louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01792440: The Sputum Colour Chart as a Predictor of Lung Inflammation and Proteolysis in Non-cystic Fibrosis Bronchiectasis
Official title: The Sputum Colour Chart as a Predictor of Lung Inflammation, Proteolysis and Damage in Non-cystic Fibrosis Bronchiectasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-cystic Fibrosis Bronchiectasis
Healthy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: non-cystic fibrosis bronchiectasis

Brief summary: Non-cystic fibrosis bronchiectasis patients (and controls) were recruited for the study. The investigators' aim was to study the relevance of clinical parameters in terms of underlying disease severity, proteolysis and inflammation in a diverse non-cystic fibrosis bronchiectasis population.

Detailed description: Patients from the non-cystic fibrosis bronchiectasis (NCFB) outpatient clinic were recruited in our study from September 2009 till July 2010. Control healthy subjects were recruited among peers of the patient or hospital staff during the same period. For the NCFB patients, underlying etiologies of NCFB and Pseudomonas aeruginosa (PA) colonization status were analyzed and each patient was evaluated by means of spirometry (FVC and FEV1), Leicester Cough Questionnaire (LCQ) and Sputum Colour Chart (SCC). SCC assessment was both done by letting the patient predict his sputum purulence prior to sputum induction and by SCC scoring after sputum harvest by the physician.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of NCFB, based on CT findings of bronchiectatic disease in the absence of cystic fibrosis (CF) as a cause.
* stable

Exclusion Criteria:

* no recent exacerbation

Primary outcomes:
measure: Assess predictive value of sputum colour chart to evaluate airway inflammation
timeFrame: 10 months
Secondary outcomes:
measure: Link the degree of airway inflammation to the proteolytic activity of sputum enzymes.
timeFrame: 10 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
state: Vlaams-Brabent
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Pieter Goeminne, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01646840: Study Of The PF-04958242 Blood Concentrations Of A Capsule Formulation Of PF-04958242 Compared To A Solution Formulation
Official title: a Phase 1, Open-Label, Single Dose, Relative Bioavailability Study In Healthy Volunteers Comparing PF-04958242 Capsule Formulation To PF-04958242 Oral Solution In The Fasted State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PF-04958242
bioequivalence
pharmacokinetics
Schizophrenia
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 12
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 will assess the relative bioavailability of a capsule formulation of PF-04958242, relative to a oral solution formulation of PF-04958242 in healthy adult subjects.

Detailed description: This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female (of non childbearing potential) subjects between the ages of 18 and 55 years
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Any condition possibly affecting drug absorption (eg, gastrectomy).

Primary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04958242
timeFrame: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
timeFrame: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose
measure: Apparent Oral Clearance (CL/F)
timeFrame: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose
measure: Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 4 and 192 hours post-dose
Secondary outcomes:
measure: no secondary endpoints
timeFrame: no secondary endpoints
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05176340: Action Modules on Resilience and Psychological Health
Official title: Effect of Action Modules on Resilience and Psychological Health of Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Patients
Keywords: anxiety
depression
resilience
illness representation
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Specific Thematic Nursing Care Action Modules (STNC-AM) platform that we present here is an educational program that integrates education and coaching. STNC-AM has six key aspects: stroke prevention, management of emotions, management of fatigue, physical activity, caregiver training, and integrative resources. Each scope contains detailed care guidance.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to determine whether interventions that use the Specific Thematic Nursing Care Action Modules (STNC-AM) platform improve patients' psychological health over a two-month period.

Detailed description: The STNC-AM platform that investigator present here is an educational program that integrates education and coaching. STNC-AM has six key aspects: stroke prevention, management of emotions, management of fatigue, physical activity, caregiver training, and integrative resources. Each scope contains detailed care guidance. The nurse coaching component was based on the six key aspects detailed above. This online platform can guide nurses' health education for the comprehensive care of stroke patients.

Eligibility criteria: Inclusion Criteria:

* remaining hospitalized within 6 months after a stroke attack.
* being able to communicate verbally.
* being willing to participate.

Exclusion Criteria:

* Aphasia

Primary outcomes:
measure: Illness Perception_change is being assessed
timeFrame: The data collection was conducted at three time points: first week (baseline; Time 1) of admission to the rehabilitation ward and then first month (Time 2) and second month (Time 3) follow-up after discharge.
measure: Depression and Anxiety_change is being assessed
timeFrame: The data collection was conducted at three time points: first week (baseline; Time 1) of admission to the rehabilitation ward and then first month (Time 2) and second month (Time 3) follow-up after discharge.
measure: Resilience_change is being assessed
timeFrame: The data collection was conducted at three time points: first week (baseline; Time 1) of admission to the rehabilitation ward and then first month (Time 2) and second month (Time 3) follow-up after discharge.
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
References:
Clinical trial NCT00661440: Efficacy and Safety Study of Neramexane to Treat Congenital and Acquired Nystagmus
Official title: Efficacy and Safety of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus: a Randomized, Double-blind, Placebo-controlled, Single Center, Proof of Concept Study Using a Two-period Cross-over Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nystagmus, Congenital Idiopathic
Nystagmus, Acquired
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 investigate the safety and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN) in comparison to placebo. In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included; this subgroup will be analyzed in an exploratory manner only.


Eligibility criteria: Inclusion Criteria:

* patients with congenital idiopathic nystagmus or acquired nystagmus subsequent to multiple sclerosis
* male or female outpatients
* aged between 18 and 80 years (inclusive) at screening

Exclusion Criteria:

* patients with evidence of neurologic disorders other than CIN such as congenital nystagmus due to albinism or retinal diseases and/or acquired nystagmus (exemption: secondary to MS)

Primary outcomes:
measure: Visual acuity
timeFrame: Screening, Baseline, Week 3, 7, 11, 14, 18, and Follow-up
Secondary outcomes:
measure: nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University of Leicester, Leicester Royal Infirmary, Ophthalmology Group
Study officials:
affiliation: University of Leicester, Leicester, United Kingdom
name: Irene Gottlob, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00357240: Drug Interaction Study With Proton Pump Inhibitor
Official title: Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Omeprazole 20 mg on the Pharmacokinetics of Atazanavir Administered With Ritonavir in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Protease inhibitor
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-07-27
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this clinical research study is to assess the effect of omeprazole at 20 mg on the pharmacokinetics of atazanavir administered as atazanavir with ritonavir relative to atazanavir or atazanavir/ritonavir in the absence of omeprazole in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects between the ages of 18 to 50 years old with BMI 18 to 32 kg/m2

Primary outcomes:
measure: Effect of omeprazole 20 mg on PK of atazanavir (with ritonavir), coadministered or temporally separated, in healthy subjects.
Secondary outcomes:
measure: PK of ritonavir and omeprazole. Safety and tolerability of atazanavir +/- ritonavir, +/- omeprazole.
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03317340: Environmental Factors to Increase Patient Comfort During Urodynamics Testing
Official title: Environmental Factors to Increase Patient Comfort During Urodynamics Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Urologic Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing urodynamics

Brief summary: Urodynamics is a comprehensive study of the lower urinary tract. Although the information obtained from urodynamics answers several questions and assists in guiding therapies for patients, the testing environments is unnatural and may be distressing for patients. This may impact the results of the study, as it is not uncommon for patients to be unable to void for the test due to their distress. Often to alleviate the distress, music or soothing noises are used in the background. The study aims to identify simple environmental factors which may improve patient experience with urodynamic testing. The population will include patients with existing appointments for urodynamics testing at the Mayo Urology Clinic. The investigators plan to assess patient satisfaction and comfort during this assessment using a visual analog scale questionnaire. The environmental variables will include music of the patients' preference, the sound of running water, or no background noise at all. By asking patients to complete a questionnaire, The investigators will be able to assess ways to improve patient comfort in a commonly used urologic assessment.


Eligibility criteria: Inclusion Criteria:

* All adults undergoing urodynamics
* Must be able to understand and complete questionnaire

Exclusion Criteria:

Primary outcomes:
measure: Comfort level with test based off post-urodynamic survey
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Aqsa A Khan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01139840: Relative Efficacy of Vitamins D2 and D3 in Adult Humans
Official title: Vitamin D Status: Relative Efficacy of Vitamins D2 and D3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: vitamin D2
vitamin D3
ergocalciferol
cholecalciferol
vitamin D status
To determine relative potency of vitamins D2 and D3 under conditions of continuous administration
To determine change in vitamin D content of subcutaneous fat after 12 weeks' administration
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: Health Future Foundation
name: BTR Group
First posted: 2010-06-09
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Vitamin D2 in chronic dosing will produce less of an elevation of serum 25(OH)D than will the same dose of vitamin D3.


Eligibility criteria: Inclusion Criteria:

* willingness to withhold supplement use for duration of study
* willingness to avoid sun exposure for duration of study

Exclusion Criteria:

* vitamin D supplement use
* conditions that affect vitamin D metabolism by the body

Primary outcomes:
measure: AUC for increment in serum 25(OH)D
timeFrame: 12 weeks
Secondary outcomes:
measure: change in vitamin D content of subcutaneous fat
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
Study officials:
affiliation: Creighton University
name: Robert P Heaney, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heaney RP, Recker RR, Grote J, Horst RL, Armas LA. Vitamin D(3) is more potent than vitamin D(2) in humans. J Clin Endocrinol Metab. 2011 Mar;96(3):E447-52. doi: 10.1210/jc.2010-2230. Epub 2010 Dec 22.
Clinical trial NCT01241240: Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Ocular hypertension or primary open-angle glaucoma in each eye
* Requires treatment with IOP-lowering medication in both eyes

Exclusion Criteria:

* Required chronic use of ocular medications during the study other than study medication
* Use of any corticosteroids within 30 days
* History of any prior eye surgery, except for uncomplicated eye surgery performed more than 6 months before the Screening visit
* Anticipated wearing of contact lenses during the study

Primary outcomes:
measure: Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Mean Worse Eye IOP
timeFrame: Baseline, Weeks 1, 2, 4 and 8
measure: Mean Worse Eye IOP
timeFrame: Weeks 1, 2, 4, 8 and 12
Other outcomes:
Locations:
city: Bogotá
country: Colombia
city: Mexico City
country: Mexico
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Hartleben C, Parra JC, Batoosingh A, Bernstein P, Goodkin M. A Masked, Randomized, Phase 3 Comparison of Triple Fixed-Combination Bimatoprost/Brimonidine/Timolol versus Fixed-Combination Brimonidine/Timolol for Lowering Intraocular Pressure. J Ophthalmol. 2017;2017:4586763. doi: 10.1155/2017/4586763. Epub 2017 Sep 19.
Clinical trial NCT00675740: Physical Exercise Versus Rosiglitazone in CAD and Prediabetes
Official title: Effects of Physical Exercise Versus Rosiglitazone on Endothelial Function in Coronary Artery Disease Patients With Prediabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impaired Glucose Tolerance
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2008-05-12
Enrollment: 45
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to prospectively assess the relative benefits of either treatment with rosiglitazone or physical exercise on endothelial function in patients with impaired fasting glucose or impaired glucose tolerance and coronary artery disease (CAD).


Eligibility criteria: Inclusion Criteria:

* impaired fasting glucose or impaired glucose tolerance
* angiographic evidence of coronary artery disease

Exclusion Criteria:

* diabetes mellitus type I or II
* preexisting antidiabetic medication
* unstable angina
* indication for coronary bypass surgery
* significant left main disease
* myocardial infarction within preceding 3 months
* ejection fraction \< 40%
* significant heart valve disease
* severe metabolic disorders
* severe disorders in lipoprotein metabolism
* thyroid disorders
* alcohol or drug abuse
* pregnancy
* participation in another trial

Primary outcomes:
measure: between-group difference in flow-mediated dilation of the brachial artery
timeFrame: 6 months
Secondary outcomes:
measure: relative effects of treatment on parameters of - glucose metabolism - inflammatory plasma markers - markers of endothelial function - cellular markers in muscle and fat biopsies
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06553040: The Effect of Albumin Value, HALP Score, and LCR Value on Predicting Survival and Recurrence in Patients With Pancreatic Adenocarcinoma
Official title: The Effect of Albumin Value, HALP Score, and LCR Value on Predicting Survival and Recurrence in Patients With Pancreatic Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neoplasms
Pancreas Cancer
Keywords: Pancreatic adenocancer
albumin
hemoglobin
lymphocyte
platelet
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included 87 patients who underwent either pancreaticoduodenectomy (Whipple or total pancreatectomy) operations for pancreatic adenocarcinoma in the General Surgery Clinic of Ege University Hospital between January 2017 and December 2021.

Brief summary: The aim of this study is to investigate whether the albumin value and the ratios of biochemical markers; hemoglobin, albumin, lymphocyte and platelet (HALP score) and lymphocyte-C-reactive protein ratio (LCR) can predict the survival and recurrence of the disease in patients with pancreatic adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

* Whipple operation and total pancreatectomy due to pathologically confirmed pancreatic adenocarcinoma

Exclusion Criteria:

* Patients with other malignant tumors (choledochal tumor, papilla tumor and duodenal tumor)

Primary outcomes:
measure: Disease-Free Survival Times
timeFrame: 4 Years
measure: HALP Score
timeFrame: 4 Years
measure: Overall Survival Time
timeFrame: 4 Years
measure: LCR Score
timeFrame: 4 Years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: