louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02432820: Assessment of 3D Transperineal Ultrasound Imaging w/ Matrix Array Transducers in Prostate Radiotherapy
Official title: Assessment of 3D Transperineal Ultrasound Imaging With Matrix Array Transducers as a Potential Imaging Modality for Adaptive Prostate and Post-Prostatectomy Radiotherapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2015-05-04
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate cancer patients being treated at Stanford Cancer Center

Brief summary: SPECIFIC STUDY AIMS

1. To evaluate congruence between pelvic anatomical structures segmented on MRI and/or CT scans co-registered with transperineal US scans acquired with an optically and/or electromagnetically tracked matrix array ultrasound transducer.
2. To estimate the achievable accuracy of anatomy tracking based on 3D US matrix-array transducer imaging and grey-level based image registration algorithms.

Detailed description: SPECIFIC STUDY AIMS

1. To evaluate congruence between pelvic anatomical structures segmented on MRI and/or CT scans co-registered with transperineal US scans acquired with an optically and/or electromagnetically tracked matrix array ultrasound transducer.
2. To estimate the achievable accuracy of anatomy tracking based on 3D US matrix-array transducer imaging and grey-level based image registration algorithms.

Eligibility criteria: Inclusion Criteria:

* Men that will undergo prostate radiotherapy as a primary treatment or post-prostatectomy.
* Age 18 or older
* Ability to understand and sign informed consent

Exclusion Criteria:

* Younger than 18 yrs old
* Inability to provide written and spoken consent.
* Patients with implanted actively controlled devices that may be subject to electromagnetic interference from the UroNav/PervuNav electromagnetic tracking used in the study.

Primary outcomes:
measure: Changes in dose-volume histogram (DVH) indices in prostate images
timeFrame: 1 year
measure: Changes in dose-volume histogram (DVH) indices in bladder images
timeFrame: 1 year
measure: Changes in dose-volume histogram (DVH) indices in rectal wall images
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dimitre Hristov
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Steven Hancock
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06504420: The Safety and Efficiency of Sirolimus in Primary Antiphospholipid Syndrome: a Randomized Control Study
Official title: A Randomized, Multicenter, Double-blind, Placeobo-control Study of Sirolimus for Primary Antiphospholipid Syndrome Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Primary Antiphospholipid Syndrome
Keywords: APS
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 70
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: TREATMENT

Brief summary: This study is an Investigator initiated, randomized, multicenter, double-blind, placebo-control study. The aim of this study is to evaluate the safety and efficiency of Sirolimus for primaty antiphospholipid syndrome patients at week 24 and week 48.


Eligibility criteria: Inclusion Criteria:

1. Understand and sign the informed consent form
2. Male or Female
3. aged 18-70 at the time of screening visit
4. Met 2006 Sapporo classification criteria of APS or 2023 ACR/EULAR classification criteria of APS
5. With the stable combination therapy

Exclusion Criteria:

1. history of serious adverse events or contraindication to Sirolimus
2. Catastrophic APS within 90 days
3. Acute thrombosis within 30 days
4. ≥4/11 American College of Rheumatology Classification Criteria for SLE or other systemic autoimmune diseases
5. Historically positive HIV test or test positive at screening for HIV
6. currently on any suppressive therapy for a chronic infection (such as tuberculosis, hepatitis B infection, hepatitis C infection, CMV, EBV, Syphilis, etc)
7. Surgery treatment within one month
8. History of malignant neoplasm within the last 5 years
9. White blood cell counts\<3×10\*9/L
10. Abnormal Liver function tests: ALT or AST ≥ 1.5 times the upper limit of the normal value, and total bilirubin and blood lipids ≥ 2 times the upper limit of the normal value
11. Pregnant or pregnancy preparation or breastfeed
12. Any circumstances that may cause the subjects to be unable to complete the study or pose significant risks to the subjects

Primary outcomes:
measure: Complete response(CR) rate at week 24
timeFrame: week 24
measure: Partial response (PR) rate at week 24
timeFrame: week 24
Secondary outcomes:
measure: Complete response(CR) rate at week 48
timeFrame: week 48
measure: Partial response (PR) rate at week 48
timeFrame: week 48
measure: Rate of Participants with adverse effects and serious adverse effects during treatment
timeFrame: baseline to week 48
Other outcomes:
Locations:
Study officials:
affiliation: Peking university peoples hospital
name: Zhanguo Li
role: STUDY_DIRECTOR
References:
Clinical trial NCT02063620: The Effect of Anesthetic Agents Management on ECG Changes of Patients Who Were Operated Under RIVA
Official title: The Effect of Different Anesthetic Agents Management on Electrocardiographic Changes of Patients Who Were Operated Under Regional Intravenous Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Qt Interval, Variation in
Keywords: IVRA, ketamine, lidocaine, ECG
Lead sponsor: Duzce University
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: IVRA can be performed with many local anesthetics and adjuvant agents. Investigators planned to compare cardiac effects and ECG changes by IVRA with lidocaine and lidocaine plus ketamine.

Detailed description: Methods: Patients between 18-60 years, with score of ASA 1-2 and who were undergoing IVRA for short operations on arm and forearm were included. Systolic, diastolic and mean blood pressures, heart rate, SpO2, ECG, adverse effects during the operation were recorded. Double cuffed tourniquet were placed on the extremity to be operated to hinder nerve injuries. Venous blood in the extremity was purged with Esmarch bandage. Proximal cuff was inflated with a pressure 50-100 mmHg higher than systolic blood pressure and the bandage was displaced. Randomly patients were divided into 2 groups. Group 1: %0.5 Lidocaine+Ketamine 0.8 mg/kg; 40 ml. Group 2: %0.5 Lidocaine 40 ml. Anesthetic agent was injected with a rate of 20 ml/min. 20 minutes after injection the distal cuff was inflated and the proximal cuff deflated with a rate of 50 mmHg in every 3 minutes. 0,5,10,15,30,45,60 minutes after the beginning of deflation and 10 minutes after the deflation was completed ECG were recorded. PR,QT,QTc, RR were recorded.

Eligibility criteria: Inclusion Criteria:

1. Patients between 18-60 years
2. ASA 1-2 physical status
3. Undergoing IVRA for short operations on arm and forearm

Exclusion Criteria:

1. Allergy to study drugs,
2. Serious cardiac diseases,
3. Respiratory diseases,
4. Renal failure,
5. Drug addiction,
6. Pregnancy,
7. Liver failure,
8. Hypertension,
9. Genetic diseases of musculoskeletal system,
10. Use of antiepileptic drugs, abnormal thyroid functions and operation period over 1 hour.

Primary outcomes:
measure: QT and QTc intervals
timeFrame: Change QT and QTc intervals from baseline to 60 minutes
Secondary outcomes:
measure: mean arteryel pressure
timeFrame: Change of mean arteryel pressure from baseline to 60 minutes
Other outcomes:
Locations:
city: Duzce
country: Turkey
facility: Duzce Univercity Medical Fauculty
Study officials:
affiliation: Duzce University School of Medicine
name: Gokce Akman Kose
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04293120: Training Balance Among People With Neurodevelopmental Disabilities
Official title: Training Anticipatory Postural Adjustments Among People With Neurodevelopmental Disabilities
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Posture
Balance
Cerebral Palsy
Autism
Down Syndrome
Lead sponsor: University of Hartford
Sponsor class: OTHER
Collaborators: name: Universita di Verona
First posted: 2020-03-03
Enrollment: 3
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case control, matched on gender, age, and BMI
Primary purpose: TREATMENT

Brief summary: This study is a case control pilot study to investigate the impact of a short-term intervention on training anticipatory postural adjustments in a population of people with neurodevelopmental disabilities.

Detailed description: Data will be collected by using a weighted pendulum to provide a posterior perturbation to test subjects' postural reactions pre and post-intervention. Intervention will include four sessions of weighted ball tosses/weighted tether ball stops to improve muscle activation patterns and efficiency. EMG sensors, 3D motion analysis, and force plates will be used to collect the necessary data.

Eligibility criteria: Inclusion Criteria:

Participants

1. Able to stand without assistance
2. Diagnosis of cerebral palsy, Down Syndrome, or Autism Spectrum Disorder
3. Able to stop weighted ball without falling
4. Able to follow directions

Controls

1. Able to stand without assistance
2. No neurodeveloopmental disability
3. Able to stop weighted ball without falling
4. Able to follow directions

Exclusion Criteria:

1. Pregnancy
2. Unable to maintain standing when stopping a ball on a rope

Primary outcomes:
measure: Muscle activation timing
timeFrame: Pre-intervention muscle activation timing will be assessed on the initial visit. Post-intervention muscle activation timing will be assessed immediately after the fourth training session, at most, 7 days later.
Secondary outcomes:
measure: Muscle amplitude response
timeFrame: Pre-intervention muscle amplitude response will be assessed on the initial visit. Post-intervention muscle amplitude response will be assessed immediately after the fourth training session, at most, 7 days later.
Other outcomes:
Locations:
city: West Hartford
country: United States
facility: University of Hartford
state: Connecticut
Study officials:
affiliation: University of Hartford
name: Mary E Gannotti, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00255320: Experimental Headache Induced by Vasoactive Intestinal Polypeptide
Official title: Experimental Headache Induced by Vasoactive Intestinal Polypeptide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers, Headache, Migraine, Hemodynamics, VIP, SPECT, Ultrasound
Keywords: healthy volunteers, headache, migraine, hemodynamics, VIP, SPECT, ultrasound
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2005-11-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: We hypothesized that infusion of VIP may induce headache in healthy subjects and that VIP induced headache may be associated with dilatation of intra- and extracerebral blood vessels. To test this hypothesis, we performed a double blind placebo controlled crossover study in normal human volunteers and studied the effect on headache and cerebral as well as hemodynamic parameters.

Detailed description: We hypothesized that infusion of VIP may induce headache in healthy subjects and that VIP induced headache may be associated with dilatation of intra- and extracerebral blood vessels. To test this hypothesis, we performed a double blind placebo controlled crossover study in normal human volunteers and studied the effect on headache and cerebral as well as hemodynamic parameters. In a double-blind, placebo-controlled, crossover design, the subjects were randomly allocated to receive 8 pmol/kg/min VIP or placebo (isotonic saline) over 25 min. Headache intensity, Mean velocity of blood flow in the middle cerebral artery (VmeanMCA), superfical temporal artery diameter, PetCO2, adverse events and vital signs were recorded at T-10, T0 and then every 10 min until 120 min after start of infusion. Single photon emission computerized tomography (SPECT) was performed at T-0, T20 and T60.

Eligibility criteria: Inclusion Criteria:

- healthy volunteers

Exclusion Criteria:

- migraine cerebrovascular disorders pregnancy

Primary outcomes:
measure: Headache intensity, Mean velocity of blood flow in the middle cerebral artery (VmeanMCA), superfical temporal artery diameter, PetCO2, adverse events and vital signs were recorded at T-10, T0 and then every 10 min until 120 min after start of infusion.
Secondary outcomes:
measure: All subjects were asked to complete a headache diary every hour until 10 h after the discharge. The diary included headache characteristics and accompanying symptoms according to the International Headache Society (IHS 2004)
Other outcomes:
Locations:
city: Glostrup, Copenhagen
country: Denmark
facility: Danish Headache Center , KAS Glostrup
Study officials:
affiliation: Danish Headache Center
name: Jakob Møller Hansen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06442020: Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy.
Official title: Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 158
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study deals with the hypothesis that LiESWT in addition to the administration of PDE5i can improve sexuality rehabilitation with faster recovery of a valid erection and higher IIEF-5 scores in the short and medium-term follow-up.

Detailed description: Prospective randomized controlled trial (RCT) designed to provide high level evidences describing the role of Low-intensity Extracorporeal Shock Wave Therapy LiESWT plus early introduction of PDE5i vs early PDE5i alone on penile rehabilitation of erectile dysfunction ED after treatment of post-Robot-Assisted (RA) Radical Prostatectomy (RP) RARP

Eligibility criteria: Inclusion Criteria:

* Patients aged ≤75 yrs;
* Low-risk PCa (PSA \<10 ng/mL and GS \<7, ISUP grade 1, and cT1-2a) undergoing nerve sparing RARP;
* preoperative IIEF-5 score ≥ 17;
* First PSA (45d after surgery) \<0.2
* compliants patients able to follow the study protocol and fill in IIEF-5 scores and EORTC quality of life questionnaires;
* patients able to provide a written informed consent for the trial.

Exclusion Criteria:

* anaesthesiologic contraindications to robotic surgery;
* patients submitted to pelvic radiotherapy or androgen deprivation;
* patients reporting major postoperative complications (CD≥3);
* cardiovascular contraindications to PDE5i medical treatment.

Primary outcomes:
measure: Impact of LiESWT
timeFrame: 3 years
Secondary outcomes:
measure: Assess how many patients reach orgasm
timeFrame: 3 years
measure: Questionnaires of Quality of life
timeFrame: 3 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References:
Clinical trial NCT01910220: Study to Assess the Safety and Bioeffect of REGN1033 (SAR391786)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2013-07-29
Enrollment: 125
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

1. Males and postmenopausal females aged 60 years and older with no significant health issues or clinically significant abnormal laboratory values.
2. Low activity lifestyle
3. Diet and exercise adherence

Exclusion Criteria:

1. Significant concomitant illness such as, but not limited to cardiac, renal, rheumatologic, gastrointestinal, hematological, skeletal/muscular, neurologic, psychiatric, endocrine, metabolic or immunological disease.
2. Participation in any clinical trial within 6 months prior to screening.
3. Hospitalization, immobilization, or major surgical procedure requiring general anesthesia within 6 months prior to screening, or any planned surgical procedures during the study period.
4. Limb amputation (except for toes) and/or any fracture within 6 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.

Primary outcomes:
measure: Percent change in total lean mass
timeFrame: At week 12
Secondary outcomes:
measure: Number of TEAEs
timeFrame: day 1 to day 141
measure: Appendicular lean mass by DXA
timeFrame: At week 12
Other outcomes:
Locations:
city: Gainesville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Boston
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Missouri
city: Athens
country: United States
state: Ohio
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT01391520: Efficacy and Safety of Deferiprone in Patients With Chronic Kidney Disease Undergoing a Cardiac Catheterization and Receiving Contrast Agent
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Deferiprone in the Reduction of Morbidity and Mortality in Patients With Chronic Kidney Disease Undergoing Diagnostic or Interventional Cardiac Procedures and Receiving an Iodinated Radiocontrast Agent
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury
Contrast-Induced Nephropathy
Labile Iron
Iron Chelation
Deferiprone
Lead sponsor: CorMedix
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will evaluate whether treatment with CRMD001 (unique formulations of the iron chelator, Deferiprone) will reduce morbidity and mortality in subjects with Chronic Kidney Disease (CKD) and additional risk factors. Adult subjects with moderate to severe CKD who are undergoing diagnostic or interventional coronary angiography will be randomized to either placebo or CRMD001 and followed for 90 days. Subjects will receive 8 days of randomized therapy starting 1-3 hours prior to angiography. The primary endpoint of the trial will be the difference in a composite of specified renal and cardiovascular clinical events occurring through Day 90.


Eligibility criteria: Inclusion Criteria:

1. Age 18 or older
2. eGFR between 15 ml/min/1.73 m2 and \< 60 ml/min/1.73 m2
3. Presence of at least one additional risk factor:

   * Diabetes Mellitus type 1 or 2
   * Age ≥ 75 years
   * Left Ventricular Ejection Fraction ≤ 40%

Exclusion Criteria:

1. End-Stage Renal Disease
2. Primary PCI for STEMI
3. Currently receiving mechanical ventilation
4. Known active liver disease or liver failure
5. Evidence of hemodynamic instability, such as a requirement for pressor agents
6. Exposure to contrast media within prior 10 days
7. Currently receiving fenoldopam, dopamine, theophylline, aminophylline, mannitol, or Ascorbic acid (\> 2 g/day)
8. Absolute neutrophil count \< 1500

Primary outcomes:
measure: A composite of renal and cardiovascular clinical events occurring through Day 90
timeFrame: Day 90 following index cardiac catheterization
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02201420: Evaluation of Tc 99m Tilmanocept Localization in Primary Cutaneous Kaposi's Sarcoma and Lymphatic Drainage by SPECT/CT
Official title: Evaluation of Technetium Tc 99m Tilmanocept Localization, Retention, and Distribution in Primary Cutaneous Kaposi's Sarcoma (KS) and Lymphatic Drainage From KS Lesions by SPECT/CT Imaging.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kaposi's Sarcoma
Lead sponsor: Navidea Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-07-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study (NAV3-12) is to determine the dissemination and localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects with confirmed cutaneous KS. This is a single center, open-label, within-subject study.


Eligibility criteria: Inclusion Criteria:

1. The subject has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before the initiation of any study-related procedures.
2. The subject is at least 18 years of age at the time of consent.
3. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 to 2.
4. The subject has a KS stage of T(0), I(0), S(0).
5. The subject has a marker lesion with a confirmed diagnosis of KS (CD 206-expressing cutaneous KS) via punch biopsy. The location of the marker KS lesion will be limited to locations on the extremities: from the shoulder to the metacarpal region or from the groin to the metatarsal region.
6. The subject has a marker KS lesion that is ≥ 1cm in diameter.

Exclusion Criteria:

1. The subject is pregnant or lactating.
2. The subject has had prior chemotherapy, immunotherapy, or radiation therapy to the local KS site or regional lymphatic system within one year of enrollment.
3. The subject has undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the marker KS lesion.
4. The subject has known sensitivity to dextran.

Primary outcomes:
measure: Localization
timeFrame: Up to 4 days
Secondary outcomes:
measure: Time to Localization
timeFrame: 1 hour
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: Navidea Biopharmaceuticals
name: Bonnie C Abbruzzese, MS, RD, CCRA
role: STUDY_DIRECTOR
References: