louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00068276: Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
Official title: Orthomolecular Vitamin D3 in Low-Risk Myelodysplastic Syndrome: An Open-Label Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Keywords: previously treated myelodysplastic syndromes
de novo myelodysplastic syndromes
secondary myelodysplastic syndromes
atypical chronic myeloid leukemia, BCR-ABL1 negative
myelodysplastic/myeloproliferative neoplasm, unclassifiable
childhood myelodysplastic syndromes
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-09-11
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Cholecalciferol (vitamin D) may improve quality of life by increasing blood counts, decreasing fatigue, and improving other symptoms of myelodysplastic syndrome.

PURPOSE: This phase II trial is studying how well cholecalciferol works in treating patients with myelodysplastic syndrome.

Detailed description: OBJECTIVES:

* Determine the efficacy of cholecalciferol, in terms of hematological improvement, in patients with low- or intermediate-risk myelodysplastic syndromes.
* Determine the effect of this drug on disease symptoms, fatigue, and the overall health-related quality of life of these patients.

OUTLINE: This is an open-label, pilot study.

Patients receive oral cholecalciferol once daily. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed myelodysplastic syndromes (MDS)

  * Must have undergone bone marrow aspirate and biopsy with karyotype within the past 3 months
* International Prognostic Scoring System score of 0 or 1

PATIENT CHARACTERISTICS:

Age

* Any age

Performance status

* Any

Life expectancy

* More than 1 year

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* No history of hypercalcemia

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Prior stem cell transplantation allowed
* No concurrent hematopoietic growth factors

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* More than 6 weeks since prior cholecalciferol supplements or analogs
* More than 4 weeks since any prior therapy for MDS (except supportive care)
* No other concurrent therapy for MDS

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Istvan Molnar, MD
role: STUDY_CHAIR
affiliation: Wake Forest University Health Sciences
name: Bayard L. Powell, MD
References:
Clinical trial NCT03774576: A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants
Official title: A Non-Randomized, Open Label, One Sequence, Two-Period Cross-Over Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-12-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of multiple oral doses of itraconazole on the pharmacokinetics of RO7017773 in healthy volunteers.


Eligibility criteria: Inclusion Criteria

* Healthy (absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis) as judged by the Investigator.
* Male and women of non-childbearing potential (WONCBP)

Exclusion Criteria

* History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or central nervous system (CNS) infections (e.g., meningitis)
* History of clinically significant hypersensitivity or allergic reactions
* Abnormal blood pressure
* Abnormal pulse rate
* History or presence of clinically significant ECG abnormalities before study drug administration or cardiovascular disease
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities
* Positive test for drugs of abuse or alcohol
* Evidence of human immunodeficiency virus (HIV) infection
* Presence of hepatitis B surface antigen (HBsAg) or positive HCV antibody test result at screening or within 3 months prior to starting study treatment
* Participants who regularly smoke more than 5 cigarettes daily or the equivalent and are unable or unwilling not to smoke during the in-house period

Primary outcomes:
measure: Maximum Concentration (Cmax) of RO7017773 in Plasma
timeFrame: Period 1 (RO7017773) and Period 2 (RO7017773 + Itraconazole)
Secondary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: 12 weeks
measure: Change in Suicide Risk as Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: From screening visit through Period 2 Day 11
measure: Cmax of Itraconazole in Plasma
timeFrame: Period 2
Other outcomes:
Locations:
city: Rennes
country: France
facility: BIOTRIAL
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02548676: Optical Angiography in Glaucoma
Official title: Optical Angiography in Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 open angle glaucoma patients 30 healthy age- and sex matched controls

Brief summary: Glaucoma is one of the leading causes for blindness in industrialized countries. It is characterized by a progressive loss of retinal ganglion cells, morphological changes in the optic nerve head and a characteristic loss of visual field. It has been speculated for a long time that vascular factors may also contribute to the pathogenesis of the disease. This concept has been supported by several epidemiological studies showing that small retinal vessel calibre are associated with the disease. In the recent years tremendous enhancements in the field of optical coherence tomography has been achieved. These developments made it possible to visualize the retinal vasculature in a full depth manner without the application of an intravenous marker. The proposed study tests the hypothesis that patients with glaucoma show altered vascular morphology compared to healthy subjects. This is of importance because it may clarify the degree of vascular involvement in glaucoma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of manifest open angle glaucoma as defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and/or untreated IOP ≥ 21 mmHg on at least three measurements in the medical history. Mean deviation in the visual field test \< 10dB

Exclusion Criteria:

* Normal ophthalmic findings, IOP ≤ 20mmHg
* No history of elevated IOP
* No signs of glaucomatous disc damage

Primary outcomes:
measure: Retinal vessel diameter as extracted from the angiograms
timeFrame: during the four weeks after the first screening day
Secondary outcomes:
measure: Systemic hemodynamics (Blood pressure)
timeFrame: during the four weeks after the first screening day
measure: Intraocular pressure
timeFrame: during the four weeks after the first screening day
measure: pulse
timeFrame: during the four weeks after the first screening day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT02222376: Effect of Topic Pirfenidone in Diabetic Ulcers
Official title: Effect of Treatment of Diabetic Foot Ulcers With Topic 8% 1-phenyl-5-methyl-2-[1h]-Pyridone (Pirfenidone) Combined With Modified Disulfur Diallyl Oxide (Odd-m) in Gel.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Foot Ulcers
Keywords: Diabetic ulcer, diabetic foot
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2014-08-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pirfenidone is a synthetic molecule, which acts as a potent modulator of the effect of various cytokines (TNF-α, transforming growth factor-β, platelet derived growth factor and vascular endothelial growth factor, among others) that possesses anti-inflammatory and anti-fibrinolytic properties.

The aim of this study is to compare the effect of topic treatment with pirfenidone compared to conventional treatment in chronic diabetic foot ulcers.

The hypothesis is that treatment with topic pirfenidone in chronic diabetic foot ulcers (Wagner 1 to 2) reduces the ulcer size and shortens the healing time compared to conventional treatment. This is a randomized, controlled and crossover study. Patients will be randomly assigned to conventional treatment or topic pirfenidone for eight weeks. At the end of this period they will change groups. Each week ulcers will be for size, depth, length and evidence of infection. The ulcers will have proper debridement in the conventional treatment group and debridement plus topical pirfenidone application in the pirfenidone group. Subjects will be instructed to do daily ulcer cleansing and for those in the topical pirfenidone group, in addition to cleansing they will be instructed to apply the gel twice a day.


Eligibility criteria: Inclusion Criteria:

1. Men or women
2. Type 1 or 2 diabetes
3. Age ≥ 18 years
4. Wagner 1 or 2 diabetic foot ulcer
5. Diabetic ulcer for more than 8 weeks duration
6. Willing to participate in the study with signed informed consent

Exclusion Criteria:

1. Ankle/brachial index \< 0.4 (critic ischemia)
2. Use topical or systemic antibiotics
3. Inability to attend to the weekly evaluations
4. Inability to do daily ulcer cleansing
5. Autoimmune diseases
6. Active pharmacologic topical or systemic ulcer treatment
7. Treatment with immunosuppressors such as steroids, radiotherapy, chemotherapy
8. Pregnancy or lactation

Primary outcomes:
measure: Ulcer size
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
measure: Healed ulcers
timeFrame: 16 weeks
measure: Adverse effects
timeFrame: 16 weeks
measure: Healing time
timeFrame: 16 weeks
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: Distrito Federal
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Francisco J Gomez-Perez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00758576: ReSTOR Natural +3.0D Study In Japan
Official title: ReSTOR Natural +3.0D (Diopter) Study In Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate safety and effectiveness of ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 when implanted to replace the natural lens following cataract removal.


Eligibility criteria: Inclusion Criteria:

* Planned bilateral cataract removal by phacoemulsification
* Potential postoperative best corrected visual acuity of 0.5 or over
* 1.5 Diopter (D) or less of astigmatism preoperatively, measured by keratometry

Exclusion Criteria:

* Poorly controlled glaucoma
* Progressive diabetic retinopathy

Primary outcomes:
measure: Uncorrected Intermediate Visual Acuity
timeFrame: 1 year after surgery
measure: Uncorrected Distance Visual Acuity
timeFrame: 1 year after surgery
measure: Uncorrected Near Visual Acuity
timeFrame: 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Hayashi Eye Hospital
Study officials:
References:
Clinical trial NCT05071976: A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery
Official title: Near-infrared FluORescencE Assessment of Myocutaneous Flap Microperfusion for Gynecologic RecONstrucTion (FOREFRONT): A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gynecologic Surgery
Keywords: gynecologic surgery
abdominal wall reconstruction procedure
pelvic reconstruction procedure
Near-Infrared Fluorescence Imaging
ICG
21-349
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to assess whether Near-Infrared Fluorescence/NIR Imaging perfusion alters intraoperative management of the flap or of the participant wound bed.


Eligibility criteria: Inclusion Criteria:

* Women undergoing a pelvic reconstruction procedure after radical gynecologic surgery for any indication at MSK.
* Age ≥18 years.

Exclusion Criteria:

* Women with hepatic dysfunction as evidenced by elevated transaminases (two times the upper limit of normal).
* Women with a history of cirrhosis or other chronic liver disease.
* Women with a documented severe or life threatening allergy to iodine.
* Women with an allergy to ICG or severe allergy to iodinated contrast.
* Women undergoing any free flap (non-pedicled) reconstruction.

Primary outcomes:
measure: Percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent and Followup)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent and Followup)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent and Followup)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack (Consent and Followup)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent and Followup)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Consent and Followup)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nadeem Abu-Rustum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00488176: Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis
Official title: Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation Measured by Exhaled Nitric Oxide Concentration in Children With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Seasonal Allergic Rhinitis
Keywords: seasonal allergic rhinitis
children
montelukast
cetirizine
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2007-06-20
Enrollment: 116
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.

Detailed description: During the pollen season children with seasonal allergic rhinitis without concomitant asthma are at risk of having allergic inflammation in the lower respiratory tract. About 60% of children with seasonal allergic rhinitis present bronchial hyperresponsiveness and signs and symptoms of asthma.

The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.

Eligibility criteria: Inclusion Criteria:

* clinical symptoms of seasonal allergic rhinitis during last two seasons, moderate and severe according to ARIA guidelines

Exclusion Criteria:

* diagnosis of bronchial asthma
* allergy to perennial allergens
* specific immunotherapy
* other chronic diseases
* tobacco smoking
* acute respiratory tract infection
* excluded drugs: inhaled and systemic glucocorticosteroids

Primary outcomes:
measure: exhaled nitric oxide concentration
timeFrame: baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit)
Secondary outcomes:
measure: symptoms score (based on PAQLQ), bronchial hyperresponsiveness with methacholine, spirometry, PEFR measurements
timeFrame: baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit)
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland
Study officials:
affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, Poland
name: Violetta Ścibiorek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, Poland
name: Iwona Stelmach, MD PhD Prof
role: STUDY_CHAIR
References:
Clinical trial NCT03630276: Evaluation of Neutrophil/Lymphocyte Ratio ,Platelet/Lymphocyte Ratio and CRP as Markers of Severity of Pre-eclampsia
Official title: Evaluation of Neutrophil/Lymphocyte Ratio, Platelet /Lymphocyte Ratio and CRP as Markers of Severity of Pre-eclampsia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-Eclampsia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 111
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of neutrophil/lymphocyte ratio, Platelet /lymphocyte ratio and CRP as markers of severity of Pre-eclampsia


Eligibility criteria: Inclusion Criteria:

- PREECLAMPSIA from 25_45years

Exclusion Criteria:

* chronic diseases Primary hypertension

Primary outcomes:
measure: PREECLAMPSIA
timeFrame: 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Shaza
state: Alex
Study officials:
References:
Clinical trial NCT04356976: Ventralex Vs Stratafix for Primary Ventral Hernias
Official title: Randomised Controlled Trial of Ventralex Hernia Patch Versus Stratafix Suture for Midline Primary Ventral Hernias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial comparing Ventralex hernia patch with Stratafix sutures for repair of primary ventral hernias
Primary purpose: TREATMENT

Brief summary: Randomised controlled trial comparing Ventralex Hernia Patch with Stratafix suture for repair of primary ventral hernias in the midline.

Detailed description: Primary hernias in the midline, including umbilical hernias and epigastric hernias, are among the most common conditions requiring surgery.

Mesh-reinforced as well as suture repair are used for the treatment of primary hernias, but for smaller umbilical hernias (diameter 1-3cm), there is little evidence for the superiority of mesh repair. Despite the widely use of composite ventral patch, there are few studies showing the advantage and disadvantage of ventral patch. In recent years, the barbed suture has been widely used in umbilical and incisional hernias, in laparoscopic as well as in open surgery. However, there are no studies comparing ventral patch with slowly absorbable barbed suture in open surgery.

The investigators intend to compare the use of sublay composite mesh (ventral-patch) with non-resorbable barbed prolene suture repair only and investigate recurrence rate and other short and long-term postoperative complications in these two methods.

Eligibility criteria: Inclusion Criteria:

* Defect 1-4 cm
* Primary ventral hernia in the midline
* BMI\<35

Exclusion Criteria:

* Defect \>4cm
* BMI\>35
* Recurrent hernia

Primary outcomes:
measure: Hernia recurrence
timeFrame: One year
Secondary outcomes:
measure: Rate of intra-and postoperative complications
timeFrame: 30 days
measure: Rate of seroma development
timeFrame: one year
measure: Persisting pain
timeFrame: One year
measure: Mean number of days postoperative sick leave
timeFrame: 30 days
Other outcomes:
Locations:
city: Karlskoga
country: Sweden
facility: Karlskoga Hospital
Study officials:
affiliation: Karolinska Institutet
name: Gabriel Sandblom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: