louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02591511: Effects of Patient-centered Stroke Educating System: a Randomized Controlled Trial
Official title: Effects of Health-education Application on Improving Stroke-related Knowledge and Health Related Quality of Life in Patients With Stroke: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Education
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to establish PAtient-Centered Computerized Educating System for Stroke (PACCESS) for patients with different demands and lack of knowledge.Those in the intervention group will receive the PACCESS and the control groups will receive traditional health education to test the effects of PACCESS in increasing clinical decision-making, health behavior, activities of daily living and knowledge of stroke, and health care quality.

Detailed description: To prevent recurrent stroke and improve the health-related quality of life (HRQOL) in patients with stroke, education regarding the risk factors of recurrent stroke is a crucial part of effective care for patients with stroke. The aim of this study was to develop an application capable of providing health education for recurrent-stroke prevention. We also examined the effectiveness of this app for improving stroke-related knowledge and HRQOL in patients with stroke.

Eligibility criteria: Inclusion Criteria:

* first time diagnosis of stroke (International Classification of Diseases, ninth revision, clinical modification \[ICD-9\] codes) of cerebral hemorrhage (ICD-9, 431) or cerebral infarction (ICD 9, 434)
* ability to follow instructions and complete the interviews
* having a designated caregiver who agrees to participate in the survey
* \>6 years of education
* have smartphone or the other mobile device can download the APP from internet.

Exclusion Criteria:

* cognitive impairment (Mini-Mental State Examination (MMSE scores\<24)
* having major mental diseases (i.e., depression, dementia, delirium, etc.)
* the inability to read/answer questionnaires

Primary outcomes:
measure: Stroke Health Education Knowledge Questionnaire
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University
name: Wen-Hsuan Hou, PHD
role: STUDY_CHAIR
References:
citation: Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
citation: Kang YN, Shen HN, Lin CY, Elwyn G, Huang SC, Wu TF, Hou WH. Does a Mobile app improve patients' knowledge of stroke risk factors and health-related quality of life in patients with stroke? A randomized controlled trial. BMC Med Inform Decis Mak. 2019 Dec 21;19(1):282. doi: 10.1186/s12911-019-1000-z.
Clinical trial NCT02250911: Care For The Cancer Caregiver: A Meaning-Based Workshop To Help Manage Caregiver Burden
Official title: Care For The Cancer Caregiver: A Meaning-Based Workshop To Help Manage Caregiver Burden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers
Keywords: Caregivers of patients
CCC = Care for the Cancer Caregivers
MCP-C = Meaning-Centered Psychotherapy for Cancer Caregivers
14-208
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2014-09-26
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to gather information on how easy it is to implement the workshop, as well as whether individuals find this workshop helpful. In this study, participants will be assigned at random to one of the two study groups. Based on the information we obtain, we hope to develop an easily accessible support service for caregivers.


Eligibility criteria: Inclusion Criteria:

* As per self report, a current caregiver to a patient with any site or stage of cancer
* Age 18 or over
* A score of \> 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the caregiving role
* In the judgment of the investigators and/or consenting professional, able to comprehend English to complete study assessments
* Able to perform informed consent
* Enrollment is open to caregivers with their own current/past cancer histories

Exclusion Criteria:

* Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent.
* As per self report, unable to access a computer with Internet or unable to use a computer with Internet provided by the study
* Participated in the development and refinement of the CCC Workshop (prospective exemption X14-006)

Primary outcomes:
measure: feasibility of this novel approach
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Allison Applebaum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05342311: Preoperative Ultrasonographic Evaluation of the Right Common Femoral Vein Diameter for Predicting Spinal Anesthesia-induced Hypotension in Elderly Patients
Official title: Preoperative Ultrasonographic Evaluation of the Right Common Femoral Vein Diameter for Predicting Spinal Anesthesia-induced Hypotension in Elderly Patients. A Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Anesthesia-induced Hypotension
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 68
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 68 consecutive elderly patients, aged \>65 years scheduled for elective surgical operations under spinal anesthesia will be included in the study.

Brief summary: In this study we will determine the ability of preoperative ultrasonographic evaluation of the right common femoral vein diameter to predict spinal anesthesia-induced hypotension in elderly patients.


Eligibility criteria: Inclusion Criteria:

* 65 years of age or more.
* ASA score I \& II.
* Patients scheduled for surgeries under spinal anesthesia.

Exclusion Criteria:

* Negative consent.
* pre-existing hypertension
* Diabetes mellitus or autonomic neuropathy.
* Emergency operations.
* Absolute contraindications or failure to perform spinal anesthesia.

Primary outcomes:
measure: The sensitivity of the transverse diameter (mm) value of the right common femoral vein as measured by ultrasound before anesthesia to predict spinal aneshesia-induced hypotension in elderly patients.
timeFrame: 30 minutes after spinal anesthesia
Secondary outcomes:
measure: Incidence of spinal anesthesia-induced hypotension in elderly
timeFrame: 30 minutes after spinal anesthesia
measure: The sensitivity of the peak velocity of blood flow (mm/s) in the right common femoral vein as measured by ultrasound before anesthesia to predict spinal anesthesia-induced hypotension in elderly patients
timeFrame: 30 minutes after spinal anesthesia
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university hospital
state: Giza
Study officials:
References:
Clinical trial NCT05108311: Effectiveness of a Novel Protocol for Glenohumeral Internal Rotation Deficit in General Population With Shoulder Pain
Official title: Effectiveness of a Novel Protocol for Glenohumeral Internal Rotation Deficit in General Population With Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Glenohumeral Internal Rotation Deficit
Keywords: general population.
Manual therapy
Therapeutic Exercise
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 35
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: Shoulder pain is one of the most common joint problems and disabling complaint in general population., but there is a lack of evidence about the relation between shoulder pain and glenohumeral internal rotation deficit (GIRD) in general population.

This study aimed to determine if the novel proposal for treatment of GIRD could be effectiveness and gain further evidence in the Range of Motion an Pain.


Eligibility criteria: Inclusion Criteria:

* Shoulder pain

Exclusion Criteria:

* Patient under 18 years old,
* Pain in both shoulders
* Joint prosthesis in at least one of the two shoulders.

Primary outcomes:
measure: glenohumeral internal rotation
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Boadilla del Monte
country: Spain
facility: San Pablo CEU University
state: Madrid
Study officials:
affiliation: Clínica Universidad de Navarra
name: Rafael Jácome López, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01478711: Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants
Official title: Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2011-11-23
Enrollment: 1517
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will use a rules-based expert system embedded in an electronic health record (EHR) to extract, interpret, and present salient facts and recommendations related to the healthcare of premature infants.

Detailed description: Premature infants are a vulnerable population with multiple inter-related health problems that put them at risk for poor outcomes. Electronic health records capture large amounts of information that may help guide decisions, but existing alert and reminder-based clinical decision support (CDS) frameworks do not adequately apply multiple overlapping care guidelines to complex patient histories to produce coherent clinical recommendations.

The primary objective of the study is to design and evaluate the usability of a CDS intervention to improve the quality of primary care for low birth weight (LBW) and very low birth weight (VLBW) premature infants from the time of intensive care nursery discharge through 24 months corrected gestational age

Eligibility criteria: Inclusion Criteria:

* All clinicians from participating practices.
* Premature Infants: Receive preventive healthcare from a participating practice at least twice during the study period; (2) age less than 24 months; and (3) birth weight less than 2000 g or gestational age at birth less than 35 weeks.

Exclusion Criteria:

-Residents will not eligible to participate in this study due to the fact that they receive significant ongoing education related to the inpatient and outpatient management of premature infants as part of their day-to-day training.

Primary outcomes:
measure: Evaluate usability of the intervention
timeFrame: 12 months
Secondary outcomes:
measure: Evaluate effect on care process
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital pf Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Robert Grundmeier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04525911: Assessment of Long-term Impact Post COVID-19 for Patients and Health Care Professionals of the European Hospital
Official title: Assessment of Long-term Impact Post COVID-19 for Patients and Health Care Professionals of the European Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Hôpital Européen Marseille
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 214
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: Patient and medical staff with confirmed or probable COVID-19 infection

Brief summary: The purpose of the study is to Assess of Long-term impact post COVID for patients and health care professionals.The patients and medical staff will be followed for 2 years in order to provide clinical and paraclinical data not yet published in the literature.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years,
* Symptomatic COVID-19 infection confirmed (by RT-PCR or ELISA serology) or probable (CT criteria),
* Having given free and informed written consent,
* Being affiliated with or benefiting from a social security scheme.
* Patients / caregivers may be included in several ancillary studies at the same time.

Exclusion Criteria:

-Subject to a measure for the protection of justice

Primary outcomes:
measure: Evaluation of post-traumatic stress symptoms (Post traumatic Stress Disorder (PTSD) scale) at M3 for patients and caregivers
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of post-traumatic stress symptoms (PTSD scale) at M12 and M24 for patients and caregivers
timeFrame: 12 and 24 months
measure: Change from M3 in the score of the mental (MCS), physical (PCS) components and the scores of the individual domains of the questionnaire SF36 to M12 and M24 for the entire study population
timeFrame: 12 and 24 months
measure: % of patients presenting a positive result by ELISA serology (= without distinction of IgG, IgM and IgA)
timeFrame: 3 months
measure: Comparison of M0 chest CT results at each follow-up for the entire study population
timeFrame: 24 months
Other outcomes:
measure: Change from M3 score measuring anxiety (HAD-A) and depression score (HAD-D) to M12 and M24 for patients and caregivers.
timeFrame: 12 and 24 months
measure: Change from M3 in the B-IPQ score at M12 and M24 for patients and caregivers.
timeFrame: 12 and 24 months
measure: Evaluation of the microbiotic signature according to the severity of the disease at M3, M6 and M12
timeFrame: 6 and 12 months
measure: Evaluation of the fatigue EVA score and quality of life (SF36) at M6 and M12
timeFrame: 6 and 12 months
Locations:
city: Marseille
country: France
facility: BENNANI
Study officials:
affiliation: Hôpital Europeen Marseille
name: Hervé PEGLIASCO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01914211: The Role of Tranexamic Acid in Reducing Blood Transfusion Requirements After Cardiopulmonary Bypass in Neonates
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Congenital Heart Disease
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 0
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the cardiothoracic surgery population at Nationwide Children's Hospital.

Brief summary: This is an observational, prospective study to evaluate the role of tranexamic acid in reducing blood transfusion in neonates undergoing cardiopulmonary bypass.


Eligibility criteria: Inclusion Criteria:

* All neonates undergoing arterial switch or aortic arch procedure utilizing cardiopulmonary bypass (CPB).

Exclusion Criteria:

* Jehovah's witness patients.

Primary outcomes:
measure: Level of postoperative hemostasis
timeFrame: 24 hours
Secondary outcomes:
measure: Volume of blood transfusions
timeFrame: 24 hours
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT00369811: Oxycodone vs Fentanyl for Pain Treatment After Laparoscopic Cholecystectomy
Official title: Comparative Study of Oxycodone and Fentanyl Given Intravenously in the Treatment of Early Postoperative Pain After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Cholecystectomy, postoperative
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
First posted: 2006-08-29
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the analgesic efficacy of oxycodone and fentanyl in the treatment of postoperative pain after laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* Planned outpatient laparoscopic cholecystectomy
* \>18 years

Exclusion Criteria:

* Intolerance to study drugs
* Treatment with MAO inhibitors

Primary outcomes:
measure: Pain intensity
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Anesthesiology, Aarhus University Hospital
Study officials:
affiliation: Danish Pain Research Center, Aarhus University Hospital
name: Lone Nikolajsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01044511: Quality of Life With Esophageal Stent Trial
Official title: Prospective, Randomized Trial of the Effects on HRQoL, Cost-Utility and Reintervention Rate, of Nurse Home Visits, in Patients With SEMS Treated Malignant Disease in the Esophagus and Cardia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Gastro-esophageal Junction Cancer
Keywords: Esophageal cancer
Cardia cancer
Health Related quality of Life
SEMS
Home visits
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2010-01-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to compare, specialist nurse home visits in patients with inoperable cancer in the esophagus or cardia, who are palliated with Self Expanding Metal Stent, to standard patient contact with regards to quality of life, number and character of reinterventions and cost-effectiveness.

Detailed description: The aim of this study is to compare, specialist nurse home visits in patients with inoperable cancer in the esophagus or gastro-esophageal junction (cardia), who are palliated with Self Expanding Metal Stent, to standard patient contact with regards to quality of life, number and character of reinterventions and cost-effectiveness.

Eligibility criteria: Inclusion Criteria:

* Malignant obstruction of esophagus or cardia treated with SEMS due to non-operable disease.

Exclusion Criteria:

* Mentally unable to fill out questionaire

Primary outcomes:
measure: HRQoL, EORTC C-30, EOS-18
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Afd A, OUH
state: Fyn
Study officials:
affiliation: Afd A, OUH
name: Michael B Mortensen, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05006911: Pilocarpine, Brimonidine, Oxymetazoline (PBO) Compound to Control Presbyopia Symptoms
Official title: Pilocarpine, Brimonidine, Oxymetazoline Ophthalmic Compound Safety and Efficacy in Patients With Presbyopia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Presbyopia
Lead sponsor: Optall Vision
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To determine safety and efficacy of a Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac compound to improve near uncorrected vision in healthy presbyopic patients
Primary purpose: TREATMENT

Brief summary: Safety and Efficacy of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) ophthalmic compound to improve uncorrected near vision in healthy presbyopic patients one hour after instillation.

Detailed description: To determine the safety and efficacy of a novel pharmacological compound of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) to improve uncorrected near vision in healthy presbyopic patients one hour after binocular instillation.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Presbyopic
* 40 - 60 years

Exclusion Criteria:

* Diabetics
* Previous eye surgery
* Previous eye disease
* \> 0.50 myopia
* \> 1.5 hyperopia or astigmatism

Primary outcomes:
measure: Jaeger near uncorrected visual acuity improvement
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Optall Vision
Study officials:
affiliation: Optall Vision
name: Cesar Alejandro S Galeana, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00315211: Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer
Official title: Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Mediastinal Neoplasms
Keywords: Small Cell Lung Cancer Recurrent
Lead sponsor: Aultman Health Foundation
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2006-04-18
Enrollment: 7
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 purposes of this study are:

* To determine the overall response rate of patients treated with at least 2 cycles of this regimen.
* To determine the feasibility and toxicity of the combination of topotecan and docetaxel.

Detailed description: The main objective of this study was to determine the overall response rate of patients treated with at least 2 cycles of topotecan and docetaxel. The secondary objectives were to determine the feasibility and toxicities of this combination. The final secondary objective is overall survival for patients that received 2 or more cycles.

Methods: Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment. Pts received Docetaxel 30 mg/m2 IV followed by Topotecan 3 mg/m2 IV Days 1 and 8 of a 21 day cycle. Disease assessment was done every 2 cycles. Toxicity was measured each cycle.

Eligibility criteria: Inclusion Criteria:

* Recurred greater than 90 days after initial treatment
* At least 1 measurable lesion
* Only 1 prior chemotherapy
* Must be over 18 years of age
* ECOG performance status of 0 - 2
* Adequate hematologic, renal, and hepatic function

Exclusion Criteria:

* No prior use of topotecan, docetaxel, or irinotecan
* No symptomatic brain metastases
* History of cardiac arrhythmias, congestive heart failure, stroke, or embolic events
* No prior investigational agents within 1 month prior
* Lung cancer of mixed histology
* Known uncontrolled seizure disorders

Primary outcomes:
measure: To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
Study officials:
affiliation: Aultman Hospital
name: Raza Khan, MD
role: PRINCIPAL_INVESTIGATOR
References: