louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02414360: Using a Systematic Review in Clinical Decision Making: a Pilot Parallel, Randomized Controlled Trial
Official title: Using a Systematic Review in Clinical Decision Making: a Pilot Parallel, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evidence-Based Medicine
Keywords: Review Literature as Topic
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this pilot study is to determine the feasibility of running a full-scale trial that compares two formats of a shortened systematic review to a full-length systematic review to be used in clinical decision-making.

Detailed description: Two shortened systematic review formats were developed to enhance their use in clinical decision making. An online randomized controlled trial is planned to make comparisons of the shortened formats to a full-length systematic review. To prepare for the full-scale trial, a pilot study will be conducted to test methods and procedures in order to refine the processes.

Eligibility criteria: Inclusion Criteria:

* Physicians who were in practice full- or part-time at study enrollment were recruited for participation
* Participants had to have access to the Internet as the study was conducted online.

Exclusion Criteria:

* The systematic reviews in all formats were only available in English, thus any participants who were not able to read and understand English were not eligible to participate.
* Anyone who had taken part in any phase of the development of the shortened versions of the systematic reviews (cased-based or evidence-expertise formats) were not eligible for recruitment.

Primary outcomes:
measure: Assessment of participant's answers measured using a kappa statistic
timeFrame: 6 months
measure: Rate of recruitment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Perrier L, Persaud N, Ko A, Kastner M, Grimshaw J, McKibbon KA, Straus SE. Development of two shortened systematic review formats for clinicians. Implement Sci. 2013 Jun 14;8:68. doi: 10.1186/1748-5908-8-68.
citation: Perrier L, Kealey MR, Straus SE. An iterative evaluation of two shortened systematic review formats for clinicians: a focus group study. J Am Med Inform Assoc. 2014 Oct;21(e2):e341-6. doi: 10.1136/amiajnl-2014-002660. Epub 2014 May 1.
citation: Perrier L, Kealey MR, Straus SE. A usability study of two formats of a shortened systematic review for clinicians. BMJ Open. 2014 Dec 23;4(12):e005919. doi: 10.1136/bmjopen-2014-005919.
citation: Perrier L, Persaud N, Thorpe KE, Straus SE. Using a systematic review in clinical decision making: a pilot parallel, randomized controlled trial. Implement Sci. 2015 Aug 15;10:118. doi: 10.1186/s13012-015-0303-4.
Clinical trial NCT04789460: Relationship Between Potential Predictors and Mortality in COVID-19 Patients ın Turkey
Official title: Relationship Between Potential Predictors and Mortality in COVID-19 Patients in Turkey: A New Prognostic Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: covid19
ldh
ferritin
mortality
d-dimer
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 816
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized with the diagnosis of covid-19

Brief summary: In this study, the investigators planned to examine the laboratory characteristics of patients hospitalized with the diagnosis of Covid-19 and to investigate their relationship with mortality.

Detailed description: SARS-CoV-2 infection is effective in many countries and has caused pandemics. It is observed that it affects patients in a wide spectrum in terms of their clinical features worldwide. It is known that age, gender, and comorbidity play an important role in the course of the disease. Although mortality rates vary from country to country, there is no clear information due to the fact that the pandemic has not yet ended. In this study, the investigators planned to examine the laboratory characteristics of patients hospitalized with the diagnosis of Covid-19 and to investigate their relationship with mortality in Istanbul city which is the most affected by the pandemic in Turkey

Eligibility criteria: Inclusion Criteria:

* All patients who are 18 years of age and older, positive for SARS-CoV-2 PCR test and / or Covid-19 disease findings on CT will be included in the study.

Exclusion Criteria:

* Patients with negative SARS-CoV-2 PCR test, pneumonia on CT but not given Covid-19 treatment by not considering Covid-19 by their doctor will not be included.

Primary outcomes:
measure: mortality rate
timeFrame: up to 30 days
Secondary outcomes:
measure: need for intensive care unit rate
timeFrame: up to 30 days
measure: length stay in hospital
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: SBU Sultan Abdulhamid Han
state: Asia
Study officials:
affiliation: Sultan Abdülhamid Han Training and Rsearch Hospital
name: Elif Yıldırım Ayaz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05573360: Evaluation of Safety and Tolerability of Ocular Lubricants
Official title: Evaluation of Safety and Tolerability of Ocular Lubricants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2022-10-10
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety profile of test formulations for an artificial tear product versus a comparator product.

Detailed description: Subjects will be randomized to one of five different treatment sequences. Subjects will attend 6 scheduled visits with an expected individual duration of participation of 11 to 42 days. This study will be conducted in Australia.

Eligibility criteria: Key Inclusion Criteria:

* Able to understand and sign an informed consent form.
* Willing and able to attend all study visits as required by the protocol.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any known active ocular disease.
* Any systemic condition that, in the opinion of the investigator, may affect a study outcome variable.
* Any ocular injury to either eye in the past 12 weeks prior to screening.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Number of Treatment-Emergent Adverse Events (AEs)
timeFrame: Up to Day 30 (Study Exit)
measure: Number of Subjects with Biomicroscopy Findings Outside of Normal Limits
timeFrame: Screening, up to Day 30 (Study Exit)
measure: Mean Total Ocular Surface Staining Score
timeFrame: Screening, up to Day 30 (Study Exit)
measure: Mean Best Corrected Visual Acuity (BCVA)
timeFrame: Screening, up to Day 30 (Study Exit)
measure: Number of Device Deficiencies
timeFrame: Up to Day 30 (Study Exit)
Secondary outcomes:
Other outcomes:
Locations:
city: Carlton
country: Australia
facility: Alcon Investigator 8169
state: Victoria
city: Waurn Ponds
country: Australia
facility: Alcon Investigator 8214
state: Victoria
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Dry Eye
role: STUDY_DIRECTOR
References:
Clinical trial NCT04915560: Feasibility of a Physiological Monitoring for Teleassistance to Isolated Workers in Industrial Cleaning
Official title: Etude de faisabilité Portant Sur un Dispositif de Monitoring Physiologique et d'Une Chaine de téléassistance Des Travailleurs isolés au Sein d'Une société de Nettoyage Industriel.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Work-Related Condition
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Ortec International
First posted: 2021-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Percentage of valid data obtains from a professional performing an industrial cleaning task wearing a connected T-shirt.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of the study is to test the feasibility of the monitoring of physiological parameters during operations of industrial cleaning

Detailed description: A letter about TIGER study is sent to employees eligible to participate. For volunteers, a written consent is signed after complete oral and written explanation of the protocol is signed.

On the day of the industrial cleaning task, the employee wears the connected t-shirt and performs the cleaning. Data are retrieved on a 5 min interval basis. Physiological parameters above or beyond pre-defined limits are transmitted as potential alarms to an operational teleassistance center. A missing data (Invalid recording) are considered alarms.

The number and causes of alarms are determined after the end of the cleaning task.

Eligibility criteria: Inclusion Criteria:

* Employee involved in industrial cleaning task of non-ATEX sites (EXplosive ATmosphere)
* Affiliation to the French National healthcare system
* French speaking employee

Exclusion Criteria:

* Contraindication to the measures or procedures provided for in the study (physical characteristics do not allow measurements to be taken, wounds, etc.)
* Pregnancy
* Inability to understand the study goal
* Employee protected by decision of law

Primary outcomes:
measure: Feasibility of T-shirt recording
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of alarms processed in less than 3 minutes
timeFrame: 12 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU
Study officials:
affiliation: University Hospital, Angers
name: Samir HENNI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02026960: RNA Extraction and Amplification From Biopsy Specimens in Subjects With Metastatic Renal Cell Carcinoma (AGS-NTS-017)
Official title: RNA Extraction and Amplification From Biopsy Specimens in Subjects With Metastatic Renal Cell Carcinoma (AGS-NTS-017)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metastatic Renal Cell Carcinoma
Genitourinary Cancer (Bladder, Prostate or Testicular)
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Argos Therapeutics
First posted: 2014-01-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The primary objective is to evaluate methods for AGS-003 production from surgical (stage I) and metastatic biopsy (stage II) Renal Cell Carcinoma (RCC) and a small subset of other GU cancers (expansion cohort) specimens using core needle biopsy in subjects with RCC or other GU cancers. Specifically, this study will evaluate the feasibility of RNA amplification from total tumor RNA isolated from tissues obtained by core needle tumor biopsy.


Eligibility criteria: Inclusion Criteria:

A subject with metastatic RCC, who in the opinion of the treating physician, is a potential candidate for inclusion in this study if all of the following criteria apply:

1. 18 years of age or older.
2. Suspected RCC, in the opinion of the investigator
3. Availability of either:

   * Nephrectomy or other surgically removed tissue (Stage I); or,
   * Metastatic RCC biopsy tissue utilizing needle or core biopsy procedures (Stage II).
4. ≥5 biopsy specimens available from BRPC.

   * Subjects who are having a surgical procedure (i.e. metastasectomy, nephrectomy) will have these core biopsies obtained from the surgical specimen, per the BRPC protocol.
5. Not currently being treated with systemic therapy.

Exclusion Criteria:

1. Tumor tissue is committed to other use or inadequate for RNA analysis.
2. Insufficient tissue is collected in the BRPC.

Expansion Cohort for Genitourinary Cancers:

Inclusion Criteria:

1. 18 years of age or older
2. Suspected bladder, prostate, or testicular cancer, in the opinion of the investigator.
3. Availability of surgically removed tissue or biopsy tissue.
4. At least 2 biopsy specimens available from BRPC
5. Not currently being treated with systemic therapy.

Exclusion Criteria:

1. Tumor tissue is committed to other use or inadequate for RNA analysis.
2. Insufficient tissue is collected in the BRPC.

Primary outcomes:
measure: Success rate for tumor RNA isolation and amplification
timeFrame: At time of surgery or during biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Michael Harrison, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03557060: NUCALA® Special Drug Use Investigation (EGPA, Long-term)
Official title: NUCALA ® Subcutaneous Injection Special Drug Use Investigation (EGPA, Long-term）
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Churg-Strauss Syndrome
Keywords: Nucala
Drug use investigation
EGPA
Long-term
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-06-14
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study.

Brief summary: This study is a drug use investigation program of NUCALA. The objective of this study is to collect and assess information on the safety and effectiveness of the long-term use of NUCALA SC injection in daily clinical practice in subjects with Eosinophilic Granulomatosis with Polyangiitis (EGPA). All subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study. In addition, after the approval, subjects who had already received NUCALA for EGPA prior to the conclusion of the contract will also be included. Approximately 300 subjects will be included in the study. The observation period per subject is up to 96 weeks (2 years) from the start of NUCALA administration for EGPA at a maximum. If a subject has withdrawn from/terminated administration of NUCALA, it will be until the withdrawal/termination. Additionally, to consider the safety and effectiveness of NUCALA administration in subjects who had withdrawn from/terminated due to symptom improvement, 48 weeks (1 year) follow-up investigation should be conducted as much as possible. The total study duration will be approximately 3 years (2 years observation period and 1 year follow-up) from the approval of EGPA indication to the lifting of approval condition. NUCALA is a registered trademark of the GlaxoSmithKline \[GSK\] group of companies.


Eligibility criteria: Inclusion Criteria:

* All subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study. In addition, after the approval, subjects who had already received NUCALA for EGPA prior to the conclusion of the contract will also be included.
* Subjects who had been registered to NCT03028480 for bronchial asthma, but had a change in treatment purpose from bronchial asthma to EGPA during the observation period

Exclusion Criteria:

* Not applicable.

Primary outcomes:
measure: Incidence of adverse drug reactions
timeFrame: Up to 2 years
measure: Response rate based on global assessment of effectiveness
timeFrame: Up to 2 years
measure: Time to EGPA remission and recurrence
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02185560: Prospective, Non-interventional, Post-authorization Safety Study That Includes All Patients Diagnosed as Unresectable Differentiated Thyroid Carcinoma and Treated With Sorafenib
Official title: Drug Use Investigation of Sorafenib/ NEXAVAR® for Unresectable Differentiated Thyroid Carcinoma (DTC)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Thyroid Carcinoma
Keywords: Sorafenib
Differentiated Thyroid Carcinoma,
Japan
Post Marketing Surveillance
Drug Use Investigation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 453
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with Sorafenib for Unresectable Differentiated Thyroid Carcinoma (DTC)

Brief summary: This is a non-interventional, multi center post-authorization safety study that includes all patients diagnosed as Unresectable Differentiated Thyroid Carcinoma (DTC) and treated with Sorafenib within a certain period. The investigator should have made the choice of treatment (NEXAVAR) according with the Japanese Package Insert prior to enrolling the patient in this study.

The enrollment period is of 9 months. The observation period for each patient starts when the therapy with NEXAVAR is initiated. Patients will be followed for 9 months or until it is no longer possible (e.g. lost to follow-up); this will be considered the standard observation period. Those patients, to whom a total of 24 month follow up is possible, information on effectiveness including treatment duration and survival status of the patient and of keratoacanthoma and/or squamous cell cancer development will be collected.


Eligibility criteria: Inclusion Criteria:

* Patients who start NEXAVAR treatment for radioactive iodine-refractory unresectable Differentiated Thyroid Carcinoma (DTC)

Exclusion Criteria:

* Patients who have already received NEXAVAR treatment

Primary outcomes:
measure: Number of participants with Adverse drug reaction as a measure of safety and tolerability.
timeFrame: Up to 9 months
measure: Number of participants with Serious adverse events as a measure of safety and tolerability.
timeFrame: Up to 9 months
measure: Number of participants with Serious adverse drug reaction as a measure of safety and tolerability
timeFrame: Up to 9 months
Secondary outcomes:
measure: 2-year survival
timeFrame: At 24 months
measure: Time of treatment failure (TTF)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05592860: Comparison of Glycemic Control With Smartphone Application
Official title: Comparison of Glycemic Control With Smartphone Application (Vivovitals) - Based Glucose Monitoring to Routine Home Glucose Monitoring in Poorly Controlled T2DM Patients Treated With Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is aimed to determine if a smartphone application based weekly glucose monitoring by a care provider is superior to the routine home glucose monitoring by patients in poorly controlled type 2 diabetes mellitus who are on insulin.

Detailed description: The study is a randomized, prospective cohort study. Subjects will be enrolled randomly after fulfilling the meeting criteria into two groups. Group 1 (intervention group) will used mobile application to enter their glucose level and group 2 (control group) will record their glucose level on daily diary. Data collection will be standardized in order to eliminate bias. In addition, all statistical analyses will be performed by a departmental statistician and not the study investigators. Patients in each arm of the study will be selected form the same population in order to avoid selection bias.

Eligibility criteria: Inclusion Criteria:

* Adult type 2 diabetes mellitus patients (≥ 18years of age) whose HbA1c is ≥8% on insulin.
* At least three months of daily home glucose monitoring before including in the study
* Willing to provide consent to participate in the study4. Uses a smartphone with cellular network and willing to and has ability to learn and use the Vivo vitals application on it.

Exclusion Criteria:

* Patients who have Gestational diabetes or type 1 diabetes
* Patients who have been admitted to the hospital in the last month for more than 3 days.
* Patients who have adrenal disorders or taking exogenous glucocorticoids.
* Patients who are mentally incompetent, having uncontrolled psychiatric conditions, inmates.
* Patients with active malignancies including those on treatment

Primary outcomes:
measure: HbA1c
timeFrame: at the end of 3 months follow-up
Secondary outcomes:
measure: Change in weight
timeFrame: baseline and 3 month
measure: Change in Body Mass Index (BMI)
timeFrame: baseline and 3 month
measure: Change in blood pressure
timeFrame: baseline and 3 month
Other outcomes:
Locations:
city: Jamaica
country: United States
facility: Queens Hospital Center
state: New York
Study officials:
affiliation: Icahn school of medicine Mount Sinai
name: Issac sachmechi, MD, FACE, FACP
role: PRINCIPAL_INVESTIGATOR
References: