louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04308759: An Innovative Conversational Agent (Quitbot) for Smoking Cessation
Official title: Full Scale Randomized Trial of an Innovative Conversational Agent for Smoking Cessation (QuitBot)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Cigarette Smoking-Related Carcinoma
Keywords: Smoking
smoking cessation
quitting smoking
chatbot
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-03-16
Enrollment: 1647
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This phase III trial compares two remote digital smoking cessation programs to see how well they work for quitting smoking.

Detailed description: OUTLINE:

Participants are randomized to 1 of 2 groups. Both groups receive access to a 42-day quit smoking program.

GROUP I: Experimental program, for 42 days to support quitting smoking. After the completion of study, patients are followed up at 3, 6, and 12 months.

GROUP II: Control program, for 42 days to support quitting smoking. After the completion of study, patients are followed up at 3, 6, and 12 months.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Smokes at least one cigarette a day for the past 12 months
* Wants to quit cigarette smoking within the next 30 days (consistent with text messaging intervention trials)
* If concurrently using any other nicotine or tobacco products, wants to quit using them within the next 30 days
* Interested in learning skills to quit smoking
* Willing to be randomly assigned to either intervention
* Resides in United States (US) and will continue to reside in the US for the next 12 months
* Has at least daily access to their own smartphone
* Has text messaging on their smartphone and knows how to download a smartphone application
* Willing and able to read in English, and
* Not using other smoking cessation interventions (This eligibility requirement helps ensure results are due to the treatments we recommend rather than those that participants are doing on their own.)

Exclusion Criteria:

* The reverse of the inclusion criteria

Primary outcomes:
measure: Number of participants with 30-day biochemically confirmed cigarette smoking cessation
timeFrame: At 12 months after randomization
Secondary outcomes:
measure: Number of participants with 30-day biochemically confirmed cigarette smoking cessation
timeFrame: At 3 and 6 months after randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jonathan B. Bricker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03509259: Cardiovascular Diseases in Elderly Asthma
Official title: Discovering Risk Factors for Cardiovascular Diseases in Elderly Asthma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2018-04-26
Enrollment: 72
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who visited Allergy Clinic in SMG-SNU Boramae Medical Center for asthma or ACO

Brief summary: This study is a cross-sectional study to evaluate the relationship between coronary calcium score and clinical parameters of asthma such as onset of disease, lung function parameter and airway inflammation parameter (sputum eosinophil or FeNO) in Korean elderly asthma (regardless of whether they have concomittent COPD or not) patients

Detailed description: Subjects who visited Allergy Clinic in SMG-SNU Boramae Medical Center for asthma or ACO will be recruited consecutively. Subjects who meets the inclusion criteria and agree to participate in the study will take coronary artery calcium scoring CT and asthma CT (inspiration and expiration images). The correlation between the degree of coronary calcification and airway diameter, airway wall thickness, air-trapping and emphysema will be evaluated as well as clinical parameters of asthma. We will also compare those correlations from the images of healthy control subjects who performed the coronary calcium scoring CT for health checkup purpose.

Eligibility criteria: Inclusion Criteria:

* If the doctor has been diagnosed with asthma and one or more of the following criteria is met;

  1. FEV1 increased more than 12% \& 200 mL after 10-20 minutes of inhalation of short-acting bronchodilator (200-400 mg salbutamol)
  2. Positive bronchial provocation tests (methacholine, mannitol, exercise, aspirin, etc.)
  3. FEV1 Increased more than 12% \& 200 mL from baseline FEV1 after anti-inflammatory treatment for 4 weeks or longer.

Exclusion Criteria:

* Those who were already diagnosed and treated for coronary artery diseases.
* Those with other structural lung diseases such as Tuberculosis destroyed lung and interstitial lung diseases
* Those who are unable to conduct a test or questionnaire due to severe systemic illness, or cognitive dysfunction.
* Those who are participating in other clinical trial using IND(investigational new drug) or finished other clinical trial within 30 days.
* Those who refuse to participate in the study or withdraw the consent.

Primary outcomes:
measure: coronary calcium score
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Min-Suk Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01574859: Central Hypothyroidism and Cardiovascular Risk
Official title: Central Hypothyroidism and Cardiovascular Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypopituitarism
Keywords: central hypothyroidism
hypopituitarism
levothyroxine replacement
lipids
body composition
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients at Rigshospitalet treated for pituitary hypothyroidism in the years 1993 to 2008

Brief summary: Retrospective trial of 300 patients with pituitary insufficiency treated in Department of Medica Endocrinology, Rigshospitalet, Copenhagen University concerning levothyroxine (T4) replacement and cardiovascular risk factors. The hypothesis is that subtle central hypothyroidism is associated with adverse cardiac risk factors, such as body composition and serum lipids, and that improved T4 replacement will eliminate this increased risk, independently of other pituitary hormone replacements.

Detailed description: Retrospective trial of 300 patients with pituitary insufficiency treated in Department of Medical Endocrinology, Rigshospitalet, Copenhagen University concerning levothyroxine (T4) replacement and cardiovascular risk profile. The patient files are recruited among hypopituitary patients treated with growth hormone from the period 1993 to 2008. The trial is a retrospective assessment of data already collected for routine purposes and thus an audit of daily clinical practice. All information on the patients is obtained from the paper and electronic files existing in the department and no new measurements are foreseen.

Eligibility criteria: Inclusion Criteria:

* All patients with pituitary hypopituitarism

Exclusion Criteria:

* Unavailability of data

Primary outcomes:
measure: cholesterol
timeFrame: March 2002 - March 2013
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Ulla Feldt-Rasmussen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00593359: Intraocular Pressure During Spine Surgery
Official title: The Effect of Lactated Ringer's Solution Versus Albumin and the Alpha-2 Agonist Brimonidine Versus Placebo on Intraocular Pressure During Prone Spine Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Pressure
Keywords: Spinal surgery
Prone spinal surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 60
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: PROBABILITY_SAMPLE
Study population: Patients undergoing spinal surgery in the prone position for at least 5 hours.

Brief summary: This study will compare the effect of two intravenous solutions on eye pressure during spine surgery in the following groups:

Group A - Lactated Ringer's replacement for blood loss and placebo eye drops

Group B - Lactated Ringer's replacement for blood loss and brimonidine eye drops

Group C - Albumin replacement for blood loss and placebo eye drops

Group D - Albumin replacement for blood loss and brimonidine eye drops

Detailed description: Patients will be administered either brimonidine eye drops, or placebo eye drops, preoperatively, on the day of surgery and during surgery. Eye pressure will be measured before surgery, every 30 minutes throughout your surgery and every hour for 4 hours following surgery. Subjects will be evaluated before surgery and on days 5, 8, 15 after surgery. During these evaluations, the subject will be asked questions about recovery and his/her eyes will be checked by an ophthalmologist and vision will be tested.

Eligibility criteria: Inclusion Criteria:

* Spine surgery with instrumentation in prone position expected to last at least 5 hours;
* Anticipated blood loss ≥ 1L
* Age 18-80 years old;
* ASA physical status I-III.

Exclusion Criteria:

* History of increased intraocular pressure or glaucoma;
* Diabetic retinopathy;
* Heart failure or serious left ventricular dysfunction;
* Abnormal preoperative fundus examination;
* Creatinine \> 2 mg/dL;
* Patient refuses blood transfusion or albumin administration

Primary outcomes:
measure: The primary outcome will be the maximum intraocular pressure at any time during surgery.
timeFrame: 15 days post surgery
Secondary outcomes:
measure: Intraocular pressure as a function of surgical duration; Velocity of retrobulbar blood flow; Facial edema and or chemosis; Time to extubation; Duration of recovery Correlation between Dpp and FTc.
timeFrame: 15 days post surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05795959: Ensuring Precision-Medicine Delivery for Veterans With Lung Cancer
Official title: Ensuring Precision-Medicine Delivery for Veterans With Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Precision Medicine
Lung Diseases
Lay health worker
Veteran health
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to learn if using a lay VA volunteer, who will assist patients with education regarding precision medicine, can improve care quality and outcomes for Veteran patients with lung cancer.

Detailed description: Participants in the intervention group will receive 1:1 communication with a lay VA volunteer in addition to their usual clinical care. The lay VA volunteer will provide patients with education about precision medicine and support in their care. Researchers will compare a control group who will receive their usual oncology care as provided by clinical teams at the VA. There will be no change in their care.

All participants will be asked to complete a survey at the time of enrollment in the study, and also at 1 month. This survey will measure patient participation in their cancer care, satisfaction with healthcare decisions, and overall questions about knowledge of precision medicine.

Eligibility criteria: Inclusion Criteria:

* All patients 18 years old that have been newly diagnosed with any stage of lung cancer.
* Patients must have the ability to understand and willingness to provide verbal consent.
* Participants must speak English.

Exclusion Criteria:

* Inability to consent to the study, severe mental illness (e.g. schizophrenia) or institutionalization.
* Patients who anticipate moving care outside the Veterans Affairs Palo Alto Health Care System within 6 months.

Primary outcomes:
measure: Knowledge of precision medicine for cancer care from time of enrollment to 1 month post-enrollment
timeFrame: Baseline
Secondary outcomes:
measure: Patient activation using the "Patient Activation Measure" survey
timeFrame: Baseline
measure: Patient activation using the "Patient Activation Measure" survey
timeFrame: 1 month post-enrollment
measure: Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey
timeFrame: Baseline
measure: Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey
timeFrame: 1 month post-enrollment
measure: Receipt of molecular testing
timeFrame: 6 months post-enrollment
measure: Receipt of targeted therapy for those with an eligible molecular target
timeFrame: 6 months post-enrollment
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto
state: California
Study officials:
affiliation: VA Palo Alto
name: Manali I Patel, MD MPH MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03652259: Gene Delivery Clinical Trial of SRP-9003 (Bidridistrogene Xeboparvovec) for Participants With Limb-Girdle Muscular Dystrophy, Type 2E (LGMD2E) (Beta-Sarcoglycan Deficiency)
Official title: A Single-Center, Open-Label, Systemic Gene Delivery Study to Evaluate the Safety, Tolerability, and Efficacy of SRP-9003 Administered by Systemic Infusion in Subjects With LGMD2E (β-Sarcoglycan Deficiency)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Limb-Girdle Muscular Dystrophy, Type 2E
Keywords: limb girdle muscular dystrophy
LGMD2E
beta-sarcoglycan
gene transfer
adeno-associated virus
LGMDR4
Lead sponsor: Sarepta Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-29
Enrollment: 6
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The proposed clinical trial is the first-in-human, single-center, open-label, gene delivery study of SRP-9003 (bidridistrogene xeboparvovec) in participants with LGMD2E.


Eligibility criteria: INCLUSION CRITERIA

* Males or females of any ethnic group
* β-SG deoxyribonucleic acid (DNA) gene mutations at both alleles
* Weakness demonstrated based on history of difficulty in running, jumping and climbing stairs
* A 100 meter walk/run (MWR) test result: ≥40 % of predicted for age-, height-, gender-, and weight-matched healthy controls at the screening visit

EXCLUSION CRITERIA

* Active viral infection based on clinical observations
* Cardiac magnetic resonance imaging (MRI) determined left ventricular ejection fraction (LVEF) \<40%
* Serological evidence of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
* Diagnosis of (or ongoing treatment for) an autoimmune disease
* Abnormal laboratory values considered clinically significant
* Concomitant illness or requirement for chronic drug treatment that, in the opinion of the Principal Investigator, creates unnecessary risks for gene transfer.

Other inclusion/exclusion criteria apply.

Primary outcomes:
measure: Number of Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)
timeFrame: Baseline up to 7 years
Secondary outcomes:
measure: Change From Baseline in Quantity of Beta-Sarcoglycan (β-SG) Protein Expression at Day 60, as Measured by Western Blot
timeFrame: Baseline, Day 60
measure: Change From Baseline in Quantity of β-SG Protein Expression at Day 60, as Measured by Immunofluorescence
timeFrame: Baseline, Day 60
measure: Change From Baseline in Quantity of β-SG Protein Expression at Day 60, as Measured by Immunohistochemistry Percent B-SG Positive Fibers
timeFrame: Baseline, Day 60
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Sarepta Therapeutics, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03418259: Intra-Nasal Mechanical Stimulation (INMEST) as a Treatment of Keratoconjunctivitis Sicca (Dry Eye Syndrome)
Official title: Study of Patients With Dry Eyes, Keratoconjunctivitis Sicca, During Treatment With Intra-Nasal Mechanical Stimulation (INMEST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconjunctivitis Sicca (KCS)
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Källmark Clinic
First posted: 2018-02-01
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded randomised clinical trial
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate how treatment with Intra-Nasal Mechanical Stimulation (INMEST) in the nasal cavity in patients with Keratoconjunctivitis sicca can relieve these symtoms.


Eligibility criteria: Inclusion Criteria:

* Ocular surface disease index, OSDI \> 12 points.
* Non-invasive breakup time, NIBUT \< 11 seconds.

Exclusion Criteria:

* Ocular surface disease index, OSDI \< 12 points.
* Non-invasive breakup time, NIBUT \> 11 seconds.

Primary outcomes:
measure: Ocular surface disease index, OSDI
timeFrame: Change from Baseline Ocular surface disease index at two weeks.
Secondary outcomes:
measure: Noninvasive breakup time, NIBUT
timeFrame: Change from Baseline Noninvasive breakup time at two weeks.
measure: Meibography
timeFrame: Change from Baseline Meibo scale value at two weeks.
measure: Phenol Red Thread Test, PRT
timeFrame: Change from Baseline lacrimation assessed with Phenol Red Thread Test value at two weeks.
measure: Tear (lacrimal) meniscus height
timeFrame: Change from Baseline Tear (lacrimal) meniscus height at two weeks.
measure: Lissamin green test
timeFrame: Change from Baseline spread of dry cell patches quantified with Lissamin green test at two weeks.
measure: Corneal staining with fluorescein
timeFrame: Change from Baseline Efron Grading Scale value at two weeks.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Källmarkskliniken
Study officials:
affiliation: Department of Clinical Science, Intervention and Technology (CLINTEC), H9, Karolinska Institutet
name: Jan-Erik Juto, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06630559: A Study to Compare Efficacy and Safety of CT-P55 and Cosentyx in Patients with Moderate to Severe Psoriasis
Official title: A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P55 with Cosentyx in Patients with Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2024-10-08
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this Phase 3 clinical trial is to compare efficacy and safety of CT-P55 with Cosentyx in patients with moderate to severe plaque psoriasis

Detailed description: CT-P55 is a recombinant humanized monoclonal antibody containing the active ingredient secukinumab. CT-P55 is a drug product being developed by CELLTRION, Inc. and being compared to both the EU-approved Cosentyx®. In this study, Efficacy and Safety of CT-P55 will be evaluated in patients with Moderate to Severe Chronic Plaque Psoriasis.

Eligibility criteria: Inclusion Criteria:

- Patient has had a diagnosis of chronic plaque psoriasis for at least 24 weeks.

Exclusion Criteria:

* Patient diagnosed with forms of psoriasis other than chronic plaque-type or medication-induced psoriasis.
* Patient who has previously received Secukinumab or any other biologic drug directly targeting Interleukin-17 or the IL-17 receptor.
* Patient who has allergies to any of the excipients of study drug or materials of device or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.

Primary outcomes:
measure: Percent change from baseline in Psoriasis Area and Severity Index (PASI) score
timeFrame: Week 12
Secondary outcomes:
measure: Actual PASI scores
timeFrame: Up to 56 Weeks
measure: Percent change from baseline in PASI score
timeFrame: Up to 56 Weeks
measure: Proportion of patients who achieve at least 50/75/90/100% improvement from baseline in PASI (PASI 50/75/90/100)
timeFrame: Up to 56 Weeks
measure: Proportion of patients with IGA score of clear (0) or almost clear (1)
timeFrame: Up to 56 Weeks
measure: Change from baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Up to 56 Weeks
Other outcomes:
Locations:
Study officials:
References: