louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05515731: Platelet Rich Plasma as a Treatment For Resistant Corneal Ulcers
Official title: Platelet Rich Plasma as a Treatment For Resistant Corneal Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cornea Ulcer
Lead sponsor: Egyptian Biomedical Research Network
Sponsor class: NETWORK
Collaborators: name: Al-Azhar University
First posted: 2022-08-25
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective study involved 14 patients aged \> 18 years with RCUs not responding to conventional treatment. All patients were treated with E-PRP drops (one drop), preservative-free artificial tears, antibiotic eye drop four times daily and systemic vitamin A once daily for one month. All patients were examined at 1, 2, 4, 6 and 8 weeks after the treatment initiation. In each visit, the following parameters were assessed: best corrected visual acuity (BCVA), anterior segment, corneal healing, condition of the conjunctiva, presence of abnormal discharge and symptoms reported.

Detailed description: The present prospective study involved 14 patients aged \> 18 years with RCUs not responding to conventional treatment. All patients were treated with E-PRP drops (one drop), preservative-free artificial tears, antibiotic eye drop four times daily and systemic vitamin A once daily for one month. All patients were examined at 1, 2, 4, 6 and 8 weeks after the treatment initiation. In each visit, the following parameters were assessed: best corrected visual acuity (BCVA), anterior segment, corneal healing, condition of the conjunctiva, presence of abnormal discharge and symptoms reported.

Eligibility criteria: Inclusion Criteria:

* Resistant corneal ulcers

Exclusion Criteria:

* history of topical anesthetic abuse, diagnosed with corneal dystrophies, history of neurotrophic corneal ulcers or chemical burn ulcer. Other exclusion criteria were pregnancy of systemic diseases or therapies affecting platelets count e.g. aspirin.

Primary outcomes:
measure: Pain scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University
Study officials:
affiliation: Al-Azhar University
name: Ahmed Gomaa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01167231: Prevention of Postprandial Hyperglycemia by Acarbose May be a Promising Therapeutic Strategy for Reducing the Increased Risk for Cardiovascular Disease
Official title: Acarbose in Cardiovascular Risk Management. Assessment of Clinical Efficacy and Safety of Acarbose and Its Effect on Selected Cardiovascular Risk Factors in Type 2 Diabetes Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Diabetes
Acarbose
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-07-22
Enrollment: 3310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic diabetic patients not treated with acarbose for at least 3 months.

Brief summary: The use of acarbose in impaired glucose tolerance (IGT) and type 2 diabetic subjects has been associated with a significant reduction of cardiovascular events. Additionally, acarbose has been shown to have a beneficial influence on some of the other cardiovascular risk factors (metabolic syndrome components). Thus, prevention of postprandial hyperglycemia by acarbose may be a promising therapeutic strategy for reducing the increased risk for cardiovascular disease. Further studies are needed to confirm the influence of acarbose on cardiovascular risk factors in the real life setting.


Eligibility criteria: Inclusion Criteria:

* Diabetes Mellitus
* Age \>/= 18 years
* Naive to acarbose (minimum 3 months before inclusion)

Exclusion Criteria:

* Hypersensitivity to acarbose or any of the excipients
* Age \<18 years
* Pregnancy and in nursing
* Inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction
* Chronic intestinal diseases associated with marked disorders of digestion or absorption
* States which may deteriorate as a result of increased gas formation in the intestine, (e.g. Roemheld's syndrome \[an angina pectoris-like syndrome or aggravation of an angina pectoris due to the postprandial filling of the stomach\] and larger hernias)
* Hepatic and severe renal impairment (creatinine clearance \<25 mL/min/ 1,73m2)

Primary outcomes:
measure: Safety, tolerability of acarbose and its effect on body weight, waist circumference and blood pressure
timeFrame: approximately 6 months after acarbose treatment initiation
Secondary outcomes:
measure: Effect of acarbose on HbA1c, fasting and postprandial glycemia and on lipid profile
timeFrame: approximately 6 months after acarbose treatment initiation
Other outcomes:
Locations:
city: Many Locations
country: Poland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00896831: Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Minimal Encephalopathy
Official title: Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Liver Cirrhosis and Minimal Encephalopathy: a Single Center Placebo Control Double Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatic Encephalopathy
Keywords: minimal hepatic encephalopathy
L-ornithine-L-aspartate
psychometric test
critical flicker frequency
quality of life
Treatment
Health-related quality of life
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2009-05-12
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to assess the effectiveness and safety of L-ornithine-L-aspartate in the management of hepatic encephalopathy.

Detailed description: Hepatic encephalopathy continues to be a major clinical problem in cirrhosis. Patients with minimal hepatic encephalopathy are at risk for accidents, had a decline in work performance, or complain of cognitive symptoms, with poor health-related quality of life. This study will compare L-ornithine-L-aspartate with placebo for 60 days to assess the effectiveness, safety and health-related quality of life of this drug.

Eligibility criteria: Inclusion Criteria:

* Cirrhosis and diagnosis of minimal hepatic encephalopathy using psychometric tests and critical flicker frequency

Exclusion Criteria:

* Hepatic encephalopathy grade 1 to 4
* Use of drugs to treatment of hepatic encephalopathy (lactulose, neomycin)
* Psychoactive substance use within 72 hours

Primary outcomes:
measure: Psychometric tests and critical flicker frequency
timeFrame: day 0, 15, 30, 45 and 60
Secondary outcomes:
measure: Ammonia concentration
timeFrame: time 0 and 60 days after
measure: Health-related quality of life
timeFrame: time 0 and 60 days after
measure: Safety analysis
timeFrame: time 0 and 60 days after
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Mário R Álvares-da-Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05244031: Intraoperative Placement of Superficial Erector Spinae Plane Block; A New Approach in Spine Surgery
Official title: Intraoperative Placement of Superficial Erector Spinae Plane Block in Spine Surgery; An Effective Approach at Enhanced Recovery After Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Spine Deformity
Spine Injury
Spine Fracture
Spine Malformation
Keywords: Postoperative pain
Superficial Erector Spinae Plane Block
Spine Surgery
Local anesthetic
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2022-02-17
Enrollment: 46
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: SUPPORTIVE_CARE

Brief summary: Major spine surgery causes severe postoperative pain. The primary objective of this randomized controlled study is to compare the effect of ultrasound (US)-guided superficial erector spinae plane (ESP) block on 48-hour postoperative cumulative opioid requirements with standard (opioid-based) analgesia.

Detailed description: 46 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo spine surgery, were randomized and divided into two groups. (23 patients in each of the control and superficial ESP groups). Superficial ESP block was performed for SESP group and standard (opioid-based) analgesia performed in the control group. Postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. Postoperative numeric rating scale values were the primary outcome measure. 24-hour total morphine consumption was secondary outcome measure.

Eligibility criteria: Inclusion Criteria:

* Ages of 18-65
* Patients who will undergo spine surgery (at least two level)
* ASA I-II-III patients

Exclusion Criteria:

* Clinically known local anesthetic allergy
* Morbid obesity (body mass index\>40 kg m2)
* Clinically diagnosis of opioid, alcohol and substance dependence
* Clinically diagnosis of psychiatric disease
* Coagulopathy
* Patients with ASA IV-V
* Single level surgery

Primary outcomes:
measure: NRS scores of patients
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Postoperative 48-hours total morphine consumption
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
state: Bakirkoy
Study officials:
References:
Clinical trial NCT01865331: Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Characteristics of Explorative Formulations of Insulin Degludec and IDegAsp 50 in Healthy Japanese Subjects
Official title: A Randomised, Double-blind, Placebo-controlled, Single-dose, Parallel Group Trial With Insulin 454 and SIAM 50 in Healthy Male Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-05-30
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability and pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) characteristics of insulin degludec (insulin 454) and insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM), both explorative formulations, not similar to the proposed commercial formulation, in healthy male Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Japanese passport holder
* Japanese-born parents
* Body mass index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
* Fasting blood glucose of below or equal to 6 mmol/L
* Healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data at screening, as assessment of medical history, physical exjudged by the Investigator

Exclusion Criteria:

* The receipt of any investigational drug within 3 months prior to this trial
* Subjects with a history of significant multiple drug allergies or with a known allergy to the trialproduct or any medicine chemically related to the trial product, as judged by the Investigator

Primary outcomes:
measure: Frequency of adverse events (AEs)
timeFrame: From dosing visit and until follow-up 7-21 days after last dosing visit
Secondary outcomes:
measure: Area under the serum insulin concentration curve
timeFrame: 0-96 hours after dosing
measure: Area under the glucose infusion rate curve
timeFrame: 0-24 hours after dosing
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00889031: Protocol to Obtain Blood Samples for Leukemia Research
Official title: Protocol to Obtain Blood Samples for Leukemia Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Keywords: CLL
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2009-04-28
Enrollment: 187
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 at Dartmouth-Hitchcock Medical Center's Norris Cotton Cancer Center

Brief summary: The purpose of this study is to collect a blood sample in patients with Chronic Lymphocytic Leukemia (CLL).

Detailed description: The blood sample will be used in the laboratory to perform studies focusing on Chronic Lymphocytic Leukemia (CLL).

Eligibility criteria: Inclusion Criteria:

* Patients undergoing routine blood draws as part of their ongoing follow-up for Chronic Lymphocytic Leukemia (CLL) at the Norris Cotton Cancer Center of DHMC.

Exclusion Criteria:

* Patients who have received cytotoxic drug, oral or intravenous steroid or targeted antibody therapy for CLL or other disease process within the past 6 months are excluded. Use of intravenous immunoglobulin (IVIg) is not a reason for exclusion.

Primary outcomes:
measure: To determine the frequency with which CLL cells incubated ex vivo with vincristine undergo rapid interphase apoptosis.
timeFrame: 2 Years
Secondary outcomes:
measure: To determine whether suppression or inhibition of BCL2 family members can acutely sensitize CLL cells to vincristine.
timeFrame: 2 Years
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Christopher H Lowrey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stadheim TA, Xiao H, Eastman A. Inhibition of extracellular signal-regulated kinase (ERK) mediates cell cycle phase independent apoptosis in vinblastine-treated ML-1 cells. Cancer Res. 2001 Feb 15;61(4):1533-40.
citation: Vilpo JA, Koski T, Vilpo LM. Selective toxicity of vincristine against chronic lymphocytic leukemia cells in vitro. Eur J Haematol. 2000 Dec;65(6):370-8. doi: 10.1034/j.1600-0609.2000.065006370.x.
citation: Kivekas I, Vilpo L, Vilpo J. Relationships of in vitro sensitivities tested with nine drugs and two types of irradiation in chronic lymphocytic leukemia. Leuk Res. 2002 Nov;26(11):1035-41. doi: 10.1016/s0145-2126(02)00050-4.
Clinical trial NCT05925231: Variability of Healthy People and People After Stroke Results in the Box and Block Test
Official title: Variability of Healthy People and People After Stroke Results in the Box and Block Test
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Motor Activity
Keywords: Box and Block Test
Stroke
Czech Extended Version of Manual for the Box and Block Test
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People after stroke, healthy people

Brief summary: Main aim of the study is to find out how many attempts of each subtest in the Box and Block Test should be done in clinical practice during testing people after stroke who are 20-64 years old.


Eligibility criteria: Inclusion Criteria:

* people after stroke 20 - 64 years old
* signed Informed consent for probation with inclusion to research and Consent to the collection and processing of personal data during the study at the General University Hospital in Prague
* ability to sit independently for 15 minutes
* ability to grasp and move at least one 25 mm wide cube placed on a table using the dominant and then the non-dominant upper limb across the test partition
* ability to perform a simple task following verbal instructions
* retained ability to understand - according to psychological examination
* completion of testing during hospitalization in the Beroun Rehabilitation Hospital

Exclusion Criteria:

* severe hearing impairment not corrected by a hearing aid
* severe visual impairment not corrected by glasses
* severe comprehension impairment
* other reasons not allowing the completion of the entire testing using the Box and Block Test

Primary outcomes:
measure: results from the Box and Block Test
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Beroun
country: Czechia
facility: Rehabilitation Hospital of Beroun
city: Praha
country: Czechia
facility: Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
Study officials:
References:
Clinical trial NCT07008131: Impact of Double J Catheter in Major Urological Complications in Renal Transplant Recipients
Official title: Impact on Major Urologic Complications With Prophylactic Use of Double J Catheter in Extravesical Ureteroneocystostomy in Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant
Urinary Complications
Double J Stent
Keywords: Kidney Transplant
Urinary Complications
Double J stent
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2025-06-06
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Renal transplantation is the renal replacement therapy of choice in patients with end-stage chronic kidney disease. Major urological complications such as urinary leakage, ureteral stricture and urinary tract infections are usually observed in the first three months post-transplantation and lead to higher morbidity and mortality and lower graft function.

To evaluate the use of the double J catheter on major urological complications in extravesical ureteroneocystostomy in renal recipients.

Open clinical trial. Renal transplant recipients were included, who underwent extravesical ureteroneocystostomy with trans-surgical placement of double J catheter compared to extravesical ureteroneocystostomy without trans-surgical catheter placement. The study variables were urinary leakage, ureteral stricture, urinary tract infection, surgical complications and graft function.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Renal transplantation candidates
* They agree to participate in the study

Exclusion Criteria:

* Previous renal transplantation
* Urinary tract malformations
* Urinary reservoir carriers
* Known neurogenic disease of the urinary tract
* Cadaveric donor grafts
* Grafts with double collecting system
* Patients whose trans-surgical findings require catheter placement.

Primary outcomes:
measure: Major urological complications
timeFrame: From enrollment to three months
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Unidad de Investigación Biomédica 02, Hospital de Especialidades, Centro Médico Nacional de Occidente
state: Jalisco
Study officials:
References:
Clinical trial NCT05946031: Testing the ETM: Examination and Comparison of Different Methods
Official title: Testing the Experimental Tobacco Marketplace: Examination and Comparison of Different Methods
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Cigarette Smoking
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 109
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will complete two Experimental Marketplace conditions, representing one with real and one with hypothetical purchasing outcomes. Within each condition, taxes will be increased proportionally across 6 trials to examine how cigarette purchasing, substitution, and poly-tobacco purchasing (i.e., diversity in products purchased) are affected.
Primary purpose: BASIC_SCIENCE

Brief summary: This study will experimentally assess the comparability of in-lab and remote procedures with hypothetical and real ETM purchase outcomes.

Detailed description: In a between-group within-subject repeated measures design, participants will be randomly assigned to one of two procedures (in-lab or remote; between-group) and complete two conditions (real and hypothetical; within-subject), which include six trials assessing increasing cigarette prices.

Eligibility criteria: Inclusion Criteria:

* Provide informed consent
* Be at least 21 years of age or older
* Stable tobacco use patterns for at least three months
* Smoke at least 5 cigarettes daily
* Use other tobacco products less than weekly
* Have access to a computer and internet

Exclusion Criteria:

* report uncontrolled physical or mental health conditions (e.g., uncontrolled diabetes, high blood pressure, major depressive disorder, etc.),
* use of smoking cessation medications (e.g., nicotine replacement, bupropion, varenicline) in the past 30 days,
* report concrete, immediate plans to alter/quit using their usual tobacco products in the next 30 days,
* be pregnant or lactating

Primary outcomes:
measure: Cigarette demand
timeFrame: 1 day
measure: Nicotine/tobacco products substitution
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute
state: Virginia
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute
state: Virginia
Study officials:
affiliation: Fralin Biomedical Research Institute at VTC
name: Roberta Freitas-Lemos, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: