louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03595605: Association Between Inpatient Steps Per Day and Patient Functional Status/Disposition
Official title: Association Between Inpatient Steps Per Day and Patient Functional Status/Disposition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Medicine
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 51
Sex: ALL
Minimum age (years): 66
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will incorporate the use of wearable actigraphy devices (Fitbit) on research participants admitted to medicine inpatient units at Tisch Hospital and/or NYU Brooklyn. The investigator's sample size will be 600 randomized into two groups, with basic inclusion criteria including age greater than 65 years and pre-hospital ambulatory status. While both groups will be monitored in terms of their activity (specifically pedometer data), the intervention group will have twice daily encouragement of ambulation. Once a subject is enrolled, data will be collected daily and at time of discharge.


Eligibility criteria: Inclusion Criteria:

* Admitted to acute inpatient medicine unit
* Ambulatory without assistive device prior to hospitalization
* Medical clearance to ambulate on the unit
* Active MyChart account or willing to activate MyChart account
* iOS or Android device

Exclusion Criteria:

* Patients less than or equal to 65 years old
* Not Admitted to acute inpatient medicine unit
* Ambulatory with assistive device prior to hospitalization
* No Medical clearance to ambulate on the unit
* Inactive MyChart account and not willing to activate MyChart account
* No iOS or Android device

In addition, an individual who meets any of the following criteria will be excluded from participation in this study:

* Oxygen requirement at rest
* Lower extremity prosthesis
* Admitted for joint replacement surgery
* History of frequent falls
* Admitted for syncope.
* If patients have specifically opted out of being contacted about research (visible in the Epic header while in their chart)
* Admitted from nursing home

Primary outcomes:
measure: Determine how many steps patients admitted to the medicine units are taking at baseline
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Gavriil Ilizarov
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01631305: Levothyroxine for Children With Euthyroid Sick Syndrome
Official title: Efficacy and Safety of Levothyroxine in Critical Children With Euthyroid Sick Syndrome in a Pediatric Intensive Care Unit.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Euthyroid Sick Syndrome
Keywords: Euthyroid Sick Syndromes
Thyroxine
Intensive care
Lead sponsor: Sinaloa Pediatric Hospital
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether levothyroxine is effective and safe in the treatment of children with euthyroid sick syndrome, hospitalized in a pediatric intensive care unit.

Detailed description: Children with euthyroid sick syndrome, hospitalized in a pediatric intensive care unit, will be randomised to receive either Levothyroxine or placebo, to determine if it diminishes mortality.

Eligibility criteria: Inclusion Criteria:

* All children aged 1 month to 17 years.
* Admitted to pediatric intensive care unit.
* TSH and thyroid hormones below age specific levels.

Exclusion Criteria:

* Known thyroid condition.
* Brain death.
* Gut conditions that contraindicate oral route.
* Readmissions to intensive care unit.

Primary outcomes:
measure: All cause mortality
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes:
measure: Length of time in intensive care
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Ventilation days
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Use of vasopressors
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
measure: Thyroid hormones levels
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Other outcomes:
Locations:
city: Culiacan
country: Mexico
facility: Sinaloa Pediatric Hospital
state: Sinaloa
Study officials:
affiliation: Sinaloa Pediatric Hospital
name: Jesus J Martinez, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01609205: Doppler Evaluation in RA Patients After Adalimumab.
Official title: Doppler Quantitative Evaluation and Follow-up Over 12 Months in RA Patients With Moderate and High Disease Activity Who Are Candidates for Biologic add-on Therapy With Adalimumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2012-05-31
Enrollment: 60
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 is to study the relationship between RA disease activity based on Doppler quantification and the subsequent clinical response (EULAR response) to treatment with Adalimumab during 12 months. The purpose is also to compare the Doppler quantification with conventional clinical methods and semiquantitative Doppler assessment.


Eligibility criteria: Inclusion Criteria:

* Adult patient (\> 18 years of age), male or female
* Rheumatoid arthritis according to the 1987 ACR or 2010 EULAR/ACR classification criteria
* Moderate to high disease activity
* Ongoing anti-rheumatic treatment with DMARD, with stable dosage during the last 3 months, and being a candidate for anti-TNF add-on therapy OR ongoing treatment with first anti-TNF therapy and being a candidate for switch to another anti-TNF therapy
* Women with child-bearing potential: use of an adequate method of contraception to avoid pregnancy throughout the study
* Signed Informed Consent \*Signed Informed Consent must be obtained before any study specific procedures take place.

Exclusion Criteria:

* Biologic treatment with Adalimumab before inclusion
* Two or more ongoing biologic treatments before inclusion
* Treatment with other biologic treatment than anti-TNF therapy before inclusion
* Any contraindication for treatment with Adalimumab
* Intraarticular corticosteroid injection during the last 4 weeks before each follow-up visit
* Positive for tuberculosis or hepatitis B.
* Ongoing pregnancy or lactation

Primary outcomes:
measure: The proportion of different clinical (EULAR) response
timeFrame: 6 months from BL
Secondary outcomes:
measure: The proportion of patients with good response to add-on therapy
timeFrame: 6 and 12 months from BL
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Stockholm
country: Sweden
facility: The karolinska Institute
Study officials:
affiliation: Karolinska Institutet
name: Monica Rydén Aulin, Phd
role: STUDY_CHAIR
References:
Clinical trial NCT00380705: Quality of Life in Asthma and Rhinitis Allergic With Singulair (0476-365)
Official title: Quality of Life in Asthma and Rhinitis Allergic With Singulair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Rhinitis Allergic
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-09-26
Enrollment: 91
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Allow physicians not familiar with anti-leukotriene based therapy to test it


Eligibility criteria: Inclusion Criteria:

* Establish diagnosis of mild to moderate chronic asthma and/or allergic rhinitis currently on treatment
* Voluntary acceptance to participate in the study

Exclusion Criteria:

* Patients with cystic fibrosis
* Patients with known hypersensitivity to singulair or any of its components
* Patients with severe chronic asthma

Primary outcomes:
measure: Quality of life measures
Secondary outcomes:
measure: Nocturnal wake up, work or school absences, physical activity and recurrence of asthma and/or rhinitis
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00174005: Validity and Reliability in Measuring Biceps and Triceps by Using Ultrasound
Official title: Validity and Reliability in Measuring Tendon and Muscular Morphologic Characteristics of Biceps and Triceps by Using Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: muscle
tendon
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 20
Sex: MALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to estimate the validity and reliability in the measurement of bicep and tricep tendons and muscular morphologic characteristics by using ultrasound.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects
* Age range from 19-35 years

Exclusion Criteria:

* History of shoulder or elbow pain which needs medical treatment or surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School and Graduate Institute of Physical Therapy, National Taiwan University
Study officials:
affiliation: School and Graduate Institute of Physical Therapy, National Taiwan University
name: Hsing-Kuo Wang, PhD
role: STUDY_DIRECTOR
affiliation: School and Graduate Institute of Physical Therapy, National Taiwan University
name: Hsing-Kuo Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00339105: The Usefulness of HyperQ Recordings for the Early Diagnosis of Acute Coronary Syndrome in Patients Presenting With Chest Pain
Official title: The Usefulness of HyperQ Recordings for the Early Diagnosis of Acute Coronary Syndrome in Patients Presenting With Chest Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Keywords: Acute
Coronary
Syndrome
HyperQ
High
Frequency
ECG
chest
pain
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-06-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of the study is to assess the usefulness of high Frequency mid-QRS analysis in identifying the ischemic origin of patients presenting to the Emergency Room (ER)with Chest pain.

Detailed description: Introduction:

Chest pain is the leading cause of urgent admission to the Emergency Department (ED) in western countries.Acute Coronary Syndrome(ACS) continues to be among the most difficult to predict or diagnose. Misdiagnoses may lead to discharge of patients with ACS, who should have been admitted as well as costly unnecessary hospitalizations of patients who do not have ACS.

Objectives:

To evaluate the usefulness of High Frequency mid-QRS analysis in identifying the ischemic patients out of all patients presenting to the Emergency Room (ER) with chest pain.

Comparisons:

A continuous High Frequency Mid-QRS recording will be performed using the HyperQ System (BSP Ltd.) and compared to clinical, electrophysiologic and laboratory results. The golden standards used to compare the methods will be either CT-Angio, Echocardiography or Cardiac SPECT. A follow-up inquiry will be performed after 3 months and Coronary Angiography results will be sought and compared as well.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Patients with chest pain, with possible ACS.
* Patients admitted to the 'chest pain unit'
* Chest pain appeared within 24 hours prior to admission to the 'chest pain unit'
* No history of trauma or any other evident medical cause of chest pain
* Signed an Informed Consent

Exclusion Criteria:

* Implanted pacemaker or defibrillator
* History of trauma or other evident medical cause of chest pain
* Patients admitted to Intensive Cardiac Care Unit or intermediate Cardiac Care Unit
* Patients discharged from the ER
* Patients with Bundle-Branch-Block or other intra-ventricular delay of more than 120 mSec

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: The Chest Pain Unit, ER, Sheba Medical Center, Tel-Hashomer
Study officials:
affiliation: Head of Chest Pain Unit, ER, Sheba Medical Center
name: Shlomi Matetzky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abboud S, Zlochiver S. High-frequency QRS electrocardiogram for diagnosing and monitoring ischemic heart disease. J Electrocardiol. 2006 Jan;39(1):82-6. doi: 10.1016/j.jelectrocard.2005.09.007. No abstract available.
Clinical trial NCT03728205: Yoga for Solid Tumor
Official title: A Pilot Study On The Effect Of Yoga On Fatigue, And Stress Levels In Solid Tumor Cancer Patients Undergoing Active Radiation Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Solid Tumor, Adult
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to ascertain the effect of yoga interventions on radiation-related fatigue, and stress in cancer patients with stage I and II solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Stage I and II Cancer patients with solid tumors undergoing RT for 4-8 weeks (external beam radiation).
2. Patients of age \>18, and all races will be included in the study.
3. All patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Pennsylvania.
4. Patients must be English speaking.
5. Patients must be able to attend the schedule classes.

   Exclusion Criteria:
6. Patients with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions per their physician orders.
7. Patients with metastatic disease.
8. Active smokers. Smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Self-reporting smokers that have been smoke free for 6 months may be included)
9. Patients who currently practice or have recently practiced yoga (had not taken a yoga class on a regular bases in the last 6 months).

Primary outcomes:
measure: The feasibility of implementing Eischens yoga interventions for solid tumor cancer patients undergoing radiation therapy. This will be measured by the success rate of recruitment and retention for 10 subjects.
timeFrame: 12 months
Secondary outcomes:
measure: Effects on fatigue
timeFrame: 12 months
measure: Effects on Stress Level
timeFrame: 12 Months
Other outcomes:
measure: Long Term
timeFrame: 17 months
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06571305: FAMILY Sleep Program
Official title: FAMILY Sleep Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Community Foundation for Brevard
First posted: 2024-08-26
Enrollment: 36
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 purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and partners. Participants (patient-sleep-partner caregivers dyads as a unit) participate in the study together.


Eligibility criteria: Inclusion Criteria:

* The eligibility criteria for patients are

  * newly diagnosed with stage I to IV of a solid tumor
  * diagnosis in the past three years at the time of enrollment
  * having a consistent sleep partner.
* The eligibility criterion for caregivers is

  * a sleep partner of the patient.
* Additional eligibility criteria for both patients and caregivers are

  * Pittsburgh Sleep Quality Index (PSQI) ≥ 5,
  * willing to change sub-optimal sleep habits,
  * 18 years or older,
  * able to speak/listen English at the 8th grade level for intervention sessions,
  * able to read English or Spanish at the 8th grade for self-reported questionnaires, reside in Brevard County, Florida (FL),
  * only for participants of Aim 2, \> 4 weeks after surgery, if any, prior to enrollment, and no surgery planned in the next 5 weeks during the study period because surgery affects sleep.

Exclusion Criteria:

* Exclusion criteria for both patients and caregivers are:

  * having had a diagnosis of major depressive disorder, psychosis, or bipolar disorder that is not currently treated;
  * active suicidality, or substance or alcohol dependency in the past year;
  * currently have narcolepsy, restless leg syndrome, or untreated sleep apnea that is screened using the Sleep Health Screen;
  * both patients and caregivers have an extreme chronotype, or do shift work to have no overlap in sleep schedule between them; and
  * plan trans-meridian travel during the period of data collection blocks; and
  * having hearing or visual impairment, dementia, or cognitive dysfunction.
* Adults unable to consent, individuals who are not yet adults, pregnant women, or prisoners will be excluded.

Primary outcomes:
measure: Proportion of participants adapting to BBTI
timeFrame: Up to 4 weeks
measure: Change in Sleep Disturbance Symptoms Measured by Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, Up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Youngmee Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00876005: Supplemental Oxygen and the Risk of Surgical Site Infection
Official title: Perioperative Supplemental Oxygen and the Risk of Surgical Site Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Site Infection
Keywords: Wound infection
Lead sponsor: Santa Clara Valley Health & Hospital System
Sponsor class: OTHER
First posted: 2009-04-06
Enrollment: 1202
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a study to see whether increasing the oxygen concentration during and after a cesarean section decreases the infection rate.

Detailed description: This is a double-blinded prospective randomized,controlled trial to evaluate whether using a higher concentration of oxygen during and after surgery helps to decrease the wound infection rate in patients undergoing cesarean sections.

Eligibility criteria: Inclusion Criteria:

* mentally competent patients undergoing cesarean section under spinal or epidural anesthesia

Exclusion Criteria:

* fever/chorioamnionitis; GBS positive on antibiotics; immunocompromised / HIV patients; on antibiotics for any reason; general anesthesia; age less than 18 years custody patients stat cesarean section

Primary outcomes:
measure: Surgical site infection
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Santa clara Valley Medical Center
state: California
Study officials:
affiliation: Santa Clara Valley Medical Center
name: Neena Duggal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duggal N, Poddatorri V, Noroozkhani S, Siddik-Ahmad RI, Caughey AB. Perioperative oxygen supplementation and surgical site infection after cesarean delivery: a randomized trial. Obstet Gynecol. 2013 Jul;122(1):79-84. doi: 10.1097/AOG.0b013e318297ec6c.
Clinical trial NCT01423305: Phase I Pharmacokinetic Study (BF-BLOCK)
Official title: Effect of Charcoal on Gastrointestinal Absorption of Budesonide and Formoterol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Asthma
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2011-08-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess if charcoal prevents the absorption of budesonide and formoterol via GI track. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve.


Eligibility criteria: Inclusion Criteria:

1. Healthy males and females aged 18-60 years.
2. Normal weight at least 50 kg.

Exclusion Criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
2. Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
3. Any condition requiring concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
4. Known hypersensitivity to the active substance(s) or the excipients of the drug.
5. Pregnant or lactating females.

Primary outcomes:
measure: The evaluation of primary pharmacokinetic variable AUCt
timeFrame: 4 weeks
Secondary outcomes:
measure: Pharmacokinetic variables
timeFrame: 4 weeks
measure: Pharmacokinetic variable
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Clinical Reseach Services Turku (CRST)
Study officials:
affiliation: Clinical Research Services Turku Finland
name: Mika Scheinin, M.D.Ph.D
role: PRINCIPAL_INVESTIGATOR
References: