louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00161304: Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency
Official title: Effects of Testosterone Administration on Tissues of Men With A.D.A.M. (Androgen Deficiency of Aging Men)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Men With Low Testosterone Levels
Lead sponsor: Urological Sciences Research Foundation
Sponsor class: OTHER
Collaborators: name: Solvay Pharmaceuticals
name: Watson Pharmaceuticals
First posted: 2005-09-12
Enrollment: 44
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels.

Detailed description: The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels. The primary objectives of the study are to measure the changes in tissue hormones and other biomarkers in the prostate tissue specimens.

Eligibility criteria: The screening evaluation consisted of:

1. medical history, which included the androgen deficiency of the aging male questionnaire
2. physical examination
3. multiphasic serum panel
4. measurement of total serum testosterone and PSA levels

Exclusion criteria included:

1. use in the past 6 months of any drug potentially affecting the pituitary-gonadal axis
2. serum PSA level greater than 10.0 ng/mL
3. refusal or inability to undergo prostate biopsies
4. presence of prostate cancer on initial biopsy results.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Culver City
country: United States
facility: Urological Sciences Research Foundation
state: California
Study officials:
affiliation: Urological Sciences Research Foundation
name: Leonard S Marks, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marks LS, Mazer NA, Mostaghel E, Hess DL, Dorey FJ, Epstein JI, Veltri RW, Makarov DV, Partin AW, Bostwick DG, Macairan ML, Nelson PS. Effect of testosterone replacement therapy on prostate tissue in men with late-onset hypogonadism: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2351-61. doi: 10.1001/jama.296.19.2351.
Clinical trial NCT02359604: The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy: a Pilot Study
Official title: The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Keywords: infant
ppi
proton pump inhibitor
microbiome
Microbiota
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 12
Sex: ALL
Minimum age (years): 3
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal study
Primary purpose: BASIC_SCIENCE

Brief summary: Proton Pump Inhibitors (PPI) are standard in the therapy of pediatric GERD. In the past it has been hypothesized, that either direct inhibition of bacterial ATPase or elevation of the pH may lead to changes in the intestinal microbiome. Small series published in adults suggest a predominance of streptococci, a possible reason for increased incidences of pneumonia under PPI therapy. Studies in children are yet scarce.

This study will include 20 infants. GERD will be verified by 24h-intraluminal impedance monitoring. All patients will have undergone conservative measures prior to initiation of PPI therapy (due to persisting symptoms). Children will receive a commercial PPI for 8 weeks (esomeprazole 1mg/kg/day). Stool samples will be collected before initiation of PPI, under PPI (4 weeks after initiation) and 8 weeks after discontinuing PPI therapy. The intestinal microbiome will be determined by 16S rDNA-based microbial community profiling by high-throughput pyrosequencing.

Data will be compared by dependent non parametric test (Wilcoxon). P-values \<0.05 will be considered statistically significant.


Eligibility criteria: Inclusion Criteria:

symptomatic GERD (proved by impedance monitoring) despite conservative treatment requiring PPI therapy

Exclusion Criteria:

neurological impairments

Primary outcomes:
measure: microbial community profiling of stool to include: rate [or prevalence] of specific phyla [i.e. Proteobacteria and Firmicutes], contributing to fecal microbial communities
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Pediatric and Adolescent Surgery, Medical University of Graz
state: Styria
Study officials:
affiliation: Dept. of Pediatric and Adolescent Surgery, Medical University Graz
name: Christoph Castellani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castellani C, Singer G, Kashofer K, Huber-Zeyringer A, Flucher C, Kaiser M, Till H. The Influence of Proton Pump Inhibitors on the Fecal Microbiome of Infants with Gastroesophageal Reflux-A Prospective Longitudinal Interventional Study. Front Cell Infect Microbiol. 2017 Oct 11;7:444. doi: 10.3389/fcimb.2017.00444. eCollection 2017.
Clinical trial NCT04408404: Factors Influencing Perioperative Mortality in Type A Acute Aortic Dissections Operated at Dijon University Hospital
Official title: Factors Influencing Perioperative Mortality in Type A Acute Aortic Dissections Operated at Dijon University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Dissection
Lead sponsor: Centre Hospitalier La Chartreuse
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent aortic dissection surgery in Dijon Burgundy University Hospital since the 01 January 2007 and the 31 december 2017.

Brief summary: Type A acute aortic dissections are a rare condition whose natural evolution is catastrophic. Global mortality remains high even if it decreased last years. This is probably due to improvement of diagnostic techniques and the evolution of surgical practices. It is however important to have medical data and statistics obtained in past years in order to better understand the factors influencing peroperative mortality and thereby to continue this improvement.


Eligibility criteria: Inclusion Criteria:

* patients who underwent aortic dissection surgery in Dijon Burgundy University Hospital

Exclusion Criteria:

* patients who died before the surgical incision

Primary outcomes:
measure: Monitor peri-operative mortality incidence rates
timeFrame: 1 day
Secondary outcomes:
measure: Monitor peri-operative morbidity incidence rates
timeFrame: 1 day
Other outcomes:
Locations:
city: Dijon
country: France
facility: Cardiovascular and thoracic surgery Unit - Dijon University Hopital
Study officials:
References:
Clinical trial NCT05088304: GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer
Official title: The Application Value of Preoperative Fat-free Mass Index Within GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of Stomach
Cancer of Esophagus
Malnutrition
Muscle Loss
Keywords: FFIM
GLIM
Cancer
Postoperative complications
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: Jiangsu Cancer Institute & Hospital
name: Subei People's Hospital of Jiangsu Province
name: Peking Union Medical College
First posted: 2021-10-21
Enrollment: 205
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: Elective surgery for esophagogastric cancer (there was a clear pathological diagnosis before surgery)

Brief summary: The present study aims to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the Global Leadership Initiative on Malnutrition (GLIM) criteria.

Detailed description: The GLIM criteria of malnutrition as a consensus lack of optimal combination in clinical validation. After the publication of the GLIM consensus, few studies have examined the effect of reduced FFMI on the clinical prognosis of patients with esophagogastric cancer, and whether the FFMI can be used as an effective diagnostic criterion of malnutrition in esophagogastric cancer needs to be further studied.

Therefore, the present study aims were to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the GLIM consensus for malnutrition.

Eligibility criteria: Inclusion Criteria:

Elective surgery for esophagogastric cancer (there was a clear pathological diagnosis before surgery); NRS2002≥3; Preoperative BIA examination was performed.

Exclusion Criteria:

Discharged from a hospital within 24 hours; No BIA examination and not suitable for BIA examination (such as ascites, edema, amputation and pace-maker); Hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin\>3mg/dL) ; Renal insufficiency (serum creatinine\>1.5mg/dL); Emergency operation; Pregnancy; Missing the postoperative information follow-up data.

Primary outcomes:
measure: postoperative complications
timeFrame: Within 60 days after surgery
Secondary outcomes:
measure: length of stay (LOS)
timeFrame: Within 60 days after surgery
measure: wound healing time
timeFrame: Within 60 days after surgery
measure: postoperative antibiotic time
timeFrame: Within 60 days after surgery
measure: nutritional status
timeFrame: up to 4 weeks
measure: hospitalization cost
timeFrame: Within 60 days after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00209404: Iodixanol in Multidetector-Row Computed Tomography-Coronary Angiography (MDCT-CA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: MDCT
Coronary Artery
Heart Rate
Image Quality
Diagnostic Quality
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Image quality in coronary artery computed tomography is influenced by the heart rate variation during the examination. The purpose of this clinical trial is to investigate the change in heart rate following injection of a contrast medium called Visipaque™ (iodixanol). Image quality and diagnostic quality of the examination will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Subjects with low to moderate suspicion of coronary artery disease referred for retrospective electrocardiogram (ECG)-gated multidetector row computed tomography coronary angiography and with a heart rate \>75 beats per minute (bpm) will be included.

Exclusion Criteria:

* Subjects who take medications that slow down the heart rate or present cardiac arrhythmia at rest will not be included.

Primary outcomes:
measure: Change in mean heart rate
Secondary outcomes:
measure: Image quality
measure: Diagnostic quality
measure: Overall diagnostic information
measure: Frequency and intensity of adverse events
Other outcomes:
Locations:
city: Velizy Cedex
country: France
facility: Amersham Health S.A.
Study officials:
affiliation: GE Healthcare
name: Jean-Paul Antonini
role: STUDY_DIRECTOR
References:
Clinical trial NCT05919004: Uncontrolled Postviral Asthma and Persistent Symptoms After COVID-19
Official title: Uncontrolled Postviral Asthma in Patients With Long Covid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long COVID
Keywords: postviral asthma
diagnosis
long covid
telemedicine
lung function
digital spirometer
Lead sponsor: The Norwegian Sports Medicine Centre - Football Association, Oslo, Norway
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with long covid for more than 6 months

Brief summary: Patients with long covid referred for physical rehabilitation at the Norwegian Sports Medicine Centre - Football Association in Oslo, Norway, were assessed for postviral asthma.

Detailed description: All patients performed methacholin bronchial provocation test, and those with a negative bronchial provocation were eqipped with an app-based spirometer to detect excessive lung variability. Eventual detection of postviral asthma will be treated according to GINA guidelines and eventual effect will be assessed by lung function variability and symptoms.

Eligibility criteria: Inclusion Criteria:

° Patients with long covid for more than 6 months referred for physical rehabilitation

Exclusion Criteria:

° None

Primary outcomes:
measure: Excessive lung function variation
timeFrame: 8 months
measure: Perceived symptoms of long covid
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Idrettens Helsesenter
Study officials:
References:
Clinical trial NCT05348304: Hypoglycemic Effects of a Dietary Supplement With Inositols, Gymnema Silvestre, Alpha-lactalbumin and Zinc.
Official title: Hypoglycemic Effects of a Dietary Supplement That Combines the Properties of Myo-inositol and D-chiro-inositol With Gymnema Silvestre, Alpha-lactalbumin and Zinc.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolism Disorder
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2022-04-27
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is aimed at evaluating the hypoglycemic effects of a dietary supplement that associates the properties of two inositols (myo-inositol and D-chiro-inositol) in the ratio 40:1 to Gymnema sylvestre, alpha-lactalbumin and zinc.


Eligibility criteria: Inclusion Criteria:

* BMI between 30 and 35
* Basal Glycemia between 100 and 125 mg/dl

Exclusion Criteria:

* Diabetes diagnosis
* Use of food supplements containing inositols, gymnema, alpha-lactalbumin and zinc
* Intolerance to inositols, gymnema, alpha-lactalbumin and zinc

Primary outcomes:
measure: Insulinemia
timeFrame: Three time points: change in insulin levels from the baseline to three and six months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sapienza University of Rome
state: RM
Study officials:
affiliation: University of Roma La Sapienza
name: Sabrina Basciani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06493604: A Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease
Official title: A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Keywords: reproxalap
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-10
Enrollment: 116
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: A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Detailed description: Dry eye chamber challenge trial

Eligibility criteria: Inclusion Criteria:

* 18 years of age (either gender and any race)
* Ability to provide written informed consent and sign the Health Information Portability and Accountability Act form
* Reported history of ocular discomfort associated with dry eye disease for at least 6 months prior to Visit 1
* Reported history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

Exclusion Criteria:

* Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters
* Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
* Contact lens use within 7 days of Visit 1 or anticipated use of contact lenses during the trial
* Previous laser-assisted in situ keratomileusis surgery within the last 12 months
* Systemic corticosteroid or other immunomodulator therapy (not including inhaled corticosteroids) within 14 days of Visit 1, or any planned immunomodulatory therapy throughout the clinical trial
* Use of and unwillingness to discontinue topical ophthalmic prescriptions (including medications for glaucoma) or over-the-counter solutions (not including artificial tears), gels, or scrubs for the duration of the trial (excluding medications allowed for the conduct of the trial)

Primary outcomes:
measure: Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 1 and Visit 3
timeFrame: Day -14 to Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References:
Clinical trial NCT00670904: Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation
Official title: Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Smoking
Keywords: Smoking cessation
Pharmacist-delivered
Lead sponsor: University of Montana
Sponsor class: OTHER
Collaborators: name: Prevent Cancer Foundation
First posted: 2008-05-02
Enrollment: 101
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized trial compared the effectiveness of a three session pharmacist-delivered group program for smoking versus one 5 to 10 minute standard care session delivered over the telephone on 7-day point prevalence quit rates. Participants in both groups were offered their choice of bupropion IR or nicotine patch at no cost. At 6 months after the established quit date, self-reported cessation was biochemically verified using tests for urinary cotinine.


Eligibility criteria: Inclusion Criteria:

* Smoked one or more cigarettes daily for 7 days
* Somewhat ready to quit in the next 2 weeks (4 or more on a 10- point scale)
* Willing and capable of attending three scheduled sessions at the clinic
* Interested in participating in the study

Exclusion Criteria:

* Planned to leave the area in the next 6 months
* Used pharmacotherapy for smoking cessation in the last 30 days
* Used other forms of tobacco in the last 30 days
* Schizophrenia
* Prior participation

Primary outcomes:
measure: The primary outcome variable for the study was biochemically verified 7-day point prevalence smoking cessation at 6 months, defined as having smoked no cigarettes - not even a puff - for the previous 7 days.
timeFrame: 6 months
Secondary outcomes:
measure: Secondary outcomes included 30-day point prevalence abstinence and prolonged abstinence (>6 months).
timeFrame: 6 months
Other outcomes:
Locations:
city: Missoula
country: United States
facility: Missoula VA Clinic
state: Montana
Study officials:
affiliation: The University of Montana
name: Larry A. Dent, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00530504: Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
Official title: Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Artery Disease
Keywords: Carotid Artery Disease
Embolic Protection
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2007-09-17
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purposes of this study are:

1. To provide additional safety and effectiveness information on the commercial use of Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection Device.
2. To evaluate rare and unanticipated adverse events.
3. To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.


Eligibility criteria: Inclusion Criteria:

* 18 years and above
* Informed consent
* Intent to use the PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX and SpiderFX™ to treat carotid artery disease per Instructions for Use
* Meet Instruction for Use (IFU)/ Centers for Medicare \& Medicaid Services (CMS)defined anatomical or clinical high risk criteria

Exclusion Criteria:

* Subjects with contraindications as outlined in the Instructions for Use

Primary outcomes:
measure: Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Kingsport
country: United States
facility: Wellmont Medical Center
state: Tennessee
Study officials:
affiliation: MidWest Cardiology Research Foundation
name: Gary Ansel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: William Beaumont Hospitals
name: Robert Safian, MD
role: PRINCIPAL_INVESTIGATOR
References: