louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06359119: Implementation of Apnoea Test for Patients With Suspected Brain Death
Official title: Implementation of Apnoea Test for Patients With Suspected Brain Death (IMAPing SUBDEP)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Brain Death
Keywords: brain death determination
apnoea test
survey
Lead sponsor: Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
Sponsor class: OTHER_GOV
Collaborators: name: Veszprém County Ferenc Csolnoky Hospital
First posted: 2024-04-11
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any physician working in intensive care can fill the form and participate in the study.

Brief summary: This study consists of a survey created for intensive care physicians regarding their current practice of the implementation of apnoea test for patients with suspected brain death.

Detailed description: Although the apnoea test is part of nearly all protocols for determining brain death; implementation significantly differs among intensive care physicians according to national-level acts, national society protocols or local protocols.

This cross-sectional study is based on an international, web-based questionnaire created for intensive care physicians, consisting of 25 questions in English.

The survey will provide a current state of the practice of apnoea testing in patients with suspected brain death. The results can support the determination of future acts to standardize the apnoea test process.

The given answers are anonymous. The e-mail address of the respondent is not recorded. Answers are treated solely for scientific purposes.

Eligibility criteria: Inclusion Criteria:

* Physicians working in intensive care units

Exclusion Criteria:

-

Primary outcomes:
measure: Number of apnoea tests
timeFrame: last 1 year
measure: Timeframe between apnoea tests
timeFrame: last 1 year
measure: Preoxygenation
timeFrame: last 1 year
measure: Baseline arterial carbon dioxide (CO2) level
timeFrame: Last 1 year
Secondary outcomes:
measure: Detection of possible spontaneous breath movements
timeFrame: last 1 year
measure: Satisfaction with current practice
timeFrame: last 1 year
Other outcomes:
measure: Continuous positive airway pressure (CPAP)
timeFrame: last 1 year
Locations:
Study officials:
References:
Clinical trial NCT00528619: A Study To Find The Best Dose Of SU011248 When Given With Pemetrexed, Pemetrexed And Cisplatin Or Pemetrexed And Carboplatin In Patients With Advanced Solid Tumors
Official title: Phase I Study Of SU011248 In Combination With Pemetrexed, Pemetrexed/Cisplatin And Pemetrexed/Carboplatin In Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Solid tumor malignancy
non-small cell lung cancer
sunitinib
pemetrexed
Phase 1
Mesothelioma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-09-12
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin in patients with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists.
* Patient has a good performance status (ECOG 0 or 1).

Exclusion Criteria:

* Prior treatment with either pemetrexed or SU011248.
* Coughing up blood within 4 weeks before starting study treatment (small amounts okay).
* Hypertension that cannot be controlled by medications.

Primary outcomes:
measure: To determine maximally tolerated dose of SU011248 (dosed continuously or on a 2/1 Schedule) when given in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin.
timeFrame: From screening until at least 28 days beyond discontinuation of study treatment
Secondary outcomes:
measure: To evaluate the plasma pharmacokinetics of SU011248 and its metabolite, SU012662 in addition to pemetrexed, SU011248 and pemetrexed/cisplatin, and SU011248 and pemetrexed/carboplatin when these drugs are co-administered.
timeFrame: From screening until disease progression or discontinuation of the study
measure: To preliminarily assess the antitumor activity of SU011248 in addition to pemetrexed, SU011248 and pemetrexed/cisplatin, and SU011248 and pemetrexed/carboplatin in patients with non-small cell lung cancer or advanced unresectable mesothelioma.
timeFrame: From screening until disease progression or discontinuation of the study
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04055519: Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
Official title: Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: Contact Lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2019-08-13
Enrollment: 36
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: The purpose of this study is to obtain on-eye performance data to inform contact lens product development.

Detailed description: Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.

Eligibility criteria: Inclusion Criteria:

* Sign Informed Consent document.
* Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
* Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

* Any eye condition or disease or use of medication that contraindicates contact lens wear.
* Eye surgery, irregular cornea, eye injury as specified in the protocol.
* Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.
* Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.
* Habitually wears Biofinity contact lenses.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Distance VA (logMAR) With Study Lenses
timeFrame: Day 30 after a minimum of 6 hours of wear, each product
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Alcon Investigative Site
state: Florida
city: Bloomington
country: United States
facility: Alcon Investigative Site
state: Illinois
city: Memphis
country: United States
facility: Alcon Investigative Site
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: CDMA Project Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT03961919: Phase II Trial in Elderly Patients With AML or MDS in Complete Remission Not Eligible for Allogenic Transplant
Official title: Evaluation of Safety and Efficacy of Treosulfan-cytarabine-fludarabine (FLAT) Combination Prior to Autologous Stem Cell Transplant (HSCT) in Elderly Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndromes
Transplant-Related Hematologic Malignancy
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: FLAT-Auto is a phase II trial. fludarabine and ARA-C will be combined with the alkylating agent treosulfan (FLAT), to investigate the feasibility and the efficacy of a new regimen, supported with autologous peripheral blood SCT (PBSCT), as final postremission consolidation in AML/MDS elderly patients.


Eligibility criteria: Inclusion Criteria:

* Pts with de novo or secondary AML or with Int 2 or High risk MDS according to IPSS.
* Pts unable or unfit to receive SCT from an HLA (human leukocyte antigen)-identical related (SIB) or unrelated (MUD), or HLA-haploidentical related (HAPLO) donor.
* Hematologic CR (Appendix D) after 1 or 2 cycles of induction standard chemotherapy.
* Successful collection of autologous PBSC: ≥ 5.0x10e6 /kg patient bodyweight (BW)
* Age ≥ 65 years.
* Performance status 0-2 ECOG (Eastern Cooperative Oncology Group), 60-100% Karnofsky (Appendix E).
* Written informed consent.

Exclusion Criteria:

* Diagnosis of AML M3.
* Second concomitant malignancies.
* Severe concomitant illnesses/medical conditions (e.g. impaired respiratory and/or cardiac function).
* Known and manifested malignant involvement of the central nervous system (CNS)
* Active infectious disease
* HIV- positivity or active hepatitis infection
* Impaired liver function (bilirubin \> 1.5 x upper normal limit; transaminases \> 3.0 x upper normal limit)
* Impaired renal function (creatinine-clearance \< 60 ml/min; serum creatinine \> 1.5 x upper normal limit).
* Known hypersensitivity to treosulfan and/or cytarabine and/or fludarabine
* Participation in another experimental drug trial within 4 weeks before day -6
* Non-cooperative behaviour or non-compliance
* Psychiatric diseases or conditions that might impair the ability to give informed consent

Primary outcomes:
measure: Evaluation of disease free survival from first Complete Remission (CR)
timeFrame: 2 years after transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombardia
Study officials:
affiliation: San Raffaele Hospital IRCCS
name: Fabio Ciceri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05952219: Study to Evaluate the Safety and Pharmacokinetics of CKD-379
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-379 in Healthy Volunteers Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Type II Diabetes Mellitus
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2023-07-19
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to compare the pharmacokinetics and safety between CKD-379 and D759, D745, D029, D150 combination

Detailed description: A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-379 in healthy volunteers under fed conditions

Eligibility criteria: Inclusion Criteria:

* Between 19 aged and 50 aged in healthy adult
* 18.0kg/m2≤body mass index(BMI)≤27.0kg/m2 and 50.0kg≤Body weight≤90.0kg

Exclusion Criteria:

* Have clinical significant medical history or disease that blood, kidney(moderate nephropathy and etc.), endocrine system(type I or type II diabetes mellitus, diabetic ketoacidosis, diabetic coma and etc.), respiratory system, gastrointestinal system, urinary system, cardiovascular system(heart failure, Torsades de pointes and etc.), liver(moderate liver disorder and etc.), mental system, nervous system, immune system
* Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery
* Those who are pregnant or breastfeeding
* Those who are deemed inappropriate to participate in clinical trial by investigators

Primary outcomes:
measure: AUCt
timeFrame: 0~48hours
measure: Cmax
timeFrame: 0~48hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
affiliation: Chonbuk National University Hospital
name: Seol Ju Moon, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01075919: Cognitive and Mood Effects of Docosahexaenoic Acid (DHA)-Rich and Eicosapentaenoic Acid (EPA)-Rich Fish Oil in Healthy Young Adults
Official title: Cognitive and Mood Effects of DHA-rich and EPA-rich Fish Oil in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Mood
Keywords: n-3 PUFAs
Cognitive function
Healthy young adults
Fish oil
Mood
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Ginsana SA
First posted: 2010-02-25
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To date, only a small handful of studies have assessed the effects of omega-3 polyunsaturated fatty acids (n-3 PUFAs) on cognitive function in healthy adults. The results from these studies are mixed, and have differed greatly in terms of methodology as regards sample size, treatment formulation and duration of the intervention. In order to address these issues, the present study aims to assess the effects of two different formulations of fish oil in parallel, and at doses consistent with the current recommended daily intake of oily fish, across a range of cognitive domains. The aim of the present investigation is therefore to specifically evaluate the effects of 12 weeks supplementation of DHA-rich fish oil and EPA-rich fish oil dietary supplements on cognitive function in healthy young adults maintaining a regular diet containing oily fish not more than once a week. Self-report mood assessments will form the secondary part of this investigation.


Eligibility criteria: Inclusion Criteria:

* Male/Female
* 18-35 years
* Healthy
* No herbal supplements/prescription medications (excl. contraceptive pill)
* Non smoker
* Native English speaker

Exclusion Criteria:

* Consumes ≥ 1 portion oily fish/week
* takes omega-3 supplement
* Food allergies to treatment ingredients

Primary outcomes:
measure: Cognitive performance
timeFrame: 12 weeks
Secondary outcomes:
measure: Mood
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria University
state: Tyne and Wear
Study officials:
affiliation: Northumbria University
name: Philippa A Jackson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01170819: Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.
Official title: Double Balloon Catheter Versus Vaginal PGE2 for Pre-induction Cervical Ripening: a Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Ripening
Labor Induction
Keywords: Cervical ripening
Induction of labor
Prostaglandins
Mechanical methods
Balloon catheter
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of transcervical double balloon catheters versus controlled release dinoprostone vaginal inserts for pre-induction cervical ripening in term women with unfavourable cervices.


Eligibility criteria: Inclusion Criteria:

* singleton gestation
* gestational age greater than 34 weeks
* cephalic presentation
* intact membranes
* Bishop score of ≤4
* reactive fetal heart rate (FHR) pattern on admission

Exclusion Criteria:

* any condition precluding vaginal delivery
* any contraindication to receiving prostaglandins, including history of asthma, glaucoma, or cardiac or cardiovascular disease
* previous cesarean section or other uterine incision

Primary outcomes:
measure: Vaginal delivery within 24 hours
timeFrame: 24 hours from start of cervical ripening
Secondary outcomes:
measure: Cesarean section rate
timeFrame: 48 hours from start of ripening
measure: Onset of active labor
timeFrame: 36 hours from start of ripening
measure: Uterine hyperstimulation
timeFrame: 12 hours (double ballon catheter arm) and 24 hours (dinoprostone vaginal insert arm) from start of ripening
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Del Ponte Hospital
Study officials:
References:
Clinical trial NCT01046019: Measurement of Early Bone Loss Around a Total Hip Arthroplasty
Official title: Measurement of Early Bone Loss Around a Total Hip Arthroplasty. A Prospective Trial With Dual Energy X-ray Absorptiometry.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coxarthrosis
Keywords: DXA
Hip
Arthroplasty
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with degenerative hip osteoarthritis decided for operation with total hip arthroplasty.

Brief summary: Research with DXA has shown the pattern of bone remodelling around an implant. The baseline and reference value for such calculations is the first measurement after the operation. The baseline measurement is performed at different time from study to study. If there is a rapid bone loss the first weeks after an operation, this will influence the reference value and then the results. To evaluate DXA as a method we decided to set up a study with 3 DXA measurements within the first 2 weeks. Our hypothesis is that there is a rapid bone loss the first 2 weeks after operation and that timing of the first post operative measurement will influence the later results.

Detailed description: Dual x-ray absorptiometry (DXA) has become the most used and proven to be a precise method to investigate changes in bone mass density (BMD). Research with DXA has shown the pattern of bone remodelling around an implant. Results from implant studies are often presented as changes in BMD as a function of time. The baseline and reference value for such calculations is the first measurement after the operation. The most pronounced bone loss after implantation of hip prosthesis usually comes within 3 months. The baseline measurement is performed at different time from study to study. If there is a rapid bone loss the first weeks after an operation, this will influence the reference value and then the results. To evaluate DXA as a method we decided to set up a study with 3 DXA measurements within the first 2 weeks.

We included 23 patients operated with total hip prosthesis (THP). They were measured with DXA at 1, 5 and 14 days, 3 and 12 months after the operation. Results were given in percent (+/-SD) for each Gruen zone. There were no changes in bone density between the first 3 measurements. In all zones, except zone 1, the lowest BMD was measured after 3 months. We concluded that DXA measurements done within 14 days after the operation can be used as reference measurements for later follow ups.

Eligibility criteria: Inclusion Criteria:

* degenerative hip osteoarthritis

Exclusion Criteria:

* metastasis to bone
* dementia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ullevaal University Hospital
name: Lars Nordsletten, Professor
role: STUDY_DIRECTOR
affiliation: Ullevaal University Hospital
name: Berte G Bøe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02383719: A Feasibility Study Evaluating the Use of a Non-invasive Ventilation Mask
Official title: Oro-nasal Mask Patient Comfort Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Noninvasive Ventilation
Respiratory Insufficiency
Lead sponsor: Convergent Engineering, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluate the clinicians assessment of the use of an oro-nasal mask during non-invasive ventilation (non-intubated) with a feasibility study.


Eligibility criteria: Inclusion Criteria:

* patient requiring non-invasive ventilation in an intensive care unit

Exclusion Criteria:

* patient not stable for non-invasive ventilation
* patient with unprotected airway
* excessive secretions
* patient with facial surgery
* agitated patient

Primary outcomes:
measure: Clinician Assessment of Use With a Questionnaire
timeFrame: During non-invasive ventilation with the oro-nasal mask
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Hassan Alnuaimat, M.D.
role: PRINCIPAL_INVESTIGATOR
References: