louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02867228: Noninvasive Estimation of Work of Breathing
Official title: Noninvasive Estimation of Work of Breathing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Respironics, California, Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate the correlation between invasively measured parameters (work of breathing/power of breathing, resistance and elastance), derived using esophageal pressure measurements, and their corresponding non-invasive estimated values (noninvasive work of breathing/power of breathing, resistance and elastance), computed using airway pressure and flow measurements only.

Detailed description: This study will evaluate the correlation between invasively measured parameters (work of breathing/power of breathing, resistance and elastance), derived using esophageal pressure measurements, and their corresponding non-invasive estimated values (noninvasive work of breathing/power of breathing, resistance and elastance), computed using airway pressure and flow measurements only. Vent settings will be adjusted to test accuracy over a range of respiratory support conditions.

Eligibility criteria: Inclusion Criteria:

* Adult medical/surgical ICU patients (Age≥18) on mechanical ventilation for respiratory failure, spontaneously breathing and receiving eligible for pressure support ventilation (PSV).

Exclusion Criteria:

* Prisoners and patients with closed-head injury (e.g., trauma), hemodynamic instability, multiple organ system failure or late term pregnancy will not be studied.

Primary outcomes:
measure: Accuracy of lung mechanics measurements
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: David H Chong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banner MJ, Kirby RR, Kirton OC, DeHaven CB, Blanch PB. Breathing frequency and pattern are poor predictors of work of breathing in patients receiving pressure support ventilation. Chest. 1995 Nov;108(5):1338-44. doi: 10.1378/chest.108.5.1338.
citation: Kirton OC, DeHaven CB, Hudson-Civetta J, Morgan JP, Windsor J, Civetta JM. Re-engineering ventilatory support to decrease days and improve resource utilization. Ann Surg. 1996 Sep;224(3):396-402; discussion 402-4. doi: 10.1097/00000658-199609000-00016.
Clinical trial NCT04557228: ADAM17 and Vascular Function in Diabetes
Official title: Targeting ADAM17 Activity for Correction of Vascular Insulin Resistance in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: endothelial dysfunction
vascular function
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 36
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blinded design with 34 subjects
Primary purpose: PREVENTION

Brief summary: The objective of this project is to determine the extent to which administration of the dietary supplement phosphatidylserine (PS), a competitive inhibitor of ADAM17 sheddase activity, effects vascular function and insulin-stimulated leg blood flow in subjects with T2D.

Detailed description: As part of a randomized (1:1, experimental/placebo), double-blinded parallel design, each of the 34 subjects will complete 4 weeks (+/-4 days) of supplementation with either 900mg of a PS supplement or placebo. Assessment visits (2) will occur pre-intervention and post-intervention and include: 24-hour ambulatory blood pressure measurement (ABPM), Vitals, DEXA scan for body composition, fasting blood work, carotid-femoral pulse wave velocity (cfPWV), brachial and femoral artery FMDs, Femoral blood flow imaging during passive leg movement (PLM), glycocalyx integrity assessment via Glycocheck, and an oral glucose tolerance test (OGTT) with blood flow measurements and beat-to-beat sphygmomanometry via Finometer.

Eligibility criteria: Inclusion Criteria:

1. Men and women with a BMI of 25-39 kg/m2, who are 45-64 years of age at randomization.
2. T2D patients classified based on physician diagnosis.
3. No vulnerable populations (e.g., prisoners, pregnant, children) will be enrolled.

Exclusion Criteria:

1. Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke
2. History of chronic renal or hepatic disease
3. Active cancer
4. Autoimmune diseases
5. Immunosuppressant therapy
6. Hormone replacement therapy
7. Excessive alcohol consumption (\>14 drinks/week for men, \>7 drinks/week for women)
8. Current tobacco use
9. Pregnancy
10. Bodyweight change ≥5% within the last 6 months

Primary outcomes:
measure: Change in Insulin-stimulated blood flow
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: Change in Vascular function
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri- NextGen Clinical Translational Science Unit
state: Missouri
Study officials:
References:
Clinical trial NCT05599828: A Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants
Official title: An Open-label Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics of AMG 510 in Healthy Subjects Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy Participants
AMG 510
Famotidine
Omeprazole
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-10-31
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of this study is to evaluate the PK of AMG 510 alone and in combination with either famotidine or omeprazole in healthy participants under fed conditions.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects or female subjects, between 18 and 60 years of age (inclusive), at the time of Screening.
* Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.
* Females of nonchildbearing potential

Exclusion Criteria:

* Inability to swallow oral medication or history of malabsorption syndrome.
* History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
* Poor peripheral venous access.
* History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of AMG 510
timeFrame: Day 1, Day 4, Day 11
measure: Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 510
timeFrame: Day 1, Day 4, Day 11
measure: AUC from time Zero to Infinity (AUCinf) of AMG 510
timeFrame: Day 1, Day 4, Day 11
Secondary outcomes:
measure: Number of Participants with an Adverse Event (AE)
timeFrame: Day 1 to Day 13
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Clinical Research Unit, Inc
state: Texas
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00802828: Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fasting Conditions
Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Famotidine 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability
Keywords: bioavailability
famotidine
Lead sponsor: Perrigo Company
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* healthy men or women 18 years of age or older
* body mass index below 30.0 kg/m2
* willing to participate and sin a copy of the informed consent form

Exclusion Criteria:

* recent history of drug or alcohol addiction or abuse
* pregnant or lactating women
* history of allergic response to heparin, famotidine, other H2-receptor antagonists, or other related drugs
* evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
* recipient of any drugs as part of a research study within 30 days prior to study dosing

Primary outcomes:
measure: Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04233528: Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity
Official title: Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Dyslipidemias
Keywords: laser speckle contrast imaging
Lead sponsor: National Institute of Cardiology, Laranjeiras, Brazil
Sponsor class: OTHER_GOV
First posted: 2020-01-18
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Obesity is known to be a risk factor for cardiovascular disease (CVD), type 2 diabetes mellitus, gastrointestinal tract disease, respiratory problems (such as obstructive sleep apnea), joint and muscle problems, reproductive disorders, depression and cancer.

However, recently a new classification has emerged about obesity, the metabolically healthy obesity (MHO). According to the definition of the term, MHO represents obesity that occurs segregated from the metabolic syndrome criteria defined by the International Diabetes Federation (IDF). However, as there is still disagreement about the definition of MHO, the cardiovascular risk of these individuals is also uncertain. This phenotype may present as an intermediate risk between metabolically healthy normal-weight individuals and metabolically unhealthy obese individuals (MUO) or as a transition stage of the disease; when evolving to MUO, represents a higher risk of developing CVDs.

The hypothesis of the present study is that obese individuals classified as metabolically healthy have worse vascular endothelial function when compared to non-obese individuals, demonstrating increased cardiovascular risk even in this subgroup considered "low risk". The detection of endothelial dysfunction in metabolically healthy obese may help in the prevention, treatment and follow-up of these individuals, aiming to reduce the development and morbidity and mortality of CVD.

In the present study, the investigators will use a laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function.


Eligibility criteria: Inclusion Criteria:

• obese individuals (BMI ≥ 30.0 kg / m2) meeting the criteria for metabolically healthy obesity

Exclusion Criteria:

* Pregnancy or lactation.
* Endocrine disorders except diabetes, cardiovascular disease except systemic arterial hypertension, autoimmune diseases, malignant neoplasms.

Primary outcomes:
measure: Baseline and post-iontophoresis of acetylcholine endothelium-dependent skin microvascular reactivity
timeFrame: Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: National Institute of Cardiology
Study officials:
References:
Clinical trial NCT01376128: Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder)
Official title: Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Panic Disorder
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 96
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female Japanese subjects whose age is under 18 with panic disorder, who are considered appropriate to prescribe paroxetine tablet according to the prescribing information

Brief summary: The objectives of this survey was to retrospectively collect and evaluate the information on the efficacy and safety of PAXIL tablets ("PAXIL", hereinafter) in pediatric subjects (aged under 18) with panic disorder under conditions of actual use.


Eligibility criteria: Inclusion Criteria:

* Aged under 18 at the time of the panic disorder diagnosis
* Aged under 18 on the starting day of PAXIL treatment
* Having been making periodic visits to the hospital to receive treatment for panic disorder

Exclusion Criteria:

* Subjects who have been treated with paroxetine prior to this investigation
* Subjects with hypersensitivity to paroxetine
* Subjects taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
* Concomitant use in patients taking pimozide

Primary outcomes:
measure: Incidence of adverse events in Japanese pediatric subjects with panic disorder treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice
timeFrame: From the starting day of the treatment to the time of treatment termination/discontinuation was assessed from 1 month at minimum up to 2 years
measure: Efficacy evaluation based on overall improvement
timeFrame: From the starting day of the treatment to the time of treatment termination/discontinuation was assessed from 1 month at minimum up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05751161: Effect of Gait Training With Auditory Stimuli on Balance, Gait & Funtional Independence in Stroke
Official title: Effect of Gait Training With Auditory Stimuli on Dynamic Balance, Gait and Functional Independence in Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effect of gait training with auditory stimuli on dynamic balance, gait and functional independence on chronic stroke.

Detailed description: The purpose of this study is to find the effect of gait training with auditory stimuli using a smart phone metronome application on dynamic balance, gait and functional abilities of chronic stroke patients.

Eligibility criteria: Inclusion Criteria:

* both gender
* Age between 30-70
* More than 6 months after the stroke
* Able to walk more than 10 meters independently
* MMSE score of 24

Exclusion Criteria:

* Dependent gait
* Aphasia
* Any hearing or visual defects
* Moderate to severe cognitive disorder
* People not willing to participtae

Primary outcomes:
measure: Berg balance scale
timeFrame: 6 weeks
Secondary outcomes:
measure: Barthel index
timeFrame: 6 weeks
measure: Gait speed
timeFrame: 6 weeks
measure: POMA
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pakistan society for the rehabilitation of disabled
state: Punjab
Study officials:
affiliation: Riphah International University
name: maria samad
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: fatima tariq
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park MH, Won JI. The effects of task-oriented training with altered sensory input on balance in patients with chronic stroke. J Phys Ther Sci. 2017 Jul;29(7):1208-1211. doi: 10.1589/jpts.29.1208. Epub 2017 Jul 15.
Clinical trial NCT00473161: Use of Surface Electromyography Biofeedback to Improve Reaching in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Weakness
Hypertonia
Keywords: movement disorders
childhood
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2007-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with movement disorders, cerebral palsy.

Brief summary: A newly-developed device for biofeedback of surface EMG will be used to either increase or decrease activity in the muscles of children with poor reaching due to cerebral palsy.

Detailed description: Children ages newborn to 21 with a diagnosis of arm weakness, hypertonia, or hyperkinesia due to cerebral palsy will be recruited. A muscle that is either over-active or under-active will be selected for each child. The child will be provided with the device to wear for 1 month in order to call attention to the identified muscle. At the beginning and end of the month, reaching will be assessed using three-dimensional kinematic motion capture. The outcome measure will be the speed and curvature of reaching to a target in front of the child.

Eligibility criteria: Inclusion Criteria:

* weakness, hypertonia, or hyperkinetic disorder affecting one or both arms
* reduced speed or quality of reaching

Exclusion Criteria:

* any condition that would increase the risk of participation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Terence D Sanger, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01715961: Clinical and Prognostic Value of Sarcopenia in Patients Older Than 70 Years With Diffuse Large B-cell Lymphoma
Official title: Multicentric Prospective Study to Assess the Clinical and Prognostic Value of Sarcopenia in Patients Older Than 70 Years With Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diffuse Large B Cell Lymphoma
Grade IIIB Follicular Lymphoma
Keywords: 70 years old
DLBCL
Rituximab-CHOP
Sarcopenia
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 98
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial is a multicentric prospective study to assess the clinical and prognostic value of sarcopenia in patients older than 70 years with diffuse large B-cell lymphoma.

Detailed description: Sarcopenia status is assessed by CT scan imaging on the overall survival at 18 months in patients older than 70 years with diffuse large B-cell lymphoma treated by R-CHOP.

Eligibility criteria: Inclusion Criteria:

* Patients \>= 70 years
* DLBCL, grade IIIB follicular lymphoma or histologically proven transformed low grade lymphoma
* Whatever the IPI score and the performance status
* Treated by Rituximab-CHOP or Rituximab-mini-CHOP
* CT scan imaging performed one month or less before inclusion
* Signed informed consent

Exclusion Criteria:

* No initial CT scan imaging performed more than one month before inclusion
* Positivity for HCV, HBV and HIV
* Anthracycline contra-indication

Primary outcomes:
measure: progression free survival
timeFrame: at 18 months
Secondary outcomes:
measure: progression free survival
timeFrame: at 24 months
measure: rate of over grade 2 toxicities
timeFrame: at the first and second courses of chemotherapy (day 21 and day 42)
measure: determination of both molecular subtypes GCB and ABC
timeFrame: at 24 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Fabrice JARDIN, MD;PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05833061: What is the Burden of Housing in Rural Areas for Individuals With Hemiplegia?
Official title: What is the Burden of Housing in Rural Areas for Individuals With Hemiplegia?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemiplegia
Lead sponsor: Uskudar State Hospital
Sponsor class: OTHER_GOV
First posted: 2023-04-27
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients who gave written consent to participate.

Brief summary: Our objective is to examine the impact of residing in urban or rural areas on the utilization of healthcare services, self-efficacy, and quality of life among individuals with hemiplegia in Turkey.

Detailed description: In this upcoming cross-sectional study, we will assess patients with hemiplegia who are scheduled to visit the physical medicine and rehabilitation outpatient clinic. Each participant will undergo a personal interview to fulfill the Stroke Self-Efficacy Questionnaire (SSEQ) and Stroke Specific Quality of Life Scale (SS-QOL). We will utilize the hospital database to determine the frequency of emergency department visits, physical medicine and rehabilitation outpatient clinic appointments, and general practitioner clinic visits specifically for hemiplegia in the previous year.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Stroke.
* Giving consent.

Exclusion Criteria:

* Not giving consent.
* Inability to read and comprehend.
* Severe cognitive impairments or communication difficulties.
* Severe visual or motor impairments

Primary outcomes:
measure: The Stroke Self-Efficacy Questionnaire (SSEQ)
timeFrame: 1 day
measure: The Stroke-Specific Quality of Life (SS-QoL) scale
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Üsküdar State Hospital
state: Üsküdar
Study officials:
affiliation: Uskudar State Hospital
name: Mustafa H Temel
role: PRINCIPAL_INVESTIGATOR
References: