louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02430675: Irreversible Electroporation(IRE) For Unresectable Laryngeal Neoplasms
Official title: Irreversible Electroporation(IRE) For Unresectable Laryngeal Neoplasms: Phase I and Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Neoplasms
Keywords: irreversible electroporation
Unresectable Laryngeal Neoplasms
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Laryngeal Neoplasms.

Detailed description: By enrolling patients with unresectable Laryngeal Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Laryngeal Neoplasms.

Eligibility criteria: Inclusion Criteria:

* Laryngeal Neoplasms diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: 6 month
Secondary outcomes:
measure: Percentage of lesions that show no sign of recurrence 12 months after IRE
timeFrame: 12 months
measure: A minimum and maximum range of voltage for safe and effective IRE
timeFrame: 3 months
measure: Progress free disease (PFS)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02654275: Effect of Proprioceptive Intervention Training on Power Capacity, Proprioceptive Ability and Technique of Young Swimmers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Injury Prevention
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Wingate College
First posted: 2016-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Many children and adolescents who engage in swimming complain of shoulder pain during or after exercise. This pain may worsen and may lead to a decline in performance as well avoidance of swimming and lastly avoidance of any physical activity whatsoever. The aim of this study is to determine whether proprioceptive intervention training will effect the power capacity, proprioceptive ability and technique of young swimmers.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Swim 3 times per week

Exclusion Criteria:

* Have not had orthopedic surgery
* No history of disease

Primary outcomes:
measure: Change in proprioceptive ability
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in muscle strength
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Wingate College
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Eias Kassem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02755675: uPAR-PET for Prognostication in Patients With Non-small Cell Lung Cancer, Malignant Pleural Mesothelioma and Large Cell Neuroendocrine Carcinoma of the Lung
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Malignant Pleural Mesothelioma
Large Cell Neuroendocrine Carcinoma of the Lung
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: uPAR PET/CT as a prognostic marker in non-small cell lung cancer.

Detailed description: Study I: uPAR PET/CT with 68Ga-NOTA-AE105 will be evaluated as a prognostic tool in patients with non-small cell lung cancer (NSCLC) (stage IV (Ia) operable disease (Ib)) by observer-blinded readings and compared to the prognostic performance of FDG PET/CT and prognostic biomarkers as uPAR.

Furthermore, uPAR PET/CT will be evaluated in a pilot study in patients with malignant pleural mesothelioma (MPM) (Study II) and large cell neuroendocrine carcinoma of the lung (LCNEC) (Study III) and correlated with immunohistochemical uPAR expression.

Eligibility criteria: Inclusion Criteria:

Study I

* Histologically verified NSCLC (Study I)
* Stage IV disease
* Operable disease
* The participants must be capable of understanding and giving full informed written consent

Study II

* Histologically verified MPM (Study II)
* The participants must be capable of understanding and giving full informed written consent

Study III

* Histologically verified LCNEC (Study III)
* The participants must be capable of understanding and giving full informed written consent

Exclusion Criteria:

Study I, II, III

* Pregnancy
* Lactation/breast feeding
* Treatment with neoadjuvant chemotherapy
* Weight above 140 kg
* Allergy to 68Ga-NOTA-AE105

Primary outcomes:
measure: Study Ia: Overall survival (OS)
timeFrame: Study Ia: OS is evaluated after clinical follow-up for 18 months (stage IV disease)
measure: Study Ib: Overall survival (OS)
timeFrame: Study Ib: OS is evaluated after clinical follow-up for 60 months (operable disease)
measure: Study II and III: Uptake of 68Ga-NOTA-AE105 in primary tumor lesion (dichotomized +/-)
timeFrame: Study II and III: Uptake of 68Ga-NOTA-AE105 is evaluated based on PET/CT scans performed within 1 hour post injection of 68Ga-NOTA-AE105
Secondary outcomes:
measure: Study Ia: Progression free survival (PFS)
timeFrame: Study Ia: PFS is evaluated after clinical follow-up for 18 months (stage IV disease)
measure: Study Ib: Disease free survival (DFS)
timeFrame: Study Ib: DFS is evaluated after clinical follow-up for 60 months (operable disease)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Study officials:
References:
Clinical trial NCT00752375: Antibiotic Prophylaxis in Children With Pyelonephritis
Official title: A Randomized Controlled Trial of Antibiotic Prophylaxis in Children With Pyelonephritis in the Abscence of Vesicoureteral Reflux
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pyelonephritis
Keywords: pyelonephritis
pediatric pyelonephritis
vesicoureteral reflux
DMSA scan
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian Urological Association
First posted: 2008-09-15
Enrollment: 0
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children who present with pyelonephritis undergo many investigations, and long term care to prevent renal damage. The focus is primarily on preventing renal failure however along the way and particularly with children, other issues arise which impact their lives, as well as their family's lives. Parents are concerned about subjecting their children to invasive procedures and long term antibiotic use, particularly if they are not sure of the benefit. This study seeks to provide information on the impact of investigation and long term antibiotic treatment in reference to long term health and quality of life in children who present with febrile urinary tract infections in the absence of anatomic abnormalities.


Eligibility criteria: Inclusion Criteria:

* Children 0 to 12 years of age presenting with first episode of acute pyelonephritis in the absence of vesicoureteral reflux.
* Acute pyelonephritis defined as presence of fever, a positive urine culture (growth of a single urinary tract pathogen at =10(8) CFU/ml for catheterization specimens and =10(4) CFU/ml for clean catch specimens), and a positive DMSA scan (a discreet defect or generalized decrease in activity).

Exclusion Criteria:

* Neurogenic bladder
* anatomic congenital anomaly
* allergy to all prophylactic antibiotics
* children whose parents do not wish to participate

Primary outcomes:
measure: To determine whether antibiotic prophylaxis prevents recurrent urinary tract infections by assessing if there is a decreased incidence of urinary tract infections.
timeFrame: one year
Secondary outcomes:
measure: To determine whether antibiotic prophylaxis prevents long-term renal scarring by assessing results of DMSA scans to look at long term renal scarring.
timeFrame: One year and five years
measure: To determine whether recurrent infections and involvement with the medical system impacts quality of life by assessing how this medical condition affects children using standardized quality of life questionnaires.
timeFrame: Yearly for five years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Darcie Kiddoo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01046175: Effect of Air-stacking on Peak Cough Flow in Patients With Acute Cervical or High Thoracic Spinal Cord Injury
Official title: Effect of Two Different Air-stacking Techniques, Combined With Manually Assisted Cough, on Peak Cough Flow (PCF) in Patients With Acute Cervical or High Thoracic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Spinal Cord Injury
Tetraplegia
Keywords: Respiratory complications
respiratory insufficiency
respiratory therapy
Lead sponsor: Ullevaal University Hospital
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Respiratory complications continue to be one of the leading causes of morbidity and mortality in people with spinal cord injury, especially among cervical and higher thoracic injuries. Both inspiratory and expiratory function are often severely decreased, leading to respiratory complications, such as atelectasis, pneumonia and ventilatory failure. The prevention of these respiratory complications needs to begin immediately after injury. To achieve effective expelling of secretions before they form mucus plugs, it is essential to improve patients ability to cough. Manually assisting the cough is one way of increasing cough flow, but an effective cough also requires adequate lung volumes. The emphasis should therefore be on expansion of the lungs before coughing. One way of expanding the lungs is by air-stacking. In air-stacking insufflations are stacked in the lungs to maximally expand them. Cough can be valued by measuring Peak Cough Flow (PCF). By combining air-stacking with manually assisted cough the PCF can be increased sufficiently. The aim of this study is to compare the effect of two different air-stacking techniques on PCF, air-stacking on a respirator versus air-stacking with a manual resuscitator.


Eligibility criteria: Inclusion Criteria:

* acute cervical or high thoracic spinal cord injury admitted to the ICU

Exclusion Criteria:

* substantial abdominal or thoracic injury
* substantial brain damage
* intubated or tracheostomized patients
* not able to cooperate
* pregnant women

Primary outcomes:
measure: Peak cough flow (PCF)
timeFrame: 2 weeks
Secondary outcomes:
measure: Patient preference of air-stacking technique
timeFrame: 2 weeks
measure: Physiotherapist preference of air-stacking technique
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevaal
Study officials:
affiliation: Oslo University Hospital
name: Helene L Soberg, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02750475: Human Phototoxicity Test
Official title: Human Phototoxicity Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-04-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To determine the phototoxic potential of a topically applied article in human subjects


Eligibility criteria: Inclusion Criteria:

* be male or female between the ages of 18 and 60 inclusive;
* be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability Act (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164;
* be in general good health as determined by the subject's medical history and in the discretion of the investigator;

Exclusion Criteria:

* have a visible sunburn;
* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses;
* must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product;
* have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products;

Primary outcomes:
measure: Intensity of skin reactions will be evaluated using the 5 point grading scale
timeFrame: Up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00585975: Efficacy and Safety of Bromfenac Ophthalmic Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cataract Surgery
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-01-04
Enrollment: 568
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy study of bromfenac ophthalmic solution


Eligibility criteria: Inclusion Criteria:

* Male or female greater than or equal to 18 years of age, and scheduled for cataract surgery

Exclusion Criteria:

* Active corneal pathology in either eye

Primary outcomes:
measure: Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero
timeFrame: Day 15
Secondary outcomes:
measure: Number of Participants That Are Pain Free
timeFrame: Day 1
Other outcomes:
Locations:
city: Irvine
country: United States
facility: ISTA Pharmaceuticals, Inc.
state: California
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Tim McNamara, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01601275: Database of All Patients With Microbiologically Proven Mycobacteria Tuberculosis Infection
Official title: Prospective Database of All Patients With Microbiologically Proven Mycobacteria Tuberculosis Infection Treated at Singapore General Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: tuberculosis
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 4600
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with microbiologically proven mycobacteria tuberculosis infection treated at the Singapore General Hospital.

Brief summary: Prospective data collection of all patients with microbiologically proven mycobacteria tuberculosis infection treated at Singapore General Hospital.

Detailed description: Tuberculosis currently infects one third of the world's population and is responsible for killing approximately 2 million individuals annually. This is a major public health concern worldwide, and there has been a huge impetus to implement strategies for better tuberculosis control.

The investigators have established a system to track all patients with microbiologically proven tuberculosis treated at Singapore General Hospital, with vigilant recording and reporting systems, from the first instance when patients were diagnosed to the time they have completed anti-tuberculosis chemotherapy. The investigators endeavour to use this system to improve patient care by adopting patient-supportive approaches that lead to high compliance rates and best possible outcomes of treatment.

Eligibility criteria: Inclusion Criteria:

1) All patients with microbiologically proven mycobacteria tuberculosis infection treated at the Singapore General Hospital.

Primary outcomes:
measure: Final outcomes of patients who have been diagnosed with microbiologically proven mycobacteria tuberculosis infection at Singapore General Hospital
timeFrame: From diagnosis to final outcome
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Su Ying Low, BMBCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dye C, Watt CJ, Bleed DM, Hosseini SM, Raviglione MC. Evolution of tuberculosis control and prospects for reducing tuberculosis incidence, prevalence, and deaths globally. JAMA. 2005 Jun 8;293(22):2767-75. doi: 10.1001/jama.293.22.2767.
citation: DeAngelis CD, Flanagin A. Tuberculosis--a global problem requiring a global solution. JAMA. 2005 Jun 8;293(22):2793-4. doi: 10.1001/jama.293.22.2793. No abstract available.
Clinical trial NCT00350675: Medical Utilization in Israel During Second Intifada
Official title: Medical Utilization, Psychotropic Prescriptions, and Somatic Complaints in Israel During the Second Intifada: An Ecological Study of the Impact of Stress.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anxiety
Depression
Stress
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-07-11
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: In this ecological study we examine the impact of stress from repeated terrorist attacks during the second initifada on medical utilization by the Israeli population. We hypothesize that in weeks following serious terror attacks there will be an increase in prescriptions for psychiatric medications and an increased number of unexplained somatic complaints. We will also examine associations with overall medical utlization. We will consider age, gender and effects of geographic poximity to location of attacks.


Eligibility criteria: Inclusion Criteria:

Ecological study We will examine patterns of visits and prescirptions for all participants in two large health provider institutions in Israel.

Exclusion Criteria:

None - ecological study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gertner Institute, Sheba Medical Center
name: Joshua D Lipsitz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gertner Institute, Sheba Medical Center
name: Raz Gross, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03851770: Laryngeal Motor Evoked-potentials as a Biomarker of Vagus Nerve Stimulation in Epileptic Patients
Official title: NEURO-LARYNX:Laryngeal Motor Evoked-potentials as a Biomarker of Vagus Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Keywords: Epilepsy
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients participating will be asked to come to the Neurophysiology Department of Saint Luc Clinic to peform the laryngeal evoked motor potential.
Primary purpose: OTHER

Brief summary: The goal of this study is to record and characterize larynx evoked motor potentials induced by vagus nerve stimulation. This study will include 10 adult patients implanted with a Vagus nerve stimulator, followed at the Center for Refractory Epilepsy at Cliniques St Luc. The inclusion criteria are: (1) patient aged between 18 and 65 years ; (2) cervical VNS device (Cyberonics, Houston, TX, USA) implanted for at least 6 months, (3) normal electrode impedance of the electrode. Exclusion criteria are (1) presence of a concomitant laryngeal pathology or recurrent laryngeal nerve damage, independent from VNS ; (2) important VNS side effects reported by the patient, such as severe dyspnea (grade III-IV) or severe pain in the neck/ear region.


Eligibility criteria: Inclusion Criteria:

* patients aged between 18 and 65 years
* Vagus nerve stimulation implanted for at least 6 months
* No impedance issues with the VNS electrode

Exclusion Criteria:

* presence of a concomitant laryngeal pathology or RLN damage, independent from vagus nerve stimulation
* important side effects of the VNS reported by the patient such as dyspnea, pain in neck/ear region and gastrointestinal complaints.

Primary outcomes:
measure: Laryngeal motor evoked potential (LMEP)
timeFrame: the LMEP is recorded for 60 minutes from the moment the patient arrives to the clinic to perform the test
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires St Luc
Study officials:
References: