louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06562764: To Evaluate Newly Developed Pictogram Cards and Their Utility in Improving Inhaler Techniques in Asthmatic Patients
Official title: Role of Pharmaceutical Pictograms in Disease Management: A Mix Method Study of Various Stakeholders in Pakistan
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asthma
Keywords: Pictograms
MDI
DPI
Inhaler
Pictogram cards
Asthma
Lead sponsor: Islamia University of Bahawalpur
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel study is a type of clinical study in which two or more groups of participants receive different interventions. Participants are assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate newly developed pictogram cards and their utility in improving inhaler techniques in asthmatic patients.

Detailed description: A prospective, open-label, randomized controlled clinical study. For this purpose, pictogram cards are designed for Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI).

The pictogram labels are designed and printed in colors with Urdu language and then attached to the inhaler devices as cards. The demographic, clinical, and medical data are collected from the patients and their medical files. Moreover, the different clinical measures are also evaluated in the recruited patients.

Eligibility criteria: Inclusion Criteria:

* Asthmatic Patients, should take inhalers regularly for at least 3 months and come personally for re-fill.

Exclusion Criteria:

* Coexistence of other chronic respiratory conditions.
* Those who were difficult to communicate.

Primary outcomes:
measure: Proper/Improper use of inhaler
timeFrame: 12 weeks
Secondary outcomes:
measure: Determine the adherence via a validated tool named the Medication Adherence Report Scale (MARS-5).
timeFrame: 12 weeks
measure: Determine the Asthma Control in the asthmatic patients via ACT questionnaire.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bahāwalpur
country: Pakistan
facility: The Islamia University of Bahawalpur
state: Bahawalpur
Study officials:
affiliation: The Islamia University of Bahawalpur
name: Dr. Muhammad Atif, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06405464: Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study:Uptake, Outcome, and Risk Factors for Treatment Failures
Official title: Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study: Uptake, Outcome, and Risk Factors for Treatment Failures in a Real-world Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infections
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss HIV Cohort Study
First posted: 2024-05-08
Enrollment: 600
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: The study population consists of SHCS participants initiating the CAB+RPV LA regimen and a matched control population on a SOC oral regimen (including dual drug regimens)

Brief summary: This study aims to characterize Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen, assess adherence to Swiss label indications, and describe treatment outcomes in this large, multicentre, heterogeneous, high-income setting. Moreover, the study aims to assess virological, immunological, demographic, clinical, and behavioural factors associated with viral failure under CAB+RPV LA regimen.


Eligibility criteria: Inclusion Criteria:

* Participant in the SHCS
* All SHCS participants initiating the CAB+RPV LA regimen
* All SHCS participants on SOC oral regimen

Exclusion Criteria:

* Not participating in the SHCS

Primary outcomes:
measure: Proportion of individuals with viral blips
timeFrame: Month 24
measure: Proportion of individuals with confirmed viral failures
timeFrame: Month 24
measure: Proportion of individuals switching off CAB+RPV LA to previous or another oral regimen
timeFrame: Month 24
measure: Time to viral failure
timeFrame: Up to month 24
measure: Proportion of participants who discontinue treatment due to drug-related reasons
timeFrame: Month 24
measure: Proportion of participants who discontinue treatment due to drug-unrelated reasons
timeFrame: Month 24
measure: Proportion of participants by characteristics
timeFrame: Month 24
measure: Overall adherence to Swiss label indication in CAB+RPV LA prescriptions
timeFrame: Month 24
measure: Overall adherence to the proposed injection schedules
timeFrame: Month 24
measure: Proportion of participants by treatment adherence category
timeFrame: Month 24
Secondary outcomes:
measure: Investigate in-depth factors associated with viral blips and viral failure
timeFrame: Month 24
measure: Measure intact proviral DNA as potential predictor for viral failure
timeFrame: Month 24
measure: Assessment of resistance associated mutations from proviral DNA as potential predictor for viral failure
timeFrame: Month 24
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich
name: Jessy J Duran Ramirez, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05807464: Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO18)
Official title: Determination of SpO2 and PR Accuracy Specifications at Rest / Accuracy of Pulse Oximeters With Profound Hypoxia NIHO 18/ Pulse Oximeter Accuracy Evaluation Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Lead sponsor: Nihon Kohden
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2023-04-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers. At least 10 subjects will be recruited to complete the study. Of these 3 will be dark pigmented (FItzpatrick Scale Type 4, 5 or 6). If the number of samples is less than the required 200 or if less than 3 of dark pigment subjects successfully complete the study, subjects will be added to include 3 of dark pigmented subjects and at least 200 data points.

Brief summary: The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.

Detailed description: This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.

Eligibility criteria: Inclusion Criteria:

* Both male and female subjects who can give written informed consent
* Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
* Meeting the demographic requirements

Exclusion Criteria:

* Age below 18 or over 50
* Pregnant women
* Significant arrhythmia
* Blood pressure above 150 systolic or 90 diastolic
* Carboxyhemoglobin levels over 3%
* Subjects whom the investigator consider ineligible for the study

Primary outcomes:
measure: Accuracy of Sensor Oxygen Saturation by Arms Calculation
timeFrame: 30 seconds
Secondary outcomes:
measure: Accuracy of Sensor Pulse Rate by Arms Calculation
timeFrame: 30 seconds
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Hypoxia Research Laboratory
state: California
Study officials:
affiliation: UCSF Hypoxia Research Laboratory
name: Philip Bickler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04494464: Treatment Rates and Compliance to Treatment in Patients With Familial Hypercholesterolemia
Official title: Awareness, Treatment Rates and Compliance to Treatment in Patients With Serum LDL Cholesterol Higher Than 250 mg/dL, and Possible, Probable or Definite Familial Hypercholesterolemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Familial Hypercholesterolemia
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years old and have a serum LDL-C≥250 mg/dL

Brief summary: Familial hypercholesterolemia is a genetic disease characterized by increased levels of low density lipoprotein cholesterol (LDL-C). It is underdiagnosed and undertreated despite relatively high prevalence and significant association with increased mortality.

Detailed description: Patients older than 18 years old and have a serum low density LDL-C≥250 mg/dL were identified from the hospital database. A questionnaire was completed via phone. Patients were classified as definite, probable and possible familial hypercholesterolemia according to Dutch Lipid Clinical Network Criteria

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old and have a serum LDL-C≥250 mg/dL

Exclusion Criteria:

* Patients who refuse dto interview
* Serum TSH≥10 mIU/mL
* Glomerulonephritis or nephrotic syndrome
* ALT or AST higher than 3 times of normal limits
* Serum triglyceride \>400 mg/dL

Primary outcomes:
measure: Treatment rates
timeFrame: January 2010 and December 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Yaman S, Ozdemir D, Akman BT, Cakir B, Ersoy O. Awareness, treatment rates, and compliance to treatment in patients with serum LDL cholesterol higher than 250 mg/dL, and possible, probable, or definite familial hypercholesterolemia. Postgrad Med. 2021 Mar;133(2):146-153. doi: 10.1080/00325481.2020.1805212. Epub 2020 Sep 23.
Clinical trial NCT00174564: EXIBIT: Oxaliplatin in Biliary Tract Cancer
Official title: A Multicentre Phase II Trial of Gemcitabine and Oxaliplatin (GEMOX) in Patients With Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Biliary Tract Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the efficacy of the GEMOX treatment as 1st line therapy in patients with advanced biliary tract cancer based on response rate measured by the RECIST unidimensional criteria.

Secondary objectives are : Progression free survival, overall survival and safety.


Eligibility criteria: * Histologically proven, locally advanced or metastatic carcinoma of the biliary tract (gallbladder, intrahepatic bile ducts, extrahepatic bile ducts, ampula of Vater)
* For intrahepatic bile ducts, if the diagnosis of biliary tract origin is not evident by imaging or surgical exploration, and so equivalent to liver metastasis with unknown primary site, inclusion is possible if:

  * unknown primary after an exhaustive search for the primary site (chest radiography- , thoracic and abdomino pelvic CT scan, colonoscopy, oesogastroduodenal endoscopy, PSA determination for men or mammography for women, and PET scan if possible).
  * histological examination compatible with adenocarcinoma of bile ducts with the immunostaining expression of cytokeratin : 7+, 20- and 19 +. (Shimonishi, 2000 \^22)
* No prior chemotherapy for advanced disease (first line)
* No radiation therapy within 4 weeks prior to the first gemcitabine administration.
* Unidimensionally measurable disease.
* For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
* No known allergy to one of the study drugs
* No prior malignancy
* No CNS metastases
* No peripheral neuropathy \> grade 2
* ECOG PS \<=2
* ANC \> 1.5 X 10\^9 /L
* Platelets \> 100 X 10\^9 /L
* Creatinine \< 1.5 x ULN
* SGPT (ALT) \< 5 x ULN
* Bilirubin \< 2.5 x ULN (patients with jaundice or evidence of bile duct obstruction and in whom the biliary tree can be decompressed by endoscopic percutaneous endoprothesis, with subsequent reduction in bilirubin \< 2.5 x ULN will be eligible for the study).

Primary outcomes:
measure: To evaluate response rate according to RECIST criteria
Secondary outcomes:
measure: To evaluate the progression-free survival in the ITT population
measure: To investigate safety using NCI-CTC criteria version 2
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Jean-Philippe Aussel
role: STUDY_DIRECTOR
References:
Clinical trial NCT06170164: Radiation Treatment of Lymph Node Recurrence From Prostate Cancer : is 11C-choline PET/CT Predictive of Survival Outcomes?
Official title: Radiation Treatment of Lymph Node Recurrence From Prostate Cancer : is 11C-choline PET/CT Predictive of Survival Outcomes?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 68
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study is retrospective observational and the results of the choline PET diagnostic tests of 68 patients performed at our center from 2005 to 2013 were reviewed.

Brief summary: The role of PET/CT with Choline in the restaging of prostatic disease is now universally recognized, and its use has become routine in numerous centers in Italy and abroad. The indication for the test is provided exclusively by an increase in PSA. It was interesting to understand whether these prognostic factors have an influence on the probability of detecting disease by PET with Choline to identify patients who have a greater probability of benefiting from the use of this method with the possibility of identifying the disease in earlier stages.


Eligibility criteria: Inclusion Criteria:

* patients operated with radical prostatectomy
* patients that present biochemical recurrence of the disease;

Exclusion Criteria:

* patients \<18 years

Primary outcomes:
measure: PET/CT with Choline in the restaging of prostatic disease.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Irccs San Raffaele
state: Italia
Study officials:
References:
Clinical trial NCT02578264: Molecular Stethoscope
Official title: Molecular Stethoscope for Colon Cancer Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Neoplasms
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
Collaborators: name: Sequenom, Inc.
First posted: 2015-10-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colorectal cancer that will be receiving surgical removal of their cancer as part of their care.

Brief summary: The study aims to provide a more complete characterization and understanding of the genetic causes of and tumor DNA detection potential in colorectal cancer. Ultimately findings of this study will be used to develop early detection tests for colorectal cancer that are minimally invasive (based on a blood test). It is hoped that reliable, minimally invasive, early detection methods will lead to improved screening rates, increased screening safety, longer colorectal cancer survival, and overall cost savings.

In order to assess the test's ability to detect tumor DNA, 25 participants with known colorectal cancer who will be undergoing surgical resection of the colon as part of their clinical care will be recruited. The investigators will collect blood from participants prior to surgery, tumor and normal tissue removed during surgery, a series of blood samples after surgery for up to one year and relevant medical records. DNA variants identified in blood will be compared against tissue samples. Serial samples will be analyzed to assess the variance in amount of circulating tumor DNA across time with standard treatment.


Eligibility criteria: Inclusion Criteria:

* Colorectal cancer sent for surgical colonic resection (all stages) OR
* High risk adenoma sent for surgical colonic resection

Exclusion Criteria:

* Chemotherapy before surgical treatment
* Invasive procedure resulting in damage to tissue (e.g., surgery, biopsy, thermal ablation) in the 7 days prior to baseline (pre-surgical) blood collection
* Radiation therapy before surgical treatment
* Bone marrow transplant

Primary outcomes:
measure: Determining sensitivity of assay in known cancer patients
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Scripps Translational Science Institute
name: Eric Topol, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02119364: Working Memory Training for Children With Cerebral Palsy
Official title: Computer Based Working Memory Training in Children With Cerebral Palsy (CP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
working memory
cognitive training
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: Helse Sor-Ost
First posted: 2014-04-21
Enrollment: 115
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cerebral palsy (CP) is the most common motor disability in childhood (2-3 per 1000 live born), and is frequently accompanied by cognitive impairments and behavioural problems. The present study is a controlled clinical trial, a multicenter-study involving three health regions, as well as the Norwegian University of Science and Technology (NTNU). Its primary research goal will be to evaluate the effects of computer-based cognitive training in children with CP. In addition, this study will be the first to conduct a comprehensive neuropsychological examination to improve our understanding of cognitive impairments as well as cognitive resources in CP children in Norway to aid in intervention planning.


Eligibility criteria: Inclusion Criteria:

* Cerebral Palsy
* School age (7-15 years of age)

Exclusion Criteria:

* Not able to use computer, blind, deaf

Primary outcomes:
measure: Spatial span
timeFrame: 9-12 weeks after inclusion
Secondary outcomes:
measure: Verbal working memory
timeFrame: 9-12 weeks after inclusion
Other outcomes:
measure: Attention Deficit Hyperactivity Disorder rating scale
timeFrame: 9-12 weeks after inclusion
measure: Activity of daily life
timeFrame: 9-12 weeks after inclusion
measure: Attention/executive functions assessed by parents
timeFrame: 9-12 weeks after inclusion
Locations:
city: Arendal
country: Norway
facility: Sorlandet Hospital
state: Aust-Agder
Study officials:
affiliation: Department of Child rehabilitation, Sørlandet Hospital, Arendal, Norway
name: Gro CC Lohaugen, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lohaugen GC, Beneventi H, Andersen GL, Sundberg C, Ostgard HF, Bakkan E, Walther G, Vik T, Skranes J. Do children with cerebral palsy benefit from computerized working memory training? Study protocol for a randomized controlled trial. Trials. 2014 Jul 7;15:269. doi: 10.1186/1745-6215-15-269.
Clinical trial NCT04901364: Study of Risk Factors for Intraductal Papillary Mucinous Neoplasms Degeneration at the Nancy CHRU (IPMN)
Official title: Sensitivity and Specificity Study of Risk Factors for Intraductal Papillary Mucinous Neoplasms Degeneration at the Nancy CHRU (IPMN)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Study of Risk Factors for IPMNs Degeneration at the Nancy CHRU
Keywords: IPMNs
Intraductal Papillary Mucinous Neoplasms
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a Branch Duct, Main Duct or mixed IPMNs operated at the Nancy CHRU between September 2009 and October 2021

Brief summary: Cystic lesions of the pancreas are frequent with a risk of degeneration into adenocarcinoma with pejorative prognosis.

IPMNs require characterization to clarify their potential for degeneration. Clinical and morphological risk factors for degeneration determine the monitoring rate and the indication for pancreatic surgery.

Pancreatic surgery remains invasive with high morbidity and mortality rates.

Detailed description: This is a monoservice and monocentric retrospective study at the Nancy CHRU. We will study the risk factors for IPMNs degeneration in order to determine the most sensitive and specific.

To do this, we will use high-grade dysplasia or invasive cancer on the histological analysis of surgical specimens as the primary endpoint.

The study population will be patients with Branch Duct, Main Duct or mixed IPMNs operated at the Nancy CHRU between September 2009 and October 2021.

Eligibility criteria: Inclusion Criteria:

* Patients with a Branch Duct, Main Duct or mixed IPMNs operated at the Nancy CHRU between September 2009 and October 2021, adults and without legal protection measures

Exclusion Criteria:

* IPMNs not operated
* Pancreatic cancer without IPMNs
* Patients whose state of health contraindicates pancreatic surgery
* Non-adult patient
* Patients under legal protection

Primary outcomes:
measure: High-grade dysplasia or invasive cancer
timeFrame: 12 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Jean-Baptiste CHEVAUX
Study officials:
affiliation: Centre Hospitalier Regional Universitaire de Nancy
name: Jean Baptiste JC CHEVAUX
role: PRINCIPAL_INVESTIGATOR
References: