louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02272127: Study of Chemotherapy Plus Icotinib to Treat EGFR Mutation-positive Non-small-cell Lung Cancer
Official title: Intercalated Combination of Chemotherapy Plus Icotinib for Patients Undergoing Resection of EGRF Mutation-positive Non-small-cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: NSCLC
Keywords: EGFR tyrosine kinase inhibitor
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Non-small-cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor (EGFR) mutations are exquisitely sensitive to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) which is widely used in advanced patients. Whether treatment with EGFR-TKIs improves outcomes in patients with resected NSCLC harboring EGFR mutations is still under investigated. This study aims to observe and compare the efficacy and safety of intercalated combination of chemotherapy plus icotinib in patients undergoing resection of EGRF mutation-positive non-small cell lung cancer stagingⅠB (with high risk factor) to ⅢA.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing completely resection of EGRF mutation-positive NSCLC
* Staging ⅠB (with high risk factor) to ⅢA
* PS\<2
* Adequate hematological, biochemical and organ functions.

Exclusion Criteria:

* Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating.

Primary outcomes:
measure: Disease free survival
timeFrame: from the date of surgery until the date of first confirmed disease relapse or metastasis, assessed up to 5 years
Secondary outcomes:
measure: Number of Participants with Adverse Effects
timeFrame: duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Kaican Cai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05691127: Burden of Respiratory Illnesses in Pediatric Intensive Care Unit and Its Outcome
Official title: Burden of Respiratory Illnesses in Pediatric Intensive Care Unit and Its Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Illnesses
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with pneumonia, bronchiolitis, bronchial asthma, chemical pneumonitis, cystic fibrosis and other respiratory diseases, Cardiorespiratory cases and Neurological cases with respiratory illness

Brief summary: Acute respiratory infections (ARI) are an important cause of mortality and morbidity among children; one-fifths of under-five mortality being contributed by them (predominantly pneumonias ).

About 11.9 million episodes of severe and 3.0 million episodes of very severe acute lower respiratory infections (ALRI) result in hospital admissions in young children worldwide.

Respiratory infections and illnesses in children thus form a substantial disease burden in Pediatric intensive care unit. With this is mind, we studied clinical profile and risk factors contributing to mortality, and outcome of children with acute respiratory infections.


Eligibility criteria: Inclusion Criteria:

Children with pneumonia, bronchiolitis, bronchial asthma, chemical pneumonitis, cystic fibrosis and other respiratory diseases, Cardiorespiratory cases and Neurological cases with respiratory illness

Exclusion Criteria:

Post trauma case. Postoperative cases (developing respiratory complications during PICU stay).

Primary outcomes:
measure: incidence of respiratory illnesses
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Khilnani P, Sarma D, Singh R, Uttam R, Rajdev S, Makkar A, Kaur J. Demographic profile and outcome analysis of a tertiary level pediatric intensive care unit. Indian J Pediatr. 2004 Jul;71(7):587-91. doi: 10.1007/BF02724117.
citation: Nair H, Simoes EA, Rudan I, Gessner BD, Azziz-Baumgartner E, Zhang JSF, Feikin DR, Mackenzie GA, Moiisi JC, Roca A, Baggett HC, Zaman SM, Singleton RJ, Lucero MG, Chandran A, Gentile A, Cohen C, Krishnan A, Bhutta ZA, Arguedas A, Clara AW, Andrade AL, Ope M, Ruvinsky RO, Hortal M, McCracken JP, Madhi SA, Bruce N, Qazi SA, Morris SS, El Arifeen S, Weber MW, Scott JAG, Brooks WA, Breiman RF, Campbell H; Severe Acute Lower Respiratory Infections Working Group. Global and regional burden of hospital admissions for severe acute lower respiratory infections in young children in 2010: a systematic analysis. Lancet. 2013 Apr 20;381(9875):1380-1390. doi: 10.1016/S0140-6736(12)61901-1. Epub 2013 Jan 29.
citation: Tan GH, Tan TH, Goh DY, Yap HK. Risk factors for predicting mortality in a paediatric intensive care unit. Ann Acad Med Singap. 1998 Nov;27(6):813-8.
Clinical trial NCT02991027: OCT Image Quality Performance Evaluation
Official title: OCT Image Quality Performance Evaluation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy Eyes
Keywords: no known ocular pathology
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2016-12-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources.

Detailed description: To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources with equivalent specifications: the micro-electro-mechanical short cavity tunable laser and the micro-electro-mechanical tunable vertical cavity surface emitting laser.

Eligibility criteria: Inclusion Criteria

1. Participants must be at least 18 years of age
2. They must be able to complete all testing (all OCT scans)
3. They must volunteer to be in the study and sign the consent form

Exclusion Criteria

1. Subject with history of ocular disease or ocular pathology
2. Subjects unable to complete all OCT imaging modes

Primary outcomes:
measure: OCT image quality
timeFrame: 5 minutes
measure: OCT angiography image quality
timeFrame: 5 minutes
Secondary outcomes:
measure: Full Retinal Thickness
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Topcon Medical Systems Inc.
state: New Jersey
Study officials:
affiliation: Topcon Corporation
name: Zhenguo Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00329927: Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Elderly Subjects
Official title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Commercially Available Surface Antigen, Inactivated, (Adjuvanted With MF59C.1) Influenza Vaccine, Formulation 2006-2007, When Administered to Elderly Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Adjuvanted Influenza Vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2006-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over


Eligibility criteria: Inclusion Criteria:

* 65 years of age or older

Exclusion Criteria:

* any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
* hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine - - history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
* known or suspected (or high risk of developing) impairment/alteration of immune function within the past 7 days
* any acute disease or infections requiring systemic antibiotic or antiviral therapy fever within the past 3 days

Primary outcomes:
measure: CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
Secondary outcomes:
measure: Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
measure: Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
measure: Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).
Other outcomes:
Locations:
city: Via dei Vestini
country: Italy
facility: Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
state: Chieti
city: Lanciano
country: Italy
facility: Ufficio Igiene e Sanità Pubblica di Lanciano, Via S. Spaventa, 37
Study officials:
affiliation: Novartis Vaccines & Diagnostics
name: Novartis Vaccines - Drug Information Services
role: STUDY_CHAIR
References:
Clinical trial NCT04852627: Effect of Brisk Walking on Primary Dysmenorrhea
Official title: Effect of Brisk Walking on Primary Dysmenorrhea Among Medical Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysmenorrhea Primary
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 170
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dysmenorrhea is a common problem in women. Exercise is commonly cited as a possible remedy. We will measure the effect of brisk walking on primary dysmenorrhea among medical students.


Eligibility criteria: Inclusion Criteria:

* BMI: 18-25
* regular menstrual cycles

Exclusion Criteria:

* Marriage or previous sexual activity
* medical disorders
* previous abdominal or pelvic surgery
* skeletal disorders
* hormonal or psychiatric treatment
* atheletes

Primary outcomes:
measure: Dysmenorrhea score
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams Maternity Hospital
Study officials:
affiliation: Ain Shams University
name: Maii Nawara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01151527: Peripheral Blood Biomarkers in Idiopathic Interstitial Pneumonias
Official title: Genetics, Genomics, and Proteomics of Idiopathic Interstitial Pneumonias: Identification of Susceptibility Genes, Biomarkers, and Molecular Phenotyping
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Idiopathic Interstitial Pneumonias
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Jewish Health
name: Vanderbilt University
First posted: 2010-06-28
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are recruiting patients with Idiopathic Pulmonary Fibrosis and other types of Idiopathic Interstitial Pneumonias that occur sporadically or familial (2 or more affected individuals in a family).

Brief summary: We hypothesize that a peripheral blood biomarker or biological signature (gene or protein expression pattern) of idiopathic interstitial pneumonias (IIPs) will simplify and improve the accuracy of diagnosis of IIP and diagnose individuals at an earlier, more treatable, stage of their disease.

Detailed description: The Broad Challenge Area addressed in this proposal is (03) Biomarker Discovery and Validation, and the Specific Challenge Topic is 03-HL-101 (Identify and validate clinically relevant, quantifiable biomarkers of diagnostic and therapeutic responses for blood, vascular, cardiac, and respiratory tract dysfunction). Idiopathic interstitial pneumonia (IIP) is a lung disease(s) that primarily affects the elderly, but is present in all age groups. IIP causes respiratory insufficiency and is often fatal. In about half of the patients, the diagnosis requires an invasive lung biopsy which can cause complications, and is not always accurate.

The current diagnostic tools for IIP are inadequate. In addition to inaccurate diagnosis, they are very costly, and often result in delayed diagnosis and treatment. The challenge(s) we intend to address in this proposal is to improve the accurate and early diagnosis of idiopathic interstitial lung pneumonia (IIP), and to improve the ability to differentiate the subtypes of idiopathic interstitial pneumonias (IIPs) by developing peripheral blood biomarkers.

Eligibility criteria: Inclusion Criteria:

* Sporadic cases of Idiopathic Pulmonary Fibrosis and other types of Idiopathic Interstitial Pneumonias.
* Family members ( with or without clinical disease) with a family history of pulmonary fibrosis.

Exclusion Criteria:

* None.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Mark P Steele, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Jewish Health
name: David A Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04211727: Affinity: Hospital Trial
Official title: Affinity: Hospital Trial. Early Prototype Testing for a Home Oncology Monitoring System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Oncology
Cancer
Lead sponsor: Entia Ltd
Sponsor class: INDUSTRY
Collaborators: name: The Christie NHS Foundation Trust
First posted: 2019-12-26
Enrollment: 247
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 undergoing systemic anti-cancer therapy (SACT)

Brief summary: Method comparison study to compare the Affinity prototype device using a capillary blood sample against routine venous laboratory results, in patients undergoing systemic anti-cancer therapy (SACT). Tests will be performed by healthcare professionals (Cohort 1) and participants self-testing (Cohort 2)

Detailed description: In this study the Investigators wish to compare 200 finger prick sample (capillary) blood results taken and analysed using the Affinity prototype device to standard of care venous blood samples, taken from the participant on the same day. The blood tests will analyse Full Blood Count (FBC)

200 patients will be recruited in total. 100 will take part in Cohort 1, where a member of the clinical research team will take their blood sample using the Affinity prototype device. The other 100 will take part in Cohort 2, where the participant will self test and take the blood sample themselves. Participants will be asked to complete a short questionnaire after using the device to provide any feedback on its design and use.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years old at the time of study entry Currently receiving standard of care systemic anti-cancer therapy for solid organ malignancy and has received at least one cycle
* Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care
* Can provide written informed consent
* Cohort 2 only- Able to independently complete participant questionnaires

Exclusion Criteria:

* Receiving systemic anti-cancer therapy for a haematological malignancy
* Known parasitic infection
* Known inherited or acquired bleeding disorder
* History of haematological malignancy
* Known poorly controlled anti-coagulation
* Cohort 2 only- Participant or carer unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result

Primary outcomes:
measure: To assess the accuracy (bias) of the Affinity prototype device against laboratory testing (capillary vs. venous sample)
timeFrame: 1 year
Secondary outcomes:
measure: Assessment and feedback
timeFrame: 1 year
measure: Assessment and feedback
timeFrame: 1 year
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
References:
Clinical trial NCT04229927: BPDO-1603 Intervention Trial in Patients With Moderate-to-severe Alzheimer's Disease
Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of BPDO-1603 in Patients With Moderate-to-severe Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Moderate-to-severe Alzheimer's Disease
Lead sponsor: Hyundai Pharmaceutical Co., LTD.
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 712
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to evaluate the efficacy and safety of BPDO-1603 in patients with moderate-to-severe Alzheimer's disease


Eligibility criteria: Inclusion Criteria:

* A voluntary, written informed consent from the patient or the patient´s representative.
* Male or female patients ≥ 45 years of age as of the date of informed consent.
* Diagnosed with probable AD according to the National Institute on Aging-Alzheimer's Association \[NIA-AA (2011)\] criteria.
* MMSE score of ≥ 5 and ≤ 20 during screening period.
* CDR-GS of 2 \~ 3 or GDS of 4 \~ 7 during screening period.
* Ongoing cholinesterase inhibitor therapy with stable dose of 10 mg/day donepezil hydrochloride for more than 12 weeks (inclusive) prior to screening, and can continue this therapy until randomization without any change in the dosage regimen of donepezil hydrochloride.

Exclusion Criteria:

* Magnetic resonance imaging (MRI) or computed tomography (CT) findings obtained within the past 12 months (ie, 48 weeks) from screening or at screening, as a cause of dementia other than probable AD.
* History of other organic disease, such as vascular dementia, CNS infections (e.g., human immunodeficiency virus \[HIV\], syphilis), head injury, Creutzfeldt-Jakob disease, Niemann-Pick's disease, Huntington's disease, Parkinson's disease, epilepsy, or stroke.
* Evidence of other neurological disorders which include seizure disorder that may interfere with the patient's cognition or ability to perform the study procedures.
* Use of Memantine Hydrochloride within 1 month prior to screening

Primary outcomes:
measure: Change in SIB total scores
timeFrame: from baseline to Week 24
measure: CIBIC-plus total score
timeFrame: at Week 24 (Baseline score will be from CIBIS
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
affiliation: Inha University Hospital
name: Seonghye CHOI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06629727: The Effect Of Virtual Reality Glasses On Pain And Anxiety During The Kidney Stone Lithotripsy Procedure
Official title: The Effect Of Virtual Realty Glasses On Pain And Anxiety During The Kidney Stone Lithotripsy Procedure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain Management
Extracorporeal Shock Wave Lithotripsy
Virtual Reality
Keywords: extracorporeal shock wave lithotripsy
pain
Virtual reality
Anxiety
Lead sponsor: University of Beykent
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine the pain and anxiety levels of patients using virtual reality glasses during the extracorporeal shock wave lithotripsy procedure.

Detailed description: This randomized clinical trial included 60 patients with lithotripsy procedure. The research group of 60 people was divided into two groups, 30 in the experimental group and 30 in the control group. While the standard stone crushing process was applied to the control group, the experimental group was watched with virtual reality glasses during the procedure. The State-Trait Anxiety Inventory and the Numerical Rating Scale, which was used to measure the level of pain and anxiety level.

Eligibility criteria: Inclusion criteria

- Performing ESWL procedure

Exclusion criteria

* Presence of psychiatric disease
* Vision problem
* Hearing problem
* Drug and alcohol addiction

Primary outcomes:
measure: Numeric Pain Scale
timeFrame: During ESWL procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Beykent University
Study officials:
References:
citation: Guitynavard F, Azadvari M, Gholamnejad M, et al. Decreasing discomfort during shock-wave lithotripsy using transcutaneous electrical nerve stimulation. Translational Research in Urology. 2022; 4(2): 71-76
citation: Lei M, Li G, Tang Y, Yuan J, Yang T, Gao Z. Efficacy of music therapy for pain control of extracorporeal shock wave lithotripsy: A meta-analysis of randomized controlled studies. Medicine (Baltimore). 2024 May 31;103(22):e38182. doi: 10.1097/MD.0000000000038182.
citation: Ozsaker E, Diramali A. The effect of transcutaneous electrical nerve stimulation for pain relief during extracorporeal shock-wave lithotripsy procedure. Pain Manag Nurs. 2014 Mar;15(1):59-68. doi: 10.1016/j.pmn.2012.06.003. Epub 2012 Aug 18.