louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05936970: Prospective, Multi-Center, Observational, Whole Blood Specimen Collection Study in Participants with Rheumatoid Arthritis with Inadequate Response or Intolerance to a DMARD Starting a New BDMARD or TsDMARD Treatment +/- CsDMARD
Official title: Prospective, Multi-Center, Observational, Whole Blood Specimen Collection Study in Participants with Rheumatoid Arthritis with Inadequate Response or Intolerance to a DMARD Starting a New BDMARD or TsDMARD Treatment +/- CsDMARD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Lead sponsor: Aqtual, Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-10
Enrollment: 1410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults diagnosed with RA who are planning to initiate a new bDMARD +/- csDMARD or tsDMARD +/- csDMARD treatment

Brief summary: The primary goal of this study is to assess a cfDNA-based blood test using genetic, transcriptomic and/or epigenetic information to help doctors predict the best treatment options for rheumatoid arthritis (RA) patients with inadequate response or intolerance to previous therapies.

Detailed description: PRIMA - 102 aims to predict response to bDMARD or tsDMARD therapy through analysis of cfDNA in blood. PRIMA - 102 will enroll participants with inadequate response or intolerance to previous therapies. Participants will undergo screening and baseline visits, followed by the initiation of new bDMARD or tsDMARD therapy per standard of care. The study will evaluate treatment response and disease activity at a 12-week follow-up visit. Blood will be drawn and Clinical Outcome Assessments performed at baseline and at the 12-week follow-up visit.

Eligibility criteria: Inclusion Criteria:

* Ability to understand and provide written informed consent.
* Male or female ≥18 years of age at enrollment.
* Diagnosis of Rheumatoid Arthritis at the time of enrollment.
* Prior treatment with at least 1 csDMARD, bDMARD, or tsDMARD
* Planning to initiate a new bDMARD (+/- csDMARD) or tsDMARD (+/- csDMARD), within 1 month after enrollment.
* Moderate to high Clinical Disease Activity Index (CDAI) of (\>10) with a minimum 4 tender joints and 4 swollen joints at the time of screening.

Exclusion Criteria:

* Unsuitable for participation in the opinion of the principal investigator.

Primary outcomes:
measure: Clinical Response Prediction
timeFrame: Approximately 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Arthritis and Osteoporosis Consultants of the Carolinas
state: North Carolina
Study officials:
affiliation: CEO
name: Diana Abdueva
role: STUDY_DIRECTOR
References:
Clinical trial NCT01883570: Improving Search Strategy for Identifying Urgent Conditions on the Chest X-ray
Official title: Improving Search Strategy for Identifying Urgent Conditions on the Chest X-ray. (Original Title in French: Améliorer la stratégie de Recherche et l'Identification Des Conditions Urgentes Sur Une Radiographie Pulmonaire: Impact de l'Utilisation d'un Logiciel Interactif de Lecture systématique)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Using Expert Visual Search Strategy to Train Students to Read the Chest X-ray
Keywords: visual search strategy, training, chest x-ray
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Currently, teaching X-ray interpretation to medical students is not standardized, and is generally not very effective.

Objective: The goal of our study is to evaluate whether directly teaching an expert search strategy for x-ray interpretation to 3d year medical students is effective.

Methods:

* An expert's visual search strategy was recorded using a gaze-tracking device. The search strategy was then reproduced using a dynamic cursor moving across the corresponding chest x-ray, and incorporated into a teaching program accessible via the internet.
* Participants are 3rd year medical students who will be randomized into two groups. The experimental group will have access to the teaching program as described. The control group will have access to the same x-rays but not the expert's search strategy.
* At the end of the study period the investigators will collect performance data (the participants' accuracy at reading a series of chest x-rays) and process data (using gaze-tracking to evaluate the participants' search strategies); the experimental and control groups will be compared.

Expected results:

The investigators expect the group trained in expert search strategy to show improved accuracy at reading chest x-rays, and an improvement in their visual search strategy


Eligibility criteria: Inclusion Criteria:

* 3rd year medical students enrolled in medicine or surgery rotations during the planned study period

Primary outcomes:
measure: Improvement in medical student's visual search strategy at reading a chest x-ray
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
Study officials:
References:
Clinical trial NCT00682370: Effects of Heme Arginate in Healthy Male Subjects
Official title: Dose Escalation, Randomized, Placebo Controlled Study to Investigate the Effects of Intravenous Heme Arginate on Heme Oxygenase-1 (HO-1) and Heme Metabolism in Association With HO-1 Gene GTn Promoter Polymorphism in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Heme Oxygenase
Genetic Polymorphism
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Heme oxygenase 1 (HO-1) serves as a protective gene. It has been shown that one factor modulating HO-1 activity is a genetic variation in the HO-1 gene (functional GT length polymorphism in the promotor region). Heme arginate is a strong inducer of HO-1 as shown in several animal experimental studies. The aim of this clinical trial is to evaluate the HO-1 stimulation of heme arginate in healthy humans.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure.
* Male aged between 18 and 45 years (inclusive) at screening.
* No clinically significant findings on the physical examination at screening.
* Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) at screening.
* 12-lead ECG without clinically relevant abnormalities at screening.
* Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
* Negative results from urine drug screen at screening.
* Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.

Exclusion Criteria:

* Known hypersensitivity to the study drug or any excipients of the drug formulation.
* Treatment with another investigational drug within 3 months prior to screening.
* History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs.
* Smoking within the last 3 months prior to screening.
* Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening.
* Loss of 250 ml or more of blood within 3 months prior to screening.
* Positive results from the hepatitis serology, except for vaccinated subjects, at screening.
* Positive results from the HIV serology at screening.
* Presumed non-compliance.
* Legal incapacity or limited legal capacity at screening.

Primary outcomes:
measure: The maximal HO-1 mRNA expression in PBMCs
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT01477970: Double GnRH Antagonist Daily Dose in Hyperresponding IVF/ICSI Cycles May Prevent the OHSS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Hyperstimulation Syndrome
Keywords: GnRH antagonists
OHSS
ovarian stimulation
Lead sponsor: Iakentro Fertility Centre
Sponsor class: OTHER
Collaborators: name: Aristotle University Of Thessaloniki
First posted: 2011-11-23
Enrollment: 38
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PILOT STUDY

Brief summary: The possibility to prevent the early ovarian hyperstimulation syndrome (OHSS) by doubling the daily dose of GnRH-antagonist in women stimulated with the antagonist protocol who are at risk for OHSS was evaluated. Thirty-eight women of a study group who underwent ovarian stimulation using the GnRH-antagonist protocol and might have had their cycle cancelled because of OHSS were compared to 76 women of a control group. All cases of the study group were IVF women presenting a rapid rise of E2 ≥ 3500 pg/ml on the 7th day of stimulation or later while the follicles (\> 12mm) were \> 15 in total and the biggest one was ≤ 16mm in diameter. By decreasing the rFSH dose to 100IU a day and adding an additional dose of GnRH-antagonist (0.25 twice a day), estradiol levels were lowered or reached a plateau before hCG was given. A marked decrease or plateau of estradiol levels was observed the day of oocyte retrieval while the pregnancy rate was not adversely affected when compared with an optimum ovarian response cycles. None of the women were cancelled or developed OHSS.

In overresponding IVF cycles, doubling the usual GnRH-antagonist daily-dose during the ovarian stimulation, the estradiol rise could be blocked while a minimal follicular stimulation may continue without the risk of OHSS or adversely affect pregnancy rate.


Eligibility criteria: Inclusion Criteria:

* Women stimulated with the antagonist protocol who are at risk of ovarian hyperstimulation syndrome

Exclusion Criteria:

* Has chosen other preventive protocols (coasting and/or cryopreservation)were excluded

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02237170: Immune Monitoring on Sipuleucel-T
Official title: A Systems Biology Approach to Immune Monitoring in Patients With Castration-resistant Prostate Cancer Receiving SiPuleucel-T
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Sipuleucel-T
Castration Resistant Prostate Cancer
Provenge
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2014-09-11
Enrollment: 36
Sex: MALE
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: Patients will be recruited from those patients who receive their care at Mount Sinai Medical Center, or a participating site

Brief summary: The purpose of this protocol is perform comprehensive immune monitoring studies in patients with castration-resistant prostate cancer receiving Sipuleucel-T in an effort to better understand the mechanism of action of this treatment.

Detailed description: The primary objectives of this study are to:

1. Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T.
2. Determine the induction and the quality of prostate antigen-specific T cell immunity in patients undergoing treatment with Sipuleucel-T.
3. Correlate whole-blood RNA transcript-based signatures with clinical outcomes in patients treated with Sipuleucel-T.
4. Evaluate the cytokine and chemokine milieu in the peripheral blood pre- and post-treatment with Sipuleucel-T.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years of age
* Written informed consent obtained
* Patients with castration-resistant prostate cancer who are initiating Sipuleucel-T as standard therapy
* No prior systemic chemotherapy for metastatic prostate cancer
* Hemoglobin \> 9 mg/dl

Exclusion Criteria:

* Patients unable to understand the research protocol and/or provide informed consent

Primary outcomes:
measure: Change in Regulatory T cells (Tregs)
timeFrame: baseline and 1 year
Secondary outcomes:
measure: Change in Antigen Presenting Cells
timeFrame: baseline and 1 year
measure: Change in Prostate Antigen-specific T Cell Immunity
timeFrame: baseline and one year
measure: Whole-blood RNA transcript-based signatures
timeFrame: baseline
measure: Whole-blood RNA transcript-based signatures
timeFrame: up to 1 year
measure: Change in cytokine milieu
timeFrame: baseline and 1 year
measure: Change in chemokine milieu
timeFrame: baseline and 1 year
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Comprehensive Cancer Center of Nevada
state: Nevada
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Matthew Galsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05024370: Multiparas Attitude to Outpatient Cesarean Section
Official title: Multiparas Attitude to Outpatient Care After Cesarean Section - A Qualitative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Complication
Keywords: qualitative
planned cesarean section
outpatient care
Multiparas attitude
Lead sponsor: Herning Hospital
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 10
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Mulitparas having a planned cesarean section at the department of Obstetrics and Gynecology at Herning Hospital

Brief summary: The main purpose of this study is to explore multiparas attitude to outpatient care after a planned cesarean section.

Detailed description: This qualitative study should provide information about:

* Multiparas reflections in relation to prefer inpatient care after a planned cesarean section
* Womens anticipation of having inpatient care after cesarean section
* The womens experiences in relation to a planned cesarean birth and the first postnatal weeks

Eligibility criteria: Inclusion Criteria:

* Planned elective cesarean section of multiparous women
* Singleton pregnancy
* Age of at least 18
* Gestational age between 37 and 42 weeks

Exclusion Criteria:

* Lack of consent
* Women with no or little understanding of Danish and ability to speak Danish.
* Allergies to medicine included in the pain management regimes
* Expected maternal or neonatal complications after delivery
* Birth weight of less than 2500 grams

Primary outcomes:
measure: womens attitude an reflections about based on interviews
timeFrame: october 2013- june 2014
Secondary outcomes:
Other outcomes:
measure: womens attitude and reflections
timeFrame: october 2013- june 2014
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
affiliation: Department of Obstetrics and Gynecology, Herning Hospital
name: Iben P Lorentzen, Midwife
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02286570: Face-to-face Tracheal Intubation: a Comparison of Airtraq, Glidescope and Fastrach
Official title: Face-to-face Tracheal Intubation With Fastrach or Videolaryngoscopes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intubation Difficult
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Trauma victims had to be intubated at the scene of area in different conditions. Face-to-face intubation in an entrapped patient is one of these situations. The investigators want to compare the efficacy of Glidescope, Airtraq and Fastrach in simulating face-ro-face intubation in adult patients aged between 18-60 years.

Detailed description: The investigators record the demographic and the airway data of the patients (thyromental distance, sternomental distance, mallampati score, mandibula protrusions, interincisor distance..etc). The hemodynamic data of the patients baseline preoperatively, after induction, after insertion of the device, after intubation, and 2 minutes intervals after intubation during the ten minutes. Cormack-Lehane grade of the videolaryngoscopes, insertion time, intubation time, need of optimisation maneuvers, mucosal damage, teeth and tongue damage, postoperative sore throat, hoarseness, dysphagia were recorded.

Eligibility criteria: Inclusion Criteria:

* 18-60 years of age
* Elective surgery requiring endotracheal intubation
* Normal airway variables
* BMI\< 30

Exclusion Criteria:

* \< 18 years or \> 60 years
* Emergency procedures
* Known difficult airways
* BMI\> 30

Primary outcomes:
measure: intubation time
timeFrame: elapsing between the handling of the device till intubation 2 minutes
Secondary outcomes:
measure: mucosal damage
timeFrame: blood on the device after removal 1 minute
measure: postoperative minor complications sore troat, teeth damage, tongue damage, desaturation, hoarseness, disphagia
timeFrame: sore troat, teeth damage, tongue damage, desaturation, hoarseness, disphagia 30 minutes
measure: need of optimisation maneuvers
timeFrame: chandy, side-to-side, handling force, up-down, reinserting 15 minutes
measure: hemodynamic changes (mean arteriial pressure)
timeFrame: entübation and after 15 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Anesthesiology and Reanimation
name: Zehra I ARSLAN, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00296270: Memory for Flu Facts and Myths and Effects on Vaccine Intentions
Official title: "Myths and Facts" About the Flu: Health Education Campaigns Can Reduce Vaccination Intentions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza Vaccines
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2006-02-24
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: ECT

Brief summary: Objectives: To determine whether people systematically misremember the "myths" (false information) as true, and to assess effects on perceptions of risk and behavioral intentions.

Detailed description: Public information campaigns often warn people about false and unreliable medical claims by juxtaposing "myths" and "facts." The effectiveness of such communications has rarely been assessed. We assessed whether people systematically misremember the "myths" (false information) as true, and to assess effects on perceptions of risk and behavioral intentions.

In an experimental study, participants read either a published CDC flyer on "Facts and Myths" about the flu vaccine, or a "Facts Only" version; a separate control group read no flyer. Participants completed the outcome measures either immediately or after 30 minutes.

Primary measures were memory for information about the flu presented in the flyer, ratings of perceived risks associated with the flu, and personal intentions to get vaccinated in the upcoming season.

After a delay of 30 minutes, participants who read the "Facts and Myths" flyer systematically misremembered myths as facts. Both versions of the flyer had the immediate effect of increasing intentions to get a flu vaccine, compared to the control group. After 30 minutes, however, participants who read the "Facts and Myths" flyer reported lower intentions to get vaccinated, compared to those who read the same flyer with no delay, and compared to all participants who read the "Facts Only" flyer.

In sum, people show a bias to think that incompletely remembered information is true, turning "myths" into "facts." Hence public information campaigns should emphasize information that is true. Repeating false information, even as a warning, can create the unintended consequence of belief in the information.

Eligibility criteria: Inclusion Criteria:

* Must be able to read and write fluent English

Exclusion Criteria:

-

Primary outcomes:
measure: Memory for truth of information in a flyer.
Secondary outcomes:
measure: Intention to get flu vaccine in upcoming season.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Toronto
country: Canada
facility: Rotman School of Management, University of Toronto
state: Ontario
Study officials:
affiliation: Rotman School of Management, University of Toronto
name: Ian Skurnik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04298970: Novel Organic Kale Products for Prevention of Obesity/Type 2 Diabetes
Official title: Novel Organic Kale Products for Prevention of Obesity/Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Future Food Innovation
First posted: 2020-03-06
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigating the health beneficial effects of freeze-dried Brassica oleracea var. acephala with a high content of fibers, protein, vitamin, minerals, and secondary metabolites on patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes, dietary treatment and/or with oral anti-diabetics
* Diabetes debut \> 30 year
* Plasma fasting blood glucose \> 4mM and \< 12 mM
* HbA1c \> 43 and ≤ 108 mmol/mol
* BMI between 23-40 kg/m2
* Fasting triglyceride \> 1.7 mmol/L and HDL-cholesterol, men: \< 1.03 mmol/L and women: 1.29 mmol/L.

Exclusion Criteria:

* Participating or have been participating in other clinical trials within the last 2 months.
* In treatment with insulin, systemic glucocorticoids, glitazones or GLP-1 analogs.
* Cardiovascular-, physiological-, neurological-, and/or kidney diseases.
* Alcohol- or pill abuse.
* Acute diseases.
* Blood pressure ≥ 160/100
* Pregnant or breastfeeding women.

Primary outcomes:
measure: iAUC
timeFrame: Throughout the study (up to 1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University
Study officials:
References: