louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05754047: Tumor Characteristics and Survival Rate of HER2-Low Breast Cancer Patients
Official title: Tumor Characteristics and Survival Rate of HER2-Low Breast Cancer Patients; a Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HER2 Low Breast Carcinoma
Keywords: Breast cancer, ErbB-2, HER2-low, Disease-Free Survival, Survival Rate
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 3582
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: There were 3918 patients with human epidermal growth factor receptor 2 (HER2) status in the database of the Cancer Research Center (CRC), among which, 24 male patients and 312 patients with missing DFS and OS information were excluded. In total, 3582 patients have been included in DFS and OS analysis.

Brief summary: In this large-scale cross-sectional study, we evaluated disease-free survival (DFS), overall survival (OS), and clinicopathological characteristics of BC patients from 1991 to 2022, retrospectively. We recruited patients referred to the Cancer Research Center in Tehran, Iran, and their HER2 status, which is classified as HER2-low, HER2-positive, or HER2-negative, was obtained from prospectively maintained registries. we aimed to dive more deeply into the clinicopathological characteristics and survival features of HER2-low breast cancer patients and campared it with HER2-negative and HER2-positive groups.

Question 1: Is HER2-low breast cancer (BC) a new subtype in the standard classification of BCs? Question 2: How is the DFS and OS rate of HER2-low breast cancer patients in comparison with HER2-negative and HER2-positive groups?


Eligibility criteria: Inclusion Criteria:

All breast cancer patients with human epidermal growth factor receptor 2 (HER2) status in the database of the Cancer Research Center (CRC),from April 1991 to March 2022

Exclusion Criteria:

The male gender Patients with indeterminate or missing HER2 status, or patients with missing DFS and OS information

Primary outcomes:
measure: HER2-low OS
timeFrame: 38 months
measure: HER2-low DFS
timeFrame: 33 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cancer Research Center, Shohadaye Tajrish Hospital, Shahid Beheshti University of Medical Sciences
name: Mohammad Esmail Akbari, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02995447: Differential Effects of Propofol on Scalp and Intracranial EEG
Official title: Differential Effects of Propofol on Scalp and Intracranial Electroencephalogram
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: General Anesthesia
Keywords: propofol
electroencephalogram
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 15
Sex: ALL
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 suffering from epilepsy

Brief summary: The anesthetic propofol has a dose-depending effect on the EEG, which differs in comparison between scalp and intracerebral electrodes

Detailed description: The electrical activity of the brain (electroencephalogram EEG) is usually assessed from the surface of the head, which is approximately 1-2 cm above the cerebral cortex. Thus, the spatial resolution of the EEG is low, and the electrical activity recorded originates from a multitude of neurons.

Deep brain structures such as the hippocampus also generate electrical activity which cannot be assessed from the surface of the head. However, in some patients electrodes are implanted into the brain to look for the origin of epileptic seizures. Along the way, these intracerebral electrodes enable to record the EEG from intracerebral structures which are generated from few neurons only. Once the origin of epilepsy has been identified, the intracerebral electrodes are removed under general anesthesia.

Anesthetics such as propofol characteristically modify the EEG in a dose-dependant manner. More over, the propofol effect on the EEG recorded from the surface is likely to be different from the intracerebral EEG, however little is known so far. Therefore we aim to investigate the differential effect of propofol on the superficial versus intracerebral recorded EEG.

Eligibility criteria: Inclusion Criteria:

* Patients with implanted intracerebral EEG electrodes

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: EEG amplitude
timeFrame: up to two hours of EEG recording
measure: EEG frequency spectrum
timeFrame: up to two hours of EEG recording
Secondary outcomes:
measure: EEG Burst Suppression Ratio
timeFrame: up to two hours of EEG recording
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
Study officials:
affiliation: Dept. of Anesthesiology and Intensive Care Medicine
name: Martin Soehle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02582047: Influenza Vaccine and Pneumococcal Vaccine
Official title: Immunogenicity and Safety of an Influenza Vaccine Administered Concomitantly With a 13-Valent Pneumococcal Conjugate Vaccine or 23-Valent Polysaccharide Pneumococcal Vaccine in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza, Human
Pneumococcal Infections
Keywords: influenza vaccine
pneumococcal vaccine
simultaneous vaccination
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 224
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Previous studies have demonstrated the immunogenicity and safety of the co-administration of the trivalent inactivated influenza vaccine (IIV3) with the polysaccharide pneumococcal vaccine (PPV) or pneumococcal conjugate vaccine (PCV). However, there is no direct comparison study that evaluates the immunogenicity and safety of IIV3 given concomitantly with PCV13 or PPV23 in the elderly. This study is intended to compare the immunogenicity and safety of concomitant administration in the elderly subjects.

Detailed description: During the influenza vaccination period, 224 healthy elderly volunteers randomly received IIV3 given concomitantly with either PCV13 (PCV13+IIV3) or PPV23 (PPV23+IIV3) in a 1:1 ratio. Serum hemagglutination-inhibiting (HI) antibodies for IIV3 were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded prospectively in a clinical diary during a 7-day period.

Eligibility criteria: Inclusion Criteria:

* Adults aged ≥65 years who signed the informed consent

Exclusion Criteria:

* Previous pneumococcal vaccine recipients
* Egg allergy
* History of serious adverse event after vaccination
* Any acute disease or infection
* History of neurological symptoms or signs
* Impairment of immune function or immunosuppressant use
* Bleeding diathesis
* Fever (defined as axillary temperature ³38.0°C) within 3 days
* History of Streptococcal pneumoniae infection within the previous 5 years

Primary outcomes:
measure: Seroconversion rates (A/H1N1, A/H3N2, and B)
timeFrame: Change from baseline titer at 4 weeks
Secondary outcomes:
measure: Seroprotection rates (A/H1N1, A/H3N2, and B)
timeFrame: Change from baseline titer at 4 weeks
measure: GMT folds (A/H1N1, A/H3N2, and B)
timeFrame: Change from baseline titer at 4 weeks
Other outcomes:
measure: Frequency and duration of local and systemic adverse events
timeFrame: Monitor using a clinical diary for seven days after vaccination
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Kyoungido
city: Seoul
country: Korea, Republic of
facility: Hallym University Gangnam Sacred Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Hee Jin Cheong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01843647: Neoadjuvant Therapy of Icotinib in Epidermal Growth Factor Receptor Mutated NSCLC Patients
Official title: Randomized, Controlled, Multicenter Study of Neoadjuvant Therapy With Icotinib in IIIA NSCLC Patients With Epidermal Growth Factor Receptor Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small-cell Lung Cancer
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-04-30
Enrollment: 100
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: The purpose of this study is to evaluate the overall response rate and disease free survival for IIIAN2 non-small-cell lung cancer patients with EGFR 19 or 21 exon mutation.

Detailed description: Neoadjuvant therapy has been used for years to treat patients with non-small-cell lung cancer whose primary tumors are too large to allow for surgery. Reduction in size of the primary tumor with neoadjuvant therapy has made it possible for those patients. Moreover, the goals have expanded to include: determination of the sensitivity of the tumor so that subsequent therapy can be modified accordingly; to prolong disease free survival; to prolong survival.

Eligibility criteria: Inclusion Criteria:

* 1.The patients signed the written informed consent. 2.The patients present with operable IIIAN2 non-small-cell lung cancers with 19 or 21 exon mutation.

  3.The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, and surgical therapy.

  4.The patients' Eastern Cooperative Oncology Group scores are ≤ 0-1. 5.The age of patient is ≥ 18 years old with a life expectancy longer than 3 months.

Exclusion Criteria:

* 1. Patients with unresected tumor. 2. Wild EGFR type. 3. Allergic to the study drug. 4. Patients have severe non-cancerous diseases. 5. Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials.

Primary outcomes:
measure: Objective response rate
timeFrame: 8 weeks
measure: Disease free survival
timeFrame: 1 year
Secondary outcomes:
measure: The pathological complete response rate after neoadjuvant therapy with icotinib
timeFrame: 8 weeks
measure: The lymph node staging reduction rate of patients after neoadjuvant therapy with icotinib
timeFrame: 8 weeks
measure: The resection rate of patients after neoadjuvant therapy with icotinib
timeFrame: 2 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang cancer hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Weimin Mao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01361347: Safety of Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
Official title: Phase 4 Study: Milk Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Milk Allergy
Anaphylaxis
Keywords: milk allergy
desensitization
anaphylaxis
school-age
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2011-05-26
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the number of Participants with Adverse Events as a Measure of Safety and Tolerability.

Detailed description: Eligibility criteria:

Age 6 - 16 yrs

* IgE-mediated milk allergy
* and milk provocation within 3 months prior to or an documented accidental milk contact with clear immediate symptoms

Outcome measures:

* number of patients with successful desensitization (195 - 200 ml milk per day)
* number of patients with adverse events

Eligibility criteria: Inclusion Criteria:

* IgE-mediated milk allergy
* An immediately positive challenge test result to milk prior to inclusion

Exclusion Criteria:

* Not willing to participate

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants drinking 2 dl/day of milk (success in desensitization)
timeFrame: 12 months
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital, Allergy Centre
Study officials:
affiliation: Consultant Pediatric Allergist
name: Marita Paassilta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01488747: Bioavailability of Fish Oils: Emulsified Versus Capsular Triglyceride
Official title: Bioavailability of Fish Oils: Emulsified vs. Capsular Triglyceride
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Keywords: Omega-3 fatty acids
Phospholipid fatty acids
chymlomicron fatty acids
Bioavailability fo fish oil supplements in healthy adults
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2011-12-08
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this investigation is to determine the relative percentage and rate of incorporation of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and total omega-3 (n-3) fatty acids after ingestion of 4 emulsified flavored triglyceride fish oil supplements versus an encapsulated triglyceride in defined plasma lipid pools.

The primary endpoints to be evaluated include the fatty acid composition of plasma lipids before and after consumption of a single dose of emulsified triglyceride based fish oil and triglyceride of similar n-3 compositions in capsule form. The investigators will measure changes in plasma phospholipid, and chylomicron fatty acids.


Eligibility criteria: Inclusion Criteria:

1. Healthy adults ages 18 to 60.
2. Body mass index between 22 and 32 kg/m2.
3. Medical history (interview) demonstrating good health.
4. Nonsmoker.
5. Consumption of a typical American diet with no unusual dietary habits.
6. Willingness to comply with the study protocol.
7. Low reported n-3 intake (\<100 mg/d) on the Omega-3 Checklist

Exclusion Criteria:

1. Any active, uncontrolled medical problem.
2. Consumption of essential fatty acid supplements within the past 6 months.
3. Use of lipid lowering drugs.
4. Fish consumption greater than 1 fish meal per week

Primary outcomes:
measure: Area under the curve for phospholipid fatty acids
timeFrame: 48 hours
Secondary outcomes:
measure: Area under the curve for chylomicron fatty acids
timeFrame: 48 hours
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Susan Raatz, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raatz SK, Redmon JB, Wimmergren N, Donadio JV, Bibus DM. Enhanced absorption of n-3 fatty acids from emulsified compared with encapsulated fish oil. J Am Diet Assoc. 2009 Jun;109(6):1076-81. doi: 10.1016/j.jada.2009.03.006.
Clinical trial NCT05127447: Effects of External Electric Stimulating in Individuals With Urinary Incontinence After Prostatectomy
Official title: Effects of External Electric Stimulating in Individuals With Urinary Incontinence After Prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly divided into two groups (such as ES and sham groups)
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate effects of external electric stimulating in individuals with urinary incontinence after prostatectomy.

Detailed description: Urinary incontinence (UI) is common in men after prostotectomy, and patients' quality of life is adversely affected. In addition, electric stimulation (ES) can be played an important role in the management of UI . However, there are limitations in clearly demonstrating the effects of ES on men with UI after prostatectomy.

Eligibility criteria: Inclusion Criteria:

* Being a male individual with stress or stress-dominant mixed UI symptoms after undergoing prostatectomy surgery for prostate cancer in the urology clinic
* Being over 40 years old
* Being 24 and over with Mini Mental Test results in individuals over 65 years of age.
* Not having residual cancerous tissue
* Volunteering to participate in the study

Exclusion Criteria:

* Having serious cardiovascular disease (unstable angina and arrhythmia patients, heart failure patients, etc.)
* Having sensory loss
* Having an ongoing urinary infection
* Having only urgency urinary incontinence
* Using a pacemaker
* Receiving active cancer treatment (radiotherapy, chemotherapy)
* Lack of evaluation parameters
* Not continuing the treatment regularly

Primary outcomes:
measure: Pad Test
timeFrame: change from baseline at 8 weeks
measure: UI symptoms
timeFrame: change from baseline at 8 weeks
Secondary outcomes:
measure: Life quality
timeFrame: change from baseline at 8 weeks
measure: Sexual Function
timeFrame: change from baseline at 8 weeks
measure: Evaluation of Subjective Improvement Perception
timeFrame: after treatment (8th week)
measure: Evaluation of Treatment Satisfaction
timeFrame: after treatment (8th week)
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03234647: First In Human Study of the Doraya Catheter for the Treatment of AHF Patients
Official title: First In Human Study of the Doraya Catheter for the Treatment of AHF Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Heart Failure
Lead sponsor: Revamp Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2017-07-31
Enrollment: 9
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
Primary purpose: TREATMENT

Brief summary: Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.

Detailed description: The purpose of this clinical investigation is to evaluate the safety and performance of the Doraya catheter in patients admitted with AHF, presenting persistent volume over load and poor response to diuretic treatment.

Eligibility criteria: Inclusion Criteria:

* AHF subjects with poor diuretic response

Exclusion Criteria:

* AHF subjects with sufficient diuretic response

Primary outcomes:
measure: Device or procedure related Serious Adverse Event (SAE) rate through 60 days
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis Aalst
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Katowice
country: Poland
facility: Śląski Uniwersytet Medyczny w Katowicach
city: Wrocław
country: Poland
facility: 4th Military
city: Wrocław
country: Poland
facility: University Hospital
Study officials:
affiliation: Shaare Zedek Medical Center
name: Tal Hasin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04779047: Comparative Therapeutic Efficacy and Safety of Different Antiviral and Anti Inflammatory Drugs in COVID-19 Patients.
Official title: Comparative Therapeutic Efficacy and Safety of Remdesivir Plus Lopinavir/ Ritonavir and Tocilizumab Versus Hydroxychloroquine Plus Ivermectin and Tocilizumab in COVID-19 Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Covid19
Pneumonia
Keywords: covid19
Lead sponsor: October 6 University
Sponsor class: OTHER
Collaborators: name: Beni-Suef University
First posted: 2021-03-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received different Antiviral and Anti Inflammatory Drugs.

Detailed description: Aim of the study

1. To assess the difference in patients' clinical status improvement between patients.
2. To detect time to improvement in oxygenation among both groups.
3. To detect duration of hospitalization and mortality rate in both groups.
4. To detect incidence and duration of mechanical ventilation in both treatment arms.
5. To monitor of adverse events of both drugs

Eligibility criteria: Inclusion Criteria:

* Hospitalized adult patients with pneumonia evidenced by chest CT scan.
* Laboratory (RT-PCR) confirmed infection with 2019-nCoV or strongly suspected to be infected with SARS-COV2 with confirmation studies pending.
* And at least one of the following:

  1. Respiratory frequency ≥30/min.
  2. Blood oxygen saturation ≤93% on room air (RA).
  3. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) \<300.
  4. Worsening of lung involvement, defined as an increase in number and/or extension of pulmonary areas of consolidation, need for increased FiO2 to maintain stable O2 saturation, or worsening O2 saturation of \>3% with stable FiO2.

Exclusion Criteria:

* Baseline elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 3-fold the upper limit of the normal range.
* Pregnancy.

Primary outcomes:
measure: Percentage of clinical cure in each arm
timeFrame: through an average of 5-7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef University
Study officials:
affiliation: Beni-Suef University
name: Marian Boshra, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sarhan RM, Harb HS, Abou Warda AE, Salem-Bekhit MM, Shakeel F, Alzahrani SA, Madney YM, Boshra MS. Efficacy of the early treatment with tocilizumab-hydroxychloroquine and tocilizumab-remdesivir in severe COVID-19 Patients. J Infect Public Health. 2022 Jan;15(1):116-122. doi: 10.1016/j.jiph.2021.10.024. Epub 2021 Nov 2.