louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04383431: Cross-linking as Treatment in Infectious Keratitis
Official title: Standard Cross-linking Versus Accelerated Photoactivated Chromophore Cross-linking (PACK-CXL) for Treatment of Infectious Keratitis: A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infectious Keratitis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare between SCXL and ACXL for treatment of infectious keratitis

Detailed description: Standard epithelium-off CXL, 30 minutes soaking time with riboflavin, 30 minutes UVA corneal irradiation continuous mode (Group A). Accelerated CXL 11 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation pulsed mode (Group B).

Eligibility criteria: Inclusion Criteria:

* Fungal infectious keratitis
* bacterial infectious keratitis
* Must be not responding to medication

Exclusion Criteria:

* Viral keratitis
* Pregnancy and lactation

Primary outcomes:
measure: Corneal healing
timeFrame: 3 months
measure: Corneal edema
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of medicine
Study officials:
affiliation: 00201068559840
name: Mohammed Iqbal, MD. PhP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04883931: Mother Milk as a Eye Drop & Premature Retinopathy
Official title: The Effect of Using Breast Milk as a Topical Ophthalmic Drop on Retinopathy of Prematurity. Randomized Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinopathy of Prematurity
Keywords: Breast milk
Retinopathy of Prematurity
Lead sponsor: Baskent University
Sponsor class: OTHER
Collaborators: name: Konya City Hospital
name: Konya Dr. Ali Kemal Belviranli Hospital for Obstetrics and Pediatrics
name: Baskent University, Adana Hospital
First posted: 2021-05-12
Enrollment: 101
Sex: ALL
Minimum age (years): 22
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Porspective Randomized Placebo Controlled Trail
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the effect of using breast milk as eye drops on ROP (Retinopathy of prematurity) disease observed in less then 32 weeks gestational age preterm babies.

Detailed description: Study Design: Prospective randomized placebo controlled trial Setting/Participants: Premature babies who are at high risk for retinopathy of prematurity (ROP) during their stay in the neonatal intensive care unit (NICU). The study will be carried out at Baskent University and it is planned that 70 participants will be included in the study.

Study Interventions and Measures: After the randomization of the patients, 0.5 ml breast milk of the babies' own mothers will drop on the eye to the intervention group twice a day. IN the control group, %0.9 normal saline will drop as same amount. Primary outcome is any stage of ROP, secondary outcome is severe ROP (laser requiring ROP).

Eligibility criteria: Inclusion Criteria:

* Infants born between 22 and 32 gestational age weeks or under 1500 gr birth weight.

Exclusion Criteria:

* Infant death before first examination for ROP
* parents who want to leave from the study
* Contraindications for breast milk use (Active HIV infection, Active tuberculosis, CMV infection)
* Inborn error of metabolism like galactosemia.
* Congenital eye development disorders like agenesis, or situations that do not allow retina examination.
* other lethal congenital molformations
* congenital infections that affect the retina like TORCH infections.

Primary outcomes:
measure: Retinopathy of Prematurity
timeFrame: by 55 weeks post menstrual age
Secondary outcomes:
measure: Retinopathy of Prematurity
timeFrame: by 55 weeks post menstrual age
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Baskent University
Study officials:
References:
Clinical trial NCT01558531: Drug Eluting Balloon in Peripheral Intervention for In-Stent Restenosis
Official title: Drug Eluting Balloon in peripherAl inTErvention for In-Stent Restenosis: the DEBATE-ISR Study
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Peripheral Arterial Disease
Keywords: peripheral arterial disease
drug-eluting balloon
restenosis
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referring to our institution for peripheral artery disease

Brief summary: The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed versus conventional balloon angioplasty in superficial femoral artery and popliteal artery re-stenosis.


Eligibility criteria: Inclusion Criteria:

* age\>18 years
* intermittent claudication (Fontane III or IV)
* angiographic stenosis\>50% or occlusion of superficial femoral-popliteal artery\>40mm, previously treated with nitinol stent implantation, with at least one below-knee vessel to the ankle

Exclusion Criteria:

* allergy to Paclitaxel
* contraindication for combined antiplatelet treatment
* life expectancy \<1 year
* hypersensitivity or contraindication to one of the study drugs
* lack of consent
* need for amputation
* angiographic evidence of stent fracture

Primary outcomes:
measure: angiographic binary re-restenosis
timeFrame: 12 months
Secondary outcomes:
measure: major amputation
timeFrame: 24 months
measure: stent thrombosis
timeFrame: 24 months
measure: target lesion revascularization
timeFrame: 24 months
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Cardiovascular Department, Ospedale S.Donato
state: AR
Study officials:
References:
citation: Grotti S, Liistro F, Angioli P, Ducci K, Falsini G, Porto I, Ricci L, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Paclitaxel-Eluting Balloon vs Standard Angioplasty to Reduce Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: Three-Year Results of the DEBATE-ISR Study. J Endovasc Ther. 2016 Feb;23(1):52-7. doi: 10.1177/1526602815614555. Epub 2015 Oct 28.
citation: Liistro F, Angioli P, Porto I, Ricci L, Ducci K, Grotti S, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Paclitaxel-eluting balloon vs. standard angioplasty to reduce recurrent restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: the DEBATE-ISR study. J Endovasc Ther. 2014 Feb;21(1):1-8. doi: 10.1583/13-4420R.1.
Clinical trial NCT00512031: Characterizing PAI-1 Modulation on Monocyte Adhesion
Official title: Characterizing the Effects of PAI-1 Modulation on Human Monocyte Function - The Effect of PAI-1 Post-transcriptional Regulation on Human Monocyte Adhesion
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atherosclerosis
Keywords: atherosclerosis
metabolic pathways
monocyte adhesion,
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2007-08-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: To determine how altering the expression of a gene known as PAI-1 may affect the adhesive capacity of cells that play a critical role in the developement of human atherosclerosis.

Detailed description: The principal aim of this study is to determine if molecular regulation of the human gene PAI-1 alters the migratory properties of human myeloid and endothelial cells sufficiently enough to regulate entry and exit from the vascular space. Human monocyte become the key cellular orchestrators of human atherosclerotic plaque. We believe that a "loss" of PAI-1 activity may promote a pro-atherogenic effect in human vasculature thereby defining a novel atheroprotective effect for PAI-1 when expressed at normal levels in humans. By using RNA interference to achieve PAI-1 gene, we hope to elucidate the mechanistic basis of how PAI-1 regulation may affect human migration within the vasculature.

Eligibility criteria: Inclusion Criteria:

* Ages 18-50
* No current or past medical problems

Exclusion Criteria:

* Patients taking prescription drugs (hormonal birth control or herbal supplements may be taken)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Mohan Sathyamoorthy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00258531: Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy
Official title: Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy for Visualisation of Endoscope Localisation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Any Symptom Requiring Colonoscopy
Lead sponsor: Sykehuset Telemark
Sponsor class: OTHER_GOV
First posted: 2005-11-24
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: * A commercial 3-dimentional magnetic imaging system (Olympus ScopeGuide) is available for routine use during colonoscopy.
* No randomised trials have been performed to evaluate if, and to what extent, the use of this technology may improve the coecal intubation rate and reduce the patient's experience of discomfort and pain by making the insertion of the endoscope easier

Detailed description: Endoscopist at different level of experience are to participate. Patients routinely referred to the outpatients department for colonoscopy are asked to participate in a randomised trial where coecal intubation rate and pain experienced by the patient are end-point. Written informed consent is obtained. For each endoscopist, allocated patients are randomised to colonoscopy with no imaging technique (usual care) or using the 3-dimentional imager.

Eligibility criteria: Inclusion Criteria:

* A successive series of patients referred for routine colonoscopy

Exclusion Criteria:

* Age under 18 years
* Pregnant women
* Persons with pacemaker
* Unwillingness to restrict sedation to "on demand"
* Inability to understand the information given

Primary outcomes:
measure: Pain experienced during colonoscopy
Secondary outcomes:
measure: Coecal intubation rate
Other outcomes:
Locations:
city: Skien
country: Norway
facility: Medical Outpatients dept, Sykehuset Telemark
Study officials:
affiliation: Sykehuset Telemark
name: Geir Hoff, MBChB PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01689831: Dose Study of Tuberculin Purified Protein Derivative (JHP/Dose)
Official title: Dose Comparison Study of Tuberculin Purified Protein Derivative (PPD)With Standard Tuberculin Purified Protein Derivative.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tuberculosis Infection
Lead sponsor: JHP Pharmaceuticals LLC
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2012-09-21
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2).

Detailed description: JHP proposes to demonstrate clinical comparability of Aplisol formulated from the new Tuberculin PPD drug substance to the standard PPD-S2.

Eligibility criteria: Inclusion Criteria:

1. Males or nonpregnant females age 18 to 60 years
2. Documented PPD reactivity of 5 to 21 mm in the past, documented in a medical record. Self-reported PPD reactivity will be accepted if medical records cannot be obtained.
3. Give written informed consent to participate
4. Generally healthy, as determined by medical history and targeted physical examination, if indicated
5. Possess 2 forearms that are free of burns, scars, eczema, or any physical deformity, which could impair injection of study preparation or the readings of the injections
6. Comprehension of the study requirements; expressed availability for the required study period, including readings at the nominal time points of 48 and 72 hours

Exclusion Criteria:

1. Prior PPD test within the past 30 days
2. Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating
3. History of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration, necrosis) or other severe reaction to PPD in the past
4. Subject received a Bacillus Calmette-Guérin (BCG) vaccination in the past, or was born or lived outside the US as a child and is uncertain of his/her BCG vaccination status
5. Presence of conditions that may suppress TST reactivity

Primary outcomes:
measure: Confirm the potency of Aplisol equipotent to PPD-S2.
timeFrame: 72 hours
Secondary outcomes:
measure: Assess tolerability of Aplisol with new tuberculin PPD
timeFrame: 72 hours
Other outcomes:
Locations:
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler
state: Texas
Study officials:
References:
Clinical trial NCT02179931: Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)
Official title: Interventional, Single Dose, Open-label, Randomised, Crossover, Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Men and Women
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2014-07-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To establish bioequivalence of flupentixol/melitracen between a new film-coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen and the marketed coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen (Deanxit®), administered as single doses.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women ≥18 and ≤55 years of age with a body mass index (BMI) of \>18.5 and \<30 kg/m2.
* Women will be non-pregnant and non-lactating.

Other protocol-defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Area under the flupentixol plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)
timeFrame: Up to 72 hours post dose
measure: Maximum observed concentration (Cmax) of flupentixol
timeFrame: Up to 312 hours post dose
measure: Area under the melitracen plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)
timeFrame: Up to 72 hours post dose
measure: Maximum observed concentration (Cmax) of melitracen
timeFrame: Up to 312 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT03897231: Prevalence of Non-adherence to Medication Among Patients on Chronic Hemodialysis
Official title: Prevalence of Non-adherence to Medication Among Patients on Chronic Hemodialysis - a Multicenter Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medication Adherence
End Stage Renal Failure on Dialysis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
name: Hillerod Hospital, Denmark
First posted: 2019-04-01
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with end stage kidney disease receiving hemodialysis treatment ≥3 month at a hospital-based outpatient hemodialysis Centre in the Capital region of Denmark

Brief summary: Background:

Non-adherence to medication among patients on chronic hemodialysis compromises treatment effects and results in increased morbidity, mortality and extensive costs to the healthcare system. To our knowledge, no studies have investigated the prevalence of non-adherence among Danish hemodialysis patients using a validated measure of non-adherence.

Aim:

The primary aim of this study was to investigate the prevalence of non-adherence among Danish patients on chronic hemodialysis measured by self-report.

Our second aim was to explore patients' beliefs about medicines and potential associations between beliefs and non-adherence to medication.

Our third aim was to explore the prevalence and severity of physical and emotional symptoms and potential associations with non-adherence to medication.

Design:

A multi-centre cross-sectional study according to the STROBE statement will be conducted from May 2019 - April 2021. The study will take place in the outpatient hemodialysis centres at three large University Hospitals in the Capital Region of Denmark.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of end stage kidney disease
* Must have received hemodialysis treatment ≥3 month at a hospital-based outpatient hemodialysis Centre
* Must be able to understand and speak Danish

Exclusion Criteria:

* cognitive impairment
* no current medication prescriptions

Primary outcomes:
measure: the Morisky-Green-Levine scale (MAQ)
timeFrame: up to 8 months
measure: Medication adherence report scale (MARS)
timeFrame: up to 8 months
Secondary outcomes:
measure: Beliefs about medicines (BMQ)
timeFrame: up to 8 months
measure: Dialysis symptom index
timeFrame: up to 8 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nephology
Study officials:
affiliation: Department of Nephrology, Rigshospitalet
name: Bo Feldt-rasmussen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05760131: Awareness of Osteoporosis in Patients With Hypothyroidism
Official title: Awareness of Osteoporosis in Patients With Hypothyroidism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypothyroidism
Osteoporosis
Osteoporosis Risk
Lead sponsor: Uskudar State Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 to 90 years with a diagnosis of hypothyroidism who gave consent to participate in the study.

Brief summary: Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Patients with hypothyroidism are at increased risk for developing osteoporosis. Identifying whether multiple sclerosis patients have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in patients with hypothyroidism.

Detailed description: Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an increased risk for fractures in older individuals. It can affect people from different ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic inflammation. Patients with multiple sclerosis are at high risk of developing osteoporosis due to chronic inflammation and their medications. Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with hypothyroidism.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hypothyroidism
* Must be between the ages of 18 and 99
* Must give consent to participate in the study

Exclusion Criteria:

• Not giving consent

Primary outcomes:
measure: Revised Osteoporosis Knowledge Test
timeFrame: 1 day
Secondary outcomes:
measure: Osteoporosis Self-Efficacy Scale
timeFrame: 1 day
measure: Osteoporosis Health Belief Scale
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Uskudar State Hospital
name: Mustafa H Temel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02029131: Exercise and Low Back Pain
Official title: Effects of a Home-based Exercise Program on Low Back Pain in Employees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers With and Without Chronic Low Back Pain
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluation of the effectiveness of an individually educated exercise program for the lower back at home in employees over a period of 20 weeks.

We hypothesize that regular exercise for the lower back results in greater improvements of low back strengths compared to controls.


Eligibility criteria: Inclusion Criteria:

* men and women
* age between 18 and 67 years

Exclusion Criteria:

* beeing currently involved in an exercise program for the lower back
* known drug or alcohol abuse
* any disease that excludes the participation in an exercise program
* clinical relevant acute or chronic infections
* pregnant women

Primary outcomes:
measure: Back strength (kg)
timeFrame: At baseline and after 20 weeks
Secondary outcomes:
measure: Strenght at lateral flexion of the trunk (kg)
timeFrame: At baseline and after 20 weeks
measure: Oswestry Low Back Pain Disability Score
timeFrame: At baseline and after 20 weeks
measure: Pain (scale)
timeFrame: At baseline and after 20 weeks
measure: Quality of life (score)
timeFrame: At baseline and after 20 weeks
measure: Work ability index (score)
timeFrame: At baseline and afetr 20 weeks
measure: Physical activity (score)
timeFrame: At baseline and after 20 weeks
measure: Fat mass and fat-free mass (kg)
timeFrame: At baseline and after 20 weeks
measure: sick days (numbers)
timeFrame: At baseline and after 20 weeks
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
state: Lower Saxony
Study officials:
References:
citation: Bayerle P, Kerling A, Kuck M, Rolff S, Boeck HT, Sundermeier T, Ensslen R, Tegtbur U, Lauenstein D, Bothig D, Bara C, Hanke A, Terkamp C, Haverich A, Stiesch M, de Zwaan M, Haufe S, Nachbar L. Effectiveness of wearable devices as a support strategy for maintaining physical activity after a structured exercise intervention for employees with metabolic syndrome: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2022 Feb 10;14(1):24. doi: 10.1186/s13102-022-00409-1.