louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03791034: Cell Free DNA for the Diagnosis and Treatment in Early NSCLC
Official title: Prospective Feasibility Study of Cell Free Circulating Tumor DNA for the Diagnosis and Treatment Monitoring in Early-stage Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small cell lung cancer
Recurrence
cfDNA
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Guardant Health, Inc.
First posted: 2019-01-02
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: non-small cell lung cancer patients who undergone curative surgery

Brief summary: The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA (cfDNA) can aid screening of recurrence after complete resection of early stage non-small cell lung cancer.

Detailed description: During evolution of primary tumor, tumor cells can be released into the bloodstream. It has also been shown that circulating cell-free tumor DNA (cfDNA) is released from apoptotic or necrotic tumor cells. In a study of cfDNA level after surgery in colon cancer patients, they suggested that cfDNA could detect recurrence of cancer several months earlier than the conventional follow up studies. Following several reports have suggested that cfDNA can invade host cells and alter host cell biology to cause cancer metastasis.

In this regard, we will collect from non-small cell lung cancer patients cohort who underwent curative resection, and will evaluate whether peripheral cfDNA can aid early detection of cancer recurrence. We will also study the genomic signature of cfDNA to assess the relationship between cfDNA and clinical outcome of non-small cell lung cancer patients.

Eligibility criteria: Inclusion Criteria:

* All subjects need to sign the informed consent form
* All subjects have Non-small cell lung cancer which suspected on chest CT or confirmed pathologically preoperatively.
* Non-small cell lung cancer have to confirmed pathologically after operation
* Clinical stage I - IIIA by AJCC 7th staging system

Exclusion Criteria:

* Have been undergone chemotherapy or radiotherapy due to non-small call lung cancer
* Have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine cervix with 3 years before enrollment
* Recurrent lung cancer
* Stage IIIB, IV by AJCC 7th staging system

Primary outcomes:
measure: Recurrence
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jhingook Kim, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01213134: Evaluating the Implementation of Portfolio Assessment in Resident Training Program
Official title: Evaluating the Implementation of Portfolio Assessment in Resident Training Program
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Residents' Perceptions on Portfolio Use in Clinical Training
Keywords: Medical Education
Resident Training
Portfolio
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-10-01
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: residents tutors

Brief summary: Portfolios are the records of learning process, providing evidences of experiential learning. It can be a valuable tool not only for understanding the learning process but also for evaluating the accomplishment. Portfolios promote learners to reflecting, thinking, improving in learning as well as achieving learning goals. It has been widely applied in medical education. The goals of resident training outcomes in Wan-Fang Hospital are the ACGME six core competences. The Wan-Fang hospital, one of Taipei Medical University affiliated hospitals and the first implementing portfolio assessment teaching hospitals in Taiwan, will conduct portfolio assessment to assess residents competences. Facilitating residents bring reflective learning into practice, personal and professional growth and demonstrating the outcomes of training program. This study describes initiating and implementing portfolio assessment procedures. Qualitative and quantitative research methods are applied for evaluating the portfolio assessment process and the data of validity and reliability. Qualitative data collection methods of interview, focus groups and meetings will be used understanding the experiences and viewpoints of residents, mentors and assessors. Then quantitative data collection method of questionnaire will be subsequently used. The results of this study will provide experiences and suggestions for the implementation of portfolio assessment system in medical education.


Eligibility criteria: Inclusion Criteria:

* residents in Wanfang Hospital willing to be enrolled to this study

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University - WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Wei-Pin Ho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05881434: Influence of a Questionnaire on Patients' Emergency Room Expectations
Official title: Influence of a Questionnaire on Patients' Emergency Room Expectations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergencies
Satisfaction, Patient
Expectations
Physician-Patient Relations
Lead sponsor: Orange Park Medical Center
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to determine whether a novel questionnaire designed to illicit patient's self-reported expectations across four domains (overall purpose of visit, medication intervention, imaging intervention and disposition) improves patient-provider communication as evaluated by an exit survey during an emergency room visit.


Eligibility criteria: Inclusion Criteria:

* Patients who arrive through the ED main entrance (non-EMS)
* Patients aged 18 years and older
* Patients who demonstrate decision making capacity
* Patients who willingly consent to participate

Exclusion criteria:

* Patients in distress (physical, emotional, or other) as determined by investigator
* Patients who demonstrate altered mental status or lack of capacity to consent
* Patients who require immediate medical intervention including diagnostic and/or treatment intervention
* Prisoners and patient under involuntary holds

Primary outcomes:
measure: Patient reported provider understanding of patient's visit expectations
timeFrame: After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event
Secondary outcomes:
measure: Patient reported degree to which visit expectations were met
timeFrame: After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event
measure: Patient reported provider courtesy
timeFrame: After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event
measure: Patient reported provider listening
timeFrame: After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event
measure: Patient reported inclusion in treatment decisions
timeFrame: After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event
Other outcomes:
Locations:
city: Orange Park
country: United States
facility: Orange Park Medical Center
state: Florida
Study officials:
References:
Clinical trial NCT06561334: Spasmodic Dysphonia Interviews
Official title: The Socioeconomic Impact of Spasmodic Dysphonia Patients and the Role of Botulinum Toxin
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Spasmodic Dysphonia
Quality of Life
Keywords: Qualitative study
Interviews
Quality of life
Spasmodic Dysphonia
Botulinum toxin
Laryngology
Voice disorder
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2024-08-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with diagnosed Spasmodic Dysphonia

Brief summary: Previous research has shown that patients with voice disorders often have a lower quality of life and struggle with employment. Spasmodic Dysphonia (SD) is a voice disorder that causes abrupt and uncontrollable spasms of the voice box, often resulting in the person having lifelong changes in their voice and speech pattern. The current mainstay of treatment is injecting botulinum toxin (BT) injections into the vocal cord to ease the spasms. The same research team conducted a pilot study in April 2021 on patients with SD. The pilot study used questionnaires and short interviews to understand the livelihood of 10 SD patients. It displayed that SD may impact patients' quality of life. The investigators now aim to run an official research project, ethically approved, to explore the following questions further:

1. Does SD impact the socio-economic lives of its patients? If so, how?
2. What role does BT play in the socio-economic livelihood of SD patients?

To answer these questions, the investigators aim to interview 20 patients with Spasmodic Dysphonia.


Eligibility criteria: Inclusion Criteria:

* Adults diagnosed with Spasmodic Dysphonia who have received at least one botulinum toxin injection.

Exclusion Criteria:

* Below 18 years of age; additional laryngeal condition(s) severely affecting voice.

Primary outcomes:
measure: Does Spasmodic Dysphonia impact the socio-economic lives of its patients? If so, how?
timeFrame: Through study completion, which is expected to be a year
Secondary outcomes:
measure: What role do botulinum toxin injections play in the socio-economic livelihood of Spasmodic Dysphonia patients?
timeFrame: Through study completion, which is expected to be a year
Other outcomes:
Locations:
Study officials:
affiliation: Manchester University NHS Foundation Trust
name: Sadie Khwaja, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04424134: BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization
Official title: Open Label Randomized Clinical Trial BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID 19
Keywords: COVID 19
bromhexine
spironolactone
Lead sponsor: Lomonosov Moscow State University Medical Research and Educational Center
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 80
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: Patients with mild and severe COVID 19 will be randomized 1:1 into two groups: experimental, which will get bromhexine and spironolactone, and control. Patients will get investigated therapy for ten days. Change in clinical assessment score COVID 19 (CAS COVID 19) between baseline and 12th day will be evaluated as a primary endpoint. Forty-five-day risk of death or mechanical ventilation will also be assessed.


Eligibility criteria: Inclusion Criteria:

signed inform consent COVID 19 with the mild and severe course. The diagnosis could be made with positive polymerase chain reaction (PCR) (International Statistical Classification (ICD-10) code - U07.1) and/or virus pneumonia in computer tomography (ICD 10 code - U07.2) 5. Lung exposure on CT more than 25% 6. Sp02 without supportive oxygen ≤ 93% 7. C-reactive protein \> 60 mg/l or elevation of C reactive protein 3 times in 8-14 days after first symptoms

Exclusion Criteria:

* pregnancy and breastfeeding
* hypersensitivity to Spironolactone
* hypersensitivity to Bromhexine
* Known liver failure
* Glomerular filtration rate \<20 ml/ min
* physician judgment that the patient will need mechanical ventilation in 24 hours
* other indications for Spironolactone
* Active cancer

Primary outcomes:
measure: Change from baseline in clinical assessment score COVID 19 (CAS COVID 19)
timeFrame: baseline, day 12
Secondary outcomes:
measure: - Combine endpoint -
timeFrame: 12 days, 45 days
measure: C-reactive protein
timeFrame: 12 days, 45 days
measure: D-dimer
timeFrame: 12 days, 45 days
measure: EuroQol Group. EQ-5D™
timeFrame: 12 days, 45 days
measure: EuroQol Group. EQ VAS
timeFrame: 12 days, 45 days
measure: HADS
timeFrame: 14 days, 45 days
measure: Hospital length of stay
timeFrame: up to 45 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Lomonosov Moscow State University Medical Research and Educational Center
state: Moscow Region
Study officials:
References:
Clinical trial NCT04732234: Pre-emptive US Guided Superior Hypogastric Plexus Block in Pelvic Cancer Surgeries : a Randomized Double-Blinded Study
Official title: Pre-emptive Ultrasound Guided Superior Hypogastric Plexus Block in Pelvic Cancer Surgeries : a Randomized Double-Blinded Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group S (SHPB group 18 ultrasound guided SHPB ) using 20 ml Bupivacaine 0.5% before skin incision.

Group C (Control group 18 patients) in which same technique will be done but using normal saline 0.9%
Primary purpose: TREATMENT

Brief summary: The superior hypogastric plexus (SHP) is a retroperitoneal structure with a predominance of afferent sympathetic nerve fibers. The perception of central pelvic pain is thought mainly to involve transmission through this plexus. Therefore, blocking or of SHP has been used to treat pelvic pain.

Detailed description: Ultrasound guided superior hypogastric plexus block there is 2 equal groups:

Group S (SHPB group 18 patients) ultrasound guided SHPB is done after induction of balanced general anesthesia (fentanyl, propofol and rocuronium) using 20 ml Bupivacaine 0.5% before skin incision, Group C (Control group 18 patients) in which same technique will be done but using normal saline 0.9% instead of bupivacaine. Patients of both groups will receive patient controlled analgesia using morphine with continous background infusion of morphine 1.5 mg/h with adding granisterone 2mg/60 ml and ability to give bolus of 0.5 mg morphine on demand.

• Dosing and administration; Group S (SHPB group 18 ultrasound guided SHPB ) using 20 ml Bupivacaine 0.5% before skin incision.

Group C (Control group 18 patients) in which same technique will be done but using normal saline 0.9%

Eligibility criteria: Inclusion Criteria:

* ASA II,III.
* Patients undergoing pelvic surgeries.

Exclusion Criteria:

* Patients refusal,
* Coagulopathy,
* Infection.

Primary outcomes:
measure: morphine consumption
timeFrame: baseline till 24 hours postoperative
Secondary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: Visual analogue scale (VAS) at baseline till 24 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Nataional Cancer Instituite
Study officials:
affiliation: Anesthesia & pain management Dept, National Cancer Institute-Cairo - Egypt
name: Mohamed abdel wadod, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02831634: A Feasibility Study to Identify T-cell Responses to Neo-epitopes in Tumor Invaded Lymph Nodes (NeoEpitope)
Official title: A Feasibility Study to Identify T-cell Responses to Neo-epitopes in Tumor Invaded Lymph Nodes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cutaneous Melanoma
Keywords: Breast cancer
cutaneous melanoma
Lead sponsor: Institut Curie
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2016-07-13
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: OTHER

Brief summary: Feasibility study for a method allowing identification of tumor mutated epitopes in patients with breast cancer or cutaneous melanoma, and quantification of CD8+ T cells specific for these tumor neo-antigens in their lymph nodes


Eligibility criteria: Inclusion Criteria:

Patients over 18 years Patient with HR+ , HER2- and node-positive (proven by cytology) invasive ductal carcinoma breast cancer, grade (SBR) II or III, and having an axillary dissection programmed, Or patient having cutaneous melanoma scheduled for a lymph node dissection at the Institut Curie including dissection of the lymph nodes draining the tumor, Voluntary having signed and dated written informed consents prior to any specific study procedure,

Exclusion Criteria:

Patients treated for a breast cancer who received neoadjuvant chemotherapy Patients treated for breast cancer with distant metastases (M+)• Only for patients with breast cancer: oral or systemic corticosteroids treatment received within 30 days prior surgery Patients on immunosuppressive treatment or diagnosed of an immunodeficiency Patients with known chronic viral infection as HIV1 or 2, HBV, HCV Patients with other cancer diagnosed within 5 years (except squamous cell cutaneous carcinomas) Patients without a French social security Patients deprived of liberty or placed under the authority of a tutor

Primary outcomes:
measure: Feasibility of a method allowing identification of tumor mutated epitopes in patients with breast cancer or cutaneous melanoma and quantification of CD8+ T cells specific for the tumor neo-antigens identified in the lymph nodes.
timeFrame: up to 24 months
Secondary outcomes:
measure: Quantification of CD4+ T lymphocytes specific for identified tumor neo-antigens in the lymph nodes.
timeFrame: up to 24 months
measure: Quantification of CD4+ and CD8+ T lymphocytes specific for identified neo-antigens in the blood and tumor.
timeFrame: up to 24 months
measure: Comparison of the frequency and relative amplitude of the T cell response specific for the tumor neo-epitopes with other immune responses and responses against known tumor antigens.
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
References:
Clinical trial NCT01898234: Dialysis Membranes and Hemodynamic Tolerance
Official title: Assessment of Subjective and Hemodynamic Tolerance of Different High- and Low-flux Dialysis Membranes in Patients Undergoing Chronic Intermittent Hemodialysis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dialysis Membranes and Hemodynamic Tolerance
Keywords: Hemodynamics
intradialytic hypotension
subjective tolerance
dialysis membranes
high flux
low flux
hemodialysis
Lead sponsor: Ospedale Regionale di Locarno
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Background:

High- and low-flux dialysis membranes made of different materials may correlate with various hemodynamic tolerance profiles. This study aims to investigate hemodynamic response and incidence of hypotensive episodes by comparing some of the most commonly used high- and low-flux dialyzers.

Methodology:

The study was designed as an open label, randomized, cross-over investigation, including 25 patients undergoing chronic hemodialysis. Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other. The hemodynamic profile was assessed with a non-invasive technique and patients were asked to provide tolerance feedback through a questionnaire.


Eligibility criteria: Inclusion Criteria:

* age 18 and older
* ability to understand the information presented and sign the informed consent
* chronic hemodialysis for at least 8 weeks
* stable dialysis prescriptions and modality in the 2 weeks prior to protocol implementation

Exclusion Criteria:

* mental illness;
* inability to understand the information presented and sign the informed consent;
* acute disease requiring hospitalization at the time of patient enrolment
* pregnancy and breast feeding

Primary outcomes:
measure: comparative evaluation of mean hemodynamic parameters (i.e. systolic and diastolic blood pressure, peripheral resistance and cardiac output) during dialysis
timeFrame: 4 weeks
measure: comparative evaluation of subjective tolerance across the various membranes
timeFrame: 4 weeks
measure: comparative evaluation of Kt/V and of beta-2 microglobulin removal
timeFrame: 4 weeks
Secondary outcomes:
measure: comparative analysis of the incidence of symptomatic and non-symptomatic systolic pressure drops (> 20 mmHg)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Locarno
country: Switzerland
facility: Ospedale Regionale di Locarno
state: Ticino
Study officials:
affiliation: Ospedale Regionale Locarno
name: Luca Gabutti, MD
role: PRINCIPAL_INVESTIGATOR
References: