louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01748344: Phase II Study Evaluating ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis
Official title: A Randomised, Placebo Controlled, Four Period Crossover Study to Evaluate the Efficacy, Safety of Oral Repeat Doses of ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis in the Vienna Challenge Chamber.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2012-12-12
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate if ONO-4053 relieves symptoms of allergic rhinitis in seasonal allergic rhinitis subjects exposed to pollen under controlled conditions.

Detailed description: The purpose of this study is to investigate if ONO-4053 will impact allergic rhinitis symptoms in subjects with seasonal allergic rhinitis when they are exposed to pollen administered at a fixed rate in an inhalation exposure chamber compared to the standard treatment Cetirizine 10mg under the same conditions.

Eligibility criteria: Inclusion Criteria:

* The subject is aged between 18 and 65 years inclusive, and healthy with the exception of allergic rhinitis or mild asthma that does not require treatment and has provided written informed consent, which signifies an agreement to enter the study and comply with the restrictions and requirements listed in the informed consent form.
* The subject exhibits a moderate to severe response to grass pollen grains in the allergen challenge chamber at Screening.

Exclusion Criteria:

* The subject on examination is found to have nasal structural abnormalities or nasal polyps; a history of frequent nose bleeds, nasal biopsy, nasal trauma or nasal surgery.
* Pregnant or breast-feeding females.

Primary outcomes:
measure: Total Nasal Symptom Score
timeFrame: 4 months
Secondary outcomes:
measure: Total Nasal Symptom Score
timeFrame: 4 months
measure: Total Ocular Symptom Score
timeFrame: 4 months
measure: Pharmacokinetics
timeFrame: Days 1 and 8
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Clinical Site
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06427044: Effect of Bupivacaine Liposome Anterior Serratus Deep Block on Chronic Pain After Breast Cancer Surgery: a Randomized Controlled Study
Official title: Effect of Bupivacaine Liposome Anterior Serratus Deep Block on Chronic Pain After Breast Cancer Surgery: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer Patients With Chronic Pain After Surgery
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 143
Sex: MALE
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: This study aims to investigate the effect and influence of liposome bupivacaine anterior serrat plane block on postoperative chronic pain in breast cancer patients, evaluate the therapeutic effect of liposome bupivacaine in postoperative chronic pain, and provide a new method for patients with postoperative chronic pain.


Eligibility criteria: Inclusion Criteria:

* Adult patients (aged ≥18 years) who are scheduled to undergo unilateral modified radical breast cancer surgery

Exclusion Criteria:

* 1. Patients with coagulation dysfunction 2. There are infected patients at the puncture site 3. For patients allergic to any trial drug 4. Patients who take painkillers within 48 hours before surgery 5. Severe cardiopulmonary insufficiency, such as EF\< 40%, FEVC \< 50% expected; Uncontrolled hypertension; 6. Refuse to perform nerve block puncture 7. Mental disorders, epilepsy history; 8. Unable to give informed consent or are participating in other clinical trials.

Primary outcomes:
measure: Incidence of chronic pain 3 months after surgery
timeFrame: Three months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT03906344: Expanded Access Use of INCB052793 to Treat a Single Patient With Myelofibrosis
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2019-04-08
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Expanded access use of INCB052793 to treat a single patient with Myelofibrosis.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: Michael Savona, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06048744: Ultrasound Guided Erector Spinae Plane Block vs External Oblique Intercostal Plane Block for Nephrectomy
Official title: Ultrasound Guided Erector Spinae Plane Block vs External Oblique Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Subcoastal Nephrectomy: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The patients will be randomly allocated into two equal groups using a computer program.

Group A: will receive U S guided external oblique intercostal block after induction.

Group B:

Patients will receive US guided erector spine block after induction.

Detailed description: Patients will be premedicated with IV midazolam (0.05 mg/kg). Under standard monitoring including Electrocardiography, Non-Invasive Blood Pressure, and Pulse Oximetry. General Anesthesia will be induced with Fentanyl (1-2 μg/kg), Propofol (2-3 mg/kg), and Atracurium (0.5-0.8 mg/kg). Pressure controlled Volume guarantee Ventilation mode will be used to maintain O2 Saturation Above 98%. Anesthesia will be maintained with Isoflurane 1.2 Minimum Alveolar Concentration inhalation

Eligibility criteria: Inclusion Criteria:

* Eligible patients will be older than 21 years old with American society of anesthesiology ASA physical status I\& II\&III scheduled for elective (Subcostal) Nephrectomy

Exclusion Criteria:

* Patients who are:
* Uncooperative.
* Having allergy to any of the study drugs.
* Known abuse of alcohol or medication.
* Having Local infection at the site of injection or systemic infection.
* Pregnancy.
* With coagulation disorders or on anticoagulation therapy.

Primary outcomes:
measure: time for first rescue analgesia
timeFrame: day 0
Secondary outcomes:
measure: visual analogue score VAS score
timeFrame: 24 hours
measure: the number of rescue analgesics
timeFrame: 24hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Menoufia university
state: Shibin Elkom
Study officials:
affiliation: Menoufia University
name: AMAL G SAFAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02842944: Weaning From Mechanical Ventilation Comparison of Open-loop Decision Support System and Routine Care
Official title: Weaning From Mechanical Ventilation Comparison of Open-loop Decision Support System and Routine Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiration, Artificial
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-07-25
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare mechanical ventilation following advice from the Beacon Caresystem to that of routine care in patients from the state of requiring invasive mechanical ventilation until successful extubation. The Beacon Caresystem will be compared to routine care to investigate whether use of the system results in similar care and reduced time for weaning from mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

* Patient is on invasive mechanical ventilation more 48 hours
* Age \> 18 years
* Patients are ventilated using Maquet Servo-I, Draeger Infinity V500 or Draeger Evita XL mechanical ventilators in "pressure support", "volume controlled", or "pressure controlled" ventilation modes.
* Haemodynamically stable (mean blood pressure ≥ 65 mmHg)
* Patients or, in the case that the patient is unable, next of kin understand and accept oral and written information describing the study or patient consent retrospectively in case of emergency inclusion.

Exclusion Criteria:

* The absence of an arterial catheter for blood sampling.
* Medical history of home mechanical ventilation
* Severe ARDS (PaO2/FiO2 ≤ 100 mmHg)
* Head trauma or other conditions where intra-cranial pressure may be elevated and tight regulation of arterial CO2 level is paramount.
* Severe neurological patients (Glasgow coma score \<10, neurologic damage with limited prognosis, stroke hemiplegia).
* Known or suspected severe myopathy or neuropathy (including ICU neuromyopathy)
* Quadriplegia
* Severe heart failure
* Broncho alveolar fistula with more than 100ml leakage
* History of home mechanical ventilation
* Pregnancy.

Primary outcomes:
measure: Duration of mechanical ventilation
timeFrame: 14 days
measure: Time to successful extubation
timeFrame: Successful extubation is defined as ≥ 7 days of unassisted spontaneous breathing after extubation
measure: Time from support mode to successful extubation
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Elie ZOGHEIB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04135144: Different Home Exercise Programs in Neck Pain
Official title: Comparison of the Effects of Two Different Home Exercise Programs in Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Exercise Training
Lead sponsor: Istanbul Arel University
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: The aim of this study was to compare the effects of two different home exercise methods on exercise compliance, neck pain and neck disability in individuals with neck pain.

Material and metods: The study, carried out between February 2018 and May 2018 at Istanbul Arel University Vocational School, was performed with 60 people aged 25-60 years who were suffering from neck pain in academic and administrative staff. The cases were randomly divided into two groups. In Group 1, the case was given home exercise method (B.M.E.Y) with printed materials whereas Group 2 was given exercise with home exercise method (V.H.E.Y) with video phone reminder. Pain intensity was evaluated before and after exercise with 'Visual Analog Scale' (VAS), whereas the level of neck disability was evaluated before and after exercise with 'Neck Pain and Disability Score' (NPDS). The obtained results were analyzed using appropriate statistical methods.

Detailed description: Both groups were prescribed the same type of exercise, duration of exercise and number of repetitions. group 1 completed the exercise program and marked the exercise attendance schedule. At the end of the program, these charts were collected from the subjects and the continuity was evaluated. The group marked the exercises completed with 2 phone app. In the program used, exercise continuity of the cases was evaluated as days.

Exercises were given at least 3 times a week for 10 weeks and 1 set per day for a total of 6 weeks. individuals; normal joint movement exercises; neck flexion, lateral flexion, rotation, extension and retraction movements, isometric exercises; neck flexion, extension, lateral flexion and rotation movements and stretching exercises; neck lateral flexion, neck rotation and flexion movements were given.

Eligibility criteria: Inclusion Criteria:

* complaint of neck pain,
* Being between 25-60 years of age

Exclusion Criteria:

* taking painkillers regularly,
* undergoing any neck surgery and severe trauma,
* presence of any diagnosed neck disease

Primary outcomes:
measure: Neck disability
timeFrame: 6 weeks
measure: Pain intensity
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Arel University
Study officials:
affiliation: İstanbul Arel Uiversity
name: Özden Laçin
role: STUDY_DIRECTOR
References:
Clinical trial NCT02243644: Effects of 2 Different Duration of Albendazole Therapy in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT
Official title: A Clinical Trial to Study the Effects of Two Different Duration of Same Drug Albendazole in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT Scan Head at the End of 6 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neurocysticercosis
Keywords: parenchymal neurocysticercosis upto five lesions
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2014-09-18
Enrollment: 97
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing the effect of two different duration of same drug albendazole in patients with Neurocysticercosis less than or equal to 5 lesions on CT head at the end of 6 months.

Detailed description: The trial will be comparing the effectiveness of short and long duration of albendazole ie 7 and 28 days therapy in patients with parenchymal neurocysticercosis in terms of complete resolution or calcification of cyst on CT head at the end of 6 months after starting albendazole

Eligibility criteria: Inclusion Criteria:

* Age 2-18 years.
* Number of parenchymal lesions: upto 5\*
* Stages of cysticerci at which albendazole treatment is effective
* Vesicular stage
* Colloid vesicular stage
* Granular nodular stage

Exclusion Criteria:

* Cysticercotic encephalitis
* Calcified cyst
* Hydrocephalus
* Intraventricular cyst
* Subarachnoid cyst
* Ophthalmic Cysticercosis
* No of cysts \>5
* Known allergy to benzimidazole class of compound which includes anaphylaxis, hypotension, severe skin reactions .
* Features of raised ICT (papilloedema, hyperventilation, hypertension, tonic posturing, B/L 6th nerve palsy, features of midline shift on CT/MRI)
* Critically sick (respiratory failure, cardiovascular instability)
* Already received albendazole or praziquantel or steroid therapy

Primary outcomes:
measure: Number of cyst resolved/ calcified completely after therapy. Resolution or calcification of cyst assessed on CT head at the end of 6 months after starting albendazole
timeFrame: 1 year
Secondary outcomes:
measure: Frequency of seizure occurrence
timeFrame: 1 year
measure: Frequency of occurrence of other symptoms attributable to Neurocysticercosis
timeFrame: 1 year
measure: Frequency of occurrence of side effects of albendazole
timeFrame: 1 year
Other outcomes:
Locations:
city: New Delhi
country: India
facility: sheffali Gulati
state: Delhi
Study officials:
affiliation: AIIMS, New Delhi
name: Sheffali Gulati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02324244: CMV Intensive Care Units
Official title: A Prospective Monitoring Study of Cytomegalovirus Infection in Immunocompetent Critical Heart Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CMV Infection
Keywords: Cytomegalovirus
critical patient
ICU
immunocompetent
clinical suspicion
risk factors
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 150
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: immunocompetent adults admitted to a major heart surgery intensive care unit

Brief summary: Prospectively assessment of CMV viremia by real-time polymerase chain reaction (PCR) in a broad cohort of consecutive immunocompetent adults admitted to a major heart surgery intensive care unit (MHS-ICU) with the goal of determining the epidemiology, risk factors, and clinical significance of CMV infection.


Eligibility criteria: Inclusion Criteria:

* Agreeing to participate in the study
* Age of at least 18 years
* Admission to the MHS-ICU for at least 72 hours

Exclusion Criteria:

* Inability to give informed consent
* Age younger than 18 years
* AIDS
* Pregnancy
* Organ or bone marrow transplant, receipt of immunosuppressive therapy including corticosteroids within 30 days, and cancer or hematologic malignancy treated with radiotherapy or chemotherapy

Primary outcomes:
measure: incidence number of participants with a positive CMV positive result
timeFrame: month 8
Secondary outcomes:
measure: risk factors for CMV reactivation
timeFrame: month 8
measure: mortality by day 30
timeFrame: month 8
measure: prolonged hospitalization . More than 30 days
timeFrame: month 8
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Servicio de Microbiologia y Enfermedades Infecciosas
Study officials:
affiliation: Hospital General Universitario Gregorio Marañon
name: Patricia Muñoz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00870844: Safety and Pharmacokinetic Study of Carbamylated Erythropoietin (CEPO) to Treat Patients With Acute Ischemic Stroke
Official title: A Randomised, Double-blind, Placebo-controlled, Multiple-dose, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Lu AA24493 in Patients With Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Ischemic Stroke
Keywords: Acute ischemic stroke
Erythropoietin
Carbamylated
Neuroprotection
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2009-03-27
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of the study is to determine whether carbamylated erythropoietin (CEPO) dosed once daily for 5 days is a safe treatment for patients who have suffered an acute ischemic stroke.

Detailed description: Acute ischemic stroke is a major cause of death and severe disability. The naturally occurring hormone, erythropoietin (EPO), is able to protect various neuronal tissues from ischemic injury and is beneficial in animal models of acute ischemic stroke. Lu AA24493 is a modified (carbamylated) version of EPO, neuroprotective but without the haematopoietic side effects. Lu AA24493 is developed for treatment of patients with acute ischemic stroke.

Eligibility criteria: Inclusion Criteria:

* Age between 50 and 90 years
* Clinical diagnosis of acute ischemic stroke
* Measurable stroke-related deficit
* Patient is stable
* Treatment can be initiated between 0 hours and 48 hours after the onset of stroke
* Expected hospital stay of at least 120 hours after first dose of study medication
* If female then not of childbearing potential

Exclusion Criteria:

* Primary intracerebral haemorrhage (ICH), or parenchymal haemorrhagic transformation of infarction (type PHI or PHII as defined in ECASS), subarachnoid haemorrhage (SAH), arterio-venous malformation (AVM), cerebral aneurysm, or cerebral neoplasm
* Treated with a thrombolytic \<24 hours (if \>24 hours and excluded ICH then eligible)
* Score \>=1 on the NIHSS item 1a
* Pre-stroke mRS score \>=2
* Uncontrolled hypertension
* Previous treatment with erythropoietin
* Previous exposure to Lu AA24493

Primary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS)
timeFrame: NIHSS = Baseline: Day 2, 3, 4, 5, Day 6/Discharge, Day 14, 30. mRS = Baseline, Day 6/Discharge, Day 14, 30
Secondary outcomes:
measure: Pharmacokinetics, immunogenicity and biomarkers
timeFrame: Baseline, Days 1-6, Day 30
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: FI004
city: Paris
country: France
facility: FR002
city: Breda
country: Netherlands
facility: NL005
city: Singapore
country: Singapore
facility: SG003
city: Glasgow
country: United Kingdom
facility: GB001
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT01636544: Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity
Official title: Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Squamous Cell Carcinoma of the Oral Cavity
Leukoplakia Oral
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
First posted: 2012-07-10
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: BASIC_SCIENCE

Brief summary: Recent studies estimated that 15 to 20% of all cancers in humans are associated with viruses. Among oral cancer about 90% are oral squamous cell carcinomas (OSCC). Alcohol and tobacco consumption have been recognized for years as the main risk factors for development of OSCCs. However, 10 to 20% of patients suffering from OSCCs are non-smokers and/ or non-drinkers. Consequently, the hypothesis of another agent responsible has risen. Indeed, several studies have suggested the possibility that a virus could be associated with or be a causal agent of OSCC. The first objective is to detect and characterize the presence of infectious agent (mostly virus) transcripts in pre-malignant or malignant tumours from patients with OSCCs.The secondary objectives are (i) to associate and (ii) if possible define a causality link between these agents and a subset of potentially malignant disorders and/or OSCCs.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years,
* For subgroup "potentially malignant disorder : clinical diagnosis of leukoplakia,
* For subgroup "OSCC" : histological diagnosis of OSCC,
* Patient who never smoked, or light smoker, (≤5 pack-year) or 15 years of cessation,
* Patient who never drank, or light drinker (≤ 20 g/day for men and 10g/day for women) or 15 years of cessation,
* Informed consent signed.

Exclusion Criteria:

• Previous treatment of oral cancer,

Primary outcomes:
measure: Detection and characterization of HPV (human papillomavirus)by using qPCR (quantitative polymerase chain reaction) method.
timeFrame: 30 months
measure: Detection of others infectious agents
timeFrame: 30 months
Secondary outcomes:
measure: Clonality of viral agent
timeFrame: 30 months
Other outcomes:
Locations:
city: Paris
country: France
facility: hôpital la Pitié Salpêtrière - APHP
Study officials:
affiliation: APHP
name: Chloé Bertolus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Pasteur
name: Antoine Gessain, PhD
role: STUDY_CHAIR
References: