louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04278625: Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease
Official title: Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric congenital heard disease patients undergoing cardiac surgery and receiving IV acetaminophen during their surgical procedure as standard of care.

Brief summary: This is a prospective study of pediatric patients with congenital heart disease, in which acetaminophen serum concentrations will be measured following a single intraoperative intravenous dose of acetaminophen. These levels will be used to develop a pharmacokinetic model. Serum concentrations will be compared between two groups of patients: (1) cyanotic patients presenting for the Fontan completion operation and (2) patients with acyanotic congenital heart disease presenting for repair via median sternotomy.


Eligibility criteria: Inclusion Criteria:

* Patients presenting for Fontan palliation or for surgical repair requiring median sternotomy, will be included in the study.
* Only patients who receive intravenous acetaminophen in the operating room will have serum levels drawn.

Exclusion Criteria:

* Documentation of an allergy to acetaminophen
* Severe hepatic disease or other contraindications to acetaminophen use
* Patient has received acetaminophen within 24 hours of their procedure

Primary outcomes:
measure: Acetaminophen Serum Concentrations
timeFrame: 15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; and 6-Hours Post-IV acetaminophen administration
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT05533125: Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Recently Diagnosed
Official title: Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Polymyalgia Rheumatica
Lead sponsor: Sint Maartenskliniek
Sponsor class: OTHER
Collaborators: name: Dutch Arthritis Association
name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2022-09-08
Enrollment: 114
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polymyalgia rheumatica (PMR) is prevalent among elderly. Untreated, it leads to major reduction in quality of life. Glucocorticoids are the cornerstone of treatment, but have drawbacks, warranting glucocorticoid sparing treatment. A proof of concept study on Rituximab (RTX) vs placebo showed efficacy in 48 vs 21%(p=0.049) in glucocorticoid free remission after 21 weeks (Marsman et al. 2021). Though promising, the short study duration and small sample size require further confirmation. Therefore a larger randomised controlled trial with longer follow up will be performed on RTX efficacy on glucocorticoid free remission in newly diagnosed PMR patients during glucocorticoid taper.


Eligibility criteria: Inclusion Criteria:

* Polymyalgia rheumatica diagnosis fulfilling the 2012 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria
* Diagnoses less than 12 weeks ago
* Glucocorticoid treatment less than 8 weeks and with dose equivalent of prednisolone ≤ 30 mg/day
* Informed consent

Exclusion Criteria:

* treatment with systemic immunosuppressants (other than glucocorticoids) 3 months prior to inclusion;
* (clinical) suspect concomitant giant cell arteritis or other rheumatic inflammatory diseases;
* concomitant conditions that might significantly interfere with PMR pain or movement evaluation as judged by the investigator;
* previous hypersensitivity for RTX or contra-indications to RTX.

Primary outcomes:
measure: Between group difference in percentage of patients in glucocorticoid-free remission
timeFrame: At week 52
Secondary outcomes:
measure: Percentage of patients in glucocorticoid-free remission
timeFrame: 21 weeks
measure: Percentage of patients with glucocorticoid dose of ≤5mg/day
timeFrame: 52 weeks
measure: Number of relapses
timeFrame: 52 weeks
measure: Time to glucocorticoid-free remission
timeFrame: 52 weeks
measure: Time to relapse
timeFrame: 52 weeks
measure: Cumulative glucocorticoid dose
timeFrame: 52 weeks
measure: Percentage of patients needing RTX/Placebo retreatment
timeFrame: 52 weeks
measure: Adverse events
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Ubbergen
country: Netherlands
facility: Sint Maartensklineik
state: Gelderland
Study officials:
affiliation: Sint Maartenskliniek
name: Aatke van der Maas, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06077825: Effects of Lower Limbs Symmetrical Loading on Risk of Fall
Official title: Does Symmetrical Lower Limb Loads Distribution Effects Balance and Risk of Fall After Total Hip Arthroplasty?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Replacement
Keywords: total hip arthroplasty
static balance
postoperative rehabilitation
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective: To assess the impact of total hip arthroplasty (THA) on functional outcomes and fall risk in patients with hip osteoarthritis. The objective was to investigate the effectiveness of physical therapy in postoperative rehabilitation and identify fall risk factors to guide fall prevention strategies after THA.

Methods: A non-randomized, interventional clinical trial was conducted with 30 patients scheduled for THA. Functional outcomes were evaluated using the Harris Hip Score (HHS), 40-meter fast-paced walk test (40mFPWT), 30-Second Chair Test, and Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). Balance and fall risk were assessed using the Single-Leg Standing Test and a posturography device (TETRAX). The Nottingham Health Profile (NHP) was used to measure subjective health status and quality of life. Assessments were performed preoperatively, at 6 weeks postoperatively, and at 3 months postoperatively.


Eligibility criteria: Inclusion Criteria:

* Clinical and radiographic evidence of unilateral hip osteoarthritis
* Volunteering to participate in the study

Exclusion Criteria:

* History of neurologic disorders affecting postural control (e.g., Parkinson disease)
* Have other problems that affect balance, such as vertigo
* Undergoing revision hip surgery
* Osteoarthritis in the other lower extremity joints

Primary outcomes:
measure: Harris Hip Score (HHS)
timeFrame: preoperative, postoperative 6 weeks and 3 months
measure: 40-meter fast-paced walk test
timeFrame: preoperative, postoperative 6 weeks and 3 months
measure: 30-Second Chair Test
timeFrame: preoperative, postoperative 6 weeks and 3 months
measure: Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: preoperative, postoperative 6 weeks and 3 months
measure: Static balance and fall risk
timeFrame: preoperative, postoperative 6 weeks and 3 months
measure: Single-Leg Standing Test
timeFrame: preoperative, postoperative 6 weeks and 3 months
Secondary outcomes:
measure: The Nottingham Health Profile (NHP)
timeFrame: preoperative, postoperative 6 weeks and 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Acibadem Maslak Hospital
name: Selvi Yüce, PhD(c)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04720625: Adapt2Quit - An Adaptive Motivational System for Socio-Economically Disadvantaged Smokers
Official title: Adapt2Quit - A Machine-Learning, Adaptive Motivational System: RCT for Socio-Economically Disadvantaged Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
name: Johns Hopkins University
name: Baystate Health
First posted: 2021-01-22
Enrollment: 757
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this research is to test the Adapt2Quit computer program that uses participant input (message rating on how much the text motivational message might influence one to quit smoking) to select and text motivational messages that are more likely to help a user stop smoking. This Adapt2Quit system will be compared with a quitline facilitation-only control (text messages will be sent to facilitate quitline use). The primary research hypothesis is that the Adapt2Quit recommender-selected messages will be more effective than a texting quitline facilitation-only control for smoking cessation among socioeconomically disadvantaged (SED) smokers.


Eligibility criteria: Inclusion Criteria:

* Current smoker
* Socioeconomically disadvantaged (SED) (using the following criteria: unemployed or underemployed, low income as defined by the federal poverty level guidelines, uninsured or underinsured, and/or have less than a high school education)
* English-speaking
* Active in care (at least two clinical visits in the last year)
* Have a texting-enabled cell phone

Exclusion Criteria:

* Not a current smoker
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners
* Pregnant women
* Pilot study participants

Primary outcomes:
measure: Self-Reported Participant Tobacco Cessation Rate (quit rate)
timeFrame: 6-months post-randomization
measure: Biochemical Carbon Monoxide (CO) Verification of Tobacco Cessation
timeFrame: 6-months post-randomization
Secondary outcomes:
measure: Time to First Quit Attempt
timeFrame: From randomization to 6-months post-randomization
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Springfield
country: United States
facility: Baystate Health
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: Associate Professor
name: Rajani Sadasivam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04896125: Comparison of Different Drugs on Ocular Surface Disease in Glaucoma Patients: a Prospective Randomised Study
Official title: Comparison of Benzalkonium Chloride-containing Latanoprost and Preservative-free Bimatoprost on Ocular Surface Disease in Glaucoma Patients: a Prospective Randomised Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma; Ocular Disorders (I.E. Caused by Ocular Disorders)
Keywords: Benzalkonium chloride
Ocular surface disease
Latanoprost
Bimatoprost
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were considered eligible for enrolment if they were newly diagnosed with glaucoma and started to receive ocular hypotensive eye drops at our clinic.

Brief summary: Participants were randomised to receive benzalkonium chloride-containing latanoprost (Xalatan) or preservative-free bimatoprost (Lumigan). Through this study, the investigators would like to analyze the impact of different antiglaucoma medications on ocular surface disease in glaucoma patients.

Detailed description: The purpose of our study is to assess the effect of antiglaucoma medication on ocular surface disease in glaucoma patients before and after treatment with different antiglaucoma medication. All included patients are newly diagnosed with glaucoma and received no previous antiglaucoma treatment. Medical records will be collected prospectively from Sep. 15th 2019 to Aug. 31st 2022. The symptoms and signs of ocular surface disease in each individual will be assessed with questionnaire and clinical exams, including the basal Schirmer's test, non-invasive tear film breakup time, meibography, and in vivo confocal microscopy before and at 1, 3, 6 months after treatment.

Eligibility criteria: Inclusion Criteria:

* Patients are not diagnosed with glaucoma and don't receive any ocular hypotensive eye drops at our clinic.
* Patients accept the rules for follow-up visits for at least six months.

Exclusion Criteria:

* Patients are with a history of ocular trauma.
* Patients are with contact lens use.
* Patients are diagnosed with secondary glaucoma.
* Patients have significant diseases affecting the meibomian gland and ocular surface.
* Patients have poor IOP control that required additional ocular hypotensive eye drops.

Primary outcomes:
measure: The influence of glaucoma eye drops on ocular surface disease index (OSDI) in patients
timeFrame: Change from Baseline OSDI at 1 month
measure: The influence of glaucoma eye drops on ocular surface disease index (OSDI) in patients
timeFrame: Change from Baseline OSDI at 4 month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT02548325: Prevalence of Hepatitis B in Vallés Occidental. Observational Multicentric Study
Official title: Prevalence of Hepatitis B in Vallés Occidental. Observational Multicentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Hospital Mutua de Terrassa
name: Consorci Sanitari de Terrassa
First posted: 2015-09-14
Enrollment: 1001
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The are Included consecutively for one year ( 1 June 2014 to 31 May 2015 ) all patients who are in the inclusion criteria

Brief summary: The aim of this study is to evaluate the prevalence of hepatitis B in Vallés Occidental. Also, describe the stage of the disease, and whether if they are under medical treatment or not.

Detailed description: The hepatitis B virus ( HBV ) is a global health problem . It is estimated that in the world there are about 350-400 million carriers of HBV surface antigen ( HBsAg ) 1 .

The prevalence in Spain is estimated at a 2-7 % and is considered a second intermediate prevalence.

For over 20 years, has carried out a program of primary prevention through universal vaccination against hepatitis B including it in the childhood vaccination schedule and has already been observed that in some estudi3 the prevalence has declined . For this reason , we want to evaluate what is the currently prevalence in our area of influence. There aren't recent studies to assess what is the current status of these patients ( how many , what risk factors which needs of treatment and with answer ...)

Eligibility criteria: Inclusion Criteria:

* Patients with HBsAg + visited in Digestive/Hepatology outpatient visits and Hepatology of the participating hospitals

Exclusion Criteria:

* Patients \< 18 aged
* Duplicity on record

Primary outcomes:
measure: prevalence hepatitis B
timeFrame: 12 months
Secondary outcomes:
measure: stage of the disease and if they are in treatment or not
timeFrame: 1 day
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Mútua de Terrassa
state: Barcelona
Study officials:
References:
Clinical trial NCT02242825: Study to Evaluate the Effect of Micardis® / MicardisPlus® on Metabolic Parameters in Patients With Essential Hypertension and Diabetes Mellitus
Official title: Micardis® / MicardisPlus® Monitoring of Morning Hypertension and Metabolism II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-17
Enrollment: 8148
Sex: ALL
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 with hypertension and diabetes mellitus recruited by cardiologists, nephrologists or diabetologists

Brief summary: The primary objective is to evaluate the effect of the treatment with Micardis® or MicardisPlus® on blood pressure. Secondary objectives are the effect of Micardis® / MicardisPlus® on metabolic parameters (triglycerides, cholesterol, blood glucose and HbA1c) in patients with essential hypertension and diabetes mellitus


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Hypertension
* Diabetes mellitus

Exclusion Criteria:

* Age \< 18 years

Primary outcomes:
measure: Change from Baseline in systolic blood pressure (SBP)
timeFrame: Baseline, after 6 months
measure: Change from Baseline in diastolic blood pressure (DBP)
timeFrame: Baseline, afterr 6 months
Secondary outcomes:
measure: Assessment of efficacy by investigator on a 6-point scale
timeFrame: after 6 months
measure: Assessment of metabolic effect on a 4-point scale
timeFrame: after 6 months
measure: Change from Baseline in laboratory parameters
timeFrame: Baseline, after 6 months
measure: Assessment of tolerability by investigator on a 5-point scale
timeFrame: after 6 months
measure: Number of patients with adverse events
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02621125: Fertilix Supplements and Assisted Reproductive Technology
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Spermatozoa
Lead sponsor: University Reproductive Associates
Sponsor class: OTHER
Collaborators: name: CellOxess LLC
First posted: 2015-12-03
Enrollment: 0
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double blind, randomized, placebo controlled clinical trial to test the efficacy of the antioxidant formulation Fertilix® in lowering the levels of damaged sperm DNA in men diagnosed with moderate to high Sperm Oxidative DNA Damage (SODD)


Eligibility criteria: Inclusion Criteria:

* Males with a sperm sample containing 8-OHdG levels \> 15% and must be capable of producing an ejaculate containing \>10million sperm upon study enrollment.
* Male is between 20-55 years of age seeking treatment for infertility with his partner at URA and who is a candidate for an IUI, IVF or IVF-ICSI (excluding donor egg) procedure.
* Female is between 20-42 years of age
* Female exhibits tubal patency on hydrosonogram or hysterosalpingogram (HSG)
* Female exhibits normal uterine cavity by hysteroscopy, hydrosonogram or hysterosalpingogram (HSG).

Exclusion Criteria

* Subjects with initial semen analysis of an ejaculate containing \< 10 million sperm.
* Men who have been taking nutraceuticals, vitamins or other compounds known to have antioxidant activities within4 weeks of the study. No other supplements may be taken with Fertilix.
* Men who have hypersensitivity or an allergy to any of the ingredients in Fertilix®.
* Men who have been treated with a chemotherapeutic agent known to cause sterility, such as cyclophosphamide.
* Men who have taking anabolic steroids or testosterone replacement within 4 months of the study.
* Men currently being treated with a Ca++ channel blocker or other medical treatment known to adversely affect sperm production or function.
* Men with HIV, hepatitis B and C.

Primary outcomes:
measure: Reduction in sperm DNA damage
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hasbrouck Heights
country: United States
facility: University Reproductive Associates
state: New Jersey
Study officials:
References:
Clinical trial NCT00910325: Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy
Official title: Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Cholelithiasis
Keywords: Female
Cholelithiasis
Natural Orifice Surgery
Laparoscopic- Assisted
Transvaginal
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2009-05-29
Enrollment: 3
Sex: FEMALE
Minimum age (years): 26
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the feasibility, safety, and efficacy of a novel minimally invasive approach to cholecystectomy and to establish a description of this novel translumenal technique in humans at this institution.


Eligibility criteria: Inclusion Criteria:

* Females who are postmenopausal or who no longer wish to bear children
* Females \>25 years old and \<65 years old
* Diagnosis of biliary disease requiring cholecystectomy
* American Society of Anesthesiology (ASA) Class I or II
* Females who are able to understand and willing to sign an informed consent document

Exclusion Criteria:

* Pregnancy
* BMI \>= 30
* Patients who are still interested in childbearing
* Patients taking immunosuppressive medications or who are immunocompromised
* Patients with acute cholecystitis or history of acute cholecystitis ( as defined by right upper quadrant pain with history of fevers and/or elevated white blood cell count and/or positive ultrasound findings, ie, gallbladder wall thickening or pericholecystic fluid)
* Patients with suspicion of gallbladder cancer
* Patients with history of previous open abdominal surgery
* Patients with untreated common bile duct stones

Primary outcomes:
measure: The safety and efficacy of the procedure
timeFrame: one year
Secondary outcomes:
measure: Post-operative pain
timeFrame: one year
measure: Time to return to work
timeFrame: one year
measure: Time to return to daily activities
timeFrame: one year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: David W Rattner, MD
role: PRINCIPAL_INVESTIGATOR
References: