louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00795119: A Trial to Determine the Efficacy of Near Infrared Spectroscopy to Detect Intracranial Hemorrhage in Children
Official title: A Clinical Assessment of the Reliability of Near Infrared Spectroscopy for the Detection of Intracranial Hemorrhage in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Hemorrhage
Keywords: Near Infrared Spectroscopy
Diagnosis
Children
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 73
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: To diagnose bleeding inside the head, children need to have a CT Scan or MRI of their heads. Not all doctors order these though, especially when there is no history of injury or when children don't look too sick. Unfortunately, this means that some children's bleeding doesn't get diagnosed as early as it could. This study wants to find a way to detect bleeding inside the head without using a CT scan or MRI.


Eligibility criteria: Inclusion Criteria:

* All children under 3 years of age who undergo a CT of the head or MRI of the head.

Exclusion Criteria:

* Lack of parental consent
* Neurosurgical intervention between CT/MRI and NIRS scanning.
* Scalp hematoma

Primary outcomes:
measure: Sensitivity of NIRS
timeFrame: Study conclusion
Secondary outcomes:
measure: specificity of NIRS, positive/negative predictive value
timeFrame: Study conclusion
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Steven Bellemare, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01463319: Warm Water and Unsedated Colonoscopy
Official title: Warm Water Colonoscopy: a Novel Method for Unsedated Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Gastrointestinal Diseases
Digestive System Diseases
Keywords: colonoscopy
warm water method
hydrocolonoscopy
unsedated colonoscopy
Lead sponsor: Presidio Ospedaliero Santa Barbara
Sponsor class: OTHER
First posted: 2011-11-01
Enrollment: 818
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Unsedated or slightly sedated colonoscopy has fast recovery time, less cost and lower or no incidence of drug-related side effects. May be slightly painful or discomforting for the patient. Based on numerous recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of warm water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation or with a low dose of sedatives.


Eligibility criteria: Inclusion Criteria:

* 18 Years to 85 Years
* adult patients willing to undergo colonoscopy without routine initial sedation

Exclusion Criteria:

* refuse to initiate colonoscopy without routine sedation
* inadequate bowel preparation
* incapacity to give informed consent

Primary outcomes:
measure: number of patients undergoing complete unsedated or slightly sedated colonoscopy
timeFrame: 9 months
Secondary outcomes:
measure: evaluation of pain and tolerability scores
timeFrame: 1 hour
measure: percentage of caecum intubation
timeFrame: 1 hour
measure: time to reach caecum
timeFrame: 1 hour
measure: Adenoma detection rate
timeFrame: 9 months
Other outcomes:
Locations:
city: Iglesias
country: Italy
facility: Servizio Endoscopia Digestiva
state: Carbonia-Iglesias
city: San Gavino Monreale
country: Italy
facility: U.O.S.D. Diagnostica e Terapia Endoscopica
state: Medio Campidano (VS)
Study officials:
affiliation: A.S.L. 07 Sardegna
name: Sergio Cadoni, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02438319: Automatic vs. Manual Optic Disc Planimetry
Official title: Automatic vs. Manual Optic Cup and Optic Disc Segmentation in Glaucoma
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Open Angle Glaucoma
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
First posted: 2015-05-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with a diagnosis of open-angle glaucoma

Brief summary: Manually and automatically by mashing learning algorithm optic disc will be evaluated (planimetry).

Detailed description: Cross-Over non-randomized Case-Series. Arm 1 (Manual segmentation): Manually marking of the boundaries of the optic disc and it's excavation on color photographs of the optic disc. Arm 2 (Automated segmentation): Automatic detection of the boundaries of the optic disc and it's excavation. Calculation of cup size, size of excavation, cup-to-disc ratio, and rim area. Comparison of all parameters of both arms and computing of agreement.

Eligibility criteria: Inclusion Criteria:

* open-angle glaucoma

Exclusion Criteria:

* no fundus photography of the optic disc performed

Primary outcomes:
measure: agreement measured by kappa statistics
timeFrame: Baseline visit in the outpatient department
Secondary outcomes:
measure: Cup size
timeFrame: Baseline visit in the outpatient department
measure: size of excavation
timeFrame: Baseline visit in the outpatient department
measure: vertical cup to disc ratio
timeFrame: Baseline visit in the outpatient department
measure: rim area
timeFrame: Baseline visit in the outpatient department
Other outcomes:
Locations:
Study officials:
affiliation: University of Zurich
name: Jens Funk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jonas JB. [Glaucoma diagnosis of the optic disc using photography and planimetry]. Ophthalmologe. 2003 Jan;100(1):13-20. doi: 10.1007/s00347-002-0752-4. German.
Clinical trial NCT01997619: Biological Mesh Repair of Complex Hernias in High Risk Patients
Official title: Biological Mesh Repair of Complex Ventral Hernias in High Risk Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia
Keywords: biological mesh
contaminated hernia
abdominal wall reconstruction
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 16 consecutive patients with biological mesh repair

Brief summary: Complex ventral hernia repair is a significant surgical challenge with high frequencies of both wound complications and recurrence. The Ventral Hernia Working Group (VHWG) described in 2010 recommendations regarding grading and technique of repair, which we have followed since November 2011.The purpose of the this study was to evaluate our results after biologic mesh repair of complex hernias.

Detailed description: Obervational study

Primare outcome: Surgical site occurence

Secondary outcome: Hernia recurrence

Biolocal mesh: Ventral hernia repair in a population with severe co-morbidity and contaminated hernia.

Eligibility criteria: Inclusion Criteria: Abdominal wall reconstruction with biological mesh -

Exclusion Criteria: Pregancy,

-

Primary outcomes:
measure: surgical site occurence
timeFrame: 30 days
Secondary outcomes:
measure: hernia recurrence
timeFrame: 20 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Copenhagen, University of Copenhagen
name: Linda Bardram, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02470819: Genomic and Proteomic Profiling Targets Influenced Treatment in Metastatic Breast Cancer
Official title: A Two Arm Pilot Study Utilizing Molecular Profiling to Find Potential Targets and Influence Treatments for Patients With Metastatic Breast Cancer or Advanced Gynecological Malignancies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Metastatic Breast Cancer
Breast Tumor
Advanced Gynecologic Cancer
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
First posted: 2015-06-12
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: TREATMENT

Brief summary: The primary objective is to examine the impact on progression-free survival of targeted therapy for breast cancer suggested by proteomic and genomic profiling.

Detailed description: To explore the impact of targeted therapy for breast cancer suggested by proteomic and genomic profiling using RPMA, targeted resequencing, IHC analysis, WGS, RNA-seq, and Exome sequencing on progression-free survival. When a molecular target cannot be identified, the patient will be treated with a therapy selected on an empirical basis by the investigator/treating physician at the individual site and will be followed for survival status. Only available, FDA-approved agents will be used.

Eligibility criteria: Inclusion Criteria:

* Life expectancy of \>3 months
* Diagnosis of metastatic breast cancer or an advanced gynecological malignancy with measurable disease
* Age greater than or equal to 18 years
* ECOG performance status of 0-1
* Able to undergo two biopsies to obtain tissue with first biopsy required and second biopsy optional
* Have failed or unable to tolerate previous treatment regimen
* Adequate organ and bone marrow function as defined by ANC ≥ 1.5 x 109/L; Hgb 9 g/dL; platelets greater than 100 x 109/L; creatinine ≤ 1.5 mg/dL; bilirubin ≤ 2.5 x ULN; AST and ALT ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases); INR ≤ 1.5 x ULN (except in the case of anticoagulation therapy)

Exclusion Criteria:

* Metastatic lesions that are not accessible to biopsy
* Symptomatic CNS metastasis
* Previous history of another malignancy within 5 years of study entry
* Uncontrolled concurrent illness
* Known HIV, HBB, and/or HCV infection
* Pregnant or breast feeding or childbearing potential and not using adequate birth control

Primary outcomes:
measure: Progression-free survival
timeFrame: 4 months
Secondary outcomes:
measure: Tumor assessment
timeFrame: 4 months
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
Study officials:
affiliation: Avera McKennan
name: Brian Leyland-Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04160819: The Effects of Individualized Nutritional Intervention Program in Malnutrition Elderly With Pneumonia
Official title: The Effects of Individualized Nutritional Intervention Program in Malnutrition Elderly With Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Keywords: nutritional intervention
malnutrition
respiratory disease
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 82
Sex: ALL
Minimum age (years): 66
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate the effects of an individualized nutritional intervention programs (iNIPs) on nutritional status and readmission rate in older adults with pneumonia during hospitalization and 3 and 6 months after discharge.

Detailed description: Method: Eighty-two malnourished older adults with primary diagnosis of pneumonia participated. Patients were randomly allocated to either a nutrition intervention (NI) group or a standard care (SC) group. Participants in the NI group received an iNIP according to energy and protein intake requirements in addition to dietary advice based on face-to-face interviews with their family members during hospitalization. After discharge, phone calls are adopted for prescribing iNIPs. Anthropometry (i.e., body mass index, limb circumference, and subcutaneous fat thickness), blood parameters (i.e., albumin and total lymphocyte count), hospital stay, Mini-Nutritional Assessment-Short Form (MNA-SF) score, target daily calorie intake, total calorie intake adherence rate, and three-major-nutrient intake were assessed during hospitalization and 3 and 6 months after discharge. Both groups received regular follow-up through phone calls. Furthermore, the rate of readmission resulting from pneumonia was recorded after discharge.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of pneumonia by a physician
* Age more than 65 years
* Malnutrition status indicated by body mass index (BMI) \<18.5 kg/m2 or Mini-Nutritional Assessment-Short Form (MNA-SF) score≤7

Exclusion Criteria:

* Renal insufficiency (glomerular filtration rate \[GFR\] \<60 mL/min/1.73 m2 or GFR staging of G3b-G5)
* Cancer
* Hospital stay \<7 days

Primary outcomes:
measure: nutritional status
timeFrame: up to 6 months of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Pei-Hsin Yang
Study officials:
References:
Clinical trial NCT04345419: Remdesivir Efficacy in Coronavirus Disease
Official title: Remdesivir in COVID-19 Treatment: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: COVID
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: COVID 19 treatment using Remedesvir.

Detailed description: COVID 19 treatment using Remedesvir. Is this drug effective?

Eligibility criteria: Inclusion Criteria:

* COVID 19 patients

Exclusion Criteria:

* allergy or contraindication to the drug

Primary outcomes:
measure: Number of patients with improvement or mortality
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university hospital, Assuit University, Ainshams University
Study officials:
affiliation: Tanta University Faculty of medicine
name: Sherief Abd-Elsalam, ass. prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04301219: Knowledge and Practices of ADR Reporting in LMICs
Official title: Knowledge and Practices of Adverse Drug Reaction Reporting Among Healthcare Professionals in Low and Middle-income Countries: a Cross-sectional Survey.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Reaction
Lead sponsor: Getz Pharma
Sponsor class: INDUSTRY
First posted: 2020-03-10
Enrollment: 1500
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A self-administered questionnaire was distributed to 1500 HCPs in 11 countries (Afghanistan, Cambodia, Kazakhstan, Kenya, Laos, Myanmar, Nigeria, Pakistan, Philippines, Sri Lanka, and Sudan). The participants were approached at various scientific events and academic interactions during the period and were requested to participate in the survey on a voluntary basis.

Brief summary: The reported literature suggests that knowledge about pharmacovigilance is on a lower side and ADR reporting is not common in developing countries. This survey may help us to identify the common gaps in knowledge and practices about pharmacovigilance so that we can devise the strategy on the basis of outcome.

Detailed description: Safety evaluation of a product in a market is like a moving ball which need re-evaluation as the data gather in its life cycle.(1) As per the definition of International society of harmonization and World Health Organization, adverse reaction is Adverse drug reaction (ADR) is defined as "A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function." (2) Adverse reaction and adverse event are interchangeable use in pharmacovigilance sector by knowing the difference is that ADR term used when drug is causing the effect (1). The frequency of ADR is getting higher due to the increasing prevalence of chronic disease with the growing trend of combination drugs (3). The non-profitable organization of pharmacovigilance is playing tremendous role in disseminating the awareness of proper usage of drug globally.(3) According to Uppsala database statistics, approximately 3 million reports were listed as suspected ADRs. (4) Nearly 6.7% of hospitalizations were due to serious ADRs (5)

Eligibility criteria: Inclusion Criteria:

- Participants who would like to voluntarily fill the survey form

Exclusion Criteria:

* Students
* Other than Health care professionals (including but not limited to Physicians, Doctors, Nurses and/or pharmacist)

Primary outcomes:
measure: Country-wise Analysis on knowledge of HCPs
timeFrame: 2 years
measure: Country-wise Analysis on practices of HCPs
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Shaheed Zulfiqar Ali Bhutto Medical University
state: Sindh
Study officials:
affiliation: Shaheed Zulfiqar Ali Bhutto Medical University
name: Mahwish Raza, Pharm-D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06129019: the Effect of Reiki Application on Depression, Anxiety and Physical Activity in Patient With Multiple Sclerosis
Official title: Investigation of the Effect of Reiki Application on Depression, Anxiety and Physical Activity in Individuals Diagnosed With Relapsing-Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: reiki
anxiety
physical activity
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: During Reiki application, individuals may report feeling a slight warm sensation under and near the therapist's hand. The only rule in Reiki practice is that the individual must give permission to the practitioner to facilitate the flow of energy. The person receiving Reiki during the application does not have to believe in Reiki. Because Reiki is universal life energy and is available to everyone. Reiki is generally safe and no serious side effects have been reported. Reiki practice in the last 10 years; It is increasing among physicians, nurses and other healthcare professionals.

This study was planned to investigate the effect of reiki application on depression, anxiety and physical activity in individuals diagnosed with Relapsing-Remitting Multiple Sclerosis.

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Eligibility criteria: Inclusion Criteria:

* Being over 18 years of age
* Having the ability to use technological devices
* Not using Reiki and similar integrative treatment methods
* No verbal communication disability (hearing and speaking)
* Not having a diagnosed psychiatric disorder
* Patients who have been receiving Relapsing-Remitting MS treatment for more than three months

Exclusion Criteria:

* Patients using any complementary alternative treatment methods
* Patients who cannot communicate by phone to participate in remote reiki application
* Patients with autoimmune diseases other than multiple sclerosis
* Patients with communication disabilities
* Patients with another known neurological system disease (dementia, Alzheimer's, etc.).

Primary outcomes:
measure: Beck Depression Scale
timeFrame: 4 week
measure: Beck Anxiety Scale
timeFrame: 4 week
measure: International Physical Activity Survey
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Elazıg
country: Turkey
facility: Firat University
Study officials:
References:
Clinical trial NCT01805219: Global Positioning Satellite and Accelerometry to Assess Human Locomotion (ACTI GPS)
Official title: Assessment of Human Locomotion and Energy Expenditure Using Global Positioning Satellite and Accelerometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: École Normale Supérieure de Cachan
name: Institut de Formation en Education Physique et en Sport d'Angers/Les Ponts de Cé
First posted: 2013-03-06
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects

Brief summary: The aim of the study is to validate the association of the GPS and accelerometer tools in order to assess the humain locomotion during exercises.

The hypotheses are:

1. GPS and accelerometer together can assess the human locomotion
2. GPS and accelerometer together can assess the energy expenditure during exercises

Detailed description: The assessment of the physical activity (PA) and the energy expenditure (EE) is very important to estimate the morbi-mortality. However, each of these tools has its advantages and disadvantages but none of them provides a measure of all components dimensions that characterize the associated PA and EE. The current scientific prospects for measurement of PA tend to associate several measuring devices. To date, these perspectives are facilitated by technological developments and miniaturization of various devices. Thus, the purpose of the study is to evaluate wether GPS associated with accelerometer are able to assess the humain locomotion and energy expenditure during exercises.

Eligibility criteria: Inclusion Criteria:

* Older than 18
* Informed consent of the participant
* Able to understand the protocol of the study
* Register to the social health insurance
* No exercise limitation

Exclusion Criteria:

* No informed consent of the participant
* pregnant woman

Primary outcomes:
measure: Defining optimal analysis parameter to accurately detect walking from stopping periods
timeFrame: up to 1 week
Secondary outcomes:
measure: Defining optimal analysis parameter to accurately detect speed and distance of periods of walking
timeFrame: up to 1 week
Other outcomes:
measure: Determine the accuraccy of GPS and acceleropmetry to estimate energy expediture in healthy volunteers
timeFrame: up to 1 week
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
References:
citation: de Mullenheim PY, Dumond R, Gernigon M, Mahe G, Lavenu A, Bickert S, Prioux J, Noury-Desvaux B, Le Faucheur A. Predicting metabolic rate during level and uphill outdoor walking using a low-cost GPS receiver. J Appl Physiol (1985). 2016 Aug 1;121(2):577-88. doi: 10.1152/japplphysiol.00224.2016. Epub 2016 Jul 8.