louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03892304: Gynecological Health Improvement of Adult Women With Cystic Fibrosis
Official title: Gynecological Health of Adult Women With Cystic Fibrosis: Positive Impact of the Implementation of an On-site Gynecological Consultation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women at least 18 years old diagnosed with Cystic Fibrosis

Brief summary: Following the results of the research team's cross-sectional study conducted in 2014 describing insufficient gynecological care, the research team implemented an on-site gynecological consultation in the adult Cystic Fibrosis (CF) centre in 2015. The study aimed to compare the results of two surveys conducted successively in 2014 and in 2017 on a cohort of women with CF attending the Lyon CF adult referral centre. All the women attending the adult CF center in 2017 were asked to complete the same self-report written questionnaire that was completed in 2014 about their contraceptive choices, gynecological follow-up and cervical screening. Questions concerning gynecological comorbidities were added to the 2017 questionnaire.

This current study aimed to evaluate the impact of the implementation of an on-site gynecological consultation on gynecological health of women with CF, as measured through 3 indicators: the proportion of women with regular gynecological follow-up, cervical screening coverage, and contraceptive coverage. The identification of specific gynecological comorbidities was the other objective of this study.


Eligibility criteria: Inclusion Criteria:

* women with cystic fibrosis
* subjects followed by the Cystic Fibrosis Adult Referral Centre in Lyon, France in 2017

Exclusion Criteria:

* None

Primary outcomes:
measure: Proportion of women with regular gynecological follow-up
timeFrame: 2014 - 2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon, Cystic Fibrosis Adult Referral Centre, Department of Internal Medicine, Centre Hospitalier Lyon Sud
name: Christine Rousset-Jablonski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01323504: Pain and Music Therapy in Patients Suffering Arteritis
Official title: Pain and Music Therapy During the Wound Healing in Patient Suffering Arteritis of Stage 5 or 6.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Arteritis
Keywords: Stage 5 arteritis
Stage 6 arteritis
rutherford classification
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2011-03-25
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: It is estimated that 800,000 people in France suffer from peripheral artery disease (PAD), of whom 1-2% present the most severe form critical limb ischaemia (CLI). In this situation, the patient frequently presents painful non-healing ulcers and focal gangrene. Wound care is generally associated with increasing pain. Pain relief may be challenging in spite of major analgesics.

Several studies in this country and elsewhere assessed the usefulness of music for chronic or acute pain relief during care. However, no data are published regarding the interest of music therapy for pain relief during local care in PAD patients.


Eligibility criteria: Inclusion Criteria:

* Men and women, aged at least 18 years, affiliated to the health insurance scheme.
* Patients affected by arteritis of stage 5 or 6 at Limoges University Hospital in department cardiovascular Surgery.
* Patients requiring a daily repair of bandage, not exceeding fifteen minutes and provoking a pain
* Initial pain equal to three during local care in the digital scale.
* Having given their enlightened consent writes

Exclusion Criteria:

* Bypass and / or angioplasty lower than one week
* Diabetic neuropathy
* Patient who is going to undergo a surgery of amputation
* Patients affected by demented pathologies or by confusion
* Pregnant or breast-feeding women or without effective contraception
* Patients being the object of a saving of justice

Primary outcomes:
measure: Pain relief during local care with music or not.
timeFrame: 7 days
Secondary outcomes:
measure: Quantification in equivalent morphine of the analgesic prescription at the seventh day
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Limoges
name: Marc LASKAR, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04639804: Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers
Official title: An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Tegoprazan and Non-steroidal Anti-inflammatory Drugs (NSAIDs) After Multiple Oral Dosing in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: drug-drug interaction
pharmacokinetic
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2020-11-23
Enrollment: 60
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the pharmacokinetic (PK) interaction between tegoprazan and non-steroidal anti-inflammatory drugs (NSAIDs) after given each alone and in their combination in healthy male adults.

Detailed description: A randomized, open-label, multiple-dose, 6-sequence-arm, 3-period cross-over study

Eligibility criteria: Inclusion Criteria:

* Healthy adult aged ≥ 19 and \< 55 year-old at screening
* Body mass index (BMI) ≥ 19.0 kg/m2 and \< 27.0 kg/m2 with a body weight ≥ 55 kg at screening.

Exclusion Criteria:

* History or evidence of clinically significant disease
* History of GI disease or surgery that may affect the absorption of a drug
* Laboratory test result which falls into the following values( ALT or AST \> 2 × upper limit of normal (ULN))
* History of regular alcohol consumption exceeding 210 g/week within 6 months
* Daily use of ≥ 20 cigarettes within 6 months
* Has taken any investigational agent within 6 months prior to the first dose of IMP
* Subjects who are considered ineligible to participate in this study at the discretion of the investigator.

Primary outcomes:
measure: AUCτ of tegoprazan and NSAIDs
timeFrame: pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7
measure: Css,max of tegoprazan and NSAIDs
timeFrame: pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
affiliation: Chonbuk university hospital
name: Min-Gul Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moon SJ, Shin N, Kang M, Kim B, Kim MG. Pharmacokinetic Interactions Between Tegoprazan and Naproxen, Aceclofenac, and Celecoxib in Healthy Korean Male Subjects. Clin Ther. 2022 Jul;44(7):930-944.e1. doi: 10.1016/j.clinthera.2022.06.002. Epub 2022 Jul 1.
Clinical trial NCT04872504: Hypotension Prediction Index in Patients Undergoing Liver Transplantation
Official title: Performance of the Hypotension Prediction Index With Invasive Arterial Pressure Waveform in Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraoperative Hypotension
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A prospective, open-label and single-center study to determine whether the use of Acumen Hypotension Prediction Index software predicts the occurrence of hypotension.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age ≥ 20 years;
* Scheduled liver transplantation
* Planned pressure monitoring with an arterial line;
* General anesthesia

Exclusion Criteria:

* Contraindication for invasive blood pressure monitoring
* End-staged renal disease
* pre-operative MAP \<65 mmHg
* Severe heart failure
* Severe cardiac shunt
* Severe aortic stenosis
* Severe atrial fibrillation

Primary outcomes:
measure: Accurate hypotension prediction of EV1000 system
timeFrame: MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day.
measure: Incidence of intraoperative hypotension
timeFrame: MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day
measure: Severity of intraoperative hypotension
timeFrame: MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day
Secondary outcomes:
measure: Hospital stay and ICU stay
timeFrame: Days from admission to discharge, assessed up to 1 month
measure: Mortality after surgery
timeFrame: Days from admission to discharge, assessed up to 1 month
measure: Adverse effects
timeFrame: Days from admission to discharge, assessed up to 1 month
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT00166504: Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)
Official title: A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 203
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 is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hypercholesterolemia
* LDL-C \>/= 130 mg/dL but \</=250 mg/dL and triglyceride (TG) \</= 350 mg/dL
* National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline

Exclusion Criteria:

* Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitors or Ezetimibe

Primary outcomes:
measure: LDL-C Lowering Efficacy
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06315504: Circulating Factors in Nephrotic Syndrome
Official title: Circulating Factors in Nephrotic Syndrome - A Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Nephrotic Syndrome
Membranous Nephropathy
Minimal Change Disease
Primary Focal Segmental Glomerulosclerosis
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: De novo nephrotic syndrome admitted to hospital for a clinically indicated kidney biopsy.

Brief summary: A prospective observational study to investigate the treatment-associated changes of circulating factors associated with glomerular diseases among patients with de novo nephrotic syndrome admitted to hospital for a kidney biopsy.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Plasma albumin \< 36 g/L
* Urine protein \>3.5 g/day or urine protein/creatinine-ratio (UPCR) \> 3.5 or urine albumin/creatinine-ratio (UACR) \>2200 mg/g
* Planned kidney biopsy
* Able to give written informed consent

Exclusion Criteria:

* Kidney transplant recipient
* Previously undergone a kidney biopsy
* Unable to understand written information in Danish

Primary outcomes:
measure: levels of anti-nephrin in blood by ELISA
timeFrame: up to 12 months
Secondary outcomes:
measure: changes in auto-antibodies in blood associated with membranous nephropathy
timeFrame: up to 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00921804: Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients
Official title: A Phase IIa, Double-blind, Double-Dummy, Placebo-controlled, Active-controlled, Randomized, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD8529 in Adult Schizophrenia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Hallucinations
Paranoia
Inpatient schizophrenia clinical trial
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-16
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether treatment with daily oral dose of AZD8529 40 mg administered over 28 days is safe, well tolerated and improves main symptoms of schizophrenia in adult schizophrenia patients.


Eligibility criteria: Inclusion Criteria:

* Patient will need to read, understand and sign an informed consent prior to any study specific procedures
* Patient will have certain schizophrenia symptoms deemed by the investigator as appropriate for the study entry

Exclusion Criteria:

* Patients will be excluded based on recent history of significant illness or current disease as assessed by the investigator during screening process (based on physical examination, laboratory studies and electrocardiogram studies)
* Patients will be excluded if urine drug screen test show positive results
* Smoking of more than 2 packs of cigarettes a day

Primary outcomes:
measure: PANSS Total Score
timeFrame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
Secondary outcomes:
measure: PANSS Positive, Negative, and General Psychopathology Subscale Scores
timeFrame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
measure: CGI-S
timeFrame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
measure: Vital signs measurements, body weight, physical exam, clinical laboratory evaluations, ECGs, Extrapyramidal Symptoms, suicidal symptoms, cognition and incidence of adverse events
timeFrame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 1, 8, 15, 22, and 28
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Research Site
state: California
city: Glendale
country: United States
facility: Research Site
state: California
city: Rockville
country: United States
facility: Research Site
state: Maryland
Study officials:
affiliation: CBH Health9605 Medical Center Drive Suite 270Rockville, MD, 20850
name: Robert, Litman, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca1800 Concord PikeWilmington, DE, 19850
name: Mark Smith
role: STUDY_DIRECTOR
References:
Clinical trial NCT04572204: Management of Grades 3-5 Renal Trauma in Pediatrics
Official title: Management of Grades 3-5 Renal Trauma in Pediatrics: A Prospective Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Trauma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 33
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 children (age group 0-18 years) will be added to my study divided into two groups regardless of sex

Brief summary: comparing conservative management versus interventional management in hemodynamically stable paediatric patient with blunt renal trauma, evidence suggests that there is a reduced rate of renal loss and blood transfusion in patients managed conservatively.


Eligibility criteria: Inclusion Criteria:

* Children ( age group 0-18) who are diagnosed to have renal tissue injury grade 3-5 by contrast CT

Exclusion Criteria:

* Age group more than 18 years
* Low grade renal trauma 1-2
* Patients who get explored due to extra urologic indication without proper urologic assessment

Primary outcomes:
measure: Stabilization of haemodynamic status of the patient in the first 24-72 hours
timeFrame: 24 to 72 hours
Secondary outcomes:
measure: Resolution of perinephric collection during follow up Triphasic MSCT abdomen and pelvis
timeFrame: 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT00439504: Ph1 Lobeline Interaction Study - 1
Official title: Double-Blind, Placebo-Controlled, Cross-Over Assessment of Intravenous Methamphetamine and Sublingual Lobeline Interactions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Methamphetamine Dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2007-02-23
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if there are significant cardiovascular or other interactions between sublingual lobeline and intravenous methamphetamine.


Eligibility criteria: Inclusion Criteria:

* Be between the ages of 18 and 45 years of age
* Be in general good health with a history of methamphetamine (MA) abuse (but not dependence)
* If female and of child bearing potential, agrees to use birth control
* Be able to understand and provide written informed consent
* Have a body mass index between 18 and 30
* Have reported use of (MA) during the past three months without experiencing adverse consequence plus a life time MA or amphetamine use history of at least four occasions of use
* Have a negative drug test (barbiturates, benzodiazepines, amphetamines, opiates, cocaine, cannabinoids, ethanol) at screening and at the time of admission

Exclusion Criteria:

* Please contact site for details

Primary outcomes:
measure: Cardiovascular responses
Secondary outcomes:
measure: Subjective effects
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Langley Porter Psychiatric Institute
state: California
Study officials:
affiliation: Langley Porter Psychiatric Institute
name: Reese Jones, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06611904: The Effect of Combined Dulaglutide and Dapagliflozin Treatment vs DPP-4 Inhibitors in Endothelial and Vascular Function in Patients With Type 2 Diabetes Mellitus and Albuminuria
Official title: Study of Endothelial Glycocalyx and Vascular Function in Patients With Type 2 Diabetes and Albuminuria After Administration of Dulaglutide and Dapagliflozin vs DPP-4 Inhibitors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urine Albumin (UAlb)
Glycocalyx
Arterial Stiffness
Keywords: type 2 diabetes
albuminuria
arterial stiffness
glycocalyx
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Patients with Type 2 Diabetes Mellitus and albuminuria will be randomised eitheer to dulaglutide and dapagliflozin combination or DPP-4 inhibitor, as an add-on treatment to metformin. Arterial stiffness, UACR, endothelial glycocalyx and global longitudinal strain will be assesed at baseline, 4 and 12 months.

Detailed description: Patients with Type 2 Diabetes Mellitus and albuminuria will be randomised eitheer to dulaglutide and dapagliflozin combination or DPP-4 inhibitor, as an add-on treatment to metformin. Arterial stiffness via pulse wave velocity (PWV), UACR, endothelial glycocalyx via Microscan camera, and global longitudinal strain via echocardiography will be assesed at baseline, 4 and 12 months after treatment.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus Albuminuria HbA1c: 7-10% eGFR\&gt; 60 ml/min

Exclusion Criteria:

* Type 1 diabetes mellitus Inflammation, chronic or acute Established cardiovascular disease Malignancy within the last 5 years

Primary outcomes:
measure: UACR
timeFrame: 4 and 12 months
measure: PWV
timeFrame: 4 and 12 months
measure: PBR
timeFrame: 4 and 12 months
measure: GLS
timeFrame: 4 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chaidari
country: Greece
facility: Attikon University General Hospital
state: Attica
Study officials:
References:
citation: Lambadiari V, Pavlidis G, Kousathana F, Maratou E, Georgiou D, Andreadou I, Kountouri A, Varoudi M, Balampanis K, Parissis J, Triantafyllidi H, Katogiannis K, Birba D, Lekakis J, Dimitriadis G, Ikonomidis I. Effects of Different Antidiabetic Medications on Endothelial Glycocalyx, Myocardial Function, and Vascular Function in Type 2 Diabetic Patients: One Year Follow-Up Study. J Clin Med. 2019 Jul 5;8(7):983. doi: 10.3390/jcm8070983.
citation: Lambadiari V, Pavlidis G, Kousathana F, Varoudi M, Vlastos D, Maratou E, Georgiou D, Andreadou I, Parissis J, Triantafyllidi H, Lekakis J, Iliodromitis E, Dimitriadis G, Ikonomidis I. Effects of 6-month treatment with the glucagon like peptide-1 analogue liraglutide on arterial stiffness, left ventricular myocardial deformation and oxidative stress in subjects with newly diagnosed type 2 diabetes. Cardiovasc Diabetol. 2018 Jan 8;17(1):8. doi: 10.1186/s12933-017-0646-z.