louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04574375: Chronic VEnous dIsorders maNagement and Treatment effectivenesS evaluaTion in Chronic vEnous Disease, an International Program
Official title: A Prospective, Observational (Non-interventional), International Study to Assess Effectiveness of Conservative Treatments in Chronic Venous Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Venous Disease
Keywords: observationnal
QoL
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2020-10-05
Enrollment: 6419
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: Male and female patients consulting spontaneously or referred for symptomatic CVD not requiring surgical treatment

Brief summary: The primary objective of this study is to assess in real-life settings the effectiveness of conservative treatments on symptoms, signs and quality of life, in patients consulting for CVD


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old
* Patient consulting spontaneously or referred for symptomatic venous disorders
* Diagnosis of chronic venous disease according to investigator's judgment

Exclusion Criteria:

* Presence of known severe systemic disease likely to interfere with the study evaluation
* Patients with lower limb arterial disease
* Patient with any other concomitant disease or treatment that may interfere with lower limb pain or edema
* Patient consulting for an emergency not related to venous disease
* Patient currently taking any treatment for chronic venous disorders, either with venoactive drug or with compression hosiery
* Procedure or surgery for venous disease planned during the study
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Global leg symptoms severity
timeFrame: week 4
measure: Global improvement
timeFrame: Week 4
measure: Disease severity
timeFrame: Week 4
measure: Quality of Life
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Servier Affaires Medicales
Study officials:
References:
Clinical trial NCT00056875: Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants
Official title: Safety and Efficacy of Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Graft Versus Host Disease
Keywords: graft versus host disease
bone marrow transplant
alternative donor
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2003-03-27
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: PREVENTION

Brief summary: This is a single arm dose escalation study of recombinant human keratinocyte growth factor given to patients undergoing allogeneic bone marrow transplantation who are at high risk for graft versus host disease (GVHD).

Detailed description: Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: Eligible for full intensity bone marrow transplant (BMT) conditioning but who lack a 6/6 HLA idential sibling donor

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
Study officials:
affiliation: Univeristy of Michigan
name: John Levine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00145275: To Assess the Efficacy of Over-the-counter Analgesics in the Prevention/Treatment of Transient Post-dose Symptoms Following Zoledronate Infusion in Post-menopausal Women
Official title: To Assess the Efficacy of Over-the-counter Analgesics in the Prevention/Treatment of Transient Post-dose Symptoms Following Zoledronate Infusion in Post-menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteopenia
Keywords: zoledronic acid
bisphosphonate
Low bone mass
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 455
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Zoledronic acid is a medicine being studied in people with low bone mass. Side effects such as headache, fever, muscle aches, and pains, may occur following the infusion. This study will investigate the use of over-the-counter medicines to improve these symptoms.


Eligibility criteria: Inclusion Criteria:

* Women greater than or equal to 45 years and less than or equal to 75 years of age inclusive
* Low bone mineral density

Exclusion Criteria:

* Certain prior treatments for low bone mass/osteopenia
* Current use of medicines (prescription or non-prescription) for pain, fever, or inflammation
* Impaired kidney function

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Temperature increase
Secondary outcomes:
measure: Questionnaires
measure: VAS (visual analog scale)
Other outcomes:
Locations:
city: Unavailable
country: United States
state: Georgia
city: Unavailable
country: United States
state: Illinois
city: Unavailable
country: United States
state: Indiana
city: Unavailable
country: United States
state: Iowa
city: Unavailable
country: United States
state: Kansas
city: Unavailable
country: United States
state: Washington
city: Multiple
country: Australia
city: Multiple
country: Canada
city: Multiple
country: Russian Federation
city: Multiple
country: South Africa
Study officials:
References:
Clinical trial NCT03081975: Comparison of ADR Using NBI Versus HD White Light Colonoscopy in Screening and Surveillance Colonoscopies
Official title: Comparison of Adenoma Detection Rate Using Narrow Band Imaging Versus HD White Light Colonoscopy in Screening and Surveillance Colonoscopies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Narrow Band Imaging
Keywords: adenoma detection rate
narrow band imaging
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 500
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare ADR using HD-NBI or HD-WLE during screening and surveillance colonoscopies.

Detailed description: Background:

Despite recent advances in endoscopic technology adenoma miss rate still is up to 20% and contributes to the occurrence of interval cancers. Therefore, improved imaging modalities have been introduced to increase adenoma detection rate (ADR) during screening and surveillance colonoscopies. Recently, narrow band imaging (NBI; Exera II series, Olympus Corporation) was not significantly better than high definition white light colonoscopy (WLC) for the detection of patients with colorectal polyps, or colorectal adenomas1. However, Olympus' current Exera III series is characterized by better illumination of the bowel lumen and may be associated with a higher ADR than high definition WLC.

Methods:

Investigators performed a prospective evaluation in patients referred to the Department of Interdisciplinary Endoscopy at Jena University Hospital for screening or surveillance colonoscopy between January and November 2015 in daily clinical practice. Colonoscopy was performed by use of HD-WLC or HD-NBI upon withdrawal of the colonoscope (Exera III series, Olympus Corporation).

Eligibility criteria: Inclusion Criteria:

* Screening colonoscopies

Exclusion Criteria:

* Insufficient bowel cleansing
* Age under 55years

Primary outcomes:
measure: Adenoma detection rate
timeFrame: up to 60min
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: University Clinic Jena
state: Thueringia
Study officials:
affiliation: University Clinic Jena
name: Carsten Schmidt, MD
role: STUDY_DIRECTOR
References:
citation: Burger M, Weber M, Petersen I, Stallmach A, Schmidt C. Adenoma detection rate using narrow-band imaging is inferior to high-definition white light colonoscopy in screening and surveillance colonoscopies in daily clinical care: A randomized controlled trial. Medicine (Baltimore). 2022 Aug 12;101(32):e29858. doi: 10.1097/MD.0000000000029858.
Clinical trial NCT02398175: Thoracic Injuries in Pediatric Polytraumatized Patients: Epidemiology, Treatment and Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Trauma
Keywords: Pediatric polytrauma
thoracic injuries
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 71
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric (age \< 18 years) polytrauma patients with associated thoracic injuries, admitted to this Level I Trauma center, between January 1992 and December 2008

Brief summary: The present study predicts that concomitant chest injuries in polytraumatized pediatric patients are a potential source of substantial morbidity and mortality.


Eligibility criteria: Inclusion Criteria:

Children with isolated, but severe and potentially life-threatening injuries ISS ≥16 injuries to only one body cavity together with a single long bone fracture thoracic injuries

Exclusion Criteria:

Injury Severity Score (ISS) of \< 16 age \>18 no thoracic injuries

Primary outcomes:
measure: Injury Severity Score
timeFrame: at least one year follow up
measure: Thoracic Injuries
timeFrame: at least one year follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00999570: High Volume Specialty Knee Replacement Surgeons Achieve Better Clinical and Quality-of-Life Scores
Official title: High Volume Specialty Knee Replacement Surgeons Achieve Better Clinical and Quality-of-Life Scores
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Arthroplasty
Keywords: outcome
quality of life
total knee arthroplasty
clinical outcome scores post total knee arthroplasty
quality of life scores post total knee arthroplasty
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2009-10-22
Enrollment: 3458
Sex: ALL
Minimum age (years): 37
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients seen at Singapore General Hospital who require total knee arthroplasty

Brief summary: To determine whether specialty training or high volume of operative experience is associated with better clinical outcome and quality-of-life scores.

Detailed description: Primary total knee replacements are becoming a commonly performed procedure. Many general orthopaedists can perform large numbers of such surgeries. Thus, we aim to find out if there is value of having surgeons with AR fellowship training to perform primary total knee arthroplasty. This has an implication in the direction of the training of future AR surgeons and in the distribution of operative cases.

Eligibility criteria: Inclusion Criteria:

* patients who require total knee arthroplasty seen during the specified period

Exclusion Criteria:

* revision total knee arthroplasty
* unicompartmental or bicompartmental knee arthroplasty

Primary outcomes:
measure: To determine whether specialty training or high volume of operative experience is associated with better clinical outcome and quality-of-life scores.
timeFrame: 2 years
Secondary outcomes:
measure: To determine which other factors are predictors of better outcome score and quality-of-life scores.
timeFrame: 2 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Sok Chuen Tan, MBBS, MRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapore General Hospital
name: Seng Jin Yeo, FRCS, FAMS
role: STUDY_DIRECTOR
References:
citation: Katz JN, Mahomed NN, Baron JA, Barrett JA, Fossel AH, Creel AH, Wright J, Wright EA, Losina E. Association of hospital and surgeon procedure volume with patient-centered outcomes of total knee replacement in a population-based cohort of patients age 65 years and older. Arthritis Rheum. 2007 Feb;56(2):568-74. doi: 10.1002/art.22333.
Clinical trial NCT06268470: Antiplatelet Therapy in Chronic Urticaria
Official title: Efficacy of Antiplatelet Therapy for the Treatment of Chronic Recalcitrant Urticaria
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Urticaria
Keywords: Chronic urticaria
antiplatelet
D-dimer
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients diagnosed with chronic urticaria will be assigned to 2 treatment arms. 1. high dose antihistamine with antiplatelets; and 2. high dose antihistamine alone.
Primary purpose: TREATMENT

Brief summary: This study compares the combination of antiplatelets and antihistamine versus antihistamine alone for the treatment of chronic spontaneous urticaria

Detailed description: This study is a randomized control trial comparing the effectiveness of the combination of antiplatelets and antihistamine and antihistamine alone for the treatment of chronic spontaneous urticaria

Eligibility criteria: Inclusion Criteria:

Chronic spontaneous urticaria

D-dimer levels over 500 ng/ml

Not respond to a conventional dose of antihistamine

Exclusion Criteria:

Are taking aspirin

Have bleeding tendency

Have concurrent severe medical illnesses

-

Primary outcomes:
measure: Weekly urticaria activity score
timeFrame: 4 weeks
Secondary outcomes:
measure: D-dimer levels
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Jettanong Klaewsongkram, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05661370: App Teaches Doctors to Diagnose Skin Cancer
Official title: Improving Diagnostic Accuracy in Skin Cancer Diagnostics Using Educational Mobile App: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma (Skin)
Carcinoma
Keywords: Digital Learning
e-learning
Melanoma
Carcinoma
Dermoscopy
Dermloop
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention and Controlgroup parallel design using sequential continues block randomization.
Primary purpose: OTHER

Brief summary: This study aimed to examine if self-paced learning with a novel digital patient-case-based educational platform can increase primary care physicians' diagnostic accuracy of malignant and benign skin lesions on both the level of benign/malignant and the diagnosis level. Secondarily the study aimed to investigate the time spent in reaching this change in proficiency.

Detailed description: Participants were given a questionnaire and an initial Skin Cancer Multiple Choice-Questionnaire (MCQ) to test their diagnostic skills regardining skin and mole cancer and the most common differential diagnoses.

Participants in the Intervention group was then given access to an educational mobile application (App) for 8 days and asked to diagnose 500 patient cases. The participants did so at their own leisure and time.

After 8 days they were asked to abstain from using the App for another 8 days (wash out period) and were then given a Final Skin Cancer Multiple Choice-Questionnaire (MCQ).

Participants of the control group received no intervention nor education during the 16 days of waiting before they took the final Skin Cancer Multiple Choice-Questionnaire.

Eligibility criteria: Inclusion Criteria:

* Primary Care Physician who works in General Practice

Exclusion Criteria:

-

Primary outcomes:
measure: Multiple-Choice Questionnaire (MCQ) Score
timeFrame: Before and immediately after intervention (On average 19 days after enrollment)
Secondary outcomes:
measure: Diagnostic proficiencies
timeFrame: During the 8 days of access to the educational mobile application.
measure: Time spend
timeFrame: During the 8 days of access to the educational mobile application.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: AISC Research Fascility
state: Danmark
Study officials:
References:
Clinical trial NCT04978870: Diagnosis, Incidence and Consequences of PACU-Delirium
Official title: Diagnosis, Incidence and Consequences of Postoperative Delirium in Elderly Patients in the Post-anaesthetic Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Elderly Patient
Cognitive Decline
Keywords: Post-anesthetic care
Cognitive recovery
Delirium
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 450
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients meeting inclusion criteria and presenting for sheduled surgery at the University Medical Centre Hamburg, Germany.

Brief summary: This study aims to

1. determine sensitivity and specificity of the Confusion Assessment Method for Postanesthesia Care Unit (CAM-PACU)
2. examine the effect of postanesthesia care unit delirium (PACU delirium) on the emergence of later onset postoperative delirium (POD) as well as cognitive recovery until one month postoperatively


Eligibility criteria: Inclusion Criteria:

* planned surgery in the near future
* surgery time at least 60min

Exclusion Criteria:

* intracranial surgery
* expected postoperative transfer to ICU and stay exceeding 24h
* length of postoperative stay in hospital below 24h
* insufficient German language skills
* current alcohol or drug misuse
* manifest mental illness

Primary outcomes:
measure: Group 1: Sensitivity and specificity of "Confusion Assessment Method - Postanesthetic Care Unit" (CAM-PACU)
timeFrame: 15-240 minutes postoperatively
measure: Group 2: postoperative delirium after discharge from Postanesthetic Care Unit
timeFrame: 0-5 days postoperatively
Secondary outcomes:
measure: re-test reliability
timeFrame: 15-240 minutes postoperatively
measure: cognitive performance
timeFrame: before, 7 and 30 days postoperatively
measure: postoperative complications
timeFrame: 30 days postoperatively
measure: feasibility of delirium screening by questioning of medical staff
timeFrame: before, 3 and 12 months after implementation of CAM-PACU
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Hamburg University Medical Centre Eppendorf
Study officials:
References:
Clinical trial NCT00920270: Nebulized Colistin for Hospital-Acquired Pneumonia
Official title: Efficacy and Safety of Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia Caused by Gram Negative Bacteria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pneumonia
Keywords: Hospital-Acquired Pneumonia
Gram Negative Bacteria
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2009-06-15
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia caused by Gram Negative Bacteria should be more effective than conventional therapy

Detailed description: Randomized Controlled Clinical Trial in hospitalized adult patients with hospital-acquired pneumonia. The patients are allocated to conventional group or nebulized colistin group. The conventional group receives conventional antibiotics whereas the nebulized colistin group receives nebulized colistin in addition to conventional antibiotics. The outcomes are clinical response and microbiological responses.

Eligibility criteria: Inclusion Criteria:

* Adult (age\>18 years) hospitalized patient with hospital-acquired pneumonia due to Gram negative bacteria

Exclusion Criteria:

* pregnancy
* lactating woman
* colistin allergy
* severe renal impairment
* epilepsy

Primary outcomes:
measure: Clinical response
timeFrame: 14 days after Treatment
Secondary outcomes:
measure: Microbiological response and safety
timeFrame: 14 days after treatment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Siriraj Hospital
name: Visanu Thamlikitkul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04800770: The Effect of COVID-19 Patients' Serum Phosphate Level on Mortality in ICU
Official title: Phosphate Levels of COVID-19 Patients and Mortality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Phosphate Deficiency
Covid19
Mortality
Keywords: COVID19
phosphate deficiency
4C mortality score
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants hospitalized in the intensive care unit diagnosed with COVID-19 will incluse in the study

Brief summary: The investigators aimed to investigate the relationship between phosphate level and mortality using the 4C Mortality Score in COVID-19 patients who were followed up in the intensive care unit.


Eligibility criteria: Inclusion Criteria:

* Participants hospitalized in the intensive care unit diagnosed with COVID-19 will incluse in the study

Exclusion Criteria:

* there is no exclusion criteria

Primary outcomes:
measure: 4C mortality score
timeFrame: 6 months
measure: serum phosphate levels
timeFrame: 6 months
measure: mortality
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: ankara ch bilkent
name: betül aytaç, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murer H, Forster I, Biber J. The sodium phosphate cotransporter family SLC34. Pflugers Arch. 2004 Feb;447(5):763-7. doi: 10.1007/s00424-003-1072-5. Epub 2003 May 16.
citation: Pistolesi V, Zeppilli L, Polistena F, Sacco MI, Pierucci A, Tritapepe L, Regolisti G, Fiaccadori E, Morabito S. Preventing Continuous Renal Replacement Therapy-Induced Hypophosphatemia: An Extended Clinical Experience with a Phosphate-Containing Solution in the Setting of Regional Citrate Anticoagulation. Blood Purif. 2017;44(1):8-15. doi: 10.1159/000453443. Epub 2017 Feb 21.
citation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.