louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02325921: MRI in Renal Tumors
Official title: Advanced MRI in Renal Tumors.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: Magnetic Resonance Imaging
Diffusion Weighted MRI
Diffusion Tensor Imaging
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \>18 years of with a histopathologically confirmed renal tumor diagnosis.

Brief summary: Diagnostic imaging for renal masses of unknown nature using conventional imaging modalities such as 3 phase contrast-enhanced computed tomography (CT) is not always conclusive. After (partial) nephrectomy, 10-20 % of the resected tumors show benign histology which could not be identified on diagnostic imaging. With improved imaging techniques available, leading to improvements in characterisation of renal tumors, the number of unnecessary resections may be reduced. The objective of this study is to assess the ability to discriminate oncocytoma from RCC based on the ADC distribution parameters with addition of, tumor volume, and patient demographic characteristics.


Eligibility criteria: Inclusion Criteria:

* Radiologic diagnosis of renal tumor based on previous ultrasonography, CT or MRI examinations.
* Signed Institutional Review Board (IRB) approved informed consent form.
* Being at least 18 years of age.
* Histopathologically confirmed renal tumor diagnosis.

Exclusion Criteria:

* Relative contra indications for MRI (metal device/foreign bodies, claustrophobia);
* Active renal or perirenal infection;
* Minor and/or incapacitated adult.

Primary outcomes:
measure: Discriminating malignant from benign renal lesions using Apparent Diffusion Coefficient (ADC, a metric obtained by diffusion weighted MRI) value distribution analysis.
timeFrame: 45 months
Secondary outcomes:
measure: Additional value of tumor volume and patient characteristics to discriminate malignant from benign renal lesions.
timeFrame: 45 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
Study officials:
affiliation: Radboud University Medical Center
name: Jurgen J. Futterer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01510821: Investigation of Endothelium in Saphenous Vein Grafts
Official title: A Prospective Trial to Investigate Endothelial Dysfunction in Saphenous Vein Grafts Subjected to the Maquet Vasoshield Pressure Limiting Syringe Versus Non-Regulated Vessel Dilation in Patients Undergoing Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Function of Saphenous Vein Grafts
Keywords: endoscopic vein harvest
saphenous vein graft
endothelial function
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Maquet Cardiovascular
First posted: 2012-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a single center prospective study of 30 patients undergoing elective heart bypass surgery (CABG) with at least two vein grafts from the leg (SVG). The purpose of this ex vivo study is to evaluate the function of vein grafts from small tissue samples treated with a pressure syringe and a non-pressure syringe. Syringes are routinely used to flush out the veins in preparation of bypass grafting. It is unknown if different levels of pressure in the syringe affect the vein or damage the vein. Small sections of tissue samples which are normally discarded will be obtained immediately after retrieval from the leg and before grafting to the heart. Tissue samples will be taken to the laboratory for study. There are no clinical endpoints in this study, however, clinical information will be obtained from the Society of Thoracic Surgeons database and will include demographics, risk factors, and perioperative outcomes.


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective coronary artery bypass graft surgery requiring at least 2 saphenous vein grafts

Exclusion Criteria:

* patients undergoing any concomitant surgical procedures

Primary outcomes:
measure: SVG vascular contractility
timeFrame: Day of surgery
Secondary outcomes:
measure: Nitric oxide metabolite levels
timeFrame: Day of surgery
measure: Major adverse cardiac events
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Cardiothoracic Surgery Research Laboratory
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
Study officials:
affiliation: Emory University
name: Vinod Thourani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01508221: Evaluation of the Use of Trental and Vitamin E For Prophylaxis of Radiation Necrosis
Official title: A Phase II Trial to Evaluate the Use of Trental and Vitamin E for Prophylaxis of Radiation Necrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain Metastasis
Keywords: brain metastasis
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2012-01-11
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the use of Trental and Vitamin E can help reduce the incidence of radiation necrosis (a lesion that usually occurs at the original tumor site) after radiosurgery. These two drugs are commonly used to treat radiation necrosis when it occurs but the hope is that these drugs can be used to prevent radiation necrosis from ever occurring.

Detailed description: The treatment phase of the study is 6 months. Study procedures will be conducted such as: history, physical and neurological exam, pregnancy testing (for women of child bearing age) and a Brain MRI. Follow-up appointments will be every 3 months for 1 year at which time, your participation in the study will be concluded.

Eligibility criteria: Inclusion Criteria:

* Plan to undergo single or five fraction radiosurgery for a metastatic brain tumor
* Diagnosis of a metastatic brain tumor may be accomplished by histologic confirmation or by clinical confirmation by the treating physician based on MR imaging characteristics in the setting of a known history of cancer
* Age \> 18 years
* Partial or total resection of a metastatic tumor are eligible

Exclusion Criteria:

* Known sensitivity to vitamin E or Trental
* Recent intracranial bleed or retinal hemorrhage
* Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment
* History of Avastin treatment
* Anticipated need for treatment with Avastin
* History of bleeding disorder
* History of liver disorder

Primary outcomes:
measure: Number of Participants With Symptomatic Radiation Necrosis
timeFrame: average 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Ronald Warnick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01386021: Saphenous Vein Allografts for Coronary Bypass
Official title: Single Center Evaluation of CryoVein Saphenous Vein Allografts for Coronary Artery Bypass Grafting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Occlusion of Artery
Keywords: allograft
coronary
patency
morbidity
Lead sponsor: CryoLife
Sponsor class: UNKNOWN
First posted: 2011-06-30
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having a previous implant of CryoVein Saphenous Vein allografts for CABG between 2008 - 2010, at a single instituion

Brief summary: The primary objective of this observational study is to evaluate the function (patency) of cryopreserved saphenous vein allografts used as coronary artery bypass grafts (CABG) for patients with occlusive coronary artery disease.

Detailed description: This Study is designed as a combination retrospective/prospective single center study in which all patients will be eligible for enrollment based on having a previous implant of CryoVein Saphenous Vein for CABG during the 2008-2010 time frame. A comprehensive chart review of former and previously implanted allograft patients will be performed for the retrospective portion of this Study. An effort will be made to include all patients from this site. Eligible patients will be consented into the Study for a single, prospective, observational imaging evaluation of their bypass conduits.

Eligibility criteria: Inclusion Criteria:

* Any patient implanted with a CryoVein saphenous vein allograft for CABG during 2008 - 2010 time frame.
* Patients \> 18 years of age at implant.

Exclusion Criteria:

• Patients \< 18 years of age.

Primary outcomes:
measure: Graft Patency
timeFrame: 1 to 3 years as defined by the date of their incident operation (CABG surgery).
Secondary outcomes:
measure: Morbidity
timeFrame: 1 to 3 years defined by the date of their incident operation (CABG surgery)
Other outcomes:
Locations:
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
Study officials:
name: Valavanur A Subramanian, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03260621: CMR Exercise Stress Testing in HFpEF
Official title: Cardiovascular Magnetic Resonance Real-time Exercise Stress Testing in Heart Failure With Preserved Ejection Fraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diastolic Heart Failure
Lead sponsor: University of Göttingen
Sponsor class: OTHER
Collaborators: name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
First posted: 2017-08-24
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Patients of the University Hospital Göttingen with echocardiographic signs for diastolic heart failure and indication for right heart catheterisation will undergo additional diagnostic testing with CMR including exercise stress for detailed evaluation of diastolic dysfunction and tissue characterisation correlating the results with well-established clinical standards.


Eligibility criteria: Inclusion Criteria:

* adult patients with dyspnoea under stress, echocardiographic criteria for diastolic dysfunction (E/E'\>8) and clinical indication for right heart catheterisation

Exclusion Criteria:

* arrhythmia (brady- or tachycardic)
* bronchial asthma (allergic)
* incompliant patient
* pacemaker, ICD, non MRI-capable devices
* inability to use the ergometer in the MRI
* haemodynamic relevant valvular heart disease
* pulmonary disease (vital capacity or forced expiratory flow \<80% of healthy control)
* angina pectoris
* post cardiac infarction
* anaemia (Hb \<12 g/dl)
* uncontrollable hypertension (\>150 mmHg systolic or \>100 mmHg diastolic)
* age \<18 years
* pregnancy
* claustrophobia
* renal insufficiency
* allergic to gadolinium based contrast agents

Primary outcomes:
measure: Cardiovascular magnetic resonance imaging
timeFrame: approx. 1 years
measure: Cardiovascular magnetic resonance imaging
timeFrame: approx. 1 years
measure: Cardiovascular magnetic resonance imaging
timeFrame: approx. 1 years
Secondary outcomes:
Other outcomes:
measure: Exercise spirometry
timeFrame: approx. 1 years
measure: Exercise spirometry
timeFrame: approx. 1 years
measure: Exercise spirometry
timeFrame: approx. 1 years
measure: Right heart catheterization
timeFrame: approx. 1 years
Locations:
city: Göttingen
country: Germany
facility: University Hospital Goettingen
Study officials:
affiliation: University of Göttingen
name: Andreas Schuster, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Backhaus SJ, Lange T, George EF, Hellenkamp K, Gertz RJ, Billing M, Wachter R, Steinmetz M, Kutty S, Raaz U, Lotz J, Friede T, Uecker M, Hasenfuss G, Seidler T, Schuster A. Exercise Stress Real-Time Cardiac Magnetic Resonance Imaging for Noninvasive Characterization of Heart Failure With Preserved Ejection Fraction: The HFpEF-Stress Trial. Circulation. 2021 Apr 13;143(15):1484-1498. doi: 10.1161/CIRCULATIONAHA.120.051542. Epub 2021 Jan 21.
Clinical trial NCT05850221: Anaerobic Exercise and Mental Acuity
Official title: Anaerobic Exercise as a Modulator of Microbial Composition and Mental Acuity in Sedentary Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
LPS
Mood
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial (waitlist control)
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial to examine the effect of anaerobic activity (e.g., weight training) on gut microbiome metabolism and neurological health in healthy sedentary men.

Detailed description: The human gut microbiome, which houses over 2,000 distinct bacterial species, has recently been characterized as a highly influential force on the health and longevity of its host. By way of several distinct pathways comprising the "microbiome-gut-brain axis", this diverse population is known to communicate with the human brain in a bidirectional manner and is implicated in the pathophysiology of several metabolic and psychological disease states. The ability to support a healthy, diverse microbiome through modifiable behavioral interventions - such as diet and exercise - is a topic of growing interest. Most of the evidence pertaining to the relationship between physical activity and the gut-brain axis at this time, however, investigates the influence of aerobic exercise providing limited insight to how other modalities of physical activity may differ. Specifically, this study will examine the impact of an 8-week weight training protocol on gut microbiome metabolism and neurological health in healthy sedentary men. Participants will be randomly assigned to the intervention group or the waitlist control group.

Eligibility criteria: Inclusion Criteria:

* free of any existing medical diagnoses
* willing and able to participate in moderate to vigorous exercise as determined by the ACSM Health/Fitness Facility Preparticipation Screening Questionnaire
* sedentary (defined as a score \<14 on the Godin-Shepard Leisure Time Physical Activity Questionnaire (GSLTQ))
* equipped with access to a complete gym

Exclusion Criteria:

* antibiotic use within the past six months
* prebiotic, probiotic, or high-dose antioxidant supplementation within the past 6 months
* smoker (cigarettes and/or marijuana)
* regular laxative use
* blood pressure \>129/80 at baseline

Primary outcomes:
measure: gut barrier integrity
timeFrame: change from baseline at week 8
Secondary outcomes:
measure: mood state
timeFrame: change from baseline at week 8
Other outcomes:
measure: anaerobic capacity
timeFrame: change from baseline at week 8
Locations:
city: Phoenix
country: United States
facility: 850 PBC
state: Arizona
Study officials:
References:
Clinical trial NCT05192421: An mHealth Exercise Intervention for Sedentary Adults
Official title: A Remotely Delivered, Web-Based Exercise Intervention for Sedentary Adults: Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Behavior
Lead sponsor: California State University, Long Beach
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot trial examines the feasibility and acceptability of a web-based, social networking exercise intervention in improving physical activity behavior in adults who do not perform regular exercise.

Detailed description: Primary Objective To determine the feasibility and acceptability of an 8-week remotely-delivered exercise intervention by conducting a randomized controlled study comparing 3 levels of behavioral engagement.

Secondary Objectives

To compare the effectiveness of 3 levels of web-based interaction on physical activity behavior, physiological training dose, motivation and quality of life. Participants are randomly assigned to 1 of 3 groups:

Level 1 (attention control): Participants receive health educational materials through email and the web portal.

Level 2 (videos): Participants receive health education materials + access to 24 pre-recorded exercise videos.

Level 3 (livestream classes): Participant receive health education materials + livestream exercise classes 3 days/week for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Not exceeding 60 total minutes of physical activity per week
* Access to computer or mobile device with high speed internet connection

Exclusion Criteria:

* History of myocardial infarction, angioplasty, coronary artery bypass, cerebrovascular ischemia/stroke, symptomatic congestive heart failure, atrial flutter, unstable angina, or unstable pulmonary disease; pacemaker; history of alcoholism, drug abuse or other psychiatric problems; current use of tricyclic antidepressant or clozapine medications; type 1 diabetes; orthopedic or rheumatologic problems that could impair the ability to walk.

Primary outcomes:
measure: Accrual
timeFrame: Up to 1 year
measure: Retention
timeFrame: Up to 1 month
measure: Adherence
timeFrame: Up to 2 months
Secondary outcomes:
measure: Moderate to Vigorous Physical Activity
timeFrame: Up to 2 months
measure: Resting Heart Rate
timeFrame: Baseline, 2 months
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline, 2 months
measure: Short Form-36 (SF-36)
timeFrame: Baseline, 2 months
measure: Profile of Mood States (POMS)
timeFrame: Baseline, 2 months
measure: Physical Activity Group Questionnaire
timeFrame: Baseline, 2 months
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: California State University, Long Beach
state: California
Study officials:
References:
Clinical trial NCT06011421: Wound Catheter Vs LA Bolus in Renal Transplant: RCT
Official title: Wound Catheter Vs LA Bolus in Renal Transplant: RCT
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wound
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing kidney transplant

Brief summary: Pain control is an important part of patients' care after a kidney transplant. Currently patients receive a one off injection of Local Anaesthetic (LA) in the wound at the end of the operation followed by Intravenous morphine through a Patient Controlled Analgesia System (PCAS), a button pressed to provide a calculated dose with lock out times for safety.

Through this study the aim to test the efficiency of Continuous Local Anaesthetic Infiltration via Wound Catheter (LAWC) which is a method to deliver Local Anaesthetic over a longer period of time after the operation. LAWC are currently in use in a variety of surgical specialities including Liver surgery. Patients participating in this study will be allocated randomly to one of 2 groups; one will receive LA at the end of the operation as per current practice and one will receive LAWC. It then compare outcomes such as the the dose of morphine required in the PCAS, quality of pain control and improvement in recovery.


Eligibility criteria: Inclusion Criteria:

* Primary kidney transplantation
* Single kidney transplantation
* Signed informed Consent

Exclusion Criteria:

* Midline laparotomy
* Dual kidney transplantation
* Kidney re-transplantation
* Multi-organ transplantation
* Patients on Long term opiates
* Patients with psychiatric illness

Primary outcomes:
measure: Total Dose of IV Morphine in the first 24 hours post op
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital NHS Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
Study officials:
References:
Clinical trial NCT01347021: Compare Sacrospinous Fixation Versus High Uterosacral Ligament Fixation for Uterus Vaginal Prolapse III/IV
Official title: Sacrospinous Colpopexy Versus High Uterosacral Colpopexy in the Treatment of Genital Prolapse Grade III/IV in Women With Uterus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Uterovaginal Prolapse
Prolapse of Vaginal Vault After Hysterectomy
Complete Tear, Sacrospinous Ligament
Uterosacral Ligament; Rupture
Keywords: vaginal colpopexy sacrospinous
vaginal colpopexy uterosacral
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-05-04
Enrollment: 51
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the vaginal sacrospinous colpopexy and high uterosacral colpopexy in the treatment of genital prolapse grade III/IV in women with uterus.

Detailed description: Hysterectomy is often the traditional approach for women with uterovaginal prolapse. However, hysterectomy alone does not address the underlying problem of deficient apical support. Surgical options for patients with apical prolapse include transvaginal suspension procedures using pelvic structures for fixation, such as the sacrospinous ligament or uterosacral ligaments.The objective of this study is to compare the sacrospinous fixation with high uterosacral in the treatment of uterine prolapse POP-Q stage 3 or 4 in terms of recurrence of prolapse,quality of life,complications,post-operative recovery, hospital stay.

Eligibility criteria: Inclusion Criteria:

* pelvic prolapse III/IV
* counselling and informed consent

Exclusion Criteria:

* abnormal cervical smears
* abnormal ultrasound findings of uterus or ovaries or abnormal uterine bleeding
* pelvic radiotherapy

Primary outcomes:
measure: Pelvic Organ Prolapse Quantification (POPQ) at 12 months follow-up
timeFrame: one year
Secondary outcomes:
measure: subjective improvement in quality of life measured by Quality-of-Life Questionnaire (P-QoL)after surgery at 12 months follow-up
timeFrame: one year
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Manoel C B Girão, MD
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Sergio B Martins, md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maher C, Feiner B, Baessler K, Glazener CM. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2010 Apr 14;(4):CD004014. doi: 10.1002/14651858.CD004014.pub4.