide informed consent.

Exclusion Criteria:

* Documented or observable psychiatric or neurological disorder that would interfere with study participation such as severe dementia
* Any participant that does not meet all inclusion criteria will be excluded.

Primary outcomes:
measure: Recruitment Rate
timeFrame: Up to 12 Months
measure: Participant Acceptance of the Digital Health Coaching Program
timeFrame: Up to 12 Weeks
measure: Participant Ease of Usability of the Digital Health Coaching Program
timeFrame: Up to 12 Weeks
measure: Feasibility of Utilizing the Digital Health Coaching Program
timeFrame: Up to 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Amir Alishahi Tabriz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Pamela Hodul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02731391: Clinical Research on Bowel Symptoms of Patient With Pelvic Organ Prolapse
Official title: Clinical Research on Bowel Symptoms of Patients With Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bowel Symptoms
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the prevalence of bowel symptoms in patients with pelvic organ prolapse.


Eligibility criteria: Inclusion Criteria:

* The patients with stage\>2 POP are recruited.The patients are all received surgeries, which include transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis.

Exclusion Criteria:

* Gestation；
* Inflammatory bowel disease；
* Slow transit constipation diagnosed by Colonic transit test；
* Unable to follow up.

Primary outcomes:
measure: change in the prevalence of bowel symptoms
timeFrame: baseline,1,3,6,12 months after operation.
measure: change in the severity of intestinal symptoms
timeFrame: baseline,1,3,6,12 months after operation.
Secondary outcomes:
measure: change in the quality of life
timeFrame: baseline,1,3,6,12 months after operation.
measure: length of the high-pressure zone recorded by anorectal manometry
timeFrame: baseline and 12 months after operation
measure: rectoanal inhibitory reflex recorded by anorectal manometry
timeFrame: baseline and 12 months after operation
measure: Rectal-Vaginal pressure interval during maximum Vasalva
timeFrame: baseline and 6 months after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06082791: A Clinical Validation Study to Evaluate the Diagnostic Accuracy of a Cough-based Auxiliary Diagnosis Algorithm for COPD
Official title: A Clinical Validation Study to Evaluate the Diagnostic Accuracy of a Cough-based Auxiliary Diagnosis Algorithm for Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD
Cough
Algorithm
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: three cohorts are included COPD respiratory disease without cold healthy people

Brief summary: Cough is one of the most common symptoms in COPD patients, and its different characteristics in amplitude, frequency and waveform can be analyzed by intelligent algorithms for the auxiliary diagnosis of COPD. The current study is to conduct external clinical validation of COPD auxiliary diagnosis algorithm and lung function prediction algorithm, and preliminatively verify the performance of the algorithm, with the ultimate goal of developing a portable and rapid COPD auxiliary diagnosis and condition assessment tool that can be used at home.


Eligibility criteria: Inclusion Criteria:

* patients with stable COPD were recruited for this study. Inclusion criteria were age ≥40 years and a diagnosis of COPD

Exclusion Criteria:

* Exclusion criteria were acute exacerbations of respiratory symptoms within the past 2 weeks or significant comorbid cardiovascular, neurological, musculoskeletal, immunological, or infectious diseases.

Primary outcomes:
measure: Positive Agreement Rate (PPA)
timeFrame: 12.30.2024
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT05497791: Stroke, Measurement and Rehabilitation
Official title: Stroke, Measurement and Rehabilitation With Transcranial Laser Stimulation Plus Neuromuscular Electrical Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Photobiomodulation
Electrical Stimulation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 18
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized and placebo-controlled.
Primary purpose: TREATMENT

Brief summary: The main aim of the study was to investigate the effects of transcranial laser stimulation together with neuromuscular electrical stimulation (NMES) in post-stroke patients.

Detailed description: Post-stroke sequelae includes loss functions, such as cognitive and sensory-motor which lead to emotional and social problems, reducing quality of life and well-being. The main aim of the study was to investigate the effects of transcranial laser stimulation together with neuromuscular electrical stimulation (NMES) in post-stroke patients. The clinical trial showed improvement of cognitive function, pain relief, greater manual dexterity, enhancement of physical and social-emotional health which lead to better quality of life and well-being. There was also increased temperature in the treated regions with laser and NMES. Therefore, transcranial laser stimulation associated with NMES can be an important therapeutic resource for rehabilitation after stroke.

Eligibility criteria: Inclusion Criteria:

* Female and male aged between 35 and 75 years with hemiplegia after stroke (more than 12 months from onset) as well as those who experienced only one episode of stroke.

Exclusion Criteria:

* Bedridden stroke patients, who had great difficulty standing and walking, psychiatric illnesses, endocrinopathies, heart diseases, severe osteoporosis, cancer, musculoskeletal injuries or disorders in the last six months as well as practitioners of regular physical activity, physical therapy or occupational therapy.

Primary outcomes:
measure: Inertial Sensor
timeFrame: 3 months
measure: Subjective pain scale
timeFrame: 3 months
measure: Cognitive status
timeFrame: 3 months
Secondary outcomes:
measure: Grip strength
timeFrame: 3 months
measure: Gross manual dexterity
timeFrame: 3 months
measure: Dynamic balance
timeFrame: 3 months
measure: Spasticity
timeFrame: 3 months
measure: Functional status
timeFrame: 3 months
measure: Quality of Life status
timeFrame: 3 months
measure: Well-Being status
timeFrame: 3 months
measure: Thermography
timeFrame: 3 months
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Fernanda Rossi Paolillo
state: São Paulo
Study officials:
affiliation: UEMG
name: Fernanda R Paolillo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00527891: Evaluation of the Signa Excite 3.0 T MRI Excite for Detection and Characterization of Liver Lesions
Official title: Evaluation of the Signa Excite 3.0 T MRI Excite for Detection and Characterization of Liver Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cancer
Keywords: Liver Cancer
Magnetic Resonance Imaging
Signa Excite 3.0T MRI Scan
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-09-11
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled and are eligible for an MRI of the abdomen or MRI of the liver or MRI of the kidney examination at UT MD Anderson Cancer Center.

Brief summary: Primary Objective:

1. To compare the efficacy of 1.5T vs. 3T T1 and T2-weighted MR images sequences for the detection and evaluation of liver lesions.

Detailed description: Magnetic resonance imaging is taken with scanners at different magnetic field strength. The current practice at UTMDACC is to perform these exams at 1.5 Tesla. Tesla is the unit of strength of the magnetic field. This study will compare the images taken at the standard 1.5 Tesla (T) magnetic field with those at the newer 3.0T magnetic field.

You are already scheduled to receive a standard 1.5 T MR of the liver area as requested by your doctor. As part of this study, you will then be asked to return on a separate date to have a similar exam performed with the Signal 3.0T Excite MR scanner. You will return within a two week period from the date of your first MRI examination. The examination will be performed in a machine that looks similar to the 1.5T scanner. It will also take about the same amount of time as the examination at 1.5T.

The images taken by both scanners will be evaluated and compared. After you have had the second scan, your participation in this study will be over. If there are new findings identified with the new scan your doctor will be notified.

This is an investigational study. The 3.0T scan will be performed free of charge. A total of 20 patients will take part in this study All will be enrolled at UTMDACC.

This protocol is partially funded by a research grant from General Electric Medical Systems (GEMS).

Eligibility criteria: Inclusion Criteria:

1. Patients with a liver lesion larger than 1cm detected by a prior imaging modality.
2. Patients have been scheduled and are eligible for an MRI of the abdomen or MRI of the liver or MRI of the kidney examination.

Exclusion Criteria:

1) Patients who are unable to cooperate with breath hold.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: U.T.M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Janio Szklaruk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06870591: Pivotal Study for the Cardiac Performance System (CPS)
Official title: Pivotal Method-Comparison Study for the Cardiac Performance System (CPS) to Measure Hemodynamic Parameters
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Keywords: Cardiac Performance System
CPS
Hemodynamic Parameters
Right Heart Catheterization
Lead sponsor: Sensydia Corporation
Sponsor class: INDUSTRY
First posted: 2025-03-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of adult patients aged 18 years and older who are scheduled to undergo clinically indicated right heart catheterization as part of their standard medical care. Participants will represent a diverse range of individuals with conditions requiring invasive hemodynamic assessment.

Brief summary: This multi-center, observational study evaluates the accuracy of the Cardiac Performance System (CPS), a non-invasive device, for measuring hemodynamic parameters in adult patients undergoing clinically indicated right heart catheterization. The study compares CPS measurements to invasive measurements to assess agreement and potential clinical utility.

Detailed description: The study will enroll adults undergoing right heart catheterization as part of their clinical care. A single CPS measurement will be performed before the scheduled procedure. Data from both CPS and catheterization measurements will be analyzed to assess agreement. No investigational treatment or additional follow-up visits are required.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or older
* Scheduled for clinically indicated right heart catheterization
* Ability to provide informed consent

Exclusion Criteria:

* Heart transplant recipients
* Patients with a left ventricular assist device (LVAD)
* Presence of external devices (e.g., Holter monitors) or surgical scars/wounds that interfere with CPS measurements
* Measurement concerns related to data reliability or quality

Primary outcomes:
measure: Cardiac Performance System electronic data for Pulmonary Pressure
timeFrame: Single measurement prior to right heart catheterization
measure: Pulmonary artery catheter electronic data for Pulmonary Pressure
timeFrame: During right heart catheterization procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Huntsville Hospital Heart Center
state: Alabama
city: Germantown
country: United States
facility: The Stern Cardiovascular Foundation, Inc. / Baptist Memorial Hospital
state: Tennessee
Study officials:
References:
Clinical trial NCT03446391: Matched Pair Study - Kinematic Vs Mechanical Alignment
Official title: Matched Pair Study to Assess Influence of Kinematic Versus Mechanical Alignment in Total Knee Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Joint Disease
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2018-02-26
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited during the preoperative visit at the investigational site. All patients scheduled for a total knee replacements, meeting the inclusion criteria and none of the exclusion criteria will be invited to the study.

Brief summary: The aim of this study is to evaluate postoperative knee function after total knee arthroplasty performed according to the anatomical alignment and compare these results to those of a matched historical cohort of patients operated with mechanical alignment.

Detailed description: The 25 patients, of the Kinematic group, are prospectively enrolled. While, the data of patients of the Mechanical group, are retrospectively collected from an historical collection.

Eligibility criteria: Inclusion Criteria:

1. Patients presenting with disease that meets the indications for use for Medacta implants defined by this study (on-label use).
2. Patients necessitating primary Total Knee Replacement
3. Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.

Exclusion Criteria:

1. Those with one or more medical conditions identified as a contraindication defined by the labeling on Medacta implants used in this study.
2. Previous osteotomy around the knee
3. Ligament instability likely to require higher level of constraint
4. Previous infection or inflammatory disease
5. Extraarticular deformities for which a femoral intramedullary guide rod can't be inserted into the canal and use of Computer Assisted Orthopaedic Surgery (CAOS) or Patient Specific Instrumentation (PSI) is required.

Primary outcomes:
measure: Compare clinical outcomes of mechanical vs kinematic with new Knee Society Score
timeFrame: 1-year follow-up
Secondary outcomes:
measure: Patient functional improvement, satisfaction and symptoms
timeFrame: 1-year follow-up
measure: Residual deformity
timeFrame: 1-year follow-up
measure: Flexion-extension contracture
timeFrame: 1-year follow-up
measure: Self-reported pain, function and stiffness
timeFrame: 1-year follow-up
measure: Ability to forget about artificial joint
timeFrame: 1-year follow-up
Other outcomes:
Locations:
city: Brakel
country: Germany
facility: St. Vinzenz Krankenhaus Brakel
state: North Rhine-Westphalia
Study officials:
References: