louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02016872: Prognostic Value of Tumor Hypoxia, as Measured by 18F-FMISO Breath Hold PET/CT, in Non-Small-Cell-Lung Cancer (NSCLC) Patients
Official title: Prognostic Value of Tumor Hypoxia, as Measured by 18F-FMISO Breath Hold PET/CT, in Non-Small-Cell-Lung Cancer (NSCLC) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Small-Cell-Lung Cancer (NSCLC)
Keywords: PET/CT
18F-FMISO
tumor hypoxia
13-186
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2013-12-20
Enrollment: 25
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 is to help researchers investigate if a new imaging agent named 18F-FMISO can predict if patients with lung cancer will respond to standard therapy, as well as whether disease will reoccur in the future. The study will also investigate whether a 18F-FDG PET scan in the middle of radiation treatment can predict if lung cancer will respond to standard therapy. Information obtained from this study may help doctors design future studies in which they may target tumor areas that do not respond to therapy or may likely reoccur in the future.


Eligibility criteria: Inclusion Criteria:

* Pathologic confirmation of NSCLC at MSKCC
* No prior treatment for this diagnosis of NSCLC
* Patient to be treated with neoadjuvant chemotherapy (35 patients total) or patient to be treated with definitive RT,sequential chemo-RT, or concurrent chemo-RT (minimum dose of 50 Gy in 25 fractions) (25 patients total)
* Tumor must measure ≥ 2cm on CT
* Age ≥ 18 years
* Ability to hold the breath for 10 seconds.
* Karnofsky performance status ≥ 70%
* Women of childbearing age must have a negative blood pregnancy test

Exclusion Criteria:

* Women who are pregnant or breast-feeding
* Severe diabetes (fasting Blood Glucose \> 200 mg/dl)

Primary outcomes:
measure: The Difference Between Two Baseline Fluorine-18-labeled Fluoro-misonidazole (18F-FMISO) Scans
timeFrame: 3 days from baseline
measure: Progression-free Survival (PFS)
timeFrame: 3 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jacob Shin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grkovski M, Schwartz J, Rimner A, Schoder H, Carlin SD, Zanzonico PB, Humm JL, Nehmeh SA. Reproducibility of 18F-fluoromisonidazole intratumour distribution in non-small cell lung cancer. EJNMMI Res. 2016 Dec;6(1):79. doi: 10.1186/s13550-016-0210-y. Epub 2016 Nov 7.
Clinical trial NCT03320772: TMVP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer
Official title: Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Laparoscopic Sentinel Lymph Node Detection in Cervical Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cervical Cancer
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Sentinel lymph node (SLN) mapping is an acceptable surgical strategy determine whether to perform radical lymphadenectomy in patients with early-stage cervical cancer. Investigators aim to determine the validity of this technique with our novel tumor targeted fluorescent TMVP1-ICG to increased accuracy of SLN mapping.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age, married, without childbearing requirements at the time of consent.
* FIGO stage IA1-IIB cervical squamous cell cancer and is a candidate for laparoscopy intervention, with lymph node dissection being a part of the surgical plan.
* Subject has provided written informed consent.

Exclusion Criteria:

* Breast-feeding or pregnant
* Ongoing participation in another clinical trial with an investigational drug with 3 months
* Own allergy towards ICG and/or alcohol
* Diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases
* Patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency

Primary outcomes:
measure: Detection rate of sentinel lymph node
timeFrame: 1 day
Secondary outcomes:
measure: Sensitivity
timeFrame: 7 days
measure: Specificity
timeFrame: 7 days
measure: Incidence of adverse events
timeFrame: 7 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical Colledge, HUST
state: Hubei
Study officials:
References:
Clinical trial NCT03411772: Trial on TAP Block After Bariatric Surgery
Official title: Impact of Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative Pain After Laparoscopic Bariatric Surgery: a Randomized Double Blind Controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients undergoing bariatric surgery will be divided randomly into two groups: the first will have TAP block upon completion of surgery and the second groups will not have TAP block.

Detailed description: Upon completion of the laparoscopic bariatric procedure to be performed for every patient and just before recovery from general anesthesia, an ultrasound-guided TAP block will be conducted in the operative theater by the anesthetist for group I patients whereas group II will be recovered from anesthesia without having a TAP block.

The ultrasound probe will be placed on the lateral abdominal wall in the mid-axillary line between the lower costal margin and iliac crest. Using ultrasound will allow accurate deposition of the local anesthetic in the correct neurovascular plane. A spinal needle will be advanced using in-plane technique between the aponeurosis of the internal oblique and transversus abdominis muscles. With intermittent aspiration, 20 mL of local anesthetic (0.25% bupivacaine) will be deposited in the TAP on each side and seen as a hypoechoic shadow pushing the two layers apart.

Eligibility criteria: Inclusion Criteria:

* All morbidly obese patients of both genders with BMI \>35 kg/m2 who will be admitted to the General Surgery Department within the study period to undergo laparoscopic bariatric procedures will be included in this study. Bariatric procedures to be performed will comprise LSG, roux en-Y- gastric bypass, mini-gastric bypass, gastric plication, and single anastomosis sleeve ileal (SASI) bypass.

Exclusion Criteria:

* Patients unfit for general anesthesia, patients with secondary obesity due to endocrine disorders, patients with psychiatric disorders, patients with drug abuse or history of opioid intake or chronic pain disorder, patients with contraindication to peripheral nerve block such as allergy to local anesthetics and coagulopathy.

Primary outcomes:
measure: Postoperative abdominal pain
timeFrame: first 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh H Emile, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04371172: Impact of TAVI on Cognition, Mood and Health-related Quality of Life
Official title: The Impact of Transcatheter Aortic Valve Implantation on Cognition, Mood and Health-related Quality of Life - an Explorative Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cognitive Impairment
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 128
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with percutaneous aortic valve replacement

Brief summary: In the proposed study, patients with and without embolic protection devices during Transcatheter Aortic Valve Implantation will be repeatedly examined with a comprehensive psychiatric and cognitive test battery over a post-interventional period of 6 months after TAVI, with regard to the effects on mood, cognitive Performance and health-related Quality of life.

Detailed description: The percutaneous aortic valve replacement (TAVI, Transcatheter Aortic Valve Implantation) enables the implantation of a new biological aortic valve at the beating heart. The procedure is performed under local anaesthesia and is a gold standard in the therapy of aortic stenosis, especially in patients with a too high health risk for cardiovascular surgery.

In the proposed study, patients with and without embolic protection devices during TAVI will be repeatedly examined with a comprehensive psychiatric and cognitive test battery over a post-interventional period of 6 months after TAVI, with regard to the effects on mood, cognitive Performance and health-related quality of life.

Eligibility criteria: Inclusion Criteria:

* Written declaration of consent of the study participants to participate in the study after detailed information on the nature, significance, risks and scope of the study.
* Women and men between the ages of 19 and 90
* Clinical indication for TAVI intervention
* No previous psychiatric illness before TAVI
* No other serious disease affecting the immune system

Exclusion Criteria:

* Non-compliance with the inclusion criteria
* Persons unable to give consent (e.g. dementia, delirium etc.)
* Magnetic resonance imaging (MR) contraindications
* ophthalmological inability to read

Primary outcomes:
measure: cognition
timeFrame: 12 months
Secondary outcomes:
measure: health-related quality of life
timeFrame: 12 months
Other outcomes:
measure: mood
timeFrame: 12 months
measure: MRI
timeFrame: 12 months
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University Graz, Austria
name: Andreas Baranyi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01109472: Improving Osteoporosis Care in a Home Health Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Alacare Home Health and Hospice
First posted: 2010-04-23
Enrollment: 1009
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study aims to improve osteoporosis care through patient tailored education materials in a group-randomized trial of patients referred to home health care with a history of fracture and/or an osteoporosis diagnosis. Project investigators will conduct telephone surveys and examine electronic medical record data to assess fracture related morbidity and mortality, osteoporosis treatment and adherence, and use of calcium and vitamin D supplements.

We hypothesize that patients that receive the intervention materials will be more likely to initiate or maintain osteoporosis treatment.


Eligibility criteria: Inclusion Criteria:

* prior fracture
* osteoporosis diagnosis
* received home health care

Exclusion Criteria:

* hospice
* active cancer treatment

Primary outcomes:
measure: Initiation/Maintenance of Anti-osteoporosis prescription medication
timeFrame: Three months post initial survey
Secondary outcomes:
measure: Initiation/Maintenance of calcium and vitamin D
timeFrame: Three months post initial survey
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Jeffrey R Curtis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02427672: The Effect of Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior
Official title: The Effect of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Antisocial and Aggressive Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antisocial Behavior
Aggression
Keywords: antisocial behavior
aggression
transcranial direct current stimulation
dorsolateral prefrontal cortex
associated risk factors
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the effect of upregulating prefrontal cortex activity on antisocial and aggressive behavior and risk factors for such behavior. In the double-blind, randomized controlled trial, participants will undergo anodal transcranial direct current stimulation bilaterally to the dorsolateral prefrontal cortex or a sham stimulation. During and after stimulation, they will complete survey and laboratory measures assessing antisocial and aggressive behavior and risk factors for antisocial and aggressive behavior. Heart rate and skin conductance will also be measured.


Eligibility criteria: Inclusion Criteria:

* Above 18 years of age
* Able to understand the nature of the study and give informed consent

Exclusion Criteria:

* History of or active neurologic, cardiovascular, or psychiatric disease
* Currently consuming anti-convulsant, anti-psychotic, or sedative/hypnotic medications
* Currently consuming anti-depressants
* History of seizures
* Metallic implants on the scalp
* Participation in other transcranial magnetic stimulation (TMS) or tDCS experiments on the same day
* History of adverse reactions to tDCS

Primary outcomes:
measure: Change in Antisocial Behavior Inclinations at 24 Hours
timeFrame: Baseline (an average of 15 minutes before receiving tDCS or sham) and on average, 24 hours following stimulation or sham
measure: Number of Pins Inserted Into a Virtual Voodoo Doll at 24 Hours
timeFrame: On average, 24 hours after the tDCS or sham session
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Adrian Raine, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choy O, Raine A, Hamilton RH. Stimulation of the Prefrontal Cortex Reduces Intentions to Commit Aggression: A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group Trial. J Neurosci. 2018 Jul 18;38(29):6505-6512. doi: 10.1523/JNEUROSCI.3317-17.2018. Epub 2018 Jul 2.
Clinical trial NCT04438772: Effect of LPEC Compared With a Sham Procedure in the General Anesthesia
Official title: Effect of LPEC Compared With a Sham Procedure in the General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation;Difficult
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia


Eligibility criteria: Inclusion Criteria:

* Intubation

Exclusion Criteria:

* ENT neoplasia

Primary outcomes:
measure: Cormack score
timeFrame: During laryngoscopy
Secondary outcomes:
measure: Time to intubation
timeFrame: During laryngoscopy
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Javillier
Study officials:
affiliation: University of Liege
name: Benjamin Javillier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01851772: Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer
Official title: Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: cervical
cancer
brachytherapy
electronic
device
applicator
toxicity
gynecologic
high-dose-rate (HDR)
x-ray
safety
external beam radiation therapy (EBRT)
Lead sponsor: Xoft, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Icad, Inc.
First posted: 2013-05-10
Enrollment: 3
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, performance and usability of the Xoft Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the physician's current standard treatment practice and in replacement of high-dose-rate after-loaders using Iridium-192 or low-dose-rate Cesium treatments. Data will be collected on treatment delivery, safety, and acute toxicity.

Our hypothesis is that the treatment is safe as incorporated into the physician's current standard of practice.


Eligibility criteria: INCLUSION CRITERIA:

* Brachytherapy is indicated after EBRT for all cases of locally advanced disease (Stages Ib2 - IVA)
* Inoperable Stage Ia1 and Stage Ia2 may be treated with tandem-based brachytherapy alone
* Inoperable Stage Ib1 should be treated radically with brachytherapy in conjunction with EBRT. Concurrent chemotherapy may be considered at the physician's discretion and based on the presence of high risk features.
* Subjects can be treated with brachytherapy regardless of lymph node status, grade, and presence of lymphovascular invasion, tumor size, age, or histology.
* Medically fit for general or spinal anesthesia, or conscious sedation, for the insertion process
* Subjects of childbearing potential must have a negative serum pregnancy test at Screening inclusion Criteria:

EXCLUSION CRITERIA:

* Medical Contraindications to Brachytherapy (scleroderma, collagen vascular disease, active lupus )
* Prior pelvic radiotherapy with brachytherapy
* Hemoglobin level at screening \< 8
* Life expectancy \< 6 months

Primary outcomes:
measure: Safety - Adverse Event Rate and Severity
timeFrame: Study Exit (90 days)
Secondary outcomes:
measure: Device Performance
timeFrame: Study Exit (90 days)
Other outcomes:
measure: Frequency of Adverse Events in Participants (i.e.Safety)
timeFrame: 3 months post-Study Exit
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma University
state: Oklahoma
Study officials:
affiliation: Gadsden Regional Cancer Center
name: Lowndes Harrison, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01154972: Preoperative Localisation of the Sentinel Lymph Node in Breast Cancer
Official title: Preoperative Identification of the Sentinel Lymph Node in Breast Cancer, Using Ultrasound and Radio-isotope/Percutaneous Gamma Probe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast
cancer
sentinel lymph node
Lead sponsor: NHS Tayside
Sponsor class: OTHER_GOV
Collaborators: name: University of Dundee
First posted: 2010-07-01
Enrollment: 59
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: When a person has breast cancer it is necessary to find out whether the cancer has spread to the lymph nodes in the armpit because if it has, further treatment is likely to be needed. There are many of these nodes but when the breast cancer spreads, it does so in a step-by-step fashion, starting with the so-called Sentinel Lymph Node (SLN). At present, the only way to be sure whether there is cancer in the lymph nodes or not is to perform an operation to remove at least the SLN. If the pathologist finds cancer in the SLN, a second operation is usually required to remove further nodes in case they contain cancer too. Surgical removal of the lymph nodes in the armpit can cause difficulties for the patient afterwards, such as pain and swelling in the arm. If there is no cancer in the SLN, no further operations on the armpit are needed. The investigators wish to find out whether in some patients, operations on the armpit can be avoided completely. The first step in doing this is to test whether the investigators can find out which is the SLN before the operation, using a combination of an injection and ultrasound scanning. The injection - into the skin of the breast - would be a radioactive substance, which is the usual way the surgeon finds the SLN. The radioactive substance collects in the SLN and the investigators would use a "gamma probe" over the surface of the armpit to detect the radiation. In this initial study, the investigators would aim to find the SLN before the operation and place a marker wire in it so that the surgeon could check whether the investigators had found the correct node.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with invasive breast cancer suitable for primary surgical treatment
* Booked for surgical Sentinel Lymph Node Biopsy

Exclusion Criteria:

* Unable to give informed consent
* Known bleeding disorder
* Previous axillary surgery
* Previously treated for the current tumour with chemotherapy or hormone therapy

Primary outcomes:
measure: Is the sentinel lymph node marked preoperatively confirmed as the SLN at surgery?
timeFrame: 8 Months from start of trial.
Secondary outcomes:
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
Study officials:
References: