louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05267431: Outcomes of Biological Therapy on Rheumatoid Arthritis
Official title: Outcomes of Different Biological Therapy on Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Keywords: RA
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: RA patients

Brief summary: Evaluate effect of biological therapy on activity of RA compared to usual DMARDs

Detailed description: Comparison between RA activity in both groups who recieved biological and DMARDS therapy

Eligibility criteria: Inclusion Criteria:

* RA patients

Exclusion Criteria:

* any other connective tissue disease

Primary outcomes:
measure: Change in activity of rheumatoid arthritis
timeFrame: After 3 months of treatment
Secondary outcomes:
measure: Activity of RA
timeFrame: 3 months after treatment
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag faculty of medicine
state: سوهاج
Study officials:
affiliation: Sohag faculty of medicine
name: N M AHM, Specialist
role: PRINCIPAL_INVESTIGATOR
affiliation: Sohag faculty of medicine
name: M M AHM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02317731: Effect of Use of Straw on Tolerability and Quality of Split Dose 4l-PEG Preparation
Official title: Effect of Use of Straw on Tolerability and Quality of Split Dose 4l-PEG Preparation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colon Cancer
Keywords: bowel preparation
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-12-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether patients drinking their bowel preparation solution with a straw will have improved tolerability for ingestion of their bowel preparation solution and achieve a higher bowel preparation quality score than patients drinking their bowel preparation solution without a straw.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 y/o scheduled for elective outpatient colonoscopy

Exclusion Criteria:

* History of colonic surgery, Contra-indication for preparation (PEG solution), History of inflammatory bowel disease

Primary outcomes:
measure: Bowel preparation quality
timeFrame: 1 day
Secondary outcomes:
measure: Tolerability will be measured by subjective survey including a 5-point scale and a visual analog scale filled by the subjects the day of the colonoscopy
timeFrame: 1 day
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Section of Digestive Diseases, Temple Medical Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Louis A Chaptini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01301131: Probiotics for Prevention of Ventilator-Associated Pneumonia (VAP)
Official title: Randomized Controlled Trial of Fermented Dairy Product Containing L. Casei Shirota for Prevention of Ventilator-Associated Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Drug Safety
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hospitalized patients with ventilator are randomized to receive fermented dairy product containing L. casei shirota or nothing. The main outcome is development of ventilator-associated pneumonia (VAP)

Detailed description: Fermented dairy product containing L. casei shirota has bee shown to inhibit multi-drug-resistant bacteria. This study is conducted to determine if Fermented dairy product containing L. casei shirota can prevent ventilator-associated pneumonia.

Eligibility criteria: Inclusion Criteria:

Patient age ≥ 18-year who received ventilator and agreed to participate by signing informed consent form

Exclusion Criteria:

Immunocompromised host (e.g. HIV infection, On immunosupressive agents, ANC ≤ 500 cell/ml), Pregnancy, History of congenital heart disease, rheumatic fever, previously infective endocarditis, prosthetic valve, Contraindication for enteral feeding, History of milk or milk-product allergy

Primary outcomes:
measure: Number of subjects with pneumonia
timeFrame: up to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Visanu Thamlikitkul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01505231: Vasopressin Versus Norepinephrine for the Management of Shock After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Shock
Keywords: Shock
norepinephrine
vasopressin
cardiac surgery
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-01-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Vasoplegic syndrome after cardiac surgery is a common complication after cardiac surgery, with negative impact on patient outcomes and hospital costs. Pathogenesis of vasodilatory phenomenon after cardiac surgery remains a matter of controversy. Loss of vascular tone can be partly explained by the depletion of neurohypophyseal arginine vasopressin stores. The investigators hypothesized that the use of arginine vasopressin would be more effective on treatment of shock after cardiac surgery than norepinephrine, decreasing the composite end point of mortality and severe morbidity.


Eligibility criteria: Inclusion Criteria:

* need vasopressor support

Exclusion Criteria:

* younger than 18 years;
* surgery without cardiopulmonary bypass;
* emergency procedure;
* ascending and descending thoracic aortic procedures;
* left ventricular aneurysm resection; enrollment in another study;
* pregnancy;
* neoplasm;
* Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis;
* severe hyponatremia (Na\<130mEq/L);
* acute mesenteric ischemia;
* acute myocardial infarction;
* cardiogenic shock; and refusal to consent

Primary outcomes:
measure: Composite endpoint of major morbidity according to Society of Thoracic Surgery
timeFrame: 30 days
Secondary outcomes:
measure: Hemodynamic effects
timeFrame: 28 days
measure: occurence of adverse events and safety
timeFrame: 28 days
measure: Time on mechanical ventilation
timeFrame: 30 days
measure: Incidence of infecction
timeFrame: 30-days
measure: Length of ICU and Hospital stay
timeFrame: 90 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração
Study officials:
References:
citation: O'Callaghan DJ, Gordon AC. What's new in vasopressin? Intensive Care Med. 2015 Dec;41(12):2177-9. doi: 10.1007/s00134-015-3849-3. Epub 2015 May 7. No abstract available.
Clinical trial NCT06247631: STOP-Bang Questionnaire: A Predictor of Obstructive Sleep Apnea and Difficult Mask/Intubation?
Official title: Can the STOP-Bang Questionnaire Predict Obstructive Sleep Apnea and Difficult Mask/Intubation in Patients Scheduled for Thoracic Surgery? Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Difficult Intubation
Airway Disease
Keywords: difficult intubation
difficult mask
Obstructive Sleep Apnea Syndrome
STOP-BANG
thoracic surgery
Lead sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the ages of 18-65, ASA 1-3, who will undergo thoracic surgery at the Ankara Atatürk Sanatorium Training and Research Hospital of the University of Health Sciences will be included in the study.

Brief summary: Difficult airway management remains the leading cause of anaesthesia-related morbidity and mortality. Obstructive sleep apnea syndrome (OSAS) is a warning sign of difficult airway management. Polysomnography is the gold standard for diagnosis of this syndrome, but the STOP-BANG questionnaire is the preferred screening test. In this study, we wanted to find an answer to the question How successful is the STOP-BANG questionnaire in screening for obstructive sleep apnea syndrome (OSAS) in predicting OSAS, difficult mask and difficult intubation in patients undergoing thoracic surgery?


Eligibility criteria: Inclusion Criteria:

* Patient undergoing thoracic surgery
* 18-65 years old
* ASA 1-3

Exclusion Criteria:

* Having a history of obstructive sleep apnea syndrome,
* Having a history of previous head and neck surgery/radiotherapy,
* Patients who did not agree to participate in the study

Primary outcomes:
measure: STOP-BANG questionnaire
timeFrame: 1 month (1 time)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Atatürk Sanatorium Training and Research Hospital
state: Keçiören
Study officials:
affiliation: Ankara Ataturk Sanatorium Training and Research Hospital
name: Ali ALAGÖZ, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00736931: Clinical Study in Healthy Volunteers to Investigate the Neurocognitive Effects of a New Antiepileptic Drug: Brivaracetam
Official title: Randomized, Comparative, Double-blind, Placebo-controlled, Triple-dummy, Four-way Cross-over Study to Investigate Neurocognitive Effects of Brivaracetam in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Keywords: Brivaracetam
Cognitive neurophysiological tests (CNT)
Neuropsychological assessments
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-08-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of the study is to evaluate the neurocognitive effects of brivaracetam


Eligibility criteria: Inclusion Criteria:

* Healthy male or female volunteer aged 18 to 50 years inclusive
* Body Mass Index (BMI) between 18.0 and 30.0 kg/m² inclusive
* Good physical and mental health status
* Blood pressure and heart rate within normal range
* Electrocardiogram and laboratory tests without clinically significant abnormality

Exclusion Criteria:

* IQ ≤ 80 as determined by Test of non-verbal intelligence
* Center for Epidemiological Studies Depression (CES-D Scale ≥16,
* Known allergy/intolerance to pyrrolidinone derivatives
* Abnormalities on EEG recordings
* Pregnant, lactating women
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, neurological, psychiatric disorders
* Use of any hepatic enzyme-inducing drug

Primary outcomes:
measure: Summary score from a Cognitive Neurophysiological Test (derived from electroencephalogram [EEG], event related potentials [ERP], and cognitive performance measures)
timeFrame: 3 weeks
Secondary outcomes:
measure: Component subscores from the Cognitive Neurophysiological Test and scores from neuropsychological tests/assessments: SSEQ Subject Self Evaluation Questionnaire. SMDT Symbol Digit Modalities Test. COWA Controlled Oral Word Association. MCG Parag
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Overland Park
country: United States
state: Kansas
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Meador KJ, Gevins A, Leese PT, Otoul C, Loring DW. Neurocognitive effects of brivaracetam, levetiracetam, and lorazepam. Epilepsia. 2011 Feb;52(2):264-72. doi: 10.1111/j.1528-1167.2010.02746.x. Epub 2010 Sep 30.
Clinical trial NCT04054531: Study of KN046 With Chemotherapy in First Line Advanced NSCLC
Official title: An Open-label, Phase II Study of KN046 Evaluating the Efficacy and Safety of KN046 Plus Platinum-based Doublet Chemotherapy as First Line Therapy in Advanced Non-small Cell Lung Cancer Subjects.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-08-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase II study of KN046 plus platinum-based doublet chemotherapy in previously untreated advanced non-squamous and squamous NSCLC subjects.

The study will assess primarily the safety and efficacy of KN046 plus platinum-based doublet chemotherapy.


Eligibility criteria: Key Inclusion Criteria:

* Has a histologically or cytologically confirmed diagnosis of stage IV NSCLC;
* Has not received prior systemic treatment for metastatic NSCLC;
* Has measurable disease based on RECIST 1.1.
* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
* Has adequate organ function.
* Has provided tumor tissue from locations not radiated prior to biopsy.

Key Exclusion Criteria:

* Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
* Previously untreated or symptomatic central nervous system (CNS) metastases
* Has received a live-virus vaccination within 28 days of planned treatment start.
* Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody and chemotherapy.
* Has or had active autoimmune disease.

Primary outcomes:
measure: Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to approximately 12 months
measure: Duration of Response (DOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to approximately 12 months
Secondary outcomes:
measure: Number of Participants Who Experienced a treatment-emergent adverse event (TEAE)
timeFrame: Up to approximately 12 months
measure: Number of Participants Who Experienced an immune-related AE (irAE)
timeFrame: Up to approximately 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT04037631: Compare Visual Outcomes Using a New Diagnostic Device
Official title: Prospective Clinical Study to Compare Visual Performance Obtained With a New Diagnostic Device
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Presbyopia
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2019-07-30
Enrollment: 24
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: Patients without clinically significant age-related cataract

Brief summary: Evaluation of preoperative corrected distance visual acuity (CDVA) obtained with VirtIOL device compared to postoperative CDVA.


Eligibility criteria: Inclusion Criteria:

* Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent
* Patients of any gender, aged 18 years to open age
* Assured follow-up examinations
* Healthy eyes without clinically significant age-related cataract

  -Exclusion Criteria:
* Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
* Patients whose freedom is impaired by administrative or legal order
* Concurrent participation in another drug or device investigation

Primary outcomes:
measure: Corrected distance visual acuity (CDVA)
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Internationale Innovative Ophthalmologie
Study officials:
References:
Clinical trial NCT03008031: Reduced Contrast Administration in Contrast-enhanced Spectral Mammography (CESM)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Neoplasm
Contrast-enhanced Spectral Mammography
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The optimal dose of iodine based contrast agents used in contrast-enhanced spectral mammography (CESM) is unknown. If CESM, performed with lower dose of iodine based contrast agent, visualizes a tumor comparable to CESM with regular dose of contrast agent, patients can receive less contrast agent for CESM in future and thereby risking less side effects of the contrast agent.

In order to study whether CESM remains unchanged at smaller amounts of contrast administration, a second CESM exam will be performed within one week of the first with a an alternative amount of contrast, it being either 80%, 60% or 40% of the original contrast dose. The settings of the CESM unit will remain unchanged.


Eligibility criteria: Inclusion Criteria:

* Female patient with histopathologically confirmed invasive breast cancer who recently underwent a clinical CESM exam without complications;
* Treated with primary surgery;
* Willing and able to undergo all study procedures;
* Has personally provided written informed consent.
* Age ≥ 18

Exclusion Criteria:

* Pregnancy
* Allergy for any of the ingredients of (Ultravist) contrast agent
* Being unable to give informed consent in person
* History of coronary arterial disease or unstable angina
* Acute or chronic severe renal insufficiency

Primary outcomes:
measure: Accuracy of maximum tumor size measurements for breast cancer detected with the clinical CESM exam (reference) compared to the (experimental) CESM exams with varying (lower) dose concentrations.
timeFrame: After completion of final patient inclusion (e.g. 1 year)
Secondary outcomes:
measure: Enhancement measurements for breast cancer detected with the clinical CESM exam (reference) compared to the (experimental) CESM exams with varying (lower) dose concentrations.
timeFrame: After completion of final patient inclusion (e.g. 1 year)
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: Marc BI Lobbes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Thiemo JA van Nijnatten, MD, PhD
References:
Clinical trial NCT06486831: The Effect of Stress Ball in Reducing Anxiety and Fear in 6-12 Year Old Children
Official title: The Effect of Stress Ball in Reducing Anxiety and Fear During Plastering Procedure in Extremity Fractures in Children Aged 6-12 Years
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Plaster of Paris Injury to Skin
Keywords: Children
Plaster Intervention
Stress Ball
Anxiety
Fear
Trauma
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 116
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to determine the effect of stress ball application on procedure-related anxiety and fear during plaster cast procedure in children aged 6-12 years.

Detailed description: Children aged 6-12 years will be randomly divided into two groups: stress ball and control group. Interventions will be applied 1 time per day (2 sessions) for 2 days. Children in the experimental group will be given a stress ball during the plaster procedure and will be asked to squeeze it during the procedure. Children will be assessed before, during and after the intervention. Fear and anxiety related to the cast procedure will be assessed using the Children's Fear Scale, and the Children's Anxiety Scale - Statefulness Scale. In addition, children's heart rate, respiration, blood pressure and SPO2 will be measured.

Eligibility criteria: Inclusion Criteria:

1. Age between 6 and 12 years (over 12 years old)
2. Absence of any physical and mental illness,
3. Not having taken analgesics in the last six hours
4. Hospitalization was for diagnostic or therapeutic purposes
5. The child and parents are comfortable speaking and understanding Turkish.

Exclusion Criteria:

1. Children hospitalized for surgery will not be included in the study.
2. Those who are outside the inclusion criteria will not be included in the study.

Primary outcomes:
measure: Patient Identification Form
timeFrame: baseline
Secondary outcomes:
measure: Children's Fear Scale (CFS)
timeFrame: baseline
Other outcomes:
measure: Child Anxiety Scale-Dispositional (CAS-D)
timeFrame: Baseline
Locations:
Study officials:
affiliation: ERZURUM CITY HOSPİTAL
name: Orhan DELİCE, 3
role: STUDY_CHAIR
References:
citation: Yurdakul Z, Esenay FI. Effects of two different ball types on pain and anxiety during venous blood draw in children: A randomized controlled study. J Pediatr Nurs. 2023 Sep-Oct;72:e201-e209. doi: 10.1016/j.pedn.2023.06.029. Epub 2023 Jul 5.