louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06150742: Nafamostat Efficacy in Phase 3 Registrational CRRT Study
Official title: A Randomized, Placebo-controlled, Double-blind, Multi-center Study of the Safety and Efficacy of Niyad in Patients Undergoing Continuous Renal Replacement Therapy (CRRT) Who Cannot Tolerate Heparin or Are at a Higher Risk for Bleeding
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Keywords: continuous renal replacement therapy
anticoagulation
Lead sponsor: Talphera, Inc
Sponsor class: INDUSTRY
First posted: 2023-11-29
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, randomized, placebo-controlled clinical study to investigate the safety and efficacy of Niyad (nafamostat mesylate) for anticoagulation of extracorporeal blood circulating through a dialysis filter in patients undergoing CRRT who cannot tolerate heparin or are at higher risk for bleeding.

Detailed description: Patients in intensive care units with acute kidney injury are often too frail to undergo the rapid fluid shifts that accompany intermittent hemodialysis. Continuous renal replacement therapy (CRRT) allows a more gentle continual dialysis, more similar to regular kidney function. Anticoagulation of the CRRT circuit can reduce clotting of the filter, which can lead to less filter changes and possibly less transfusions. Niyad (nafamostat mesylate), an anticoagulant with an ultra-short half-life of 8 minutes, is approved for use in South Korea and Japan for anticoagulation of the CRRT circuit. For patients who cannot tolerate heparin or who are at a high risk of bleeding, nafamostat may be an optimal anticoagulant to infuse into the CRRT circuit as the short half-life should minimize patient exposure. The primary objective of this study is to measure the anticoagulation efficacy of Niyad in the CRRT circuit versus placebo. Evaluation of the safety of Niyad in patients undergoing CRRT versus placebo will also be performed.

Eligibility criteria: Inclusion Criteria:

* Patients requiring CRRT or undergoing CRRT initiated within the prior 48 hours
* Patients who cannot tolerate heparin or are at high risk of bleeding

Exclusion Criteria:

* Patients weighing less than 50 kg
* Patients receiving systemic anticoagulation
* Patients with active bleeding

Primary outcomes:
measure: mean post-filter activated clotting time (ACT)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest
state: North Carolina
Study officials:
References:
Clinical trial NCT00285142: Effect of Rosiglitazone
Official title: Assessment of the Effect of Rosiglitazone on Insulin Secretion in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: rosiglitazone
insulin secretion
clinical trial
healthy
persons
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2006-02-01
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate :

* acute effects of a single dose of 8 mg rosiglitazone (therapeutic dose)
* on insulin secretion and
* insulin sensitivity in 12 healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* BMI between 18.0 and 24.0

Exclusion Criteria:

-

Primary outcomes:
measure: insulin response and insulin sensitivity assessed by 2-hours 10 mmol/l hyperglycemic clamp, started 45 min after treatment intake
Secondary outcomes:
measure: insulin clearance
measure: basal glycemia and insulinemia
measure: tolerance
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre d'Investigation Clinique
Study officials:
affiliation: Centre d'Investigation Clinique
name: PIERRE PETIT, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farret A, Chevassus H, Roux B, Petit P, Galtier F. Direct rosiglitazone-induced modifications in insulin secretion, action and clearance: a single-dose hyperglycaemic clamp study. Diabetologia. 2007 Jul;50(7):1384-7. doi: 10.1007/s00125-007-0682-4. Epub 2007 May 8.
Clinical trial NCT01178242: Salivary Gland Transplantation in the Treatment of Dry Eye in Patients With Stevens-Johnson Syndrome.
Official title: Salivary Gland and Labial Mucous Membrane Transplantation in the Treatment of Severe Symblepharon and Dry Eye in Patients With Stevens-Johnson Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symblepharon
Dry Eye
Ocular Surface Disease
Transplantation
Keywords: Labial mucous membrane
symblepharon
dry eye
Stevens -Johnson syndrome
salivary gland
ocular surface disease
transplantation
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 19
Sex: ALL
Minimum age (years): 10
Maximum age (years): 58
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate salivary gland and labial mucous membrane transplantation in patients with severe symblepharon and dry eye secondary to Stevens-Johnson Syndrome (SJS).

Detailed description: This study was performed to evaluate the use of salivary gland and labial mucous membrane transplantation in patients with severe symblepharon and dry eye secondary to SJS. Labial mucous membrane and salivary gland transplantation showed to be a good option in the treatment of severe symblepharon and dry eye secondary to SJS. labial mucous membrane, salivary glands, symblepharon, entropion, transplantation, graft.

Eligibility criteria: Inclusion Criteria:

* Only patients with poor visual acuity, less or equal to 20/200, and Schirmer I test equal to zero.
* Eyes with symblepharon or ankyloblepharon that did not allow the placement of a Schirmer test strip will be consider not measurable.

Exclusion Criteria:

* Active infection and corneal melting or perforation.

Primary outcomes:
measure: A Complete ophthalmic exam including Schirmer I test , slit lamp exam, fundoscopy will be perform before and six months after surgery. Symptons improvement considered positive if patients will refer improvement of eye moisturasing and motility.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: UNIFESP
state: SP
Study officials:
References:
Clinical trial NCT06731842: Molecular PET Imaging and Plasma Biomarkers in Alzheimer´s Disease and Other Neurodegenerative Diseases
Official title: Molecular PET Imaging and Plasma Biomarkers in Alzheimer´s Disease and Other Neurodegenerative Diseases
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Alzheimer´s Disease
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Multi-modal PET tracer study with the aim of studying the time course of regional deposition of tau in brain of subjects with high risk of being carriers of autosomal dominant Alzheimer´s disease and sporadic early onset and late onset Alzheimer´s disease patient (EOAD, LOAD) in tertiary memory clinic cohort in relation to MRI brain changes, plasma biomarker levels and cognitive performance.

Detailed description: Multi-PET /MRI studies , fluid biomarkers (CSF, plasma) analysis, neuropsychological testing is performed in subjects carriers and non-carriers of different APP, PS autosomal dominant AD mutatation. Both presymptomatic and symptomatic carriers and non-carriers are recruited (age range -30 to +15 years from first clinical symptoms). For comparison also a group of healthy eldersly as well as patients undergoing memory assessment with diagnosis of mild cognitive impairment (amyloid negative /amyloid positive) and diagnosis sporadic Alzheimer´s diases are recruited from Karolinska memory clinic and undergoing similar Multi-PET/MRI studies , fluid biomarker analysis, neuropsycholigal testing. The aim is to describe the evolution and spreading of tau in brain in Alzheimer continuum and compare with other pathological markers with aim of develop new diagnostic markers and therapeutic targets.

Eligibility criteria: Inclusion Criteria: a)belonging to families with known familial form of Alzheimer´s disease b) patient undergoing memory assessent at memory clinic with diagnosis mild cognitive impairment (MCI), Alzheimer´s disease c)healthy elderly cognitive normal

-

Exclusion Criteria:

cancer and other serious disease

Primary outcomes:
measure: PET measurement of regional tau spreading in brain during Alzheimer continuum
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska institutet NVS
Study officials:
affiliation: Karolinska Institutet
name: Agneta K NORDBERG, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01495442: Evaluation of a Dry Powder Aerosol Dispersion Mechanism by Radiolabeling Techniques
Official title: Evaluation of a Dry Powder Aerosol Dispersion Mechanism by Radiolabeling Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Healthy Volunteers
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
First posted: 2011-12-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective is to admix a radiolabel with albuterol sulphate for incorporation into the Handihaler® device for inhalation studies. This will allow for the investigators to determine the regional lung deposition of drug inhaled from the standard Handihaler® device compared to a novel modification of the device to provide more effective dispersion and aerosolization of the coated albuterol powder. The new mechanism of action for proof-of-concept testing consists of a bead (5.1 mm; expanded polystyrene foam) coated with drug powder, as opposed to the standard lactose formulation-filled capsule.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers adults

Exclusion Criteria:

* chronic illness

Primary outcomes:
measure: Fractional delivery of dry powder to the lung
timeFrame: 1-5 minutes post inhalation
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, CEMALB
state: North Carolina
Study officials:
References:
Clinical trial NCT03422042: Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis
Official title: An Open-labeled, Randomized Controlled Trial Comparing Between Short Duration And Standard Fourteen Days Antibiotic Treatments In Patients With Acute Common Bile Duct Stone Cholangitis After Successful Endoscopic Biliary Drainage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Cholangitis
Common Bile Duct Calculi
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 36
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: Common bile duct stone cholangitis is a potentially fatal condition, characterized by an obstruction and bacterial infection of biliary system. The principles of management are appropriate biliary drainage and systemic antibiotics. There has been limited data about appropriate time of antibiotics in patient with successful endoscopic drainage.

Detailed description: The aim is comparing the efficacy and safety between short duration and standard fourteen days antibiotic treatment in patients with acute common bile duct stone (CBDS) cholangitis after successful endoscopic biliary drainage as regards recurrence rate of acute cholangitis, complete stone clearance rate, morbidity and mortality associated acute cholangitis, and complications related ERCP procedure.

The study will be divided patients with acute CBDS cholangitis with complete stone clearance into 2 groups, group (A) will be received intravenous antibiotic until the temperature is less than 37.8 c for 72 hours and group (B) will be received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years old
* diagnosis of acute mild to moderate severity of ascending common bile duct stone cholangitis
* endoscopic retrograde cholangiopancreatography (ERCP) with biliary drainage within 72 hours after admission

Exclusion Criteria:

* pregnant woman
* the cause of obstruction other than common bile duct stone
* severe co-morbid diseases such as cardiovascular/pulmonary/kidney disease
* active concomitant infections of other organs
* history of allergy to cephalosporin group

Primary outcomes:
measure: The recurrence rate of cholangitis
timeFrame: 8 weeks
Secondary outcomes:
measure: The rate of adequacy of drainage
timeFrame: 24 hours
measure: Complication rate
timeFrame: 4 weeks
measure: Mortality rate
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
state: Songkla
Study officials:
affiliation: NKC Institute of Gastroenterology and Hepatology.
name: Nisa Netinatsunton, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02331342: Comparison of NICOM and Innocor for Non-Invasive Determination of Cardiac Output
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Keywords: Agreement of NICOM and Innocor
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: inpatients and outpatients

Brief summary: Cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac diseases. The aim of the study at hand was to evaluate NICOM (bioreactance) as a new method for determinion of CO and to compare it to Innocor (inert gas rebreathing), which previously showed promising results.


Eligibility criteria: Inclusion Criteria:

* hemodynamic stability
* respiratory stability

Exclusion Criteria:

* patient unwilling to participate

Primary outcomes:
measure: Accuracy of NICOM and Innocor
timeFrame: at time of inclusion
measure: Precision of NICOM and Innocor
timeFrame: at time of inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01673542: Evaluating the Effectiveness of Dermal Analgesia Provided by the Application of Lidocaine and Prilocaine Cream 5% on the Puncture Site of Axillary Blocks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Surgery Scheduled
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2012-08-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Prospective Study, monocentric, controlled, randomized study. Evaluating the effectiveness of dermal analgesia provided by the application of Lidocaine and Prilocaine Cream 5% on the puncture site of axillary blocks.Our study includes 70 patients. Number of subjects required for a 50% difference with the standard deviation of the control group, a significance level of 5% for a 80% power, it takes 23 people per group. Objective power of 90% obtained with 35 patients per group.

The expected benefit is the reduction of pain at the skin puncture during the realization of BAX.

Improving professional practice and quality care


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Hospitalized for upper extremity surgery scheduled
* Having an axillary block anesthesia.
* Free subject, without subordination or guardianship
* Patients undergoing a social security system or benefiting through a third party
* Informed consent and signed by the patient after clear and honest information on the study

Exclusion Criteria:

* Age \< 18 years
* Hypersensitivity to lidocaine, prilocaine, to one of the excipients, castor oil and its derivatives
* Hypersensitivity to local anesthetics of the amide
* Congenital Methemoglobinemia
* Porphyrias
* Glucose-6-phosphate dehydrogenase
* Hypersensitivity to any component of Dexeryl ®
* Disorders of atrioventricular conduction requiring permanent pacing not yet realized.
* Epilepsy uncontrolled by treatment
* Patients on anticoagulants
* Skin infection from the puncture site
* Patients with psychiatric disorders or dementia
* Cons-indication for infusion Isofundine ®:
* Severe congestive heart failure
* anuria
* oligoanuria
* Fluid retention
* hyperkalemia
* hypercalcemia
* Metabolic alkalosis
* Patients not receiving a social security system or not qualifying through a third party
* People receiving more protection ie minors, persons deprived of liberty by a judicial or administrative decision, guests staying in a hospital or office, adults under legal protection,
* Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transdermal, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, oophorectomy total )

Primary outcomes:
measure: Compare the VAS groups of Lidocaine-Prilocaine 5% and Dexeryl ®
Secondary outcomes:
measure: evaluation pain
measure: satisfaction
measure: success
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Service Anesthésie-Réanimation
Study officials:
References:
Clinical trial NCT03046342: Gastroenteritis in Pediatric Population of Qatar
Official title: Epidemiology of Acute Gastroenteritis in the Pediatric Population in Qatar: Causes, Risk Factors, Burden of Disease, Sources and Preventable Measures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroenteritis
Keywords: Gastroenteritis, Polymerase chain reaction
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2017-02-08
Enrollment: 3000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All acute gastroenteritis patients between 3 months to 14 years presenting to PEC centers with acute diarrhea+/- vomiting with or without fever

Brief summary: Comparison of clinical and laboratory diagnosis for cause of Gastroenteritis(GE) depending on the clinical manifestation.Identifying the sources of viral, bacterial and parasitic GE in Pediatric population of Qatar

Detailed description: Processing of stool samples by molecular method (PCR) for children with GE including complete data collection. Patients are followed up for 14 days

Eligibility criteria: Inclusion Criteria:

* All acute gastroenteritis patients between 3 months to 14 years presenting to PEC centers with acute diarrhea+/- vomiting with or without fever

Exclusion Criteria:

1. Cases of vomiting +/- fever only without diarrhea
2. Suspicion of surgical abdomen
3. Bile stained vomitus
4. Mal-absorption diseases as cystic fibrosis, celiac disease or increased secretion as disaccharides deficiency
5. Cases of Inflammatory bowel disease
6. Antibiotic associated diarrhea
7. Patients with immune deficiency
8. Patients with chronic diarrhea (\>2 weeks of diarrhea)
9. Patients receiving long term medication for any disease

Primary outcomes:
measure: sources of viral, bacterial and parasitic GE in the country
timeFrame: 4 years
Secondary outcomes:
measure: seasonal variation of GE in qatar determination
timeFrame: 4 years
measure: comparing the prevalence of viral GE in vaccinated children in Qatar (against rotavirus) and the other countries which implemented rotavirus vaccine
timeFrame: 4 years
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad medical corporation
Study officials:
References:
Clinical trial NCT02245542: The Impact of Alna® Ocas® on Nocturia in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH)
Official title: The Impact of Alna® Ocas® on Nocturia in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-19
Enrollment: 5775
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: BPH patients who are indicated for treatment with ALNA®OCAS® with special respect to nocturia recruited at urologists

Brief summary: Study to assess efficacy, tolerability and safety parameters of a three month ALNA®OCAS® -treatment with special respect to nocturia


Eligibility criteria: Inclusion Criteria:

* Indication for treatment with ALNA®OCAS® according to the prescribing information for a minimum period of three months

Exclusion Criteria:

* Patients fulfilling one of the general or specific contraindications listed in the ALNA®OCAS® Summary of Product Characteristics (SPC), particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency could not be included in the Post Marketing Study (PMS) study

Primary outcomes:
measure: Change from Baseline in International Prostatic Symptom Score (IPSS) by means of a patient questionnaire
timeFrame: Baseline, after 3 months
measure: Change from Baseline in Nocturia quality of life by means of a patient questionnaire
timeFrame: Baseline, after 3 months
Secondary outcomes:
measure: Change from Baseline in Maximum urinary flow rate (Qmax)
timeFrame: Baseline, after 3 months
measure: Change from Baseline in residual urine volume
timeFrame: Baseline, after 3 months
measure: Assessment of tolerability by investigator on 4-point scale
timeFrame: after 3 months
measure: Number of patients with adverse events
timeFrame: up to 3 months
Other outcomes:
Locations:
Study officials:
References: