louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02329015: Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools
Official title: Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adolescent Behavior
Keywords: stress
alternative
complementary
self-regulation
Lead sponsor: Long Island University
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 112
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the academic and psycho-social benefits of a yoga-informed health and wellness program (HWP) to a standard physical education program for middle and high school students within New York City (NYC) schools.

Detailed description: Approximately 100 students at a public New York City High School will be randomized at the level of class into either the experimental (yoga-informed health and wellness program) or control arm (physical education class). Students will receive two classes per week of approximately 45 minutes throughout the academic year. Data will be collected in September 2014 and February and May of 2015.

Eligibility criteria: Inclusion Criteria:

* • Male or female students attending NYC schools

Exclusion Criteria:

* Lack of permission to attend physical education class

Primary outcomes:
measure: Academic Performance: Grade Point Averages
timeFrame: 1 year
Secondary outcomes:
measure: Response to Stress Questionnaire (RSQ)
timeFrame: 1 year
measure: Warwick Edinburgh Mental Well Being Scale
timeFrame: 1 year
Other outcomes:
measure: Self Report Questionnaire (Child and Adolescent Mindfulness Measure)
timeFrame: 1 year
measure: Student Self-Report Behavior Rating Inventory of Executive Function
timeFrame: 1 year
measure: Teacher Report Behavior Rating Inventory of Executive Function
timeFrame: One year
Locations:
city: New York
country: United States
facility: Eastside Community High School
state: New York
Study officials:
affiliation: Long Island University
name: Marshall Hagins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06457815: Iron Deficiency in Acute Myocardial Infarction: Prevalence Pilot Study
Official title: Iron Deficiency in Acute Myocardial Infarction: Prevalence Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myocardial Infarction
Lead sponsor: South Tees Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 70
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 acute myocardial infarction

Brief summary: Acute Myocardial Infarction (heart attacks) affect about 86000 people each year in the UK. Given this large number of people, it is important that health teams look at ways to ensure the best care to improve outcomes after a heart attack.

In related heart conditions, the role of iron is important, but there isn't much information about what effect iron levels have on patients following a heart attack.

We want to plan a large scale study to look at this, but need some early data to understand how many patients have low iron levels. This small study will take part at one NHS Trust and will test for iron levels in all patients who provide consent (we expect up to 70 patients will take part). We will also collect data from medical notes for these patients and use all of this information together to understand more about iron and to plan a larger study.


Eligibility criteria: Inclusion:

1. - Adults patients who sign an informed consent form.
2. - Type 1 myocardial infarction within the previous 10 days

Exclusion

1 - Not fulfilling inclusion criteria

Primary outcomes:
measure: Prevalence of iron deficiency
timeFrame: within 10 days of acute MI
Secondary outcomes:
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals NHS Foundation Trust
state: Teesside
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals NHS Foundation Trust
Study officials:
affiliation: South Tees Hospitals NHS Foundation Trust
name: David Austin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03467815: Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease
Official title: Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease - A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Dyspnea
Keywords: Wireless monitoring
Continuous monitoring
Vital parameters
Clinical deterioration
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
name: Rigshospitalet, Denmark
First posted: 2018-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to hospital for Acute Exacerbation of COPD.

Brief summary: For patients admitted to the medical ward, it is usually difficult to predict if their clinical condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 24/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients progress beyond the point-of-no-return, where adverse events are inevitable. The WARD-COPD project aims to determine the number and duration of cardiopulmonary micro events during the first 4 days after hospital admission with Acute Exacerbation of COPD. We will also test the server installation, develop a database of core data and assess the frequency of artefacts and failure to capture the continuous monitoring signal.


Eligibility criteria: Inclusion Criteria:

Adult patients admitted to hospital for Acute Exacerbation of COPD (AECOPD). Investigators will review the electronic patient chart for a primary diagnosis of AECOPD.

Exclusion Criteria:

* Patient expected not to cooperate.
* Patient allergic to plaster, plastic or silicone.
* Active therapy withdrawn

Primary outcomes:
measure: Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm
timeFrame: The patients are monitored for 4 days
measure: Heart rate resulting in a single parameter score of 3 according to EWS algorithm
timeFrame: The patients are monitored for 4 days
measure: Respiratory rate resulting in a single parameter score of 3 according to EWS algorithm
timeFrame: The patients are monitored for 4 days
measure: Blood pressure resulting in a single parameter score of 3 according to EWS algorithm
timeFrame: The patients are monitored for 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
References:
Clinical trial NCT04949815: Awake Craniotomy for Arteriovenous Malformation
Official title: Case Series; Awake Craniotomy for Brain Arteriovenous Malformation - Experience From a Tertiary Care Center in a Low- And Middle-Income Country
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Awareness, Anesthesia
Arteriovenous Malformations
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients, irrespective of age and gender, who underwent awake craniotomy under scalp block for resection of brain AVMs at our hospital were reviewed.

Brief summary: The study aimed to retrospectively review cases of brain arteriovenous malformation that were surgical resected with the patient awake during the procedure.

Detailed description: Four patients' charts were retrospectively reviewed and neurological status before and after awake craniotomy was assessed to look for any deterioration.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of arteriovenous malformation in brain
* Awake craniotomy for surgical resection of arteriovenous malformation

Exclusion Criteria:

* Patients with incomplete records

Primary outcomes:
measure: Change in neurological status after surgery including GCS, cranial nerve functions and motor power in all four limbs (according to MRC scale).
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
References:
Clinical trial NCT03562715: microRNAs Role in Pre-eclampsia Diagnosis
Official title: Role of Mesenchymal Stem Cells Exosomes Derived microRNAs; miR-136, miR-494 and miR-495 in Pre-eclampsia Diagnosis and Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Keywords: microRNAs
exosomes
preeclampsia
mesenchymal stem cells
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PE group included 100 females with a mean age of 28.77 ± 5.72 years, while control group comprised of 100 females with a mean age of 28.06 ± 5.65 years. All enrolled patients were clinically diagnosed by physical examination and laboratory investigations.

Brief summary: Pre-eclampsia is one of the most threatening pregnancy complications. So far neither a secure, competent therapy for PE nor effective biomarkers for a premature discovery has been achieved.The aim of our study was to identify miRNAs 136, 494 and 495 genes expression in exosomes of peripheral blood compared to umbilical cord mesenchymal stem cells conditioned media released exososomes in patients with PE, as valuable markers for PE early prediction.


Eligibility criteria: Inclusion Criteria:

To have an uncomplicated pregnancy:

1. gestational age at venipuncture between 20 - 42 weeks
2. no medical, obstetrical, or surgical complications
3. absence of labor at the time of venipuncture
4. delivery of a normal term (≥ 37 weeks) neonate whose birth weight was between the 10th and 90th percentile for gestational age

Exclusion Criteria:

Patients with chronic hypertension, renal disease, and fetuses affected with congenital anomalies were excluded

Primary outcomes:
measure: The expression of miRNAs 136, 494 and 495 in exosomes of peripheral blood and UCMSCs conditioned media
timeFrame: 2-3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04528615: Testing the Effectiveness of Coping With Cancer in the Kitchen
Official title: A Randomized Controlled Trial to Test the Effectiveness of Coping With Cancer in the Kitchen, a Nutrition Education Program From Diagnosis and Beyond
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Nutrition Aspect of Cancer
Lead sponsor: American Institute for Cancer Research
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was a two-arm, randomized controlled trial in which cancer survivors were evenly assigned to either receive the 8-week CCK in-person nutrition intervention immediately or to become the control group that received a selection of CCK printed materials. The aim was to test the effectiveness of CCK for implementing a healthy plant-based diet and improving quality of life.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Need to have ever been diagnosed with cancer to be eligible
* Need to have not participated in a Living Plate cooking program
* Need to be able to attend at least seven of the eight sessions of the series with mandatory first and last sessions
* Need to have completed active cancer treatment (not including hormonal or other similar agents, e.g., tamoxifen)

Primary outcomes:
measure: Knowledge about the role of a plant-based diet in cancer risk reduction
timeFrame: 9 weeks
measure: Knowledge about the role of a plant-based diet in cancer risk reduction
timeFrame: 15 weeks
measure: Confidence preparing a variety of plant-based foods
timeFrame: 9 weeks
measure: Confidence preparing a variety of plant-based foods
timeFrame: 15 weeks
measure: Skills to practice a plant-based diet
timeFrame: 9 weeks
measure: Skills to practice a plant-based diet
timeFrame: 15 weeks
measure: Barriers to eating more fruits and vegetables and whole grains
timeFrame: 9 weeks
measure: Barriers to eating more fruits and vegetables and whole grains
timeFrame: 15 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cancer Support Community Los Angeles
state: California
Study officials:
affiliation: American Institute for Cancer Research
name: Melissa Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01539915: Pharmacokinetics and Pharmacodynamics of BCT194 in Psoriatic Patients
Official title: A Single Center, Open Label Exploratory Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Topically Administered BCT194 in Dermal Interstitial Fluid in Psoriatic Patients Using Open Flow Microperfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Keywords: Psoriasis
Stable plaque psoriasis
lesions
TNF-alpha
BCT194
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-02-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study will evaluate the pharmacokinetics and pharmacodynamics of BCT194 in psoriatic patients to better understand the skin penetration of topically applied BCT194.


Eligibility criteria: Inclusion criteria:

* Male patients and post menopausal or surgically sterile female patients aged 18 - 75 years.
* Diagnosis of stable plaque psoriasis (with or without arthritis); diagnosed or history of psoriasis for at least 6 months prior to screening
* Psoriatic plaques accessible for microperfusion at body sites (e.g. trunk) convenient for the patients.

Exclusion criteria:

* Currently have any of the nonplaque forms of psoriasis: erythrodermic, guttate, or pustular.
* Currently have drug-induced psoriasis (new onset or exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
* Recent previous treatment with anti-TNF-α therapy (or other biological therapy), immunosuppressive agents such as cyclosporine, mycophenolate, pimecrolimus, or tacrolimus.
* Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, psychiatric, or other disease which would make the patient unsuitable for the trial.
* Presence of major chronic inflammatory autoimmune diseases like rheumatoid arthritis, spondyloarthropathy, inflammatory bowel disease or systemic lupus erythematosus.
* Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: change in Maximum dermal interstitial concentration of BCT194
timeFrame: Day 1 and day 8
measure: Area under the curve interstitial concentrations of BCT194
timeFrame: day 1 and day 8
Secondary outcomes:
measure: Concentrations of locally produced tumor necrosis factor-alpha (TNF-alpha)
timeFrame: day 1 and day 8
measure: Change in plaque PASI scores of psoriasis lesions
timeFrame: day 1 and day 8
measure: BCT194 concentrations in skin biopsies
timeFrame: day 1 and day 8
measure: Change in Local tolerability score
timeFrame: Pre-dose, Day 1, Day 2, Day 3, Day 5, Day 8, Day 9 and Day 13
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novartis Investigative Site
Study officials:
References:
Clinical trial NCT03619915: Correlation Between Spirometry and Functional Independence in Adult Post-ICU Patients
Official title: Correlation Between Spirometry and Functional Independence in Adult Post-ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care (ICU) Myopathy
Functional Independence
Lead sponsor: Universidade Estadual do Oeste do Paraná
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be collected from patients admitted to the ICU from January 2012 to December 2013.

Brief summary: Several complications and comorbidities are frequently found in patients admitted to an Intensive Care Unit (ICU), including acquired ICU muscle weakness and physical and cognitive limitations. These issues lead to impaired quality of life and post-discharge functional independence. Thus, it is important to evaluate these factors in order to verify the effects of long-term hospitalization. Objective: To relate functional independence to the degree of pulmonary involvement in adult patients three months after discharge from the ICU. Methods: This will be a retrospective study with data collected from January 2012 to December 2013, that will include patients who underwent spirometry and answered the Functional Independence Measure Questionnaire. Patients will be divided into groups according to the classification of functional independence and spirometry.


Eligibility criteria: Inclusion Criteria:

* Patients who discharged alive evaluated three months after discharge from the ICU
* Patients that underwent spirometry and answer the Functional Independence Measure Questionnaire.

Exclusion Criteria:

* Patients unable to perform spirometry
* Patients unable to respond to the Functional Independence Measure questionnaire

Primary outcomes:
measure: Spirometry
timeFrame: Three months after ICU discharge
Secondary outcomes:
measure: Functional Independence Measure (FIM)
timeFrame: Three months after ICU discharge
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01341015: Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children
Official title: Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Ankle Fracture
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Objectives:

A lot of children who injure their ankles come to the emergency department for an evaluation, and often an X-ray of the ankle is obtained to determine if a bone fracture is present. In more than 85% of cases, however, the injury is a sprain and not a bone fracture and can be treated with rest, ice, elevation, and pain medications. X-rays obtained in the emergency departments are time consuming, often uncomfortable for the patient, and expose children to radiation, the long-term effects of which are not yet fully understand by doctors or scientists. Bedside ultrasound is a non-invasive and a non-painful device that does not produce radiation. It was been shown to determine the presence of bone fracture in childrens' wrists and forearms just as well as X-rays do. In our study, the investigators would like to determine if a bedside ultrasound can also be used to evaluate ankle fractures in children.

Research Procedures:

In our study, the investigators will ask the parents and children, who are scheduled to get an X-ray of their ankle in the emergency department, to examine their ankles with an ultrasound machine as well. Since the bedside ultrasound is not significantly time-consuming, does not require patients to remain still, and is readily available in the department, the procedure will be performed while kids are waiting to get an X-ray, getting registered, or awaiting further treatment. On the data collection form, the investigators will document the patients' names, birthdates, medical record numbers so that their X-ray results can be compared to the ultrasound results for the purpose of the study. The information will be stored in a secure cabinet in a locked office. The investigators will also document which side is injured, where the patient feels pain and what the ankle looks like to help perform the ultrasound. The results of both the ultrasound and X-ray will be documented for each patient.


Eligibility criteria: Inclusion Criteria:

* age 2-18 years old
* ankle ray ordered in ER

Exclusion Criteria:

* open fracture
* multi-system trauma/other significant injuries
* history of ankle fractures? (Same ankle broken within past year)

Primary outcomes:
measure: comparison of ultrasound to xray shows identical read
timeFrame: At ER visit (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Hasbro Children's Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Otto Liebmann, MD
role: PRINCIPAL_INVESTIGATOR
References: