louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02430701: Irreversible Electroporation(IRE) For Unresectable Esophageal Neoplasms
Official title: Irreversible Electroporation(IRE) For Unresectable Esophageal Neoplasms: Phase I and Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Neoplasms
Keywords: irreversible electroporation
Unresectable Esophageal 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 Esophageal Neoplasms.

Detailed description: By enrolling patients with unresectable Esophageal 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 Esophageal Neoplasms.

Eligibility criteria: Inclusion Criteria:

* Esophageal 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 NCT01843101: Investigation of Different Scanning Protocols for 3 Dimensional High-resolution Imaging of the Human Cornea With Optical Coherence Tomography (OCT) - A Pilot Study
Official title: Investigation of Different Scanning Protocols for 3 Dimensional High-resolution Imaging of the Human Cornea With Optical Coherence Tomography (OCT) - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Corneal Neovascularisation
Keratoconus
Keywords: Optical Coherence Tomography
Cornea
Imaging
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to develop a protocol for optimal corneal 3-dimensional imaging based on measurements in healthy volunteers. For this purpose, a customized ultra-high resolution Spectral Domain OCT will be used. To validate whether the protocol can also be applied in patients with corneal pathologies, for whom it is intended to be used, measurements in these patients will be performed. We propose to obtain images from patients with keratoconus, since this is one of the most frequent causes for corneal transplantations in Europe and from patients with corneal neovascularization which is a major cause of vision loss in several ophthalmic diseases. Based on the obtained measurement protocol, further studies investigating the pathophysiology or treatment success of several corneal pathologies can be planned.


Eligibility criteria: Inclusion Criteria:

Healthy volunteers:

* Men and women aged over 18 years
* Normal findings in the slit lamp examination, no corneal pathologies

Patients with keratoconus:

* Men and women aged over 18 years
* Presence of keratoconus
* No ophthalmic surgery in the 3 months preceding the study

Patients with corneal neovascularization:

* Men and women aged over 18 years
* Presence of corneal neovascularization
* No ophthalmic surgery in the 3 months preceding the study

Exclusion Criteria:

* Participation in a clinical trial in the previous 3 weeks
* Presence of any abnormalities preventing reliable measurements as judged by the investigator
* Pregnancy, planned pregnancy or lactating

Primary outcomes:
measure: Corneal Imaging
timeFrame: 1 day
Secondary outcomes:
measure: Imaging of corneal pathologies
timeFrame: 1 day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Katarzyna Napora, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05056701: Prediction of Chronic Kidney Disease Following Pre-eclampsia: Diagnosis and Early Care
Official title: Prediction of Chronic Kidney Disease Following Pre-eclampsia: Diagnosis and Early Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preeclampsia
Keywords: chronic kidney disease (CKD)
preeclampsia
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Pre-eclampsia (PE) is a pregnancy-associated syndrome of variable severity, classically defined by the combination of hypertension and proteinuria in a previously non-hypertensive or proteinuric patient. These symptoms normally resolve within 2-3 months after delivery regardless of the severity of the pre-eclampsia.

Regardless of its definition, preeclampsia is associated with an increased risk of obstetric events and, for the mother, an increased risk of developing chronic kidney disease (CKD), hypertension, diabetes and cardiovascular disease in the broad sense.

The relationship between preeclampsia and Chronic Kidney Disease is, however, complex and not fully understood.

Investigator proposes an interventional study to identify the diagnosis of Chronic Kidney Disease in patients who have developed an episode of Preeclampsia.


Eligibility criteria: Inclusion Criteria:

* Meeting the preeclampsia criteria or one of its complications (eclampsia, HELLP syndrome) according to the ISSHP 2018 definitions within the last 5 years
* Having signed the informed consent
* Person affiliated to social security

Exclusion Criteria:

* Patient with mental disability or language barrier preventing understanding of the study or consent
* Person deprived of liberty by judicial or administrative decision
* Person under forced psychiatric care
* Person subject to a legal protection measure

Primary outcomes:
measure: prevalence of the Chronic Kidney Disease (CKD)
timeFrame: until 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu Angers
city: Le MANS
country: France
facility: Centre Hospitalier Du Mans
Study officials:
References:
Clinical trial NCT03228901: Oxytocin and Non-verbal Communication
Official title: Exploring the Effects of Oxytocin on Non-verbal Communication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Social Interaction
Keywords: Oxytocin
Affiliation
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: In this protocol registration, the investigators plan a secondary data analysis of a dataset to explore the effects of intra-nasal oxytocin on the non-verbal expression of affiliation.

Detailed description: Using Liu et al.'s (2012) dataset, the investigators seek to observe whether the administration of oxytocin modifies non-verbal communication with a stranger.

This dataset involves a conversation between two strangers that took place 45 minutes after drug administration. While Liu et al. coded the video for markers of interpersonal distance (physical distance, eye contact, conversational intimacy), the investigators seek to analyse oxytocin's effects on non-verbal communication of affiliative and sexual cues (e.g., smiles, lip puckers). Based on findings that oxytocin's effects depend on context, the investigators will explore these relationships as a function of the conversational context (where participants converse with each other using low-, medium-, and high-intimacy topics, or in an unstructured conversation).

Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* pregnant;
* history of epilepsy, severe depression, severe anxiety, or psychosis;
* smoking more than 15 cigarettes a day;
* addicted to illegal substances.

Primary outcomes:
measure: Non-verbal communication
timeFrame: Measured in the interaction which commenced 45mins after drug administration
Secondary outcomes:
measure: Ratings of the person participants interacted with
timeFrame: Measured following the interaction (which commenced 45 mins after drug administration)
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: University of New South Wales
state: New South Wales
Study officials:
References:
Clinical trial NCT00576901: A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.
Official title: "An Open Label Study to Assess the Effect of Neoadjuvant Treatment With Docetaxel + Xeloda + Avastin on Pathological Response Rate in Inflammatory or Locally Advanced Breast Cancer"
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-12-19
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the efficacy and safety of combination first-line treatment with docetaxel + Xeloda + Avastin in patients with inflammatory or locally advanced breast cancer. Patients will receive 3-weekly cycles of Avastin (15mg/kg i.v. on day 1 of each cycle), docetaxel (75mg/m2 i.v. on day 1 of each cycle, after Avastin) and Xeloda (2000mg/m2 p.o. on days 1-15 of each cycle). Four cycles of chemotherapy are planned, plus an optional additional two cycles; after chemotherapy patients will be assessed for surgery. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* female patients, \>=18 years of age;
* HER2-negative, locally advanced (stage II or III) or inflammatory cancer of the breast;
* ECOG performance status 0-1.

Exclusion Criteria:

* metastatic disease (stage IV);
* previous treatment for breast cancer;
* evidence of CNS metastasis;
* current or recent (within 10 days of first dose of Avastin) use of aspirin (\>325mg/day) NSAIDs or full dose anticoagulants for therapeutic purposes;
* clinically significant cardiovascular disease.

Primary outcomes:
measure: Percentage of Participants Achieving Pathological Complete Response (pCR)
timeFrame: At time of surgery, after receiving up to 6 cycles of treatment (average of 12 to 18 weeks)
Secondary outcomes:
measure: Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)
timeFrame: Day 1 of Cycles 1-6
measure: Progression-Free Survival
timeFrame: Cycles 1-6
measure: Overall Survival
timeFrame: Cycles 1-6
measure: Percentage of Participants Undergoing Breast-Conserving Surgery
timeFrame: Following Cycle 6
Other outcomes:
Locations:
city: Madrid
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02298101: Comparison of Lung Deposition With the Aeroneb Solo Adapter and a Standard Jet Nebulizer by SPECT-CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Aerosol delivery
Lung deposition
SPECT
subjects
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Aeroneb Solo Adapter is a vibrating-mesh nebulizer Aeroneb Solo combined to a spacer specifically designed for spontaneously breathing patients. This device has not been investigated in vivo yet.

It's known that using a spacer during nebulization improves aerosol delivery. We hypothetized that lung deposition could be highly increased with the Aeroneb Solo Adapter in comparison to a standard jet nebulizer.


Eligibility criteria: Inclusion Criteria:

* Healthy respiratory function

Exclusion Criteria:

* Pulmonary disease

Primary outcomes:
measure: Pulmonary deposition
timeFrame: immediately after nebulization by imaging assessment, an expected average of 15 minutes
Secondary outcomes:
measure: Three-dimensional penetration index
timeFrame: immediately after the nebulization by imaging assessment, expected average of 30 minutes
Other outcomes:
measure: Spirometry
timeFrame: Baseline
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
References:
citation: Dugernier J, Hesse M, Vanbever R, Depoortere V, Roeseler J, Michotte JB, Laterre PF, Jamar F, Reychler G. SPECT-CT Comparison of Lung Deposition using a System combining a Vibrating-mesh Nebulizer with a Valved Holding Chamber and a Conventional Jet Nebulizer: a Randomized Cross-over Study. Pharm Res. 2017 Feb;34(2):290-300. doi: 10.1007/s11095-016-2061-7. Epub 2016 Nov 7.
Clinical trial NCT05938101: Pain Clinic Staff Harassed by Patients Pre/Post COVID
Official title: Pain Clinic Staff Harassment Caused by Patients Pre/Post COVID Pandemic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patient Violence
Keywords: Harassment by patient
Lead sponsor: Salem Anaesthesia Pain Clinic
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult chronic pain patients who are undergoing treatment in a specialist pain clinic

Brief summary: Chronic pain may cause psychological or behavioral problems. Chronic pain patients occasionally harass the pain care providers. The COVID-19 pandemic caused major stress for the general population.

Quantitative and qualitative analysis of prospective electronic and clinic diary data. Evaluation of incidents of clinic staff harassment; caused by patients, before and during COVID pandemic. Analysis of causative factors, incident outcome and lessons learned.

Detailed description: Chronic pain may be complicated by mental disease. Some patients have behavioral disorders and occasionally harass the pain care providers. The COVID-19 pandemic caused significant stress for the general population. The stress of the pandemic may aggravate the psychological dysfunction in chronic pain patients.

This is a quantitative and qualitative analysis of prospective electronic and clinic diary data. It is an evaluation of incidents of pain clinic staff harassment; caused by patients, before and during the COVID pandemic. This is an analysis of incident causative factors, incident outcomes, systemic factors and lessons learned. The qualitative information of each incident is presented in a sensitive and careful format.

Eligibility criteria: Inclusion Criteria:

* adult chronic pain patients

Exclusion Criteria:

* pediatric chronic pain patients

Primary outcomes:
measure: Percentage of patients who harassed clinic staff
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Salem Anaesthesia Pain Clinic
state: British Columbia
Study officials:
affiliation: Salem Anaesthesia Pain Clinic
name: Olu Bamgbade, MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caruso R, Toffanin T, Folesani F, Biancosino B, Romagnolo F, Riba MB, McFarland D, Palagini L, Belvederi Murri M, Zerbinati L, Grassi L. Violence Against Physicians in the Workplace: Trends, Causes, Consequences, and Strategies for Intervention. Curr Psychiatry Rep. 2022 Dec;24(12):911-924. doi: 10.1007/s11920-022-01398-1. Epub 2022 Nov 29.
Clinical trial NCT02724501: Studies of the Tumour Suppressor Gene PTEN - Endometrial Cancer
Official title: Clinical and Molecular Studies of the Tumour Suppressor Gene PTEN in Endometrioid Type Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Trials Group
name: Princess Margaret Hospital, Canada
First posted: 2016-03-31
Enrollment: 217
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Endometrial Cancer

Brief summary: This project seeks to understand the role of the PTEN tumour suppressor gene in endometrial cancer (tumours of the uterine lining), the most common gynecologic cancer in the developed world. The studies in this program span the spectrum from fruit flies to humans, as part of a synergistic partnership that will significantly enhance our understanding of the molecular genetic events involved in the development and progression of endometrial cancer. The discovery of new targets for therapy, and the ability to evaluate these in subsequent clinical trials is a significant strength of this scientific interaction, which may result in cures for patients with primary and relapse endometrial cancer and prevention of this cancer in women who are at high risk.

Detailed description: PTEN is a critical module that regulates effects of sex hormones on the growth and apoptosis of endometrial cells; and plays an important role in the pathogenesis of subgroups of endometrial cancers, their biologic behaviour and responses to therapeutic agents. Furthermore, mutational inactivation of the PTEN gene can serve as an independent molecular marker that can predict relapse and survival in endometrial cancer. The prognostic effects of PTEN may also be modulated by other tumour suppressor gene losses including P53 mutations, by hormone receptor status, and microsatellite instability.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* patients who had a hysterectomy
* patient able to provide consent and complete questionnaire

Primary outcomes:
measure: Number of endometrial cancer patients with inactivated PTEN tumor suppressor gene
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Anthony Fyles, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04570501: Angiotensin (1-7) for the Treatment of COVID-19 in Hospitalized Patients
Official title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Safety and Efficacy of Angiotensin (1-7) for the Treatment of COVID-19 in Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Covid19
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-09-30
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: The primary objective is to evaluate the safety and efficacy of intravenous (IV) infusion of Ang (1-7) compared to placebo with respect to time to recovery, disease severity, need for mechanical ventilation or extracorporeal membrane oxygenation (ECMO), and mortality in patients with COVID 19.


Eligibility criteria: Inclusion Criteria:

* Signs and symptoms suggestive of COVID-19 infection including cough or dyspnea
* Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) test ≤7 days before randomization
* Currently hospitalized or in an emergency department with planned hospitalization
* Peripheral capillary oxygen saturation (SpO2) ≤93% on room air or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) \<300 at Screening

Exclusion Criteria:

* Simultaneous participation in any other clinical study incompatible with this one
* Treatment with an antibody immunotherapy that is not standard of care for COVID-19 within 4 weeks of Screening
* Requirement for mechanical ventilation or ECMO at Screening
* Hypotension at Screening, defined as supine BP \<95 mm Hg systolic or \<55 mm Hg diastolic
* Severe liver injury defined as AST or ALT ≥5x the upper limit of normal
* Severe kidney failure defined as an estimated glomerular filtration rate (eGFR) \<30 mL/min
* Any known immune deficiency
* Pregnancy or breastfeeding

Primary outcomes:
measure: Time to recovery
timeFrame: Up to 29 days
Secondary outcomes:
measure: Incidence of mortality at Day 29
timeFrame: 29 days
measure: Number of days alive and not on mechanical ventilator or ECMO in the 28 days following first dose
timeFrame: Up to 29 days
measure: Number of participants requiring mechanical ventilation or ECMO, or dying, through Day 29
timeFrame: Up to 29 days
measure: COVID-19 disease severity scale score on Day 8
timeFrame: Day 8
measure: COVID-19 disease severity scale score on Day 15
timeFrame: Day 15
measure: COVID-19 disease severity scale score on Day 22
timeFrame: Day 22
measure: COVID-19 disease severity scale score on Day 29
timeFrame: Day 29
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Kevin V Grimes, MD
role: PRINCIPAL_INVESTIGATOR
References: