louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02755337: The Evaluation of Lung Cancer Patient Treated With Epidermal Growth Factor Receptor Tyrosine Kinase
Official title: The Evaluation of Lung Cancer Patient Treated With Epidermal Growth Factor Receptor Tyrosine Kinase
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Small-Cell Lung Cancer
Keywords: adenocarcinoma
non-adenocarcinoma
Lead sponsor: Dr. Soetomo General Hospital
Sponsor class: OTHER_GOV
First posted: 2016-04-28
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NSCLC patients (adenocarcinoma and non-adenocarcinoma histology) who harbor a positive EGFR mutation and receive Gefitinib (Iressa) as treatment.

Brief summary: To evaluate Non-Small Cell Lung Cancer (NSCLC) patients clinical profile and the outcome after treatment with Gefitinib in Pulmonary Oncology Outpatient Clinic Dr. Soetomo General Hospital, Surabaya, Indonesia.

Detailed description: Primary Objective: To determine the efficacy of Gefitinib in NSCLC patient harboring a positive EGFR mutation.

Secondary Objective: To evaluate the subjective response of NSCLC patients harboring a positive EGFR mutation who treated with Gefitinib.

Safety Objective: To evaluate the safety and tolerability of Gefitinib in NSCLC patient harboring a positive EGFR mutation.

Eligibility criteria: Inclusion Criteria:

* NSCLC based on histopathologic examination
* Adenocarcinoma and/or nonadenocarcinoma based on histology examination
* Clinical stadium stage IIIB and IV
* Age 16-70 years old
* Received gefitinib as therapy
* At least completed 2 (two) data sets of RECIST 1.1 evaluations during the study period from January 2013 until July 2015

Exclusion Criteria:

* Missing data of any variables of the treatment outcomes in the medical record

Primary outcomes:
measure: PFS (Progression Free Survival)
timeFrame: through study completion, in average of 1 year
measure: Overall Survival (OS)
timeFrame: through study completion, in average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Dr. Soetomo General Hospital
state: East Java
Study officials:
affiliation: Dr. Soetomo General Hospital
name: Laksmi Wulandari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02780037: To Motivate Elderly to Move
Official title: To Motivate Elderly to Move: Focus on Prevention or Promotion?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatric Disorder
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2016-05-23
Enrollment: 111
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study examines the short- and long-term-effects of different repeated frames in which an exercise program is offered on behavior (i.e., frequency of exercise) and motivation (i.e., autonomous/controlled) in older people (65+). The frames are manipulated experimentally as either prevention focused (e.g., to prevent worse health), promotion focused (e.g., to gain better health) or neutral (control condition).


Eligibility criteria: Inclusion Criteria:

* 65 years of age

Exclusion Criteria:

* severe mental/physical problems

Primary outcomes:
measure: Behavior at long term: exercise frequency during third week
timeFrame: third week
Secondary outcomes:
measure: Change in controlled motivation over long term: end week 3 - baseline
timeFrame: 3 weeks
measure: Change in autonomous motivation over long term: end week 3 - baseline
timeFrame: 3 weeks
measure: Change in controlled motivation over short term: end week 1 - baseline
timeFrame: 1 week
measure: Change in autonomous motivation over short term: end week 1 - baseline
timeFrame: 1 week
measure: Behavior at short term: exercise frequency during first week
timeFrame: first week
Other outcomes:
measure: Functionality: sit to stand/sit: flexion, extension, stand and sit duration (time)
timeFrame: week 1/week 2/week 3
measure: Functionality: sit to stand/sit: angular velocity flexion and extension (degrees/sec)
timeFrame: week 1/week 2/week 3
measure: Functionality: sit to stand/sit: range flexion and extension (degrees)
timeFrame: week 1/week 2/week 3
measure: Functionality: SPPB (Short Physical Performance Battery) score
timeFrame: week 1/week 2/week 3
measure: Functionality: SPPB balance score
timeFrame: week 1/week 2/week 3
measure: Functionality: SPPB gait speed score
timeFrame: week 1/week 2/week 3
measure: Functionality: SPPB chair stand score
timeFrame: week 1/week 2/week 3
measure: Functionality: sway acceleration (mG)
timeFrame: week 1/week 2/week 3
measure: Functionality: sway velocity (mm/sec)
timeFrame: week 1/week 2/week 3
measure: Functionality: sway path (mm/sec)
timeFrame: week 1/week 2/week 3
measure: Functionality: sway normalized area (mm²/sec)
timeFrame: week 1/week 2/week 3
Locations:
city: Leuven (Heverlee)
country: Belgium
facility: Department of Kinesiology
state: Vlaams-Brabant
Study officials:
References:
citation: Vanroy J, Seghers J, van Uffelen J, Boen F. Can a framed intervention motivate older adults in assisted living facilities to exercise? BMC Geriatr. 2019 Feb 18;19(1):46. doi: 10.1186/s12877-019-1060-z.
Clinical trial NCT06498037: Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.
Official title: Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cancer Pain
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a single-arm PK-study design
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective is to evaluate the effect of loading boluses when dose incresaing treatment with SC fentanyl in patients with cancer. The primary endpoint of this study is to prove the non-inferiority of fentanyl plasma concentrations 12 hours after dose augmentation compared to 48 hours after dose augmentation within each patient.

Patients will be treated with additional loading boluses and plasma-PK samples will be obtained.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years;
* Able to understand the written information and able to give informed consent.
* Current or planned treatment with SC fentanyl for cancer-related pain

Exclusion Criteria:

* Pregnancy or/ and breastfeeding
* Other ways of using fentanyl (sublingual, nasal spray and oromucosal)
* Liver function CPS B or C
* The use of strong CYP3A4 inhibitors of inducers \[9\]
* Presence of somnolence, respiratory depression or CTCAE grade 2 adverse events.

Primary outcomes:
measure: Primary endpoint of this study is to prove the non-inferiority in fentanyl plasma concentrations 12 hours after dose augmentation compared to 48 hours after dose augmentation within each patient using a bioequivalence approach
timeFrame: 48 hours after dose increase
Secondary outcomes:
measure: Investigate the safety of the loading bolus strategy by assessing whether CTCAE grade III or higher occur as a consequence of the fentanyl loading boluses.
timeFrame: up to 48 hours after dose increase
measure: Describe the course of patient reported pain intensity in the 48 hours following the loading boluses.
timeFrame: up to 48 hours after dose increase
measure: Accurately assess the rate of fentanyl absorption after SC fentanyl administered as a bolus.
timeFrame: up to 48 hours after dose increase
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
References:
Clinical trial NCT03753737: Personality Disorders and Substance Use Disorders in a Sexual Context in the Man Having Sex With Other Men Population
Official title: A Study of the Relationship Between Personality Disorders and Substance Use Disorders in a Sexual Context in the Man Having Sex With Other Men Population - An Observational Study Based on a Cross-sectional Survey.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substance Use Disorders
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 94
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men who have Sex with Men (MSM) with past or present substance-related disorder related to chemsex, and sexually active MSM who have never experienced chemsex.

Brief summary: Chemsex refers to the use of psychoactive drugs in a sexual context, mainly cathinones, GHB/GBL, methamphetamine, cocaine and ketamine. This can cause infectious or psychiatric complications, addictions, and often goes with high risk sexual behaviours. Recent studies have highlighted the relationship between personality disorders, substance use disorders and risky sexual behaviours. It is important to understand the factors associated with chemsex in order to offer adapted prevention and care plans.

The study hypothesis is that personality disorders, evaluated with the PDQ-4+ questionnaire, are more frequent among man having sex with other men with a substance use disorder linked to chemsex than among man having sex with other men who have never practised chemsex.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* Men who have Sex with Men
* No opposition to participate to the study
* Chemsex group: to attend an addiction care center for past or present mild, moderate or severe substance-related disorder(s) according to DSM-V criteria, occurring in a sexual context and concerning cathinones, GHB/GBL, methamphetamine, cocaine and/or ketamine.
* Control group: to consult for a PrEP prescription and never have used cathinones, GHB/GBL, methamphetamine, cocaine or ketamine before or during sex.

Exclusion Criteria:

* Deprivation of liberty
* Guardianship
* Chemsex group: simple experience of chemsex without substance use disorder

Primary outcomes:
measure: Personality disorders
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: CSAPA - Service Hépato-gastroentérologie
Study officials:
References:
Clinical trial NCT01745237: Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis
Official title: Detection and Prognostic Significance of Myocardial Damage Visualized by Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcoidosis
Keywords: Sarcoidosis
Cardiac Magnetic Resonance
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 27000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with biopsy proven sarcoidosis or suspected cardiac sarcoidosis

Brief summary: The primary objective of this study was to determine the ability of cardiac magnetic resonance (CMR) to identify cardiac involvement in patients with sarcoidosis. Patients were to undergo CMR in addition to routine clinical evaluation.

Detailed description: In patients with sarcoidosis, cardiac death is a leading cause of mortality which may represent unrecognized cardiac involvement. Cardiovascular magnetic resonance (CMR) can detect cardiac involvement including minute amounts of myocardial damage. Therefore, the objective of this study was to determine the usefulness of CMR and compare it with standard clinical evaluation for cardiac involvement. Patients with documented extracardiac sarcoidosis or clinically suspected cardiac sarcoidosis will be enrolled.

Eligibility criteria: Inclusion Criteria:

* Biopsy proven sarcoidosis
* Suspected cardiac sarcoidosis

Exclusion Criteria:

* Contraindication to MRI

Primary outcomes:
measure: cardiac mortality
timeFrame: > 1year
measure: arrhythmic death
timeFrame: > 1year
measure: Pulmonary mortality
timeFrame: > 1year
Secondary outcomes:
measure: all-cause mortality
timeFrame: > 1year
measure: arrhythmic events
timeFrame: > 1year
measure: Pulmonary Transplant
timeFrame: > 1 year
measure: Cardiac Transplant
timeFrame: > 1 year
measure: PPM placement/high grade AV block
timeFrame: > 1 year
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Cardiovascular Magnetic Resonance Center, Duke University Medical Center
name: Raymond J Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel MR, Cawley PJ, Heitner JF, Klem I, Parker MA, Jaroudi WA, Meine TJ, White JB, Elliott MD, Kim HW, Judd RM, Kim RJ. Detection of myocardial damage in patients with sarcoidosis. Circulation. 2009 Nov 17;120(20):1969-77. doi: 10.1161/CIRCULATIONAHA.109.851352. Epub 2009 Nov 2.
Clinical trial NCT03170037: Comparison of Two-hand Mask Ventilation Technique: Standard V-E Versus Reversal V-E Technique
Official title: Comparison of Two-hand Mask Ventilation Technique: Standard V-E Versus Reversal V-E Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Comparison of 2 two-handed mask ventilation techniques' ease to anesthesia providers
Primary purpose: OTHER

Brief summary: This study hypothesizes that a novel reversal V-E ventilation technique will retain its high efficiency as that of standard V-E technique and will be easier to use.

Detailed description: Despite advances in intubation technology, difficult airways persist. Because it is failure to oxygenate, not failure to intubate, that ultimately leads to brain injury and cardiovascular collapse, effective mask ventilation is at least as important as successful intubation. Therefore optimizing mask ventilation is crucial for clinicians. When difficult mask ventilation encounters, clinicians often switch to two hand technique to hold the mask including either "C-E" clamp or "V-E" clamp. Both volume mode ventilation and pressure mode ventilation are superior with the V-E technique as compared to the C-E technique. The study will test the hypothesis that a novel reversal V-E mask ventilation technique will retain its high efficiency as that of standard V-E technique but be easier to use than standard V-E technique.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Requiring general anesthesia
* BMI =\>30

Exclusion Criteria:

* Untreated ischemic heart diseases
* Respiratory disorders, including COPD and asthma
* American Society of Anesthesiologists(ASA) physical class of 4 or greater
* Undergoing emergency surgery
* Requiring rapid sequence intubation for aspiration protection
* Non propofol - induction of anesthesia
* Requiring fiberoptic intubation
* Pregnant women or women who have given birth within the last month

Primary outcomes:
measure: Visual score of friendliness of mask holding technique using 11 point scale
timeFrame: Conclusion of masked ventilation (approximately 5 minutes)
Secondary outcomes:
measure: AUC of exhaled tidal volume (Vt) trace
timeFrame: Period of masked ventilation (approximately 5 minutes)
measure: Vt/AUC
timeFrame: Period of masked ventilation (approximately 5 minutes)
measure: Peak inspiratory airway pressure
timeFrame: Period of masked ventilation (approximately 5 minutes)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Christopher Canlas, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01611337: Insight in Persons Presenting Schizophrenia or Related Troubles During Hospitalization in Psychiatry
Official title: Insight in Persons Presenting Schizophrenia or Related Troubles During Hospitalization in Psychiatry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia, insight
Lead sponsor: Centre Hospitalier Esquirol
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Therapeutic alliance, and drug observance are major difficulties in the care of persons presenting schizophrenic symptomatology. They appear to be linked to insight, the consciousness that one has of his troubles. Nurse care in psychiatry aims at improving it, but usually without using specific evaluation tool. Insight is usually not evaluated during care, and its evolution is also not known, although it is highly probable that a positive evolution of insight for a person in hospital correlated to an adapted and optimal care by the medical and nursing teams. The investigators do not know examples of insight evaluation during a sequence of hospital care, or any evidence of insight variation in relation to evolution abilities of some schizophrenic patients cared in hospital.

The investigators propose here to evaluate insight in people presenting schizophrenia or related troubles, at the beginning of hospitalization (I1) and 1 month later (I2), to better characterize insight variations, and identify the sociodemographic, clinical and therapeutic variables linked to it.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia,
* Persons requiring psychiatric care in one of the participating care unit
* I1 \< 6 (absent or bad consciousness of the trouble).

Exclusion Criteria:

* I1≥6
* Expression capacities incompatible with Q8 scale quotation (delirium, no understanding of the french language, mutism, contention or therapeutic isolation)
* Age under 18, absence of health care insurance

Primary outcomes:
measure: number of collected data explaining insight variation between the first week of hospitalization (I1) and 1 month later (I2) in a model of logistic regression
timeFrame: first month after hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Centre Hospitalier Esquirol
city: Saint-Vaury
country: France
facility: Centre Hospitalier La Vallette
Study officials:
affiliation: Centre Hospitalier Esquirol
name: Danielle Bourlot, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01256437: Evaluating Preventive Therapy With Oint Threolone, Synthomycine or Aqua Cream, for EGFR'I Induced Acneiform Rash
Official title: Double Blind Placebo Controlled Trial, for Evaluating Preventive Therapy With Either Oint Threolone Versus Synthomycine Versus Aqua Cream, for EGFR'I Induced Acneiform Rash
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acneiform Rash
Keywords: Acneiform eruption
papulopustular
EGFR
cetuximab
erlotinib
gefitinib
panitumumab
eruption secondary to treatment with either cetuximab
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2010-12-08
Enrollment: 90
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: The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is.

Detailed description: The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is.

Eligibility criteria: Inclusion Criteria:

* Patients who are planed to initiate treatment with either cetuximab , erlotinib, gefitinib or panitumumab.

Exclusion Criteria:

* Patients who received any facial topical treatment / systemic antibiotics or any anti-inflammatory drug during the 2 weeks prior to study initiation.
* Known hypersensitivity to ointment Synthomycine or to Threolone.
* Patients presented with cutaneous rash during the 2 weeks prior to study initiation

Primary outcomes:
measure: Number of patients developing grade 2 / above rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms.
timeFrame: 3 years
Secondary outcomes:
measure: Number of patients developing a rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms
timeFrame: 3 years
Other outcomes:
Locations:
city: Petach Tikva,
country: Israel
facility: Davidoff Center, Rabin Medical Center, Beilinson
Study officials:
References:
citation: Lee JE, Lee SJ, Lee HJ, Lee JH, Lee KH. Severe acneiform eruption induced by cetuximab (Erbitux). Yonsei Med J. 2008 Oct 31;49(5):851-2. doi: 10.3349/ymj.2008.49.5.851.
citation: Lacouture ME, Mitchell EP, Piperdi B, Pillai MV, Shearer H, Iannotti N, Xu F, Yassine M. Skin toxicity evaluation protocol with panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-Emptive Skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer. J Clin Oncol. 2010 Mar 10;28(8):1351-7. doi: 10.1200/JCO.2008.21.7828. Epub 2010 Feb 8.
Clinical trial NCT01801137: The Efficacy of RAD 001 as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium
Official title: A Multicentre Phase III Trial to Determine the Efficacy of RAD 001 (Everolimus, Afinitor) as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium Which Failed or Progressed After First Line Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urothelial Cancer
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2013-02-28
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study to determine the efficacy of Everolimus(Afinitor®) as third line therapy in patients with transitional cell carcinoma of the urothelium which failed or progressed after two lines of chemotherapy


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent
* Male or female aged more than 18 years
* Histologically proven transitional cell carcinoma of the urothelium
* Metastatic or locally advanced disease not amenable to curative surgery and/or radiotherapy
* Recurrence or progression after at least one chemotherapy regimen and for unresectable/advanced disease
* No more than 2 lines of previous chemotherapy..
* Measurable disease (RECIST criteria)
* Previously irradiated lesions are not considered measurable- ECOG performance status of 0, 1 or 2

Exclusion Criteria:

* No prior treatment with anti cancer agents, including radiotherapy, in the last 4 weeks.
* No currently active CNS involvement
* No pregnancy. Women of child bearing potential must have a negative pregnancy test.
* No uncontrolled diabetes
* No symptomatic coronary artery disease, myocardial infarction within the last six months, congestive cardiac failure greater than New York Heart Association (NYHA) class II, uncontrolled or symptomatic cardiac arrhythmia

Primary outcomes:
measure: Progression-free survival rate at 12 weeks
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital FOCH
state: Ile de France
Study officials:
References: