louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03800797: Efficacy and Safety of Loxoprofen Hydrogel Patch in Patients With Ankylosing Spondylitis
Official title: Efficacy and Safety of Loxoprofen Hydrogel Patch Versus Loxoprofen Tablet in Patients With Ankylosing Spondylitis: a 4-week Randomized, Open-label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Keywords: ankylosing spondylitis
loxoprofen
patch
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis(AS). The trial includes 70 patients who are randomly assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg t.i.d.) for 4 weeks.

Detailed description: This is a 4-week randomized, open-label trial to investigate the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis(AS). The trial includes 70 patients who are randomly assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg t.i.d.) for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* 18 to 65 years
* Meet 1984 modified New York criteria for AS
* The Bath AS Disease Activity Index (BASDAI) ≥4 on a 0-10-cm visual analog scale or the Ankylosing Spondylitis Disease Activity Score using the C-reactive protein level (ASDAS-CRP) ≥1.3
* NSAIDs washout period of at least 5 days prior to randomization
* DMARDs washout period of at least 4 weeks prior to randomization
* Corticosteroids washout period of at least 4 weeks prior to randomization
* Biological agents washout period of at least 3 months prior to randomization.

Exclusion Criteria:

* Peptic ulcer
* Unstable cardiac diseases
* Abnormal hepatic function with an elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 times of upper normal limits
* Abnormal renal function with creatinine more than upper normal limit
* Hematologic disorders
* Psychosis
* Malignancy
* Allergic to LX drug.

Primary outcomes:
measure: the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% response (ASAS20)
timeFrame: week 4
Secondary outcomes:
measure: ASAS5/6 response
timeFrame: week 4
measure: ASAS20 response
timeFrame: week 2
measure: ASAS5/6 response
timeFrame: week 2
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
name: Jieruo Gu, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT05224297: Patient Experience Data in Radiation Oncology
Official title: Patient Experience Data in Radiation Oncology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radiotherapy Side Effect
PROMs
Keywords: radiation oncology
patient reported outcome
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is aimed to include a comprehensive representative cross-section for each of the study groups.

Brief summary: The project is part of the overarching goal of improving patient-centric radiation oncology. This pilot project aims to develop an instrument that can be used to collect clinically relevant patient-reported outcome data on adverse effects during and after RT. This real-world evidence (RWE) database will be the basis to monitor and evaluate future technological developments, combination treatments (e.g. radioimmunotherapy, etc.), or changes in treatment protocols. The pseudonymized data will be linked to data in the oncological information system and dosimetric data from the treatment planning system. In this way, they represent a basic building block of patient-oriented development of clinical radiotherapy.


Eligibility criteria: Inclusion Criteria:

* all patients receiving external beam radiotherapy

Exclusion Criteria:

* unable to independently answer questionnaires on radiation-induced side effects

Primary outcomes:
measure: radiation-related side effects
timeFrame: during radiotherapy and after (up until 5 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT02286297: Pediatric Endotracheal Intubation During Resuscitation
Official title: Comparison of Intubation Through the McGrath® MAC, GlideScope®, AirTraq® and Miller Laryngoscope by Paramedics During Pediatric Cardiopulmonary Resuscitation: a Randomized Crossover Manikin Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric
Cardiopulmonary
Keywords: Intubation
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Endotracheal intubation (ETI) is perceived as the optimal method of providing and maintaining a clear and secure airway. The 2010 European Resuscitation Council (ERC) guidelines emphasized the importance of minimal interruption during cardiopulmonary resuscitation (CPR). These guidelines also suggest that skilled operators should be able to secure the airway without interrupting chest compression. The aim of the study was to compare time and success rates of different available video laryngoscopes and the Miller laryngoscope for emergency intubation during simulated pediatric CPR.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* paramedics, nurses, physicians

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases

Primary outcomes:
measure: Time to intubation
timeFrame: intraoperative
Secondary outcomes:
measure: Success of intubation
timeFrame: intraoperative
measure: Visual Analog scale (VAS) score
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: Institute of Cardiology
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02677597: Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
Official title: An Open, Multicenter, Randomized Phase III Clinical Study on Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 268
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: Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma


Eligibility criteria: Inclusion Criteria:

* Histologically proven primary thoracic esophageal squamous cell carcinoma
* Not suitable for surgery or radio or chemical therapy
* Presence of at least one index lesion measurable by CT scan or MRI radiation therapy ended at least 4 weeks, but part of the radiation does not as a measurable lesions
* 18\~70 years
* PS:0-1
* Life expectancy of ≥ 3 months
* WBC≥3.5×109/L,ANC≥1.5×109/L, PLT≥100×109/L, Hb≥100g/L
* TB ≤ 1.5UNL, ALT/AST ≤ 2.5×UNL
* Scr≥60 mL/min
* Normal electrocardiogram (ecg)
* Can normal oral drugs
* Signed written informed consent

Exclusion Criteria:

* Breast-feeding or pregnant women, no effective contraception if risk of conception exists
* Chronic diarrhea, enteritis, intestine obstruction which are not under control
* Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.
* A second primary tumor (except skin basal cell carcinoma)
* The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension
* With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or - CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms
* With bleeding tendency
* Has inherited bleeding evidence of physical or blood coagulation disorder
* With clear chemotherapy drug allergy
* Other researchers believe that patients should not participate in this testing

Primary outcomes:
measure: PFS
timeFrame: Since the date of random to disease progression or any cause of death，the average time is 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer hospital Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT06851897: Comparison of Perforated 3D Printed Versus Conventional Metal Fixed Bonded Retainer
Official title: Comparison of Perforated 3D Printed Metal Fixed Mandibular Retainer Versus Conventional Fixed Bonded Retainer A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bond, Pair
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 64
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Although different materials of mandibular fixed retainer were discussed in the literature, there is contradicting evidence regarding the bond failure of Titanium fixed metal retainer, whether immediate or after 12 months. Moreover, insufficient evidence is present regarding 3D metal printed fixed mandibular retainers.

Detailed description: In recent years a new possibility is available for dental practitioners: CAD-CAM technology and 3D printing, which find their application in all aspects of orthodontics. Orthodontists are already familiar with several products that use 3D printers (i.e. invisible aligners), also known as additive manufacturing, 3D printing is a technology whereby sequential layers of material are layered on top of one another to form an object23. Two recent articles reported the fabrication of a custom lingual retainer cut from a nickel-titanium block with CAD/CAM technology and a CAD/CAM Zirconium bar as a bonded mandibular fixed retainer.

Eligibility criteria: Inclusion Criteria:

* Patients with properly finished orthodontic treatment.
* No sex predilection.
* The presence of 4 permanent mandibular incisors and 2 permanent mandibular canines.
* No active caries, restorations, fractures, or periodontal disease of previously mentioned teeth
* Patients with good oral hygiene.

Exclusion Criteria:

* Patients with no need of fixed mandibular retention.
* Enamel hypoplasia or hypocalcification of mandibular anterior teeth.
* Abnormal morphology of mandibular anterior teeth
* Periodontal disease that contraindicates fixed orthodontic retention.
* No or poor patient's compliance \& bad oral hygiene.
* Psychological problems.

Primary outcomes:
measure: Bond Failure
timeFrame: immediate up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Mariam MA Elsebaey, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06704997: Machine Learning to Predict Factors Affecting Rehabilitation Length of Stay and Healthcare Costs for Neurological Rehabilitation
Official title: Machine Learning Predictive Analysis of Key Factors Influencing Rehabilitation Length of Stay (RLOS) and Direct Hospitalization Costs for Neurological Inpatient Rehabilitation at Tertiary Care Hospital
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke
Acquired Brain Injury
Traumatic Brain Injury
Brain Tumor
Central Nervous System Infections
Polytrauma
Keywords: Rehabilitation
Length of Stay
Stroke
Traumatic Brain Injury
Brain tumour
Cancer
Trauma
Acquired Brain Injury
Healthcare
Hospitalisation costs
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 10000
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have admitted to the rehabilitation ward during their inpatient episode for neurological rehabilitation.

Brief summary: The aim of this retrospective study is to ascertain total direct costs, rehabilitation length of stay (RLOS) and factors associated with RLOS for neurological inpatient rehabilitation at the tertiary care hospital.

Detailed description: The aim of the study is to identify factors that influence RLOS and the correlated costs for neurological rehabilitation in tertiary rehab using data extracted from EPIC. It is also aimed to identify the median direct costs to find out the main contributors to the costs in the local population. Lastly, the study aims to utilise artificial intelligence or machine learning to analyse the compiled data to develop a predictive model. The model aspires to understand factors associated with extended RLOS and to predict RLOS of patients who require neurological rehabilitation, aiding preemptive measures.

Eligibility criteria: Inclusion Criteria:

• All patients who completed inpatient rehabilitation with the index conditions in their discharge summaries

Exclusion Criteria:

• Did not complete inpatient rehabilitation as they are discharged against medical advice

Primary outcomes:
measure: Rehabilitation length of stay
timeFrame: 1998-2022
measure: Hospital bill
timeFrame: 2012-2022
measure: Housing type
timeFrame: 2014-2023
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Dr Karen Chua, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06495697: Plasma Pharmacological Monitoring of M Penicillins in Methicillin-sensitive Staphylococcus Aureus Bacteremia
Official title: Plasma Pharmacological Monitoring of M Penicillins in Methicillin-sensitive Staphylococcus Aureus Bacteremia - Single-center Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Staphylococcus Aureus Infection
Keywords: Staphylococcus aureus Infection
Staphylococcus aureus bacteremia
Penicillins
Methicillin-sensitive
Cefazolin
Infectious endocarditis
Staphylococcal endocarditis
Oxacillin
Nephrotoxicity
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient (≥18 years old) having presented an infection with Staphylococcus aureus and treated at the University Hospitals of Strasbourg between January 1, 2019 and December 31, 2022.

Brief summary: The treatment of Methicillin-sensitive Staphylococcus aureus bacteremia is based on the first-line use of cefazolin or M penicillins (oxacillin and cloxacillin). The use of the latter is recommended at high doses (150-200 mg/kg/24h). In a study on infectious endocarditis, 52 of 56 patients with staphylococcal endocarditis treated with (cl)oxacillin were overdosed with the recommended doses. Although the main mechanism of renal toxicity described for M penicillins is immunoallergic, a frequent overdose is observed in cases of acute renal failure with M penicillins. There is also a significant association between overdose and risk of neurological toxicity. The currently recommended treatment duration is a minimum of 14 days of IV treatment from the first negative blood culture, which leaves room for carrying out a plasma assay and possible dosage adjustment subsequently.

Overdose is a risk factor for nephrotoxicity and neurotoxicity. Plasma level could be predictive of clinical success. Systematic plasma dosing would reduce the risk of toxicity and improve the clinical cure rate.


Eligibility criteria: Inclusion Criteria:

* Adult patient (≥18 years old)
* Having presented an infection with Staphylococcus aureus and treated at the University Hospitals of Strasbourg between January 1, 2019 and December 31, 2022.

Exclusion Criteria:

- Patient having expressed his opposition to the reuse of his data for scientific research purposes.

Primary outcomes:
measure: Clinical healing
timeFrame: day 30 after infection
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT03787797: Epicardial Adipose Tissue Thickness PredIcts Obstructive Coronary Artery Disease in Acute Coronary Syndrome Patients
Official title: Epicardial Adipose Tissue Thickness PredIcts Obstructive Coronary Artery Disease in Acute Coronary Syndrome Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Epicardial adipose tissue
Chest pain
Echocardiography
Coronary artery disease
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 657
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusion of patients without known coronary artery disease undergoing workup for suspected acute coronary syndrome at the emergency department of the University Hospital Essen.

Brief summary: Epicardial adipose tissue (EAT) is a visceral adipose tissue that surrounds the heart and the coronary arteries. It is metabolically active, secreting pro- and anti-inflammatory mediators and cytokines. With increasing EAT volume, inflammatory activity increasing, which suggests that EAT may locally influence atherosclerosis development in the coronary artery tree. The amount of EAT is associated with cardiovascular disease risk factors as well as presence and progression of subclinical atherosclerosis. Likewise, EAT volume is increased in patient with prevalent and incident coronary artery disease manifestation. In the setting of acute coronary syndrome, EAT was found to be associated with the TIMI risk score and Syntax II score. While CT imaging of the heart is the gold standard for EAT quantification, transthoracic echocardiography allows for a quick and reliable assessment of EAT thickness, as has been used in research studies and may qualify for routine EAT assessment in clinical routine.However, currently data on how quantification of EAT in clinical routine may impact patient management is lacking. We aim to investigate, whether quantification of EAT thickness via transthoracic echocardiography enables improved risk stratification in patients presenting with acute chest pain to the emergency department.


Eligibility criteria: Inclusion Criteria:

* admission to the emergency department of the University Hospital Essen with acute chest pain suggestive of an acute coronary syndrome

Exclusion Criteria:

* Known obstructive coronary artery disease prior to presentation, prior revascularization therapy, unwillingness to provide informed consent

Primary outcomes:
measure: Coronary revascularization
timeFrame: within 90 days after initial presentation
Secondary outcomes:
measure: Invasive coronary angiography
timeFrame: within 90 days after initial presentation
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
state: NRW
Study officials:
affiliation: University Hospital, Essen
name: Amir A Mahabadi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04116697: A Randomized Controlled Trial to Evaluate the Efficacy of Acupuncture Versus Aromatherapy as Treatments to Lessen Nausea, Vomiting and Anxiety Associated With Adriamycin and Cytoxan
Official title: A Randomized Controlled Trial to Evaluate the Efficacy of Acupuncture Versus Aromatherapy as Treatments to Lessen Nausea, Vomiting and Anxiety Associated With Adriamycin and Cytoxan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea
Vomiting
Anxiety
Lead sponsor: Englewood Hospital and Medical Center
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall goal of this study is to explore the effectiveness of using acupuncture versus aromatherapy, in conjunction with standard of care anti-emetics, to decrease chemotherapy induced nausea, vomiting, and anxiety in breast cancer patients undergoing Adriamycin and Cytoxan. This study also aims to determine if aromatherapy and anti-emetics is more effective than acupuncture and anti-emetics in treating nausea, vomiting, and anxiety in patients receiving Adriamycin and Cytoxan and if acupuncture and anti-emetics is more effective than aromatherapy and anti-emetics in treating nausea, vomiting, and anxiety in patients receiving Adriamycin and Cytoxan.


Eligibility criteria: i) Inclusion

* At least 18 years of age on the day of signing informed consent
* Patient has a diagnosis of breast cancer
* Patient is planned to start Adriamycin and Cytoxan chemotherapy

ii) Exclusion

* Patients who are unable to adhere to the protocol or treatment schedule
* Patients who have a concurrent illness or take medication that induces nausea independent of chemotherapy
* Patients undergoing radiotherapy or hormone therapy during chemotherapy treatments
* Patients who have a sensitive and/or poor sense of smell
* Patients who are allergic to essential oils, specifically peppermint, ginger, and/or lavender
* Patients who are already using essential oils or acupuncture for symptom management and are unwilling to stop while participating in this study
* Patients who are afraid of or unwilling to receive acupuncture stimulation
* Patients who are allergic to stainless steel needles
* Thrombocytopenia (Platelets \< 20,000)
* Patients who have received aromatherapy and/or acupuncture treatment within 1 week of starting treatment on this study

Primary outcomes:
measure: Improvement in Nausea
timeFrame: 45 days
measure: improvement in anxiety
timeFrame: 45 days
measure: improvement in vomiting
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Englewood Health
state: New Jersey
Study officials:
References: