louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02863965: High Definition Endoscopy and Optic Enhancement Endoscopy in Gastric Neoplasia: A Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Neoplasia
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with dyspeptic symptoms and aged 40 years or older, or with Helicobacter pylori infection, histologically verified gastric intestinal metaplasia or atrophic gastritis, or with family history of gastric cancer

Brief summary: The aim of the study is to evaluate the diagnostic value of high definition endoscopy and optic enhancement in gastric neoplasia.


Eligibility criteria: Inclusion Criteria:

* patients with dyspeptic symptoms and aged 40 years or older
* or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
* or patients with family history of gastric cancer

Exclusion Criteria:

* presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
* presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
* inability to provide informed consent

Primary outcomes:
measure: Sensitivity of optical enhancement endoscopy in diagnosis of gastric neoplasia
timeFrame: 8 months
measure: Specificity of optical enhancement endoscopy in diagnosis of gastric neoplasia
timeFrame: 8 months
measure: Positive predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia
timeFrame: 8 months
measure: Negative predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia
timeFrame: 8 months
Secondary outcomes:
measure: The inter-observer and intra-observer agreement of optic enhancement endoscopy in gastric neoplasia
timeFrame: 8 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology, Qilu Hospital, Shandong University
name: Yanqing Li, PhD. MD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02519465: Evaluation of Lung Deposition of Aerosol Via HFNC in Healthy Adults
Official title: Evaluation of Lung Deposition of Aerosol Via HFNC in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: nasal cannula
Inhalation Devices
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2015-08-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aerosol associated with noninvasive ventilation (NIV) and high flow therapy with nasal interface have been employed in an attempt to relieve respiratory distress and optimize the deposition of drugs by inhalation.

Some studies report the effects of NIV association with fogging in healthy subjects, asthmatics and COPD 7.8, but studies evaluating the association between high flow nasal mist interface and therapy are scarce and most are found in vitro and animal models. The objective of this study is to evaluate the deposition of the aerosol scintigraphy using the high flow nasal interface system with vibrating mesh nebulizers using in healthy adults.


Eligibility criteria: Inclusion Criteria:

* The study included healthy individuals of both sexes,
* between 18 to 65 years,
* without history of lung disease and forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1) higher or equal to 80% from predicted values,
* ability to verbal commands understand and
* willing to provide signed consent to participate in this study.

Exclusion Criteria:

* Participants were excluded if there unable to understand and follow the procedures and were pregnant and unable to tolerate nebulization.

Primary outcomes:
measure: radioaerosol deposition index into the lungs
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Laboratório de Fisiologia e Fisioterapia Cardiopulmonar
state: Pernambuco
Study officials:
affiliation: UFPE
name: Luciana Alcoforado, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alcoforado L, Ari A, Barcelar JM, Brandao SCS, Fink JB, de Andrade AD. Impact of Gas Flow and Humidity on Trans-Nasal Aerosol Deposition via Nasal Cannula in Adults: A Randomized Cross-Over Study. Pharmaceutics. 2019 Jul 7;11(7):320. doi: 10.3390/pharmaceutics11070320.
Clinical trial NCT06522165: Pediatric Oncological Orthopaedic Reconstruction
Official title: Pediatric Oncological Orthopaedic Reconstruction : "Analysis of the Clinical and Radiographic Results"
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bone Tumor
Bone Cancer
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 400
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female pediatric patients surgically treated with an oncological reconstruction from 1991 to 2023

Brief summary: From the archives of the Rizzoli institute all the children undergoing oncological reconstruction from 1991 to 2023 (approximately 400 patients). A review will be made of the medical records, radiological imaging, and histological data of these patients


Eligibility criteria: Inclusion Criteria:

* Diagnosis of bone sarcoma
* Patients with available clinical and imaging data

Exclusion Criteria:

* At least one inclusion criteria not met

Primary outcomes:
measure: longevity of the reconstruction
timeFrame: at baseline (day 0)
Secondary outcomes:
measure: complications
timeFrame: at baseline (day 0)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Itituto Ortopedico Rizzoli
state: BO
Study officials:
References:
citation: Abdeen A, Hoang BH, Athanasian EA, Morris CD, Boland PJ, Healey JH. Allograft-prosthesis composite reconstruction of the proximal part of the humerus: functional outcome and survivorship. J Bone Joint Surg Am. 2009 Oct;91(10):2406-15. doi: 10.2106/JBJS.H.00815.
citation: Aponte-Tinao LA, Ayerza MA, Muscolo DL, Farfalli GL. Allograft reconstruction for the treatment of musculoskeletal tumors of the upper extremity. Sarcoma. 2013;2013:925413. doi: 10.1155/2013/925413. Epub 2013 Feb 14.
citation: Azoury SC, Shammas RL, Othman S, Sergesketter A, Brigman BE, Nguyen JC, Arkader A, Weber KL, Erdmann D, Levin LS, Kovach SJ, Innocenti M. Outcomes following Free Fibula Physeal Transfer for Pediatric Proximal Humerus Reconstruction: An International Multi-Institutional Study. Plast Reconstr Surg. 2023 Apr 1;151(4):805-813. doi: 10.1097/PRS.0000000000010001. Epub 2022 Dec 6.
Clinical trial NCT01530165: (Pakistan Diabetes Prevention Program PDPP)
Official title: A Translation Randodomized Trial of Culturally Specific and Cost Effective Life Style Intervention for the Prevention of Type 2 Diabetes in Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State & High Risk Individuals on the Basis of Diabetes Risk Score
Keywords: IFG
IGTT
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: International Diabetes Federation
name: University of Helsinki
First posted: 2012-02-09
Enrollment: 1564
Sex: ALL
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Intervention versus Control
Primary purpose: PREVENTION

Brief summary: The Karachi-based Pakistan Diabetes Prevention Study aims to address key issues in the prevention of type 2 diabetes. Approximately 20,000 people From four communities will be screened for diabetes risk factors using a non-invasive diabetes risk-score system. Those found to be at increased risk will be given an oral glucose tolerance test. People who, after the oral glucose tolerance test, are identified as having prediabetes or normal but with risk factors such as raised BMI and/or history of hypertension will have the opportunity to take part in the Pakistan Diabetes Prevention Study lifestyle intervention. This consists of culturally adjusted preventive strategies focusing on diet and physical activity in real-life settings. Another important aspect of this trial will be to assess the impact of urban planning on the prevalence of obesity and diabetes.

Detailed description: The aim of this study is to translate the life style intervention project to prevent diabetes into real life settings in Karachi, Pakistan, home to one sixth of the world's population.

Eligibility criteria: Inclusion Criteria:

-Adult men and women between 30-64 years of age

Exclusion Criteria:

* Diagnosed type 1 or type 2 diabetes
* Pregnancy or presence of chronic disease rendering survival for three years unlikely
* Any psychological or physical disability to interfere with participation in the study
* Ischemic heart disease

Primary outcomes:
measure: Incidence of Type 2 Diabetes
timeFrame: 2 yrs
Secondary outcomes:
measure: Components of Metabolic syndrome
timeFrame: 2 years
measure: The impact of city planning on prevalence of obesity and type 2 diabetes
timeFrame: 2 years
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Aga Khan University Hospital
state: Sindh
Study officials:
affiliation: The Aga Khan University Hospital
name: Asma Ahmed, MRCP(UK)
role: PRINCIPAL_INVESTIGATOR
affiliation: The Aga Khan University Hospital
name: Jaweed Akhter, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01571765: MNCH Programming in Southwest Uganda Maternal and Child Health In Bushenyi and Rubirizi Districts, UGANDA
Official title: Scaling Up Maternal and Child Health In Bushenyi and Rubirizi Districts, UGANDA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Mortality
Maternal Mortality (All Cause)
Keywords: maternal
newborn
child
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian International Development Agency
First posted: 2012-04-05
Enrollment: 10985
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators will assess whether in Bushenyi District in southwestern Uganda, a two year intervention providing comprehensive MNCH programming will:

* Reduce morbidity and mortality for children under five years old and;
* Improve access to maternal health services Compared to a control community without MNCH intervention?

Hypothesis:

Comprehensive maternal, newborn and child health programming in Bushenyi Distrcit can have a positive impact on morbidity and mortality for children under five years and will improve access for women to maternal health services which may lead, in the longer term, to decreased maternal mortality.

Detailed description: A detailed impact assessment will be carried out for the duration of the MNCH training and support initiative in Bushenyi District, using mixed methods. The study will assess 8 of the 11 key core MNCH indicators as identified by CIDA as a priority. Other information to be collected such as demographics and patterns of health care use, and prevalence of disease will help health planners in the districts, and will be helpful in sub analysis and interpretation of findings. The main study will use household surveys in both districts at baseline, midline and endline. Other tools will include pre and post qualitative surveys (FGDs, KII) and analysis of operational data.

The main study group will be representative communities and health centres within Bushenyi District who will receive intervention between 2012 and 2014; Rubirizi District will serve as a control area for this study but will received selected MNCH services starting in 2013 after midline data are collected.

Eligibility criteria: Inclusion Criteria:

* all households living in selected communities; all women 15-49 living in selected communities Exclusion Criteria: none

Primary outcomes:
measure: Reduced morbidity for children under five years old
timeFrame: 2 years
Secondary outcomes:
measure: improved maternal access to health services
timeFrame: 24 months
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara University of Science and Technology
Study officials:
affiliation: University of Calgary
name: Jennifer Brenner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mbarara University of Science and Technology
name: Jerome Kabakyenga, MBBS, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01855165: The Role of Clinical Pharmacist in Management of DDIs in CHF Patients
Official title: The Role of Clinical Pharmacist's Intervention in Management of Clinically Relevant Drug-drug Interactions in Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Heart Failure
Keywords: chronic heart failure
drug-drug interactions
pharmacist's intervention
Lead sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Drug-drug interactions (DDIs) are common in patients with chronic heart failure (CHF) and their incidence increases with the number of drugs that the patients are prescribed for treatment of their condition. Data bases often detect DDIs that are of high clinical relevance. The investigators have performed this study in order to detect clinically significant DDIs and to diminish their occurrence by sending notification about DDIs to attending physician.


Eligibility criteria: Inclusion Criteria:

* Patients admitted with diagnosis of CHF I50.0 - I50.9 and I11.0 - I11.9 (ICD-10)
* patients treated with at least two drugs

Exclusion Criteria:

* Patients admitted to other conditions

Primary outcomes:
measure: To assess the difference in frequency and severity of clinically significant DDIs in control arm and interventional arm between admission and discharge
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Golnik
country: Slovenia
facility: University Clinic Golnik
Study officials:
affiliation: University Clinic Golnik
name: Mitja Lainscak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roblek T, Deticek A, Leskovar B, Suskovic S, Horvat M, Belic A, Mrhar A, Lainscak M. Clinical-pharmacist intervention reduces clinically relevant drug-drug interactions in patients with heart failure: A randomized, double-blind, controlled trial. Int J Cardiol. 2016 Jan 15;203:647-52. doi: 10.1016/j.ijcard.2015.10.206. Epub 2015 Oct 28.
Clinical trial NCT06619665: A Study of MK-6552 in Sleep Deprived Healthy Participants (MK-6552-003)
Official title: A Randomized, Double-blind, 3-Period Crossover Study to Assess the Effects of MK-6552 on Sleep Latency in Sleep Deprived Healthy Participants With Modafinil as a Positive Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Narcolepsy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study examined the safety of the drug MK-6552 and if people tolerated it. It also studied whether MK-6552 works better than placebo for staying awake in sleep deprived healthy participants.


Eligibility criteria: Inclusion Criteria:

Criteria include but are not limited to the following:

* Is in good health
* Body Mass Index (BMI) between 18 and 32 kg/m\^2, inclusive.

Exclusion Criteria:

Criteria include but are not limited to the following:

* History of or current hypertension,
* Has a history of sleep disorders:

Primary outcomes:
measure: Participants with an Adverse Event (AE)
timeFrame: Up to Day 30
measure: Participants who discontinued from study due to an AE
timeFrame: Day 1
measure: Maintenance of Wakefulness Test (MWT) for MK-6552
timeFrame: Postdose time to maximum plasma concentration (Tmax) (at designated timepoints up to 24 hours postdose)
Secondary outcomes:
measure: Area under the concentration=time curve (AUC) for plasma MK-6552
timeFrame: At designated timepoints up to 24 hours postdose
measure: Concentration of plasma MK-6522 at Tmax following morning (AM) dose
timeFrame: Tmax following AM dose (at designated timepoints up to 24 hours postdose)
measure: Concentration of plasma MK-6522 at Tmax following afternoon (PM) dose
timeFrame: Tmax following PM dose (at designated timepoints up to 24 hours postdose)
measure: Concentration of plasma MK-6552 8 hours (C8h) after first dose
timeFrame: 8 hours
measure: Concentration of plasma MK-6552 24 hours (C24h) after first dose
timeFrame: 24 hours
measure: MWT for Modafinil
timeFrame: 2 hours postdose
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: NeuroTrials Research Inc (Site 0001)
state: Georgia
city: Eatontown
country: United States
facility: Clinilabs (Site 0003)
state: New Jersey
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00487565: Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System
Official title: LCS® PS: A Prospective, Multi-center Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Rheumatoid Arthritis
Post-traumatic Arthritis
Juvenile Arthritis
Keywords: Total knee replacement
Total knee arthroplasty
Osteoarthritis
Rheumatoid or other inflammatory arthritis
Post-traumatic or juvenile arthritis
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2007-06-18
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, multi-center clinical study to evaluate the clinical outcomes of the posterior stabilized design of the LCS® Complete Mobile-bearing Total Knee System

Detailed description: Prospective, multi-center study to evaluate the clinical outcome of posterior stabilized design of LCS® Complete Mobile-Bearing Total Knee System. No comparison group. 12 month enrollment, 12 month post-operative evaluation. Follow-up intervals: Pre-op, 3 month, 6 month, and 12 month.

Eligibility criteria: Inclusion Criteria:

* M/F
* 18-80
* Diagnosis of osteoarthritis, rheumatoid , post-traumatic, inflammatory, juvenile arthritis.
* Skeletally mature, sufficient bone stock to seat and support prosthesis
* Willing/able return for follow-up.
* Subject is willing and able to provide informed patient consent for participation in the study

Exclusion Criteria:

* History of recent/active joint sepsis, charcot neuropathy, psycho-social disorders, prior knee arthroplasty on affected site, metabolic disorders of calcified tissue
* Communicable diseases that may limit follow-up
* Medical-legal or workers compensation claims.

Primary outcomes:
measure: Knee Active Flexion
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
city: Pittsburgh
country: United States
facility: Joint Reconstruction Center
state: Pennsylvania
city: Virginia Beach
country: United States
facility: Jordan-Young Institute
state: Virginia
Study officials:
affiliation: DePuy
name: Tammy O'Dell, EMT, CCRA, CCRC
role: STUDY_DIRECTOR
References:
Clinical trial NCT01778465: Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease
Official title: Effect of Low Dietary Salicylate on Biochemical Markers of Aspirin Exacerbated Respiratory Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinosinusitis
Aspirin Exacerbated Respiratory Disease
Asthma
Aspirin Sensitivity
Keywords: Chronic Rhinosinusitis
Aspirin exacerbated respiratory disease
Asthma
Aspirin sensitivity
Salicylate
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Aspirin-Exacerbated Respiratory Disease, or AERD, consists of aspirin sensitivity, asthma and nasal polyps. It is currently managed by chronic steroid use, multiple endoscopic sinus surgeries and/or aspirin desensitization. However, these treatments have potential adverse effects.

A theory has been postulated that decreasing the level of dietary salicylates may help in long-term control of disease. A current trial is in the works to evaluate the clinical outcomes of decreased salicylate, but measurements of biochemical markers of disease has not yet been done. The hypothesis is that decreased dietary salicylates will result in a decrease in urinary salicylates and inflammatory markers of disease, cys-leukotrienes, which are typically elevated in this disease.


Eligibility criteria: Inclusion Criteria:

* adult patients
* Aspirin-exacerbated respiratory disease

Exclusion Criteria:

* recent use of Prednisone or other systemic steroids (greater than 3 doses in past 3 months)
* Endoscopic sinus surgery or polypectomy within the past 6 months
* Other significant systemic disease, including renal failure, or immunocompromised state.

Primary outcomes:
measure: Urinary Levels of Cys-Leukotrienes
timeFrame: 14 days after commencement
measure: Urinary Salicyluric Acid Levels
timeFrame: 14 days after commencement
measure: Urinary Salicylic Acid Levels
timeFrame: 14 days after enrollment
measure: Urinary Creatinine Levels
timeFrame: 14 days after commencement
Secondary outcomes:
measure: Sino-Nasal Outcome Test (SNOT-22)
timeFrame: 14 days after commencement
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
Study officials:
affiliation: Lawson HRI
name: Leigh J Sowerby, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sowerby LJ, Patel KB, Schmerk C, Rotenberg BW, Rocha T, Sommer DD. Effect of low salicylate diet on clinical and inflammatory markers in patients with aspirin exacerbated respiratory disease - a randomized crossover trial. J Otolaryngol Head Neck Surg. 2021 Apr 23;50(1):27. doi: 10.1186/s40463-021-00502-4.