louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03231501: HMPL-813 in Treating Patients With Glioblastoma
Official title: A Phase Ib, Multi-center, Open-label Study of Epitinib Succinate (HMPL-813) in Treating Patients With Glioblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Glioblastoma
Lead sponsor: Hutchmed
Sponsor class: INDUSTRY
First posted: 2017-07-27
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single arm, open label study with fixed dose.
Primary purpose: TREATMENT

Brief summary: This is an open-label study, to evaluated epitinib, which is a selective epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), to treat glioblastoma patients with EGFR gene amplification. As epitinib could cross blood-brain barrier (BBB), inhibition of EGFR may provide a novel mechanism in treating glioblastoma.

Detailed description: Epitinib could cross BBB and show its efficacy in brain metastasis tumors. Patients with histologically confirmed glioblastoma; standard treatment failed or no standard treatment as well as EGFR gene amplication are eligible. Patients will receive epitinib 120mg or 160mg epitinib daily. Epitinib is orally administered qd until patients reach intolerance or progression of disease. Tumor assessment takes place every 4 weeks. Simon two stage design was used, estimated making sample size of 35 cases.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed glioblastoma
2. Standard treatment failed or no standard treatment
3. EGFR gene amplification
4. Clearly measurable lesions (according to Response Assessment in Neuro-Oncolog (RANO))
5. Age ≥ 18
6. Eastern Cooperative Oncology Group (ECOG) score ≤2

Exclusion Criteria:

1. Use of Antiepileptic drugs were used\] within 2 weeks before enrollment
2. Immunotherapy, anti-angiogenesis or EGFR TKI and its downstream pathway signaling molecules and other targeted drugs within 4 weeks before enrollment; temozolomide chemotherapy, cranial radiotherapy or other systemic anti-tumor therapy within 3 weeks before enrollment
3. Previous toxic effects of anticancer therapy have not yet been recovered (defined as not restored to 0 or 1 level, except alopecia) or have not been fully recovered from previous surgery
4. Uncontrolled active infections such as acute pneumonia, Hepatitis B Virus (HBV) and so on
5. Eye disease or dry eye syndrome history
6. Positive pregnancy tested result

Primary outcomes:
measure: objective response rate (ORR)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
city: Hanzhou
country: China
facility: The second hospital affiliated to Zhejiang University Medical School
state: Zhejiang
Study officials:
affiliation: Hutchison Medipharma Ltd.
name: Rongjun Liu, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06406101: CPR Surface Choice on Chest Compression Quality
Official title: Influence of CPR Surface Choice on Chest Compression Quality: A Randomized Manikin Study Comparing Bed and Floor Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Simulation of Physical Illness
Keywords: Cardiopulmonary Resuscitation
Cardiac arrest
Simulation study
Chest Compressions
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of our randomized simulation study on mannequins with a population of Basic Life Support students is to compare the quality of chest compressions, taking depth as the main variable, in two simulated scenarios of out-of-hospital cardiac arrest on a bed: one where Cardiopulmonary Resuscitation is performed on the bed and another where the patient is transferred to the ground for Cardiopulmonary Resuscitation.


Eligibility criteria: Inclusion Criteria:

* Those individuals who sign the informed consent and do not meet exclusion criteria

Exclusion Criteria: Individuals with any limitation or contraindication for physical exercise:

* Arthritis
* Heart disease
* Advanced lung disease
* Severe physical disability
* Morbid obesity
* Chronic fatigue
* Pregnancy

Withdrawal Criteria:

* Those individuals who, due to limitations in physical exercise, do not reach 2 minutes of compressions
* Students who have not obtained the certificate of successfully completing the course.

Primary outcomes:
measure: Compressions Mean Depth
timeFrame: On the day of the simulation
Secondary outcomes:
measure: Time to first chest compression
timeFrame: On the day of the simulation
measure: Effectiveness of Chest Compressions
timeFrame: On the day of the simulation
measure: Total number of chest compressions
timeFrame: On the day of the simulation
measure: Percentage of chest compressions whit correct depth (5-6cm)
timeFrame: On the day of the simulation
measure: Mean frequency of chest compressions
timeFrame: On the day of the simulation
measure: Percentage of chest compressions with correct frequency
timeFrame: On the day of the simulation
measure: Percentage of chest compressions with correct position of hands
timeFrame: On the day of the simulation
measure: Percentage of chest compressions with correct release
timeFrame: On the day of the simulation
measure: Borg Scale for Fatigability
timeFrame: On the day of the simulation
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
Study officials:
affiliation: Hospital Clinic Barcelona, Universitat de Barcelona
name: Adriana Capdevila, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07009301: Pulmonary Embolism Following Viper's Bites: A Case Report
Official title: An Observational Study About a Case of Pulmonary Embolism Following Viper's Bite
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism (PE)
Snake Envenomation
Lead sponsor: Mohammed VI University Hospital
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People aged above 18years, developing a pulmonary embolism after snake bites

Brief summary: Viper envenomation constitutes a medical emergency predominantly occurring in rural regions, where specific viper species are endemic, with their distribution influenced by climatic variations. The literature describes numerous complications associated with viper bites, including neurological disturbance, hematological abnormalities, and irreversible renal failure.

We report the case of a 65-year-old female patient admitted to the intensive care unit for viper envenomation characterized by extensive local edema. Diagnostic investigations, including laboratory tests and imaging studies, revealed the presence of a bilateral pulmonary embolism. The patient was subsequently treated with antivenom therapy, followed by initiation of low molecular weight heparin. Despite the recognized high risk of viper envenomation described in the literature, the patient experienced an uncomplicated clinical course and was discharged in stable condition with no further complications.


Eligibility criteria: Inclusion Criteria:

* Age above 18years old

Exclusion Criteria:

* Not bitten by snakes

Primary outcomes:
measure: Evolution of hematological blood test during the ICU stay
timeFrame: From January 2025 to May 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Oujda
country: Morocco
facility: University hospital center Mohammed VI of Oujda
Study officials:
References:
Clinical trial NCT00478101: Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Solid Cancers
Keywords: Pain
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2007-05-24
Enrollment: 2006
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: For cancer patients with inadequate pain relief, a switch to an alternative opioid is the preferred option for symptomatic improvement. However, multiple opioids are often simultaneously administered for anecdotal reasons.

The present study isdesigned to assess the analgesic profiles of two different strategies in chronic cancer pain: the opioid rotation from oxycodone to transdermal fentanyl and the combination of oral oxycodone and transdermal fentanyl.

Detailed description: Patients with uncontrolled cancer pain despite treatment of oral morphine equivalent ≥100 mg/d will be randomly assigned to oral opioids to transdermal fentanyl (rotation group) or oral oxycodone plus fentanyl (combination group). Patients answer a questionnaire that included pain severity (0 to 10) and interference items at baseline and after one week. Primary outcomes are change in pain score and treatment success.

Eligibility criteria: Inclusion Criteria:

* Chronic Uncontrolled Pain That Required Stronger Opioid Therapy Than They Have Been Taking
* Histologically Confirmed Solid Cancer
* Aged Over 18 Years
* Admitted in a Palliative Cancer Care Unit

Exclusion Criteria:

* Uspected to Have Narcotic Abuse, Clinically Relevant CO2 Retention or Had an Active Skin Disease
* Inability to swallow oral medication, and impaired sensory or cognitive function
* Patients who had an active infection, uncontrolled central nervous system involvement, or on antitumor therapy of any kind

Primary outcomes:
measure: Change in pain score and treatment success
Secondary outcomes:
measure: Patient satisfaction
Other outcomes:
Locations:
Study officials:
affiliation: Gachon University Gil Medical Center, Incheon, Korea
name: Se Hoon Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim HJ, Kim YS, Park SH. Opioid rotation versus combination for cancer patients with chronic uncontrolled pain: a randomized study. BMC Palliat Care. 2015 Sep 16;14:41. doi: 10.1186/s12904-015-0038-7.
Clinical trial NCT02719301: Necklace-Shaped Sensor for Non-Invasive Monitoring of Stroke Volume and Cardiac Output
Official title: Necklace-Shaped Sensor for Non-Invasive Monitoring of Stroke Volume, Cardiac Output, Fluids, Heart Rate, Heart Rate Variability, and Respiration Rate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2016-03-25
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and Women between 18 and 85.

Brief summary: Study will compare measurements made with Necklace device for stroke volume/cardiac output with values from a FDA-approved reference device. The gold standard that will be used is Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the reference device and the Necklace.

Detailed description: Study will compare measurements made with Necklace device for stroke volume/cardiac output with values from a FDA-approved reference device. The gold standard that will be used is Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the reference device and the Necklace.

The Cardiac MRI will be received \~1-4 days after the measurement is completed. The data will be compared with data collected from the Necklace and the reference device during the study.

Eligibility criteria: Inclusion Criteria:

* Must be able to undergo Cardiac MRI

Exclusion Criteria:

* Sensitivity to electrodes

Primary outcomes:
measure: Comparison of Stroke Volume Measurement from Necklace with Cardiac MRI measurement of Stroke Volume
timeFrame: Retrospective up to 6 months after study completion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Baxter Healthcare Corporation
name: Matthew J Banet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04911101: Performance Indicators and Patient Experience in 7G and 10G Vacuum-assisted Excision of Probably Benign Breast Lesions
Official title: Performance Indicators and Patient Experience in 7G and 10G Vacuum-assisted Excision of Probably Benign Breast Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Diseases
Keywords: Vacuum-assisted excision
Breast
Minimally invasive procedure
Needle size
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Stockholm South General Hospital
name: Capio Sankt Görans Hospital
name: Uppsala University Hospital
First posted: 2021-06-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess how the needle size 7G vs 10G affects performance indicators and patient experience in vacuum-assisted excision (VAE) of probably benign breast lesions

Detailed description: After being informed about the study and potential risks, all patients giving written informed consent will have a VAE procedure to remove their breast lesion and will be randomised to either 7G or 10G needle size. After completion of the procedure, the patients fill out a questionnaire to collect data on their experience. The radiologist performing the procedure fills out a form collecting procedural performance indicators.

Eligibility criteria: Inclusion Criteria:

* Biopsy-verified probably benign breast lesion less than 20 mm size
* Biopsy-verified benign breast lesion less than 30 mm size
* Screen-detected group of microcalcifications under 10 mm size

Exclusion Criteria:

* Age less than 18 years of age
* Inability to understand the meaning of informed consent
* Pregnancy
* Breast-feeding

Primary outcomes:
measure: Excision time
timeFrame: Baseline
measure: Pain assessed by NRS 2 weeks after baseline
timeFrame: 2 weeks after baseline
Secondary outcomes:
measure: Number of patients with bleeding despite 10 minutes compression
timeFrame: Baseline
measure: Radicality assessment fractions
timeFrame: Baseline
measure: Self-reported number of patients who would recommend the procedure to others
timeFrame: 1 week after baseline
measure: Self-reported satisfaction with cosmetic result assessed by a categorical scale
timeFrame: 1 week after baseline
measure: Number of patients with self-reported occurrence of wound infection
timeFrame: 1 week after baseline
measure: Remaining scar
timeFrame: 6 months after baseline
measure: Pain assessed by NRS at baseline
timeFrame: At baseline
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Fredrik Strand, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03409601: The Role of Satiety in the Effect of Portion Size on Intake
Official title: The Role of Satiety in the Effect of Portion Size on Intake
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Feeding Behavior
Keywords: Obesity, eating behavior, food, nutrition
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study uses a crossover design in which the portion size of food is varied at each meal. Across four test meals, subjects will be served four different portions of food, and intake will be determined from pre- and post-meal food weights. The first visit will be a screening visit, at which subjects will complete the consent form, have their height and weight measured, and rate the taste of the study food. Test meals will be scheduled once a week for four weeks. At visits 2-5, subjects will eat lunch and rate characteristics of the meal. At visit 6, subjects will complete various questionnaires. The objective of this study is to determine whether any individual characteristics related to satiety influence the effect of portion size on intake.


Eligibility criteria: Inclusion Criteria:

* Be willing and able to travel to Penn State University Park campus weekly for meals
* Be a man or woman 18 - 60 years old
* Regularly eat 3 meals/day
* Be willing to avoid alcohol the day before and during test days
* Have a body mass index between 18.0 and 35.0 kg/m-squared
* Be willing to refrain from eating after 10 pm the evening before test sessions

Exclusion Criteria:

* A smoker
* An athlete in training
* Pregnant or breastfeeding at the time of screening
* Have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months
* Dislike or be unable to eat the test foods (because of allergies, intolerance, or dietary restrictions)
* Currently dieting to gain or lose weight
* Have a health condition that affects appetite
* Have participated in a similar study in our lab in the past year

Primary outcomes:
measure: Differences in energy intake
timeFrame: Weeks 1, 2, 3, and 4
measure: Differences in intake by weight
timeFrame: Weeks 1, 2, 3, and 4
Secondary outcomes:
measure: Sensory-specific satiety
timeFrame: Weeks 1, 2, 3, and 4
measure: Eating rate
timeFrame: Weeks 1, 2, 3, and 4
measure: Ratings of hunger and satiety
timeFrame: Weeks 1, 2, 3, and 4
measure: Ratings of sensory characteristics of the food
timeFrame: Weeks 1, 2, 3, and 4
measure: Ratings of meal characteristics
timeFrame: Weeks 1, 2, 3, and 4
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04528901: Study of seroPREvalence Vis-à-vis SARS-CoV2 and Correlation With Clinical Forms of COVID-19 in Patients Followed in Pneumology in the Cluster Area of the Grand-Est Region (Strasbourg University Hospital)
Official title: Study of seroPREvalence Vis-à-vis SARS-CoV2 and Correlation With Clinical Forms of COVID-19 in Patients Followed in Pneumology in the Cluster Area of the Grand-Est Region (Strasbourg University Hospital)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 1080
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: Patient followed in pulmonology at Strasbourg University Hospital

Brief summary: seroPREvalence vis-à-vis SARS-CoV2 and correlation with clinical forms of COVID-19 in patients followed in Pulmonology in the cluster area of the Grand-Est region.


Eligibility criteria: Inclusion Criteria:

* Man or woman from 18 years old and without upper age limit
* Patient followed in pulmonology at Strasbourg University Hospital
* Patient presenting at least one of the following pathologies:

  1. severe persistent asthma (200 patients)
  2. chest cancer that is active or has received treatment within a period of less than one year (300 patients)
  3. history of lung transplantation performed before the start of the epidemic (02/29/2020) (300 patients)
  4. idiopathic or other diffuse interstitial lung disease, sarcoidosis or vasculitis (70 patients)
  5. pulmonary arterial hypertension (PAH) (group 1 of the international classification) any cause or chronic thromboembolic PAH (group 4): (60 patients)
  6. Severe COPD in the respiratory failure stage (150 patients)
* Subject affiliated to a social health insurance protection scheme
* Subject able to understand the objectives of the research
* Subject having signed an informed consent

Exclusion Criteria:

* Inability to provide informed information about the subject (subject in an emergency situation, difficulty in understanding the subject, etc.)
* Subject under safeguard of justice
* Subject under guardianship or guardianship

Primary outcomes:
measure: Determine and compare the seroprevalence for SARS-CoV2 among patients with respiratory pathologies monitored in Pneumology at the Strasbourg University Hospital, in the cluster zone of the Grand Est.
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
state: Bas-Rhin
Study officials:
affiliation: CHU de Strasbourg
name: Céline MASCAUX
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00877201: Improvement of Accommodation With Anti-Oxidant Supplementation in Visual Display Terminal Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ocular Accommodation
Keywords: Accommodation
visual display terminal (VDT)
antioxidant
Lead sponsor: Ryogoku Eye Clinic
Sponsor class: OTHER
First posted: 2009-04-07
Sex: ALL
Minimum age (years): 40
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the antioxidant supplementation effect on accommodation among visual display terminal (VDT) users.


Eligibility criteria: Inclusion Criteria:

* best corrected visual acuity is over 20/20

Exclusion Criteria:

* receiving any medication or supplement that would alter the accommodation status within a week from the commencement of this study
* using multifocal spectacles or contact lenses
* pregnant or lactating mothers
* subjects with a history of drug allergy

Primary outcomes:
measure: accommodation changes
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Iidabashi Eye Clinic
Study officials:
References:
citation: Uchino Y, Uchino M, Dogru M, Fukagawa K, Tsubota K. Improvement of accommodation with anti-oxidant supplementation in visual display terminal users. J Nutr Health Aging. 2012 May;16(5):478-81. doi: 10.1007/s12603-012-0059-3.