louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06075719: Stroke Research Initiative to Advance Equity
Official title: Stroke Research Initiative to Advance Equity
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 1000
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: Stroke Survivors from the MedStar Health System and their Caregivers.

Brief summary: 1. Assess patient-centered outcomes (PCOs) amongst stroke survivors and their caregivers in the MedStar Health system longitudinally.

   i. Utilize a community advisory board (CAB) of stroke survivors and their caregivers to identify the patient-centered outcome(s) that they determine to be most important and valuable to assess based on their lived experiences.

   ii. Collect the chosen PCOs at multiple time points using an electronic survey tool (e.g. Qualtrics, Tonic or RedCap)
2. Evaluate the impact of social determinants of health (SDoH) and experiences of discrimination on the chosen PCOs.
3. Examine whether there are differences in long-term PCOs amongst stroke survivors from different racial and ethnic groups.

2.2 Hypothesis: We hypothesize that stroke survivors that come from historically marginalized populations, specifically African American and Latinos, will have lower patient-centered outcome scores overall as compared to their Caucasian counterparts. In addition, we hypothesize that the difference PCO scores between Caucasian and African American and Latino populations will be due in part to experienced discrimination and not SDoH alone.

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Eligibility criteria: Stroke Survivor:

Inclusion Criteria:

≥ 18 years old Acute Ischemic Stroke (AIS) or Intracerebral Hemorrhage (ICH) patients that have been cared for in the MedStar Healthcare system AIS of ICH in the last six weeks Ability to communicate in English, Spanish, Amharic, Mandarin Chinese or French (most common languages in the greater Washington, DC area)

Exclusion Criteria:

Transient Ischemic Attack (TIA) or Subarachnoid Hemorrhage (SAH) Unable to complete required forms Life expectancy less than 6 months

Caregiver Inclusion Criteria Age ≥ 18 Self-identify as primary caregiver for the stroke survivor Ability to communicate in English, Spanish, Amharic, Mandarin Chinese, French

Exclusion Criteria Unable to complete study survey forms Life expectancy less than 6 months

Primary outcomes:
measure: Patient-Centered Outcome Measures
timeFrame: 5 years
Secondary outcomes:
measure: Social Determinants of Health
timeFrame: 5 years
measure: Discrimination
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01334619: Ropivacaine Volume for Ultrasound-guided Retrograde Infraclavicular Brachial Plexus Block
Official title: Ropivacaine Volume for Ultrasound-guided Retrograde Infraclavicular Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Upper Extremity Injury Trauma
Keywords: Anesthetic techniques,regional
Drug delivery,volume
Anesthetic, local: ropivacaine
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2011-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The retrograde infraclavicular brachial plexus block has been proved an effective and safe approach. Realtime ultrasound guide will facilitate a successful peripheral nerve block. The purpose of this study was to determine the medium effective volume required to produce an effective retrograde infraclavicular block using an ultrasound (US)-guided technique.

Detailed description: Thirty adults undergoing elective upper limb surgery received an US-guided retrograde infraclavicular block. The initial concentration of 0.5% ropivacaine injected was 30 ml, which was subsequently varied at a ratio of 1: 1.2 for each consecutive patient according to the response of the previous patient. The medium effective volume (EV50) was determined using the Dixon and Massey up-and-down method. The effective volume in 95% of patients (EV95) was calculated using probit regression.

Eligibility criteria: Inclusion Criteria:

* Elected upper extremity operations
* BMI 17\~30kg/m2
* ASA I/II

Exclusion Criteria:

* Infection at injection site
* Sepsis
* Coagulation Dysfunction
* Phrenic nerve palsy
* Pneumothorax
* Recurrent laryngeal nerve palsy
* Clavicle fracture combined with nerve damage

Primary outcomes:
measure: VAS of brachial plexus innervated area
timeFrame: 20 minutes
Secondary outcomes:
measure: medium effective ropivacaine volume
timeFrame: about 2 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing jishuitan hospital
Study officials:
affiliation: Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China
name: Xiaoguang Zhang, MB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02645019: The Effect of EGD Probe Insertion on the Intracuff Pressure of the Laryngeal Mask Airway or Cuffed Endotracheal Tube in Children
Official title: The Effect of EGD Probe Insertion on the Intracuff Pressure of the Laryngeal Mask Airway or Cuffed Endotracheal Tube in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophagogastroduodensocopy (EGD) Procedure
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from 0-18 years old having EGD procedure with LMA or cuffed ETT.

Brief summary: A prospective study designed to access changes in the intracuff pressure of a laryngeal mask airway (LMA) or cuffed endotracheal tube (cETT) during placement of an esophagogastroduodenoscopy (EGD) probe during an EGD in the pediatric population.


Eligibility criteria: Inclusion Criteria:

* Patients from 0-18 years old having EGD procedure with a LMA or cuffed ETT.

Exclusion Criteria:

* Patients with a history of tracheomalacia, bronchomalacia or any other airway issues.

Primary outcomes:
measure: Intracuff Pressures During Probe Insertion
timeFrame: At time of EGD probe insertion
measure: Intracuff Pressure With Probe in Place
timeFrame: At time of EGD while probe is in place
measure: Intracuff Pressure After Probe Removal
timeFrame: Immediately after probe removal
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT05181319: Prediction for Bronchopulmonary Dysplasia
Official title: Development of a Nomogram for Predicting Bronchopulmonary Dysplasia in Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchopulmonary Dysplasia
Keywords: Bronchopulmonary Dysplasia; Infants；Nomogram
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 5000
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were recruited from Multi-center Collaborative Group Hospital Neonatal Intensive Care Unit (NICU) Department. The data was collected from medical records. Patients with GAs \<36 weeks, and who were admitted to the NICU within 24 h after birth were included, and the length of stay was more than 1 week.patients with inherited disease, metabolic disorders and multiple malformations were excluded.

Brief summary: In this Multi-center study performed from January 2018, we reviewed data on infants whose gestational ages were below 36 weeks. we collected data containing maternal diseases and neonatal clinical features. LASSO regression was used to select variables for the risk model. Then, we used multivariable logistic regression to build the prediction model incorporating these selected features. Discrimination was assessed by the C-index, and and calibration of the model was assessed by and calibration curve and the Hosmer-Lemeshow test.


Eligibility criteria: Inclusion Criteria:

* Patients were recruited from Multi-center Collaborative Group Hospital Neonatal Intensive Care Unit (NICU) Department.
* Patients with gestational age \<36 weeks
* admitted to the NICU within 24 h after birth
* the length of stay was more than 1 week

Exclusion Criteria:

* patients with inherited disease, metabolic disorders and multiple malformations.

Primary outcomes:
measure: bronchopulmonary dysplasia occurs
timeFrame: 2 weeks after admission
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: MU Kai, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01980719: Molecular Determinants of Persistent Cancer Related Fatigue
Official title: Molecular Determinants of Persistent Cancer Related Fatigue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatigue
Pain
Poor Sleep Quality
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female breast cancer survivors

Brief summary: The purpose of this study is to determine if inflammatory markers in blood as well as brain neurotransmitters (markers of in-brain activity and metabolism) are related to long-term or chronic fatigue.


Eligibility criteria: Inclusion Criteria:

All Participants:

- Women age 18 or older with no contraindication to magnetic resonance imaging(MRI);

Fatigued BC Participants:

* Have a diagnosis of breast cancer;
* And have completed all cancer-related treatments (i.e., surgery, chemotherapy, radiotherapy, immunotherapy, etc.) except for hormonal therapy and or herceptin at least 12 weeks previously; and be apparently cancer-free.

Age-Matched, Healthy Participants:

* Generally healthy;
* Matched in age ± 2.5 years to a Fatigued BC participant.
* No prior history of any cancer except for basal cell or squamous cell tumors of the skin that have been surgically excised;
* Have good sleep quality
* Have no chronic pain
* Have no chronic fatigue

Exclusion Criteria:

* Pregnant, wanting to become pregnant or lactating women ;
* Diagnosed with anemia \[defined as hemoglobin levels \< 12 gm/dl\] or receiving treatment for anemia ;
* Diagnosed with any comorbidities likely to cause significant fatigue (i.e., moderate to severe heart failure)
* Diagnosed with nutritional deficiencies;
* Have a diagnosis of untreated hypo- or hyper-thyroidism
* Have an initiation, a cessation or change of dose (up to three weeks prior to the study's start) of any chronic medications or dietary supplements or any planned change of chronic medications or dietary supplements during the study;
* Have implanted (e.g., surgical clips or staples) metal objects.

Primary outcomes:
measure: Compare peripheral immune markers (cytokines), C-reactive protein levels and brain neurotransmitters (glutamate, GABA, myoinositol, and resting state intrinsic connectivity).
timeFrame: 6 weeks
Secondary outcomes:
measure: Compare fatigue, pain, and sleep quality with peripheral immune markers, CRP, and brain markers.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Suzanna M Zick, ND, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05867719: The Physiological Effects of Acute and Ramp Simulated Altitude Exposure During Simulated Flight Tasks
Official title: The Physiological Effects of Acute and Ramp Simulated Altitude Exposure During Simulated Flight Tasks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Altitude Hypoxia
Lead sponsor: University of Texas, El Paso
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: • The purpose of this study is to investigate which physiological process that controls normal human body homeostasis is affected by low levels of acute hypoxic exposure and whether there is a difference in those physiological processes and simulated flight performance between a rapid and ramp hypoxic exposure. To accomplish this, pilot analogs will be exposed to normoxic, simulated 8,000 ft (2438 m), simulated 12,000 ft (3658 m), and a ramp exposure breathing at simulated 8,000 ft for 5 minutes before ascending to simulated 12,000 ft while flying in a flight simulator. During the flight simulator, participants will need to accomplish three tasks: 1) Maintaining an altitude of 5,000 ft of elevation while performing a mental math test, 2) Flying the aircraft through the center of a series of 7 targets, and 3) Taking off and flying the aircraft a short distance to land on the center of an indicated target. Physiological measures of heart rate variability (HRV), blood pressure (BP), peripheral oxygen saturation (SpO2), electrodermal activity (EDA), and neck neuromuscular activity using electromyography (EMG) will be measured for this study. Along with questionnaires to assess hypoxic symptoms, simulator sickness, and self-perceived workload for each task


Eligibility criteria: Inclusion Criteria:

* Meets body composition standards for the US Navy Active-duty personnel based on height and weight
* Normal vision/corrected to normal vision

Exclusion Criteria:

* Respiratory Deficiencies
* Cardiovascular Disorders
* Neurological/Musculoskeletal Disorders
* Photosensitive Epilepsy

Primary outcomes:
measure: Flight performance
timeFrame: 10 minutes per each of the 4 conditions
measure: Self-perceived workload
timeFrame: 1 minute to complete the survey, 3 times per condition for 4 conditions
measure: Electrodermal activity
timeFrame: 10 minutes per each of the 4 conditions
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03440619: INVSENSOR00013 Respiratory Rate Clinical Performance Study
Official title: INVSENSOR00013 Respiratory Rate Clinical Performance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2018-02-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this prospective study is to compare the noninvasive respiration from pleth (RRp) performance of the Masimo INVSENSOR00013 device against the respiratory rate measured by capnography (RRref), Masimo's RAM technology and the manual annotation.


Eligibility criteria: Inclusion Criteria:

* 18 to 70 years old
* Physical status of ASA I or II
* Must be able to read and communicate in English
* Has signed all necessary related documents, e.g. written informed consent, confidentiality agreement
* Passed health assessment screening
* Negative pregnancy test for female subjects of child bearing potential

Exclusion Criteria:

* Physical status of ASA III, IV, or V
* Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participation in the study
* Inability to tolerate sitting still or minimal movement for at least 30 minutes
* Positive pregnancy test for female subjects
* Refusal to take pregnancy test for women of child bearing potential
* Nursing female subjects
* Refusal of male subjects to agree to shave hair off areas where the sensor will be applied (neck) when deemed necessary
* Subjects wearing acrylic nails or subjects refusing to remove nail polish
* Subjects who have a nail deformity on the measurement finger
* Subjects who do not have adequate skin integrity on the measurement finger
* Excluded at the Principal Investigator's discretion

Primary outcomes:
measure: RRp Arms of Sensor Accuracy
timeFrame: 1-5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Clinical Lab
state: California
Study officials:
affiliation: Masimo Corporation
name: Ahmed Alghazi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02422719: Radotinib as 3rd or Later Line Therapy in CP-CML
Official title: Radotinib Efficacy and Safety Validation in Chronic Phase Chronic Myeloid Leukemia Patients Who Are Intolerant or Resistant to at Least Two Tyrosine Kinase Inhibitors As a Third or Subsequent Line Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Myeloid Leukemia
Keywords: Chronic myeloid leukemia
Intolerance
Resitance
Radotinib
Lead sponsor: Ulsan University Hospital
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 73
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: The purpose of this study is to determine whether radotinib is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors.

Detailed description: The purpose of this study is to determine whether radotinib 400mg bid is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors. The primary end point is major cytogenetic response by 12 months.

Eligibility criteria: Inclusion Criteria:

* Chronic myeloid leukemia chronic phase (CP-CML) patients who are not tolerable or resistant to prior 2 or more tyrosine kinase inhibitors (TKIs).
* ECOG 0, 1, 2
* Patients who are agree and signed to informed consent.

Exclusion Criteria:

* T315I mutation
* Prior exposure to radotinib
* Accelerated or blastic phase
* galactose intolerance, severe lactase deficiency or glucose galactose malabsorption
* Prior history of intensive cytotoxic chemotherapy except for TKIs
* Significant cardiac problem
* QTcF \> 450 msec
* Pancreatitis history prior to study enrollment
* Clinically significant malignant disease other than CML
* Pregnant or breast feeding woman

Primary outcomes:
measure: Rate of Major cytogenetic response
timeFrame: by 12 months after radotinib treatment
Secondary outcomes:
measure: Rate of Major Molecular response (MR3.0) on each time point
timeFrame: up to 12 months
measure: The number of Participants with Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Ulsan University Hospital
name: Hawk Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02113319: Study to Assess Dasatinib in Patients With Core Binding Factors Acute Myelogenous Leukemia
Official title: An Open-Label, Multicenter, Phase II Study to Assess Dasatinib in Patients With Core Binding Factors Acute Myelogenous Leukemia Refractory to Conventional Chemotherapy or in Molecular Relapse. Intergroupe Français Des leucémie aiguë myéloblastique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myelogenous Leukemia
Keywords: Core Binding Factors
Acute Myelogenous Leukemia refractory to conventional chemotherapy
molecular relapse
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2014-04-14
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: In patients with Core Binding Factors Acute Myelogenous Leukemia, the level of Minimal Residual Disease after chemotherapy is predictive of relapse. The relapse risk is also increased in case of mutations of receptors tyrosine kinase. For patients with a high Minimal Residual Disease level at the end of consolidation or in molecular relapse, maintenance by the inhibitor dasatinib is proposed.


Eligibility criteria: Inclusion Criteria:

* Patient presenting de novo or secondary Core Binding Factors Acute Myelogenous Leukemia
* Patient in first and presenting one of following criteria:
* "Resistant" Patient: decrease of less than 3 log of the Acute Myelogenous Leukemia transcript level in the bone marrow after 2 consolidations
* Patient in " molecular relapse ": increase of of more than 1 log of the Core Acute Myelogenous Leukemia transcript level on two successive marrow samples

Exclusion Criteria:

* Woman of childbearing potential
* Concurrent incurable malignacy other than Acute Myelogenous Leukemia

Primary outcomes:
measure: measure relapse-free survival
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
References: