louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06084650: Optical Coherence Tomography (OCT) and OCT Angiography(OCTA) Deep Learning in Waldenström's Macroglobulinemia Patients
Official title: OCT and OCTA Deep Learning in Waldenström's Macroglobulinemia Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Waldenstrom Macroglobulinemia
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participans were older than 18 years with diagnosis of Waldenstrom Macroglobulinemia. They did not present other ophthalmological disease

Brief summary: This study evaluates the ability of deep learning to improve the knowledge about structural and vascular retinal changes in Waldenström's Macroglobulinemia patients, using optical coherence tomography angiography.

Detailed description: Waldenstrom macroglobulinemia (mak-roe-glob-u-lih-NEE-me-uh) is a rare type of cancer that begins in the white blood cells.

The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features. The study evaluates the changes in optical coherence tomography angiography features in Waldenstrom macroglobulinemia, elaborating these data with artificial intelligence.

Eligibility criteria: Inclusion Criteria:

* age older than 18 years

  * diagnosis of Waldenstrom Macroglobulinemia
  * absence of previous ocular surgery and congenital eye diseases.
  * absence of errors of refraction
  * absence of lens opacities
  * absence of low-quality OCT and OCTA images

Exclusion Criteria:

* • age younger than 18 years

  * previous ocular surgery and congenital eye diseases
  * errors of refraction
  * lens opacities
  * low-quality OCT and OCTA images

Primary outcomes:
measure: The measurements of retinal and choriocapillary vessel density in Waldenstrom Macroglobulinemia patients.
timeFrame: up to three months
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: University of Naples "Federico II" Naples, Italy, 80100 Contact: Gilda Cennamo, MD 00390817143731 xgilda@hotmail.com
Study officials:
References:
Clinical trial NCT06245850: Impact of Baduanjin Exercise Combined With Rational Emotive Behavior Therapy on Sleep and Mood in Patients With Post-stroke Depression
Official title: Impact of Baduanjin Exercise Combined With Rational Emotive Behavior Therapy on Sleep and Mood in Patients With Post-stroke Depression: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients and their families all agreed .


Eligibility criteria: Inclusion Criteria:

1. Conformity to the diagnostic criteria for stroke in the \&#34;Diagnostic Essentials of Various Cerebrovascular Diseases\&#34; revised by the Fourth National Cerebrovascular Academic Conference, and confirmed by cranial CT or MRI.
2. The course of stroke was 2 weeks to 6 months, with steady conditions and stable vital signs.
3. The age ranged from 30 to 80 years old, with at least a junior high school education.
4. The patients had no serious intellectual, language comprehension and behavioral disorders, and could complete the assessment of scales.
5. Achieving a sitting balance of at least reaches level 3, Brunnstrom stage IV or above, and being able to complete Baduanjin training.
6. The National Institutes of Health Stroke Scale (NIHSS) ≤ 15 points.
7. Conforming to the diagnostic criteria for depression in the \&#34;Chinese Experts Consensus on Clinical Practice of Post-Stroke Depression\&#34;.

Exclusion Criteria:

The exclusion criteria:

1. Disturbance of consciousness, unable to cooperate with polysomnography (PSG) and scale evaluators.
2. Pre-existing diagnosis of depression before stroke.
3. Severe pre-existing sleep disorders before stroke.
4. Patients with mental illness, immune system disorders, severe liver and kidney dysfunction, and severe cardiopulmonary dysfunction

Primary outcomes:
measure: HAMD score
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan
state: Henan
Study officials:
References:
Clinical trial NCT02283450: Regulation of Immunological Cytokines by Qiliqiangxin Capsule in Dilated Cardiomyopathy Patients
Official title: Regulation of Immunological Cytokines by Qiliqiangxin Capsule in Dilated Cardiomyopathy patients--a Randomized Double Blind Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: congestive heart failure.

Brief summary: Purpose :Research into the impact of Qiliqiangxin capsule on IFN-γ，IL-4，NT-proBNP in dilated cardiomyopathy patients with heart failure.

Methods :Data were collected from the patients with idiopathic dilated cardiomyopathy ( cardiac function NYHA Ⅱ-Ⅳ) in the first affiliated hospital of Harbin Medical University from May 2012 to April 2014. These 30 cases were treated under the recommendations of normal diagnosis and treatment in cardiomyopathy. This experiment was randomized double-blinded，the experimental interferences were avoided and patients were divided into the experimental group and the placebo group. The patients in experimental group received the relevant tests and inspections before the beginning of experiment，signed the informed consent. Then the investigators get the venous blood centrifugalization and cryopreservation. The patients take the medicine qiliqiangxin three times per day，four tablets at a time. Afrer a month，the investigators evaluated the symptoms，the function of heart，blood pressure，heart rate and keep blood specimens. Three and six month later，electrocardiogram and echocardiography were taken and the determination of the NT - proBNP was done. The placebo group was followed up in the same way.


Eligibility criteria: Inclusion Criteria:

* Congetive heart failure

Exclusion Criteria:

* Valvular heart diseases

Primary outcomes:
measure: cytokine level at 3 months
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03309150: ATRi Transition Rollover Study
Official title: A Rollover Study to Provide Continued Treatment With M6620
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Stage Solid Tumors
Keywords: Ataxia telangiectasia mutated and Rad3-related protein inhibitor (ATRi)
M6620
Solid tumors
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2017-10-13
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of the study was to monitor the safety of participant receiving long-term treatment of Berzosertib as monotherapy.


Eligibility criteria: Inclusion Criteria:

* Participants ongoing treatment in Vertex study VX13-970-002.
* Participant must be able to understand and provide written informed consent.
* Participant must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures.

Exclusion Criteria:

* Participants experiencing disease progression or unacceptable toxicity at the time of transition into the this study.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Treatment Related AEs
timeFrame: Up to 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
Clinical trial NCT00239850: Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery
Official title: Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: obesity
lifestyle
treatment
Complications
endocrine changes
Lipids
C18.654.726.500.495
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2005-10-17
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of conservative treatments of obesity with surgery (gastric bypass).

Detailed description: The aim of this study is to evaluate 3 different treatments of obesity with gastric bypass. Two groups will be treated in different clinics and 1 group will be treated at our outpatient clinic. Sixty patients will participate in each group. Behavioural changes and weight loss over 4-5 years will be followed. We will also analyse changes in hormones, mental status, sexual behaviour, effect of training and quality of life.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) \> 40 or BMI \> 35 with complications

Exclusion Criteria:

* Unstable atherosclerotic disease
* Psychologically unstable
* Unable to participate in the training program

Primary outcomes:
measure: weight reduction
measure: quality of life
Secondary outcomes:
measure: reduction in obesity complications
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital, Trondheim
name: Baard Kulseng, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Olavs Hospital, Trondheim
name: Ronald Mårvik, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martins C, Strommen M, Stavne OA, Nossum R, Marvik R, Kulseng B. Bariatric surgery versus lifestyle interventions for morbid obesity--changes in body weight, risk factors and comorbidities at 1 year. Obes Surg. 2011 Jul;21(7):841-9. doi: 10.1007/s11695-010-0131-1.
citation: Ovrebo B, Strommen M, Kulseng B, Martins C. Bariatric surgery versus lifestyle interventions for severe obesity: 5-year changes in body weight, risk factors and comorbidities. Clin Obes. 2017 Jun;7(3):183-190. doi: 10.1111/cob.12190. Epub 2017 Mar 20.
Clinical trial NCT01519050: Predictors of Postoperative Left Ventricular Function in Patients Undergoing Mitral Valve Repair for Severe Degenerative Mitral Regurgitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Degenerative Mitral Regurgitation
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2012-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 patients with mitral valve proplapse ondergoing mitral valve repair for severe mitral regurgitation

Brief summary: The aim of the study is to investigate whether a predictive score (combination of several validated predictors) better predicts postoperative left ventricular function than any single predictor in patients undergoing mitral valve repair for degenerative mitral regurgitation.

A single center, prospective cohort study


Eligibility criteria: Inclusion criteria:

* Age 18- 85 years
* Patients with severe degenerative mitral regurgitation undergoing mitral valve repair at our institution

Exclusion criteria:

* Functional or ischemic mitral regurgitation
* Presence of relevant (symptomatic) Coronary Artery Disease
* Inability of exercising on semi supine bicycle

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Cardiology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Cardiology
name: Patric Biaggi, MD, Senior physican
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01786850: Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer
Official title: Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer: Phase II Study for Pain Palliation and Local Tumor Control
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Pancreas
Cancer
Locally Advanced Pancreatic Cancer
Non-invasive Treatment
Keywords: Locally advanced Pancreatic Cancer
Noninvasive treatment
High Intensity focused ultrasound
Magnetic Resonance
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2013-02-08
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT

Brief summary: Patients with unresectable pancreatic cancer in most of cases cannot benefit from percutaneous ablation modalities, due to high risk of procedure-related complications. Ultrasound-guided high intensity focused ultrasound (HIFU) ablation has been introduced as a feasible treatment option in these patients. However, in other anatomical regions US-guided HIFU has been replaced by the more accurate MR-guided focused ultrasound (MRgFUS) ablation, but the applicability of this latter technique to the treatment of pancreatic cancer is still unexplored. The aim of this study is to explore feasibility and clinical performance of MRgFUS ablation of unresectable pancreatic cancer. Two are the main end-points: Pain palliation and local tumor control.

As compared to conventional US-guided HIFU, MRgFUS could represent a more accurate, non-invasive ablation modality even for unresectable pancreatic cancer although, to date, no cases of pancreatic MRgFUS ablation have been reported.


Eligibility criteria: Inclusion Criteria:

* biopsy proven unresectable pancreatic adenocarcinoma;
* unable or not willing to undergo chemo-radiation therapy
* Celiac plexus alcoholization failed to control pain symptoms

Exclusion Criteria:

* contraindication to MR or general anesthesia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sapienza University of Rome, Policlinico Umberto I Hospital
Study officials:
affiliation: Sapienza University of Rome, Policlinico Umberto I Hospital
name: alessandro napoli
role: PRINCIPAL_INVESTIGATOR
affiliation: Sapienza University of Rome, Policlinico Umberto I Hospital
name: carlo catalano
role: STUDY_CHAIR
affiliation: Sapienza University of Rome, Policlinico Umberto I Hospital
name: michele anzidei
role: STUDY_DIRECTOR
References:
Clinical trial NCT01707550: An Observational Study of CellCept (Mycophenolate Mofetil) in Renal Allograft Recipients
Official title: Observational, Non-interventional Survey of Renal Allograft Recipients Receiving CellCept as Part of Their Immunosuppressive Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-10-16
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Renal allograft recipients receiving CellCept as part of their immunosuppressive protocol

Brief summary: This observational survey study will capture all renal transplant patients in Serbia who are currently receiving CellCept (mycophenolate mofetil) as part of their immunosuppressive protocol.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Recipients of renal allograft
* Patients receiving CellCept

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Average dose of CellCept used in immunosuppressive protocols in Serbia
timeFrame: 9 months
measure: Average dose of concomitant immunosuppressive drugs
timeFrame: 9 months
Secondary outcomes:
measure: Average duration of post-transplant period for patients in Serbia receiving CellCept
timeFrame: 9 months
Other outcomes:
Locations:
city: Belgrade
country: Serbia
city: NIS
country: Serbia
city: Novi Sad
country: Serbia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06966050: Multi-center MRD Registry for Inflammatory Breast Cancer
Official title: Multi-center MRD Registry for Inflammatory Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Center

Brief summary: To collect data from participants with IBC who may have had MRD testing and may have surgery in the future.

Detailed description: Primary Objectives

-To determine the incidence of protocol specified pre-surgery MRD-positivity in IBC (assessment between completion of planned systemic therapy and surgery).

Secondary Objectives

* To establish the feasibility of multi-institutional MRD data collection using standard of care Signatera analysis in IBC participants.
* To evaluate the association of pre-surgery MRD to pathologic response.
* To evaluate participant reported QOL for worry about recurrence based in participants receiving MRD results
* To establish protocol-optional baseline and longitudinal MRD data collection in IBC participants and report the frequency of MRD longitudinally
* To determine the median lead time between the first MRD-positive result and clinical recurrence.
* To determine whether adjuvant therapies decrease the amount of MRD in participants, and the association with relapse.

Eligibility criteria: Inclusion Criteria:

* Female or males ≥18 years of age with the ability to understand and sign a written
* Participants who have a clinical diagnosis of stage III or IV inflammatory breast cancer (IBC).
* Participants who are planning to have or already completed a minimum of one blood draw for Signatera testing, for which the result and clinical data can be deposited into the study database.
* Participants must be within eight months of diagnosis and have not undergone breast surgery for this diagnosis of breast cancer.
* Participants must be English-speaking.

Exclusion Criteria:

-

Primary outcomes:
measure: European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sadia Saleem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01712750: Near-Infrared Spectroscopic (NIRS) Tissue Oxygen Saturation and the Vascular Occlusion Test in Cardiac Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Occlusion Test
Keywords: Regional tissue oximetry
Cardiopulmonary bypass
Cardiac surgical procedures
Lead sponsor: London Health Sciences Centre
Sponsor class: OTHER
First posted: 2012-10-24
Enrollment: 13
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: Elective cardiac surgery patients undergoing coronary artery bypass and valve surgery using cardiopulmonary bypass.

Brief summary: Tissue oxygen saturation (StO2) and its recovery during a vascular occlusion test (VOT) will be measured in elective cardiac surgery patients undergoing cardiopulmonary bypass using a non-invasive near infrared spectrometry (NIRS) machine. The purpose of this study is to determine whether changes in VOT measurements occur in patients during cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Adult, elective cardiac surgery patients
* Procedure using cardiopulmonary bypass

Exclusion Criteria:

* Contraindication to pneumatic cuff inflation
* Pregnant
* Significant peripheral vascular disease of the arms
* Emergency surgery

Primary outcomes:
measure: VOT reperfusion slope
timeFrame: Intra-operative (within 12 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: John M Murkin, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04503850: Impact of Mirabegron on Erectile Function in BPH Patients
Official title: Impact of Beta 3 Agonist Mirabegron on Erectile Function on Patients With Benign Prostate Hyperplasia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Males With Benign Prostatic Hyperplasia Symptoms
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 100
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All males above age of 50 with LUTS due to BPH

Brief summary: Evaluation of impact of Mirabegron on erectile function for patients treated for BPH

Detailed description: 50 patients (Group A) will receive Mirabegron \& alpha blocker 50 patients (Group B) will receive alpha blocker only Evaluation using IIEF 5 scoring system

Eligibility criteria: Inclusion Criteria:

* All males above age 50 with LUTS due to BPH not candidate for prostatectomy

Exclusion Criteria:

* males below age 50
* neurologic abnormality
* Any indication for prostatectomy
* abnormal bladder contractility i.e diabetics

Primary outcomes:
measure: Impact of Mirabegron on erectile function
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: