louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02580318: Manipulation of Breath Alcohol Tests: Can Specific Techniques Alter Blood Alcohol Concentration Readings?
Official title: Manipulation of Breath Alcohol Tests: Can Specific Techniques Alter Blood Alcohol Concentration Readings?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Concentration Values
Alcohol Intoxication
Lead sponsor: St. Luke's Hospital and Health Network, Pennsylvania
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a prospective cohort study. The investigators will enroll 50 healthy volunteers. In a safe environment and after signing informed consent, each participant will consume a standardized alcoholic beverage. Using a Breathalyzer, the subjects BAT will be measured. If the subject's BAT is less than 0.10 +/- 0.005, the subject will drink another alcoholic beverage. This process will continue until the subject's BAT is 0.10 +/- 0.005. The number of alcoholic beverages the subject consumes will be monitored by the observers. When the target BAT is reached, the subjects will manipulate the breathalyzer in various ways and measure their BAT again after each manipulation. In a set order, the subjects will manipulate the breathalyzer by using less than the subject's maximal exhalation effort, placing the breathalyzer at the side of the subject's mouth, hyperventilating (10 rapidly (less than 1 second) and successive breaths prior to using the device), repeating breathalyzer 5 minutes and 10 minutes after hyperventilation and then drinking cold water after the breathalyzer at 10 minutes and repeating the breathalyzer after drinking some cold water. Descriptive statistical analyses as well as Pearson's product moment correlation coefficient will be employed to determine if any statistically significant correlation exists for any of the manipulations.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers over age 21

Exclusion Criteria:

* pregnancy
* alcoholism
* diabetes
* kidney/bladder stones
* kidney disease
* liver disease
* stomach ulcer
* organ transplant patients
* dialysis patients
* subjects with alcohol allergies
* subjects taking the following medications: activated charcoal, ampicillin, carbamazepine, cephaloridine, cloxacillin, methicillin, nitroglycerine, oxacillin, penicillin G, or quinicillin

Primary outcomes:
measure: Percent Alcohol Concentration Measured by Breathalyzer
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: St. Luke's Hospital
state: Pennsylvania
Study officials:
affiliation: St. Luke's University Hospital
name: Holly Stankewicz, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones AW. Quantitative measurements of the alcohol concentration and the temperature of breath during a prolonged exhalation. Acta Physiol Scand. 1982 Mar;114(3):407-12. doi: 10.1111/j.1748-1716.1982.tb07002.x.
Clinical trial NCT04517318: Treatment After Palbociclib-containing Regimens
Official title: A Multi-center Study of the Treatment Patterns and Clinical Outcomes of Subsequent Therapies After Progression on Palbociclib in HR+/HER2- Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Brief summary: To evaluate the prescription patterns and treatment outcomes of subsequent therapies after progression on palbociclib in the real world.


Eligibility criteria: Inclusion Criteria:

1. woman, age \> 18 years old
2. Diagnosed with HR+/HER2- Metastatic Breast Cancer
3. Patients received at least one-cycle next-line treatment after progression on combined palbociclib and endocrine therapy
4. Complete medical history was available

Exclusion Criteria:

1. Medical history was incomplete

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
measure: Adverse events
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Y, Li W, Gong C, Zheng Y, Ouyang Q, Xie N, Qu Q, Ge R, Wang B. A multicenter analysis of treatment patterns and clinical outcomes of subsequent therapies after progression on palbociclib in HR+/HER2- metastatic breast cancer. Ther Adv Med Oncol. 2021 Jun 11;13:17588359211022890. doi: 10.1177/17588359211022890. eCollection 2021.
Clinical trial NCT06849518: Study of Longitudinal Plasma PD-L1 Testing With Immunotherapy in Lung Cancer
Official title: Study of Longitudinal Plasma PD-L1 Testing With Immunotherapy in Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer (NSCLC)
Lead sponsor: Ballad Health
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A Circulogene liquid biopsy testing for plasma NGS ctDNA and plasma cfRNA PD-L1 expression will be drawn (i) pre-treatment, (ii) at cycle 2 treatment, (iii) every other cycle while on combined doublet chemotherapy-immune treatment, (iv) at 3 months post-starting treatment, (v) at 6 months post-starting treatment, and (vi) upon discontinuation of ICI treatment due to planned completed duration of ICI treatment or upon progressing disease. ICI treatment and radiographic evaluations will be standard of care as determined by the treating oncologist.
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective pilot study to assess dynamic changes of plasma cell-free RNA (cfRNA) PD-L1 expression in patients with lung cancer undergoing immune checkpoint inhibitor (ICI) based therapy. Results will be correlated with radiographic assessment of immunotherapy treatment response and plasma NGS ctDNA.


Eligibility criteria: Inclusion Criteria:

1. All patients with a diagnosis of stage IV or inoperable stage IIIB NSCLC without planned primary radiation therapy undergoing anti-PD-1/L1 based ICI treatment.
2. Chemo-immune or dual anti-PD-1/L1 with anti-CTLA-4 based regimens are eligible as long as receiving an anti-PD-1/L1 monoclonal antibody.
3. A documented informed consent will be obtained prior to inclusion in the study. All discussions with patients will be held in strictest confidence and out of earshot of the general public. Patients will be fully informed that their participation in the study is voluntary. Patients may decline to be part of the study. Their decision to participate in the study will not affect the care they receive.

Exclusion Criteria:

1. No anti-PD-1/L1 monoclonal antibody treatment.
2. Planned primary radiation therapy.
3. Small-cell lung cancer histology.

Primary outcomes:
measure: Correlation of plasma cfRNA PD-L1 by qPCR expression* with ICI treatment and response.
timeFrame: up to 24 months
Secondary outcomes:
measure: Correlation of plasma cfRNA PD-L1 expression* results with any available tissue PD-L1 protein expression.
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Kingsport
country: United States
facility: Ballad Health Cancer Care
state: Tennessee
Study officials:
References:
Clinical trial NCT01497418: Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System
Official title: Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the SJM Transfemoral Delivery System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-12-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that are candidate for implantation or have been implanted with the St. Jude Medical 23mm Portico Transcatheter heart valve.

Brief summary: Collect and evaluate the long term safety data.

Detailed description: The purpose of this study is to collect and evaluate the long term safety data of the 23mm Portico™ Transcatheter Heart Valve and the transfemoral Delivery System previously implanted in subjects with aortic valve disease.

Eligibility criteria: Inclusion Criteria:

1. Subject has given written study Informed Consent for participation prior to any study procedures.
2. Subject is ≥ 18 years of age or legal age in host country at time of consent.
3. Subject currently has a 23mm SJM Portico Transfemoral Transcatheter Heart Valve

Exclusion Criteria:

1. Subject currently participating in another investigational device or drug study.
2. Subject is unable or unwilling to return for the required follow-up visits.

Primary outcomes:
measure: The objective of this study is to retrospectively and prospectively collect and evaluate the long term safety of the 23mm Portico Transcatheter Aortic Heart
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: l'Institut universitaire de cardiologie et de pneumologie de Québec
city: Vancouver
country: Canada
facility: St. Paul's Hospital
Study officials:
affiliation: Providence Health Care - St. Paul's Hospital
name: John Webb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03171818: Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration
Official title: Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: PAIS
Neonatal Stroke
Perinatal Stroke
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Alberta Children's Hospital
name: The Hospital for Sick Children
First posted: 2017-05-31
Enrollment: 80
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An international multicenter, randomized placebo controlled intervention study
Primary purpose: TREATMENT

Brief summary: The aim of the study is to perform a randomized double-blind placebo controlled prospective study in newborn infants with MRI confirmed Middle Cerebral Artery (MCA) Perinatal Arterial Ischemic Stroke (PAIS) with darbepoetin. It will be investigated whether intravenous administered darbepoetin can induce the formation of neuronal tissue and restore brain function in neonates who suffered from PAIS compared to placebo treated controls. The ultimate goal of this study is therefore to develop a therapy using erythropoiesis-stimulating agents (ESA) such as darbepoetin to reduce or even prevent lifelong consequences of PAIS-related brain injury in this group of term newborns.


Eligibility criteria: Inclusion Criteria:

* Newborns ≥ 36+0 weeks of gestation, both male and female
* MRI confirmed diagnosis of acute PAIS, in the MCA region with involvement of the cortical spinal tract (e.g. Posterior Limb of Internal Capsule \[PLIC\] or peduncles) within one week after birth
* Written informed consent from custodial parent(s)

Exclusion Criteria:

* Moderate -severe Hypoxic-Ischemic Encephalopathy (HIE) with or without hypothermia therapy
* Any proven or suspected major congenital anomaly, chromosomal disorder, metabolic disorder;
* Presence of a serious infection of the central nervous system;
* No realistic prospect of survival, (e.g. severe brain injury), at the discretion of the attending physician.
* Infant for whom withdrawal of supportive care is being considered.

Primary outcomes:
measure: Change in stroke tissue loss
timeFrame: 6-8 weeks of age
Secondary outcomes:
measure: Reorganization of corticospinal connectivity
timeFrame: 6-8 weeks of age
measure: Neurodevelopment
timeFrame: 18 months of age
measure: Neurological assessment
timeFrame: 18 months of age
measure: Development of Cerebral Palsy
timeFrame: 18 months of age
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Wilhelmina Childrens Hostpital/University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Manon Benders, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benders MJ, van der Aa NE, Roks M, van Straaten HL, Isgum I, Viergever MA, Groenendaal F, de Vries LS, van Bel F. Feasibility and safety of erythropoietin for neuroprotection after perinatal arterial ischemic stroke. J Pediatr. 2014 Mar;164(3):481-6.e1-2. doi: 10.1016/j.jpeds.2013.10.084. Epub 2013 Dec 8.
Clinical trial NCT06625918: Effects of Ultraviolet B Exposure Using a Ultraviolet Skin Care Device on Vitamin D Production and Immune Response in Healthy Adults
Official title: An Investigator-led Clinical Trial to Study the Effects of Ultraviolet Exposure Using a Ultraviolet B Skin Care Device on Vitamin D Production and Immune Response in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Inflammation
Skin Melanoma
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 27
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Vitamin D regulates various physiological functions, including calcium homeostasis, bone health, and potentially reducing cancer risks. Its primary source is Ultraviolet B radiation, but factors like aging, skin type, and modern lifestyles limit sun exposure, leading to widespread deficiency. This study explores using a daily Ultraviolet B Light Emitting Diodes device to improve vitamin D levels while assessing the potential for skin inflammation.


Eligibility criteria: Inclusion Criteria:

Age ranges 19-65 years Healthy participants Patients who are willing or able to follow the doctor's instructions Fully understand the purpose and procedure of this clinical trial

Exclusion Criteria:

Participants excluded those who have any kind of disease Lactating and pregnant women Physical disabilities that could interfere with participation, a history of depression, or other psychiatric conditions

Primary outcomes:
measure: Measurement of Total white blood cells its differential
timeFrame: 2 weeks and 4 weeks
Secondary outcomes:
measure: Measurement of oxidative and inflammatory markers
timeFrame: 2 weeks and 4 weeks
Other outcomes:
Locations:
city: Wŏnju
country: Korea, Republic of
facility: Prof. Kyu-Jae Lee, Ph.D.
state: Gwando
Study officials:
References:
Clinical trial NCT01783418: Mindfulness-based Intervention for Teenagers With Cancer
Official title: A Randomized, Wait-list Controlled Clinical Trial: the Effects of a Mindfulness-based Intervention on Quality of Life, Sleep and Mood in Adolescents With Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Keywords: mindfulness-based meditation
pediatric cancer
adolescence
quality of life
sleep
affect
health psychology
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effects of a mindfulness-based meditation intervention on quality of life, sleep and mood in adolescents with cancer compared to a control group.


Eligibility criteria: Inclusion Criteria:

* Teenagers (ages 12-18) with cancer

Exclusion Criteria:

* No ongoing or lifetime severe psychopathology, such as schizophrenia, psychosis, delusional disorders or organic mental disorders

Primary outcomes:
measure: Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention
timeFrame: Baseline, Post-intervention (8 weeks)
measure: Changes in Quality of Life From Baseline to Post-intervention and 6 Months Post-intervention
timeFrame: Baseline, Post-intervention (8 weeks)
measure: Changes Sleep From Baseline to Post-intervention and 6 Months Post-intervention
timeFrame: Baseline, Post-intervention (8 weeks)
measure: Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention
timeFrame: baseline, Post-intervention (8 weeks)
measure: Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention
timeFrame: baseline, Post-intervention (8 weeks)
measure: Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention
timeFrame: Baseline, Post-intervention (8 weeks)
Secondary outcomes:
measure: Changes in Mindfulness Propensity and Skills From Baseline to Post-intervention and 6 Months Post-intervention
timeFrame: Baseline, Post-intervention (8 weeks)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine, Mother and Child University Hospital Center
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Catherine Malboeuf-Hurtubise, Ph.D. candidate
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Marie Achille, Ph.D.
role: STUDY_DIRECTOR
affiliation: Université de Montréal, St. Justine's Hospital
name: Serge Sultan, Ph.D.
role: STUDY_DIRECTOR
affiliation: St. Justine's Hospital
name: Majorie Vadnais, M.D.
role: STUDY_DIRECTOR
References:
citation: Malboeuf-Hurtubise C, Achille M, Sultan S, Vadnais M. Mindfulness-based intervention for teenagers with cancer: study protocol for a randomized controlled trial. Trials. 2013 May 10;14:135. doi: 10.1186/1745-6215-14-135.
Clinical trial NCT05001841: Renal Failure Following Lung Transplantation in Cystic Fibrosis Patients
Official title: Perioperative Acute Kidney Injury in Patients With Cystic Fibrosis Undergoing Lung Transplantation: a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergone LUTX at a single Institution

Brief summary: With this retrospective observational cohort study, we performed a longitudinal assessment of the renal function of the adult CF patients who underwent LUTX, aiming 1) to describe possible risk factors associated with perioperative AKI and 2) to describe AKI short and long term effects on clinical outcomes.

Detailed description: This study is a retrospective analysis of prospectively collected data from medical records of all consecutive CF patients who underwent LUTX at our Institution from January 2013 to December 2018.

Eligibility criteria: Inclusion Criteria:

* All patients with CF who underwent LUTX during the study period were considered.

Exclusion Criteria:

* single LUTX
* re-transplantation
* missing medical records;
* age \< 18 years old

Primary outcomes:
measure: Acute Kidney Injury
timeFrame: 1 month
Secondary outcomes:
measure: Survival
timeFrame: Until May 31 2021
Other outcomes:
measure: Chronic Kidney Injury
timeFrame: 1 year after lung transplantation
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico
Study officials:
References:
Clinical trial NCT05901441: Effect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia
Official title: Effect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Analgesia
Labor Pain
Lead sponsor: Maternal and Child Health Hospital of Hubei Province
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 240
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of three different doses of hydromorphone combined with ropivacaine and sufentanil combined with ropivacaine in epidural labor analgesia through prospective clinical trials, so as to explore whether hydromorphone combined with ropivacaine has advantages in epidural labor analgesia, and find out the optimal dose of hydromorphone.

Participants will be randomly allocated to four groups: H1 group,H2 group,H3 group and SF group.For those in H1 group: they will be administered with15 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in H2 group: they will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in H3 group: they will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in SF group: they will be administered with 40 ug/ml sufentanil and 0.08% ropivacaine for epidural labor analgesia.

The goal of this clinical trial is to provide a new treatment option for pregnant women in epidural labor analgesia, and to provide a basis for hydromorphone combined with ropivacaine in epidural labor analgesia.


Eligibility criteria: Inclusion Criteria:

no contraindication of intraspinal anesthesia the American Society of Anesthesiologists(ASA) physical status ranked Ⅰ-Ⅱ competent to provide informed consent

Exclusion Criteria:

poor respiratory functions severe cardiovascular diseases

Primary outcomes:
measure: Visual Analogue Scale(VAS)
timeFrame: 30 minutes-1 hour
Secondary outcomes:
measure: Heart rate(HR)
timeFrame: 30 minutes-1.5 hours
measure: Mean arterial pressure(MAP)
timeFrame: 30 minutes-1.5 hours
measure: Pulse oxygen saturation
timeFrame: 30 minutes-1.5 hours
measure: Duration of analgesia
timeFrame: 30 minutes-1.5 hours
measure: The number of compressions
timeFrame: 30 minutes-1.5 hours
measure: Adverse reactions
timeFrame: 30 minutes-1.5 hours
measure: The Apgar scores
timeFrame: 30 minutes-1.5 hours
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Maternal and Child Health Hospital of Hubei Province
state: Hubei
Study officials:
affiliation: Maternal and Child Health Hospital of Hubei Province
name: Na Li, MD
role: PRINCIPAL_INVESTIGATOR
References: