louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00409097: Effect of Rosiglitazone on ADMA in Critical Illness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Critical Illness
Multiple Organ Failure
Keywords: ADMA
MOF
Critical illness
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2006-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Rosiglitazone,decreases the ADMA concentration and thereby increases the arginine/ADMA ratio of critically ill patients.

Detailed description: Endothelial vasodilatation dysfunction precedes the development of arteriosclerosis. The endothelium plays a pivotal role in the control of the vascular tone by releasing nitric oxide (NO). The amino acid arginine is the sole substrate for the enzyme NO synthase (NOS). Asymmetric dimethylarginine (ADMA) is an endogenous derivative of arginine that inhibits NOS. Thus the arginine/ADMA ratio an important determinant of NO production by NOS. ADMA is an independent risk factor for cardiovascular disease, but elevated levels of ADMA have also been shown to be a strong independent predictor of ICU mortality. The central mechanism by which ADMA may cause deterioration in critically ill patients is by impairing organ blood flow and reducing cardiac function, especially during stress. Accumulation of ADMA could thereby be a causative factor in the development multi organ failure (MOF). Thus inhibition of NO production by ADMA may become especially important when cardiac demand is increased.

Eligibility criteria: Inclusion Criteria:

* critically ill patients
* age between 18 and 75 years
* SOFA score \> 7

Exclusion Criteria:

* history of Diabetes mellitus
* history of hypercholesterolemia
* history of hyperhomocysteinemia
* impaired hepatic function

Primary outcomes:
measure: ADMA concentration
Secondary outcomes:
measure: SOFA score
measure: Organ function
measure: Mortality
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Paul am Leeuwen van, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02338505: Teleassisted Surgery for Gynecological Disease in Obese Patients - OB-ALFX
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis
Keywords: Robotic Surgery
Telelap-ALFX
Gynecological disease
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: SOFAR S.p.A.
First posted: 2015-01-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II prospective single-institutional study.

Detailed description: The aim of this Phase II prospective single-institutional study is to assess feasibility and early complications rate of Telelap ALF-X surgical treatment in obese patients affected by gynecological disease.

Eligibility criteria: Inclusion Criteria:

* informed consent
* 30 ≤ BMI \< 40
* ASA \< III
* Ovarian Cyst
* Prophylactic bilateral salpingo-oophorectomy
* Ectopic Pregnancy
* Pelvic Inflammatory Disease
* Sterility/Infertility
* Benign uterine disease (fibromatosis, adenomyosis)
* Endometrial hiperplasia
* Early-stage Endometrial Cancer
* Preneoplastic lesions of the cervix
* IA1 Cervical Cancer
* Pelvic endometriosis

Exclusion Criteria:

* Pregnancy
* Liver disease
* Coagulopathies
* Clinical conditions contraindicating laparoscopy

Primary outcomes:
measure: intraoperative complication rate
timeFrame: intraoperative
Secondary outcomes:
measure: postoperative complication rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Rome,
country: Italy
facility: Catholic University of Sacred Heart Rome,
state: Rome
Study officials:
References:
citation: Gidaro S, Buscarini M, Ruiz E, Stark M, Labruzzo A. Telelap Alf-X: a novel telesurgical system for the 21st century. Surg Technol Int. 2012 Dec;22:20-5.
citation: Gidaro S, Altobelli E, Falavolti C, Bove AM, Ruiz EM, Stark M, Ravasio G, Lazzaretti SS, Maurizio B. Vesicourethral anastomosis using a novel telesurgical system with haptic sensation, the Telelap Alf-X: a pilot study. Surg Technol Int. 2014 Mar;24:35-40.
citation: Lococo A, Larocca V, Marino F, De Filippis AF, Cesario A, Lococo F. Experimental Robotic Pulmonary Lobectomy With the TELELAP/ALFX System in the Ovine Model. Surg Innov. 2015 Jun;22(3):252-6. doi: 10.1177/1553350614549633. Epub 2014 Sep 15.
citation: Falavolti C, Gidaro S, Ruiz E, Altobelli E, Stark M, Ravasio G, Ravasio G, Lazzaretti SS, Buscarini M. Experimental Nephrectomies Using a Novel Telesurgical System: (The Telelap ALF-X)-A Pilot Study. Surg Technol Int. 2014 Nov;25:37-41.
Clinical trial NCT01899105: A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor
Official title: A Phase 1, Randomized, Single-Dose, Open-Label Crossover Study to Investigate the Effect of Food on the Relative Bioavailability of 2 Fixed-Dose Combinations of Lumacaftor and Ivacaftor Tablet Formulations in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2013-07-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is designed to investigate the effect of food on the relative bioavailability of 2 different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet formulations.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects as defined in the protocol
* Subjects who weigh \>50 kg at Screening

Exclusion Criteria:

* History of any illness or condition that might confound the results of the study or pose an additional risk to the subject upon administration of study drug - Positive for hepatitis B,C, or HIV
* Standard 12-lead ECG demonstrating QTc \>450 msec for male subjects and \>480 msec for female subjects at the Screening Visit
* Abnormal renal function as defined in the protocol at Screening
* Forced expiratory volume in 1 second (FEV1) \<80% predicted at the Screening Visit
* Blood donation (of approximately 1 pint \[500 mL\] or more) within 56 days before the first dose of study drug
* Treatment with an investigational drug or device within 30 days or 5 half-lives preceding the first dose of study drug

Primary outcomes:
measure: Pharmacokinetic parameters of lumacaftor and ivacaftor, including Cmax, AUC0-tlast, and AUC0-∞
timeFrame: up to 5 days
Secondary outcomes:
measure: Safety and tolerability as assessed by adverse events (AEs), laboratory assessments (serum chemistry and hematology), vital signs, standard 12-lead electrocardiograms (ECGs), and spirometry
timeFrame: up to 25 days
Other outcomes:
Locations:
city: Daytona
country: United States
state: Florida
Study officials:
References:
citation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.
Clinical trial NCT02988505: Out-of Pocket Payments With Lymphedema in France
Official title: Out-of Pocket Payments in Patients With Lymphedema in France and Inequities of Access ti Healthcare
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Lymphedema Secondary Lymphedema
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 260
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients meeting the inclusion criteria will be included in each participating centre during the inclusion phase

Brief summary: Lymphedema is a frequent and chronic condition posing a high burden on patients. Clinical guidelines emphasize the role of compression therapy by prescription medical devices. Even in a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist due to the price and reimbursement setting processes. OOPP may threaten the equity of care and drive patients to forgo care. Our aim was to analyze the distributive effects of OOPP for lymphedema patients in France.

A prospective, multicenter study will be conducted in France in 2014 on patients with lymphedema. Household ability to pay will be specified by net income and OOPP will be assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices, nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory and voluntary health insurance reimbursements will be considered. We will combine concentration curves and concentration indices to assess the distributive effects.


Eligibility criteria: Inclusion criteria:

* Patient aged over six years, with primary or secondary lymphedema, regardless of the severity of the disease;
* Patient treated in one of the centres participating in the study;
* Patient (and her legal representative for minors) who gave her written consent \[or did not refuse to participate, according to local Law\] ;
* Patient with Internet access and an active email address.

Exclusion criteria:

* Patients with concomitant chronic venous insufficiency;
* Patient not covered by any health care insurance scheme;
* People protected under the law.

Primary outcomes:
measure: The mean monthly out-of-pocket payment as assessed by an online self-questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Departement information Medicale CHU Montpellier
Study officials:
References:
Clinical trial NCT03239405: Comparing the Cost Savings Potential of Orogastric Tubes in Laparoscopic Sleeve Gastrectomy
Official title: Comparing the Cost Savings Potential of Orogastric Tubes in Laparoscopic Sleeve Gastrectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgical Procedure, Unspecified
Keywords: laparoscopic
sleeve
gastrectomy
Lead sponsor: Boehringer Labs LLC
Sponsor class: INDUSTRY
Collaborators: name: Rochester General Hospital
First posted: 2017-08-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals already receiving a laparoscopic sleeve gastrectomy

Brief summary: Comparing the operation times and staple loads used between the use of multiple tubes and a bougie versus a one-step suction callibrated system in laparoscopic sleeve gastrectomy.

Detailed description: In this study we are comparing the cost/savings of using a bougie with a one-step suction callibrated system in laparoscopic sleeve gastrectomy. We will be looking at OR time and staple usage. This study is not affecting the treatment of the patients in any way. The surgeons would be using the devices regardless of the study. We are simply looking at procedure information after the fact.

Eligibility criteria: Inclusion Criteria:

* Patient and surgeon have both agreed that a sleeve gastrectomy is a procedure that they want performed.

Exclusion Criteria:

-

Primary outcomes:
measure: Staples Used
timeFrame: 4 hours for the end of surgery
measure: Operation time
timeFrame: 4 hours for the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Rochester General
state: New York
Study officials:
References:
Clinical trial NCT04612205: Effect of TECAR in Treating Stress Urinary Incontinence
Official title: Effect of TECAR in Treating Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence, TECAR
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stress urinary incontinence (SUI) is the defined as a leakage of urine with physical exertion, most commonly from coughing, laughing, or sneezing. It has a profound psychosocial impact not only to patients but also on their families and caregivers, resulting in loss of self stem, sexual dysfunction.Because of the higher incidence of stress urinary incontinence that reach 30% of women during childbearing period, 50% in elderly women, and its social embarrassing condition causing socio-psychological problems, disability and dependency with higher economic impact and based on TECAR therapy had better recovery of muscle strength and function in addition to there is no study has evaluated the impact of TECAR treatment on stress urinary incontinence, our study aim to assess the effectiveness of TECAR in treatment of such cases to decrease time of treatment and provide good results to patients.


Eligibility criteria: Inclusion Criteria:Participants aged between30 to 50 year and BMI not exceed 30 kg/cm2. All subjects complain from mild SUI due to hypermobility of bladder neck and weakness of pelvic floor exercise

-

Exclusion Criteria:

* Those with neurological diseases, diabetic neuropathy, congenital urologic disease, bladder cancer and neurogenic bladder, detrusor hyperactivity and bladder or urethra previous surgery

Primary outcomes:
measure: strength of pelvic floor
timeFrame: after 4 week
Secondary outcomes:
measure: severity of SUI
timeFrame: after 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: kafr elshekh university
name: eman elhosary
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03967405: A Prospective Evaluation of Clinical Equivalence Between iX and PID
Official title: A Prospective Evaluation of Clinical Equivalence Between i:X and PID
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wound
Keywords: Wound
Imaging
Lead sponsor: MolecuLight Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-30
Enrollment: 50
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 chronic wounds

Brief summary: Patients with chronic wounds will be imaged using 2 imaging devices. Two types of images will be acquired with each device, a standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 2 imaging devices will be compared off-line by many interpreters to assess for any differences in the images that would alter a clinical decision.

Detailed description: Patients (n = 50) with chronic wounds will be imaged using 2 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 2 imaging devices will be compared off-line by many interpreters to assess for any differences in the images that would alter a clinical decision.

Eligibility criteria: Inclusion Criteria:

1. Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) of unknown infection status
2. 18 years of age or older

Exclusion Criteria:

1. Treatment with an investigational drug within 1 month before study enrollment
2. Subjects with recent (\<30 days) biopsy or curettage of target wound
3. Subjects with wounds that cannot be completely imaged by study device due to anatomic location
4. Unable or unwilling to consent

Primary outcomes:
measure: Concordance
timeFrame: 2 months
Secondary outcomes:
measure: Sensitivity and Specificity
timeFrame: 2 months
Other outcomes:
measure: Bacterial Load quantification by sampling
timeFrame: 2 months
Locations:
city: North York
country: Canada
facility: Judy Dan Research and Treatment Center
state: Ontario
Study officials:
affiliation: Judy Dan Research and Treatment Center
name: Ronald Linden
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01217905: Japanese Single and Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic (PK) & Pharmacodynamic (PD) Study of AZD7687
Official title: A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD7687 After Administration of Single and Multiple Ascending Doses in Healthy Male Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Obesity
Keywords: Phase 1
Type 2 diabetes
obesity
Japanese healthy volunteer
AZD7687
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-08
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound AZD7687. It will also assess how the body handles the drug and how it responds to the drug following single dose followed by multiple dosing over 7 days.


Eligibility criteria: Inclusion Criteria:

* Suitable veins for cannulation or repeated venipuncture
* Have a body mass index (BMI) between 19 and 35 kg/m2 and weigh at least 50 kg and no more than 90 kg
* Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product

Primary outcomes:
measure: Investigate the safety and tolerability of AZD7687 following administration of single and multiple doses
timeFrame: From screening period to follow-up visit 45 days (Maximum).
Secondary outcomes:
measure: Evaluate the pharmacokinetics (PK) (plasma and urine) of AZD7687 and it´s glucuronic acid metabolite (AZ13128940) after single and multiple doses
timeFrame: Before dose and repeatedly to follow-up visit
Other outcomes:
Locations:
city: Croydon
country: United Kingdom
facility: Research site
Study officials:
affiliation: Richmond Pharmacology Limited
name: Ulrike Lorch, MD MFPM FRCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06641505: Feasibility of Deep Inspiratory Internal Jugular Vein Variability in Guiding Preoperative Fluid Replacement
Official title: Feasibility of Deep Inspiratory Internal Jugular Vein Variability in Guiding Preoperative Fluid Replacement：A Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemodynamic
Keywords: Internal jugular vein
propofol
hemodynamic
hypotension
fluid replacement
Lead sponsor: Affiliated Hospital of Jiaxing University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare the incidence of hypotension during the propofol-induced period between the internal jugular vein variability-guided fluid infusion group and the conventional fluid infusion group through a fluid infusion experiment before anesthesia induction, so as to evaluate the feasibility of using the internal jugular vein variability under deep inspiration to guide preoperative fluid infusion.

Detailed description: Ultrasound records at least one quiet breathing cycle and one deep inhalation cycle to calculate IJVV Propofol was infused target-controlled at 4 μg/ml, and changes in arterial blood pressure within 3 minutes of propofol induction were observed.

Plan to conduct a prospective randomized controlled study to compare the incidence of hypotension during the propofol-induced period between the internal jugular vein variability-guided fluid infusion group and the conventional fluid infusion group through a fluid infusion experiment before anesthesia induction.

Eligibility criteria: Inclusion Criteria:

* age over 60 years； American Society of Anesthesiology (ASA) status Ⅱ-Ⅲ； Surgery with radial artery puncture； Propofol induction；

Exclusion Criteria:

* BMI≥30kg/m2； People with short necks； Previous hypotension (systolic blood pressure \<90mmHg or mean arterial pressure\<65mmHg)； Previous poorly controlled hypertension； Cardiac insufficiency , EF value\<50%； Upper limb deep vein thrombosis； History of radiotherapy or neck surgery； Inability to maintain a supine position for necessary measurements； Mechanical ventilation status or inability to take deep breaths patients； gastrointestinal surgery； Patients allergic to propofol； Restricted fluid intake；

Primary outcomes:
measure: The incidence of a 20% drop in blood pressure after propofol induction
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jiaxing
country: China
facility: Affiliated Hospital of University
state: Zhejiang
Study officials:
affiliation: Affiliated Hospital of Jiaxing University
name: Qinghe Zhou
role: PRINCIPAL_INVESTIGATOR
References: